Harmonization of Flavour RegulationsPerspective of Food & Beverage Industry

March 2016

By - Sunil Adsule

IOFI India Task Force Workshop –2nd March 2016

o Prime Minister’s Council on Trade and Industry Aug 1998 formed

o Six Special Subject Groups with • Food & Agro-industries Management Policy

group under leadership of M/s Nulsi Wadia, Ratan Tata and A.C. Muthiah

o Critical appraisal by the Group o Recommendations made on spurring growth

in Food Sectoro “There is a need to streamline and harmonise

food laws in line with world-wide trends. o No country can act in isolation as the world food

system has become quite interdependent”

Integrated Food Bill

Erstwhile Regulatory System – Food and Beverages

● Ministry of Health and Family Welfare (MoH)- Prevention of Food Adulteration Act (PFA)

● Ministry of Food Processing Industries (MoFPI)- Fruit Product Order (FPO)

● Ministry of Consumer Affairs (MoCA)- Bureau of Indian Standards (BIS Mark)- Weights and Measures Act (PCRO)

● Ministry of Agriculture (MoA)- AGMARK – For Agro Commodities / Spices- Milk and Milk Products Order; The Insecticides Act

● Ministry of Commerce (MoC)- Tea Board / Coffee Board / Coffee Act and Rules / Export

Regulations● Ministry of Science and Technology (MoST)

- Irradiated Foods- GM and Organic Foods A strong need to simplify this cumbersome

administrative structure

Food Safety and Standards Authority of India (FSSAI ) established in 2008

www.fssai.gov.in

Food Safety & Standards Act-2006: Integrated

Food Safety and Standards Act, 2006

Prevention of Food Adulteration

Act, 1954

Fruit Products Order, 1955

Meat Food Products Order,

1973

Vegetable Oil Products

(Control) Order, 1947

Edible Oils Packaging

(Regulation) Order, 1998

Solvent Extracted Oil, Deoiled Meal, and Edible Flour (Control) Order,

1967

Milk and Milk Products Order,

1992

Any other order under Essential

Commodities Act, 1955 relating to

food

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From multi-level – multi department control to single line of command

Single reference point on all matters related to Food Safety and Standards – regulations and enforcement

Science based standards and transparency to meet dynamic requirements of national / international food trade

Driving self regulation compliance (FSMS)

Provision of graded penaltiesdepending on gravity of offence

Alignment with international regulatory guidelines

Integrated response on strategic issues – Novel / GM foods, Global trade

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• Multiplicity of regulations, which at times conflicting and confusing

• Often Manufacturers had to seek clearances from various agencies

• Lack of application of scientific principles – such as risk assessment in setting safety regulations

• Regulatory regime especially the enforcement acted as a policeman

• The penalties levied were not linked to gravity of offence

• No defined process of alignmentwith global regulatory practices

MOVING FROM To

Food Safety and Standards Act – “The WHY”

PFA

Multiple Authorities

Adulteration

Prescriptive Standards

Inspection/ Control

Insufficient Enforcement Personnel

Poor Lab Network

FSSA

Single Authority

Safety

Categorized Standards

Monitoring & Surveillance

Full time district Officer, Food Safety Officers under FSC

Goal of food Lab in each District

Critical Shifts

FSSAI - As per the Act’s Mandate

Scientific Risk Assessment to drive Regulation & Rule

Making Process

Pesticides and Antibiotics Residues

Food Authority (Apex Body)(As per Sections 4 & 5 – FSS Act 2006)

22 Member Body Headed by FSSAI Chairperson (Final Arbiter of All Regulatory Issues)

Biological hazards

One Scientific Committee (As per Section 14 – FSS Act 2006) Headed by Ex Director General – Indian Council of Medical Research. Other Members are

Chairpersons of All Scientific Panels and Six Independent Scientific Experts not belongingor affiliated to any of the Scientific Panels

Food additives, flavourings, processing aids and

materials in contact withfood

Contaminants in the food chain

Genetically modified organisms and foods

Labeling, Advertising and

Claims

Functional foods, nutraceuticals, dietetic

products and other similarproducts

Method of sampling and

analysis

Scientific Opinion / Risk Assessment

Scientific Committee finally responsible for the general co-ordinationnecessary to ensure consistency of the scientific opinion procedure

Final OutputRegulation / Rule

Eight Scientific Panels

Key Features of FSS Act

• Comprehensive definition of unsafe food• Technical breach separated from deemed adulteration

– Graded penalties based on gravity of offence• Food Safety Management Systems - Food Safety Audit

– FSMS Audits by FSSA enforcement officers– Focus on Plant Certifications (ISO 22000 etc.)

