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PET & Plastics - - Used but vilified – AN OVERVIEW ON PERCEPTION MANAGEMENT Dr. Vijay G. Habbu Reliance Industries Ltd. 10 th August 2016
Transcript
Page 1: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET amp Plastics - - Used but vilified ndash AN OVERVIEW ON PERCEPTION MANAGEMENT

Dr Vijay G Habbu

Reliance Industries Ltd

10th August 2016

Manifestations of Polymers

Polymers are a boon to mankind

1 Plastics

2 Fibres (Textiles)

3 Rubbers Elastomers

4 Coatings

5 Adhesives

6 Cosmetics

The age of plastics

3 Keeping pace with the new age

Use of Plastics

Plastics are materials consisted of any of

a wide range of synthetic or

semi-synthetic organics that can be

molded into solid objects of diverse

shapes

Packaging

Building

amp

Construction

Transportation

Medical

amp

Health

Electrical

amp

Electronics

Agriculture

Sports

amp

Leisure

Plastics

Growth in Global Plastics Production

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Consumption Growth

Indian consumption growth nearly thrice of global rate

0

50

100

150

200

250

2005 2010 2015

Major Plastic Consumption - World

PP PE PVC PET

0

3

6

9

12

15

2005 2010 2015

Major Plastic Consumption - India

PP PE PVC PET

MMT MMT

Evolution is Natural Inevitable and Irreversible 50

Replacement of conventional materials

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 2: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Manifestations of Polymers

Polymers are a boon to mankind

1 Plastics

2 Fibres (Textiles)

3 Rubbers Elastomers

4 Coatings

5 Adhesives

6 Cosmetics

The age of plastics

3 Keeping pace with the new age

Use of Plastics

Plastics are materials consisted of any of

a wide range of synthetic or

semi-synthetic organics that can be

molded into solid objects of diverse

shapes

Packaging

Building

amp

Construction

Transportation

Medical

amp

Health

Electrical

amp

Electronics

Agriculture

Sports

amp

Leisure

Plastics

Growth in Global Plastics Production

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Consumption Growth

Indian consumption growth nearly thrice of global rate

0

50

100

150

200

250

2005 2010 2015

Major Plastic Consumption - World

PP PE PVC PET

0

3

6

9

12

15

2005 2010 2015

Major Plastic Consumption - India

PP PE PVC PET

MMT MMT

Evolution is Natural Inevitable and Irreversible 50

Replacement of conventional materials

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 3: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

The age of plastics

3 Keeping pace with the new age

Use of Plastics

Plastics are materials consisted of any of

a wide range of synthetic or

semi-synthetic organics that can be

molded into solid objects of diverse

shapes

Packaging

Building

amp

Construction

Transportation

Medical

amp

Health

Electrical

amp

Electronics

Agriculture

Sports

amp

Leisure

Plastics

Growth in Global Plastics Production

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Consumption Growth

Indian consumption growth nearly thrice of global rate

0

50

100

150

200

250

2005 2010 2015

Major Plastic Consumption - World

PP PE PVC PET

0

3

6

9

12

15

2005 2010 2015

Major Plastic Consumption - India

PP PE PVC PET

MMT MMT

Evolution is Natural Inevitable and Irreversible 50

Replacement of conventional materials

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 4: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Use of Plastics

Plastics are materials consisted of any of

a wide range of synthetic or

semi-synthetic organics that can be

molded into solid objects of diverse

shapes

Packaging

Building

amp

Construction

Transportation

Medical

amp

Health

Electrical

amp

Electronics

Agriculture

Sports

amp

Leisure

Plastics

Growth in Global Plastics Production

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Consumption Growth

Indian consumption growth nearly thrice of global rate

0

50

100

150

200

250

2005 2010 2015

Major Plastic Consumption - World

PP PE PVC PET

0

3

6

9

12

15

2005 2010 2015

Major Plastic Consumption - India

PP PE PVC PET

MMT MMT

Evolution is Natural Inevitable and Irreversible 50

Replacement of conventional materials

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 5: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Growth in Global Plastics Production

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Consumption Growth

Indian consumption growth nearly thrice of global rate

0

50

100

150

200

250

2005 2010 2015

Major Plastic Consumption - World

PP PE PVC PET

0

3

6

9

12

15

2005 2010 2015

Major Plastic Consumption - India

PP PE PVC PET

MMT MMT

Evolution is Natural Inevitable and Irreversible 50

Replacement of conventional materials

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 6: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Plastic Consumption Growth

