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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Thank You