• Section 18(2) The Food Authority shall, while framing regulations or specifying standards under this Act take into account– prevalent practices and conditions in the country– international standards and practices, where international standards or

practices exist or are in the process of being formulated9

• All applicable food regulations brought under new framework – in a single integrated document– Food Safety and Standard Rules– FSS (Licensing & Registration) Regulations– FSS (Food Products Standards and Food Additives)

Regulations– FSS (Packaging and Labeling) Regulations– FSS (Prohibition and Restriction on Sales) Regulations– FSS (Contaminants, Toxins and Residues) Regulations– FSS (Laboratory and Sample Analysis) Regulations

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FSSA Rules & Regulations – August 5, 2011

• Brought regulations under the new framework – in a single integrated document

• Conflicting norms removed • However for most of regulations – no change in content was made• One example - Proprietary Food definition and provisions continued

New Act Framework……BUT….. Same Regulation Content

PFA FSSAI

Standardized Food - Proprietary Food

• FSSAI’s Regulation classifies food & beverage products in two major categories

• Standardized foods &• Non-Standardized foods (Proprietary Foods)

• Standardized foods are those which are defined under regulations (e.g.)

• Fruit Jam, Fruit Drinks, Sauces, Biscuits, Carbonated Water

• Over 375 standards are defined • Proprietary Foods are those which are not

standardized under regulations - may contain• Primary ingredients and certain generic additives • Examples : Ready to Serve Tea Based Beverages,

Custard powder (Starch, Dextrose, Flavour, Colour)

Product Approval Mandate was ……..

o Post March 2012, FSSAI made prior approval mandatory for all non-standardized (proprietary) products (Ref. Section 22 of FSS Act)

o As per the mandate every Food Business Operator –FBO had to apply and obtain Product Approval / NOC for

• In market or New - Proprietary Products• Product Approval or NOC was a pre-

requisite for License

http://www.fssai.gov.in/product_approval.aspx

Product Approval – Major Issues

Product Approvalo Complex procedureo Adverse impact on

o New Product Introductionso Business Continuity for some

companieso Unpredictability of whole mechanismo No defined timeframe for approvalso Very Slow & Inconsistent approach leading

to long hold-ups & delay in getting licenseo Disclosure of product composition

PA – Legal & Regulatory Developments …………o Litigation in Mumbai HC o FSSAI held back approval of PA applications pending

litigation & HC Ordero SLP filed in SC by FSSAIo SC upheld Mumbai HC Order – quashing Product

Approval Advisories ……..

o FSSAI Operationalization Notices• Additive allowances as per FCC – 23 Dec 2015• Licensing of Proprietary Foods – 13 Jan 2016 paved way for Licensing of Proprietary Foods

FOOD ADDITIVES

India’s Tryst with Regulatory Harmonization

Regulatory Harmonization - Timelines

o Started during erstwhile PFA – 2004-05 onwards

• INS Numbering for Food Additives - GSR 388 • Standards of Confectionery Products - GSR 184• Standards of Fruit & Vegetable Products - GSR 185• Standards of Milk & Milk Products - GSR 356• Nutrition Labelling and QUID for key ingredients – GSR

491/GSR 664

o Integrated Food Bill 2004-05o FSS Act was passed 2006o FSSAI was established 2008o FSS Regulations issued 2010-11o Harmonization with FCS – 2012-15

P F A

Harmonization – Aligning FSSR Standards and Additive Provisions

o FSSAI initiated harmonization exercise in May 2013• Joint exercise – Scientists from Public Sector, Research Institutes, Academia, Private