Indian consumption growth nearly thrice of global rate

0

50

100

150

200

250

2005 2010 2015

Major Plastic Consumption - World

PP PE PVC PET

0

3

6

9

12

15

2005 2010 2015

Major Plastic Consumption - India

PP PE PVC PET

MMT MMT

Evolution is Natural Inevitable and Irreversible 50

Replacement of conventional materials

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 7: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Evolution is Natural Inevitable and Irreversible 50

Replacement of conventional materials

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 8: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

The trails that we leave

Let us be aware of the history

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 9: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

What is Waste

Wastes are materials that are not prime products (that is products produced for the

market) for which the initial user has no further use in terms of hisher own purposes

of production transformation or consumption and of which heshe wants to dispose

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 10: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Impact of Waste

Aesthetic bull Ugliness bull Negative impact on people movements Real bull Physical choking

bull Water bodies bull Cattle bull Marine life

bull Chemical invasions bull Humans bull Other life forms

Loss of civility and revenue

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 11: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Turning Nature into a hapless entity

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 12: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Thatrsquos Not Allhellip

What to do

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 13: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

The world is watching - and responding

The consequences of an interconnected world

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 14: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

11

bull Governmental legislations

bull Judicial interventions

bull Public perception

The imminent threats

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 15: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

11

bull Text books

bull Government hoardings

The alarmist messages in India ndash Government

Seeding the negativity

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 16: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

The alarmist messages in India ndash Corporates (1)

Reinforcing negativity

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 17: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Shallow

The alarmist messages in India ndash Corporates (2)

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 18: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

bull Radio adverstisement by LG

bull Plastics have tendency for holding bacteria

bull Hence LG water purifiers have steel containers

Totally unfounded

The alarmist messages in India ndash Corporates (3)

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 19: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Public perception Does it matter

After all use of plastics is inevitable So why bother with public perception

On the other hand

Public perception hurts the bottomline if not the topline - Litigation costs - Governmental restrictions on business - Increased hostility to doing business

19

bull Public perception needs to be handled - urgently continuously

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 20: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Recent Regulatory Development

bull The Department of Health and Family Welfare has issued a draft Notification ldquoGSR 701(E)rdquo dated 29 Sept 2014 for prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations for paediatric use geriatric use and for use in case of pregnant women and women of reproductive age group

bull The Honrsquoble National Green Tribunal in its Order dated 03 Mar 2015 in the matter of Him Jagriti Uttaranchal Welfare Society has mentioned the following

ldquoPrima facie we are of the view that there has to be restriction placed upon such packaging and generation of municipal plastic waste However before we pass any order we consider it appropriate that all the stakeholders should also be heard Let a Public Notice be issued to the manufacturers and users of the multi-layeredpet bottles packaging if anybody wishes to address us on the question afore-referredrdquo

bull Remedial measures bull BIS

bull FSSAI

bull Indian Pharmacopoeia

bull PWM Rules March 2016

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 21: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PERCEPTION INFLUENCERS

- Government (campaigns legislations text books)

- Judiciary (verdicts arguments)

- Educators

- Industry bodies

- Business chain ndash the unscrupulous stakeholders

- CompetingLateral Industries

- Media

- NGOs

- Public (Self-observationsconscious citizenry)

21

bull Changes in Societal behavior needs deep engagements

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 22: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

The way forward for the Plastics industry

Let us be responsible and responsive

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 23: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

POPULATION GROWTH RATES

1800 = 1 billion (3X) Increase 80 years per billion

1960 = 3 billion (2X) Increase 13 years per billion

2000 = 6 billion Increase 13 years per billion (21)

2012 = 7 billion Increase 2

2016 = 74 billion Increase 2

2025 (est) = 8 billion

2050 (est) = 10 billion

Source UN World Population data (2012)

23

bull Huge increase in OVERALL consumption and - disposal

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 24: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Forecast of Plastics World in a Business-As-Usual Scenario

Source The New Plastics Economy Rethinking the future of plastics WEF Davos Jan 2016

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 25: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Global Flows of Plastic Packaging Materials

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 26: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Plastic Packaging Material Value Loss ndash after One Use Cycle

Source The New Plastics Economy Rethinking the future of plastics WEF

Plastics - simple and popular material for packaging but

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 27: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Changing economies

27 27

Industry needs to move to the right business models to support Circular Economy

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 28: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

The discussion at WEF Davos 27th Jan 2016

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 29: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Perception correction - Tools

- Awareness of the universality of problem

- Education on plastics

- Engagement

- Demonstration of PLASTIC Industryrsquos commitment

29

bull Sincerity and commitment will only reflect honest intentions

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 30: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PERCEPTION CORRECTION ACTION PLAN BY THE PLASTICS INDUSTRY

INDUSTRY INITIATIVES bull Acceptance of the Problem

bull Alliances with kindred Industry

bull Activities by Plastics Industry

bull Communications by Plastics Industry

BEHAVIOURAL DRIVERS

GOVERNMENTAL ACTIONS

FORMATION OF PLASTICS DISPOSAL MANAGEMENT COUNCIL bull Government

bull Public

bull Industry

bull Other stakeholders

bull World

30

bull Industry commitment is the greatest perception corrector

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 31: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Plastic

Identification

Code

Type of plastic polymer Monomers

Typical End Uses

Polyethylene terephthalate (PET PETE)

Terephthalic acid + isophthalic

acid + Ethylene glycol (or MEG)

Bottles Containers Jars Films Strappings

Fiber and Filaments Non-wovens Medical

devices etc

High-density polyethylene

(HDPE)

Ethylene Hair-oil amp other household containers

Packaging films furniture Pipes Fuel tanks

etc

Polyvinyl chloride (PVC) Vinyl Chloride monomer (VCM) Wire and cables Footwear Floorings

Packaging films Pipes and fittings Medical

devices Tarpaulins toys etc

Low-density polyethylene

(LDPE)

Ethylene Milk pouches Containers packaging films

tubings Furniture etc

Polypropylene (PP) Propylene Chairs Furniture Containers Packaging films

Automotive and Electronic components

Textiles Medical devices Aerospace

Applications etc Polystyrene (PS) Styrene Protective packaging applications Disposable

cups and containers Foams Insulations etc

Other plastics

[often Polycarbonate (PC) or

Acrylonitrile butadiene

styrene (ABS)]

PC Bisphenol-A + Diphenyl

carbonate or Phosgene

ABS acrylonitrile + butadiene +

styrene

PC Electronic Aircraft Security and

Automotive components Construction

industries Data Storage applications

ABS Electronic and Automotive components

Pipes Instruments body parts etc

Recycle Codes of various Plastics amp their end uses

Each plastic has a different chemistry 47

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 32: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Polyester ndash Polymer

PET has a very simple chemistry and involves safe chemicals 6

Rrsquo O C

O

OH CH2CH2 O C

O n

Polyester or PET is a synthetic polymer made of

Purified Terephthalic acid (PTA) and

Mono-ethylene glycol (MEG)

Degree of polymerisation (n) dependent on application ~ 85 ndash 95 for textile film ~ 120 ndash 150 for bottles packaging ~ 180 ndash 200 for industrial yarn

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 33: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Polyester (Polyethylene Terephthalate)

PES PET

Textile Applications Packaging

Applications Receptacle

Applications Packaging

Applications

PFY PSF

POY FDY IDY

PTY

SF FF NW

Sheets Bottles Films

Increase in the Degree of Polymerisation

Melt Polymerisation

Polyester Product Chain

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 34: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Polyester in Textile Usage

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 35: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET Container Manufacturing

PET+ colorant

Stretch blow

molding

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 36: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PETndash General Industrial Process

Polymer formation

Continuous process = melt is fed to the melt extrusion units (280-290degC)

Batch process = polymer is solidified and chipped

- chips are then dried and

- fed to solid-state polymerisation units for further polymerization (210-220degC)

PET is stable at high temperatures and is a simple material to process 7

Shape formation

Injection moulding (preforms) (300degC)

blow moulding (bottles) (95-130degC)

Film casting (240-300degC)

Note

a) no processing aids are needed nor added

b) PET is used to make stiff amp rigid containers hence adding of any plasticizers will actually be counterproductive

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 37: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Recently raised Concerns about PET Packaging

1 Formaldehyde amp Acetaldehyde

2 DEHP and other Phthalate based plasticizers

3 Antimony

4 Migration at high temperatures

5 Colourants

6 Bisphenol-A

7 Oestrogenic reactivity

Most of the above hazards are WRONGLY attributed to PET

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 38: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

1 Formaldehyde amp Acetaldehyde

bull Formaldehyde is used as a monomer in some types of ldquoThermosettingrdquo plastics but never used in Thermoplastics like PET (SML = 15ppm)

bull Acetaldehyde traces (lt1ppm) generated during PET processing have no effect on human health (SML = 6ppm)

bull Acetaldehyde occurs naturally in coffee bread and ripe fruit at much higher concentrations (gt200ppm)

bull Food products such as Yogurt and alcoholic beverages such as wine beer also have much higher concentration of Acetaldehyde (gt100ppm)

Formaldehyde

Acetaldehyde

Formaldehyde and Acetaldehyde are NOT added in PET

PET is safer than an apple

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 39: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

2 DEHP and Phthalate Plasticizers

bull PVC plastics have been assigned a recycle code ldquo3rdquo

bull Rigid and hard articles (eg pipes sheets etc) of PVC do not need any plasticizers

bull Phthalates are used as Plasticizers in formulations for making flexible articles from PVC eg medical tubings cables toys etc

PET neither contains nor needs phthalates of any kind at all

39

ON THE OTHER HAND

bull Polyethylene terephthalate (PET) being a different plastic has been assigned a recycle code ldquo1rdquo

bull The terephthalate polymer PET and the monomeric phthalates (plasticizers) are chemically different substances

bull Although the word phthalate appears in the name polyethylene-terephthalate PET does not use phthalates for any reasons

Phthalates

Polyethylene terephthalate

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 40: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

3 Antimony

bull Antimony is used as a catalyst in PET resin manufacture at a level of lt300 ppm in PET resin

bull It is completely fixed in the polymer matrix

bull PET resins comply with Specific Migration Limit as per bull BIS 12252-1987 (2005)

bull US FDA 21 CFR sect1771630 and

bull Regulation (EU) 102011 on plastic materials and articles intended to come into contact with food

bull International Agency for Research on Cancer (IARC) has classified Antimony trioxide in Group 2B and not as ldquoCarcinogenic to humans (Group 1)rdquo

Antimony leaching if any is well below the migration limits set by Government regulatory bodies 40

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 41: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Migration of Sb modelling at various temperatures

Welle F and Franz R Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2011 Jan 28(1)115-26 doi 101080194400492010530296

bull Maximum migration levels in beverages at room temperature even after 3 years of storage will not exceed 25 ppb

bull Antimony can leach out at a measurable but still very small rate at higher temperatures in excess of 150degC

bull Antimony migration from PET bottles can never reach or exceed the European-

specific migration limit of 40 ppb

bull Diffusion is difficult because of the large molecular size of Antimony oxide highly crystalline nature of PET bottles

Fears about oestrogenic effects caused by antimony from PET bottles are groundless

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 42: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

4 Colourants in PET

bull When used the food colourants are safe for humans

bull Conform to one or more of following regulations on colourants for food contact materials

bull US Federal Food Drug and Cosmetic Act

bull US Food and Drug Administration (FDA)

bull Council of Europe (CoE) Resolution AP (89) 1

ldquoOn the use of colorants in plastic materials coming

into contact with foodrdquo

bull BIS - 9833

Colourants used in PET bottles are compliant with US-FDA and other Food regulations

42

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 43: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

5 Bisphenol-A

bull BPA is used as Monomer in the manufacture of ldquoPolycarbonaterdquo plastics

bull BPA and phosgene react to give polycarbonate under biphasic conditions the hydrochloric acid is scavenged with aqueous base

bull Diphenyl carbonate may be used in place of phosgene Phenol is eliminated instead of hydrochloric acid This transesterification process avoids the toxicity and handling of phosgene

bull BPA-based plastic is clear and tough and hence used in consumer goods sports equipment CDs amp DVDs clear screens

PET has a totally different chemistry than other plastics and is carcinogen-free 43

Bisphenol-A (BPA) or other carcinogens are never used in PET

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 44: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET simple and safe chemistry

PET does NOT contain bull Orthopthalates (eg DEHP) bull Heavy metals (other than Sb) bull Bisphenol-A

PET does not contain any hazardous chemicals ndash neither are they used during their conversion into bottles

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 45: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

6 Endocrine Disrupting Chemicals (EDCs)

bull EDCs are not used nor are generated by PET

containers

bull They are already present in the atmosphere or in water

bodies

bull They are present in many commonly used products

NON-PLASTIC SOURCES OF EDCs

1 Herbicides (Atrazine) amp Pesticides (DDT)

2 Pharmaceuticals

bull Antibiotics or Contraceptives or Drugs

3 Flame Retardants

4 Detergents

5 Natural plant metabolites

6 Chemicals from cooking amp burning

7 Metals (cadmium nickel aluminium)

EDCs are a broad range of chemicals that interact with endocrine system of humans and animals and produce a range of adverse effects

PET does not contain EDCs

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 46: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Hazard and risk

A dangerous animal can be seen as

a bdquoHazardldquo

source Dr U Wolfmeier Clariant

Hazard x Dose (Exposure) = Risk

Be careful but know the facts 46

However when the animal is closed

in a cage it remains bdquohazardousldquo

but there is no exposure to ithellip

When the animal is free people in

its surroundings are exposed to it

Consequently there is a Risk that

these people might be attacked

consequently there is no risk

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 47: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

47

PET containers are used Globally for Pharma packing ndash by international companies and brands

Sr

No Brand Manufacturer RemarkType

1 Alka Seltzer Bayer Sinuscongestion relief

2 Benadryl McNeil Consumer Healthcare Sinuscongestion relief

3 CVS Church amp Dwight Co Antacid

4 Delsym Wallgreens congestion relief

5 Equate Walmart Cough SyrupAntacids

6 Imodium McNeil Consumer Healthcare Diarrheal

7 Lil Critters Vitafusion Vitamins

8 Listerine Johnson amp Johnson Antiseptic Mouthwash

9 Little Fevers Wallgreens Fever Relief

10 Mucinex Reckitt Benckiser congestion relief

11 Nature Made Pharmalite LLC Vitamins

12 Nurofen Reckitt Benckiser Ibuprofen

13 Nyquil Vicks (PampG) Cough Syrup

14 Pepto-Bismol Procter amp Gamble Stomach upset relief

15 Phillips Bayer Milk of Magnesia

16 Robitussin Pfizer Cough Syrup

17 Sudafed pe McNeil Consumer Healthcare CoughDegongestant

18 Tamiflu Roche labs Flu treatment

19 Trojan Church amp Dwight Co Personal Lubricant

20 Tylenol Johnson amp Johnson cold and Flu 47

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 48: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET in Medical Field

US FDA

FDA standard 21CFR 8785000 has approved the following medical devices

containing PET as safe and effective when used for

bull soft tissue approximation andor ligation including

bull cardiovascular ophthalmic and neurological tissue

bull surgical sutures

bull oesophageal and gastrointestinal dialators

bull patches pledgets and intracardiac devices (surgical mesh)

bull 394 PET-based products are in use in medical field for several decades

bull 98 PET-based products in ophthalmic applications bull Several PET-based products in use as implants

48 48

Not just packing of Pharmaceuticals but PET is safe in more critical and permanent human implants

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 49: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Chapter 3

The Regulatory environment

Let us be aware of the history

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 50: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Pharma packaging Indian Regulations allow PET GOVERNMENTAL ACTS

bull Indian Drugs and Cosmetics Act (1940) Schedule M Section 1610 Stability studies

bull Indian Drugs and Cosmetics Rules (1945) Schedule M para 11 Pharmacopoeial

compliance

FSSA Act (2006) created the Food Safety and Standards Authority of India (FSSAI)

formulates specifications for foods that have common features for Pharmaceuticals

INDIAN PHARMACOPOEIA

bull IP 2010 General Chapter 623 PET containers for packaging of Pharmaceuticals

BUREAU OF INDIAN STANDARDS

bull IS 12229-1987 Positive list of Constituents (PET) for their Safe use in Contact with

Foodstuffs Pharmaceutical and Drinking water

bull IS 12252-1987 Specifications for PET for Pharmaceuticals

bull Several other Indian standards exist to control amp allow PET containers for Pharma

packing

50

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 51: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

International Regulations allow PET for Food and Pharma packaging

INTERNATIONAL REGULATORY BODIES

bull World Health Organisation (WHO)

International Conference on Harmonisation stability guidelines Q1A-Q1F

bull International Standardisation Organisation (ISO)

ISO 220002005 Food Safety Management System (FSMS) for lsquoManufacture and

dispatch of Polyethylene Terephthalate (PET) as raw material for food packaging

applicationsrsquo

UNITED STATES GOVERNMENT

bull US FDA (Code of Federal Regulations CFR Title 21 Section 1771630)

bull US Pharamocopeia (USP Chapter 661)

EUROPEAN UNION

bull European Pharmacopoeia monograph (Sections 3115 3221 322)

International agencies have long ago approved PET for packaging of Pharmaceuticals 51

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 52: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

INTERNATIONAL Reports on PET

ILSI Belgium

PET for Food Packaging Applications (2000)

NAPCOR USA

PET Safety

Keller and Heckman USA

Opinion letter

Spanish govt

Laboratory studies of 110 PET samples (May 2014)

Albert Guart Francisco Bono-Blay Antonio Borrell Silvia Lacorte Food Chemistry 156 (2014) 73-80

Canadian govt

Scientific Review of all studies on DEHP (Nov 2014)

Hanno C Erythropel et al Appl Microbiol Biotechnol (2014) 989967ndash9981

All respectable international bodies have endorsed the usage of PET bottles for packaging of liquid Pharma formulations based on assessment under conditions harsher than those prevalent in India

52

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 53: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

THE BIS STANDARDS FOR PETPLASTICS

Year Standard Standard Title (in brief)

1987 12252 PET amp PBT for safe use in contact with Foodstuffs Pharma amp Drinking Water

1989 12287 PET for Edible Oil Packaging

1998 14537 PET for packaging of Alcoholic Liquors

1998 9845 Determination of Overall Migration of Containers of plastic materials intended to come in contact with foodstuffs pharma and drinking water

1999 10171 Guidelines of suitability of Plastics for food packaging

2000 13123 PET for packaging liquid pesticides upto 5 litres

2000 14764 PET Containers for packaging Vanaspati

2003 15410 containers for packaging of Natural Mineral water and Packaged Drinking Water

2014 9833 Pigments and Colorants in plastics for contact with Foodstufs Pharma amp Drinking water

1987 12229 Positive list of Constituents (PET) for their Safe use in Contact with Foodstuffs Pharmaceutical and Drinking water

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 54: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Recycling of Plastics BIS - PCD 127

Convener ndash Indian Centre for Plastics and Environment ICPE

Indian Standards Published - 2 IS 14534 lsquoGuidelines for the recovery and recycling of plastics wastersquo

IS 14535 lsquoRecycled plastics for the manufacturing of products ndash Designationrsquo

IS 14534 referred in Plastic Waste Management Rules 2011

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 55: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Recycling of Plastics - International Scenario

USFDA

bull Guidance for Industry Use of Recycled Plastics in Food Packaging Chemistry Considerations

bull Aug 2006

EU 2822008

bull On recycled plastic materials and articles intended for food contact

bull Regulation of 27 March 2008

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 56: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Plastic Waste Management Rules 2016

MoE F and CC bull Registration bull EPR bull Responsibilities of the ULB bull Street vendors bull Segregation amp recycling as IS 145341998 bull Annual Reports by all

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 57: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Chapter 4

The route for

Waste-to-wealth

Need a structured approach ndash all inclusive and non-combative

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 58: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Development of new features bull Bio-degradable plastics

bull Oxo-degradable plastics

bull Bio-compostable

bull Bacterium that eats PET

Ideonella sakaiensis 201-F6 Kyoto Univ 11 May 2016

Novel collection methods bull At-source collectionsegregation methodologies

Need for Innovation in Materials management

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 59: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Ooho - The Edible Water Bottle

bull Ooho ndash The Edible Water Bottle

launched in Berlin in September 2015

bull Ooho encapsulates water within

a double gelatinous membrane

using the culinary technique of spherification

bull It creates a new alternative packaging which is simple cheap

resistant hygienic biodegradable and even edible

bull This is the first project of Skipping Rocks Lab a London-based

startup cofounded by Rodrigo Garcia Gonzalez Guillaume Couche

and Pierre Paslier

Click here to see a video - wwwyoutubecomwatchv=-J68mz2agIAt=1316112015

Convenience of plastics while limiting the environmental impact

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 60: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Chapter 4

PET the best plastic for packaging

Chemically safe environmentally safe versatile and cost-effective

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 61: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET recyclability is its strength

Unlike PET glass has no outlet other than recycling back for Pharma packaging 61

PET is completely recyclable PET fibres and bottles are converted back into

bull Fibres (white)

bull Fibres (black or coloured)

bull Strappings

bull Cushions seats

bull Upholsterycurtains

bull Mattresses pillows

Premium available for textile-type materials not for bottles

PET fibres amp bottles cannot be recycled into Pharma bottles

bull Due to Pharma regulations

bull Due to business sense

bull Due to technological difficulties

Low carbon footprint

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 62: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Recycling of PET

80 PET Recycling Rate in India amp more than 50 Recyclers

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 63: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET ndash low carbon footprint packaging

1 Post Consumer PET has economic value and fetches gtINR 30 per kG

2 PET gets collected from all areas of consumption

3 India Per Capita PET consumption is 058 kG against 10-12 KG in Developed World

4 PET collection rate as percentage of PET domestic market sales is 80 The balance

20 PET remains in circulation with consumers and would enter post consumer

stream the following year

5 Over 16 million waste collectors involved in PET collection

6 There are 35 plants recycling PET into Fiber and textile products ( Ganesha Ecosphere

Shiva Reliance Arora others)

7 There are 15 plants using recycled PET for polyester strapping (ITW Furus

Plastiblends others)

1 Amount of PET Recycled in India (MT) in 2014-15 500000

2 Land Fill Space Saved (m3) 1581781

3 Amount of Crude Oil Saved (MT) 253649

4 CO2 emissions reduction (MT) 419402

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 64: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Eco-impact study

PET is the most eco-friendly packaging option

TOTAL ENERGY SOLID WASTES AND GREENHOUSE GAS EMISSIONS

FOR SOFT DRINK CONTAINERS

(per 100000 Ounces of Soft Drink)

Energy Solid Waste Greenhouse Gases

(million BTU)

weight

(lbs) (volume cu yard) (CO2 equivalent lbs)

Aluminum Can 160 767 095 2766

Glass Bottle 266 4457 214 4848

PET Bottle 110 302 067 1125

Single-serving container systems used for soft drinks 12 ounce Aluminum Can 8 ounce Glass Bottle 20 ounce PET Bottle

Franklin Associates USA (wwwfalcom) conducted LCI on behalf of PETRA (PET Resin Association)

21

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 65: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

65

AVERAGE VALUES

(of data cited

earlier) Weight of container

needed for packing

300mL of liquid

EFFECTIVE VALUES

Of

Packaging Material

Emissions EF Emissions EF

kgCO2T GhaT g Factor (wrt

PET) kgCO2T (GhaT)

Glass 990 024 162 6x 5940 144

Aluminium 10840 242 15 06x 6504 145

PET 2240 048 24 1x 2240 048

Normalisation taking into account the weight of packing material needed for packing same amount of contents

NORMALISED DATA ndash GHG Emissions and Ecological Footprints

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 66: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET is Packagers Delight

Customer Awareness + Concern for Safety + Convenience of PET + Supply Chain Advantage

More Bottles per Truck less CO2

Emission and low Freight cost

Less Noise Pollution on filling Lines ndash from 80 dB to 20 dB

Light weight amp Unbreakable

Food amp Drug Safety

Recyclable amp Ecofriendly

Reduced secondary Packaging cost

Transparent

Excellent Barrier Properties

Free from BPA amp Phthalalates

36

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 67: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET has been around for a long time the world over

PET is one of the SAFEST materials 67

67

PET fabrics have been worn

for more than

65 years

PET bottles

bull have been made for more than 42 years bull manufactured all over the world

bull more than 300 million MT already used globally

bull more than 15 trillion bottles packed and consumed

NO EPIDEMIOLOGICALLY ADVERSE OBSERVATION GLOBALLY

bull No case reported on any occupational hazards faced by the work-force (inhalation ingress)

bull No case of health effects on civilian consumers (oral ingress)

bull No case of health effects due to draping garments (dermal ingress)

bull Not a single clinical evidence correlating any ailment with PET chemistry

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 68: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

PET a boon to mankind

Challenges as we move towards 10 billion population bull Competition for land Food or fibre or packaging

bull Increased awareness on the need for hygiene and health

bull Water security

68 68 The blessing for sustainability

Thank You

Page 69: PET & Plastics...Purified Terephthalic acid (PTA) and Mono-ethylene glycol (MEG) Degree of polymerisation (n) dependent on application ~ 85 – 95 for textile / film ~ 120 – 150

Thank You


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