Sector (Industry)• Formed 80 plus eWGs to develop standards• All Standards reviewed by FSSAI’s Scientific Panel

o Aligning Vertical Standards – with existing Codex Commodity Standardso Aliging Horizontal Standards - In parallel worked to align Food Codex

Category System with current Food Product Standards from FSSR o Harmonized Horizontal FCS Additive Standards with GMP Table –

operationalized in Dec 2015o FSSR Food Product (vertical) Standards aligned with Codex to be issued o FCS provides framework for mapping these harmonized vertical

standards

• Global marketplace • lack of uniformity in the safety evaluation and

regulation of flavourings among different countries and continents

• This presents unintentional non-tariff barriers to the free movement of foods

• Large numbers and widespread use in foodstuffs along with the lack of harmonized lists of safe flavouring substances in most countries• sets the stage for disruptions in international food

trade• National authorities are hampered

• Due to lack of comprehensive national standards for the use of flavouring substances

• Ambiguity at Customs and other declarations on the use of flavouring substances

Case for Harmonization of Flavouring Regulations

Flavourings or Flavouring Substances

o Flavourings or flavouring substances are added to food to impart aroma or taste

o Like other food additives their use should not present an unacceptable risk to human health and should not mislead consumers.

o The quantity added to foods should be at the lowest level necessary to achieve the intended flavouringeffect.

o Flavours and flavouring substances should also be of appropriate food grade quality; and be prepared and handled in the same way as a food ingredient.

Current Provisions for Applicable to Flavouring Substances

• FSSR (Food Standards & Additives) 3.1.10: FLAVOURING AGENTS AND RELATED SUBSTANCES provides for – Def of flavoring agents :- Flavouring agents include flavour substances, flavour extracts or flavour

preparations, which are capable of imparting flavouring properties, namely taste or odour or both to food

• Flavouring agent classification under FSSAI – Natural Flavours and Natural Flavouring Substances:- "Natural Flavours" and "Natural Flavouring

Substances" means flavour preparations and single substance respectively, acceptable for human consumption, obtained exclusively by physical processes from vegetables, for human consumption

– Nature-Identical Flavouring Substances :- Nature-identical flavouring substances means substances chemically isolated from aromatic raw materials or obtained synthetically; they are chemically identical to substances present in natural products intended for human consumption, either processed or not

– Artificial Flavouring Substances :- Artificial Flavouring Substances means those substances which have not been identified in natural products intended for human consumption either processed or not

• Restriction on use of flavouring agents :- The use of the following flavouring agents are prohibited in any article of food, namely:

1. Coumarin and dihydrocoumarin;2. Tonkabean (Dipteryl Odorat); and3. ß asarone and cinamyl anthracilate4. Estragole5. Ethyl Methyl Ketone6. Ethyl-3-Phenylglycidate7. Eugenyl methyl ether8. Methyl ß napthyl Ketone9. P.Propyl anisole10. Saffrole and Isosaffrole11. Thujone and Isothujone α & ß thujone

• Use of anti-oxidants, emulsifying and stabilising agents and food preservatives in flavour :- The flavouring agents may contain permitted anti-oxidants, emulsifying and stabilising agents and food preservatives.

• Restriction on use of solvents :- Diethylene Glycol, Monoethyl ether not allowed be used as solvent in flavours

Current Provisions under FSSR

Safety of Flavouring Agents conducted using robust science-based Process – Codex

In addition IOFI &

FEMA evaluates safety

of flavoring agents and

all these bodies

(JECFA, IOFI, FEMA)

are recognized by

National Regulatory

Authorities globally

Review of Existing Standards to Align with Codex

o Definitions of N, NI and Ao Specify list of permitted flavouring and non-

flavouring additives, permitted solventso Review Negative list

• Guidance if the restricted substance present naturally (E.g. Saffrole)

o Review of applicability of NOTSo Contaminants – Realistic Limits depending on

• Exposure• Local Practices

Example :-FSSR Standard For ColorantsSunset Yellow and other coloursstates

“It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds,aromatic hydrocarbons, and cyanides”.

Samples failed as Enforcement Labs moved from Qualitative to Quantitative testing

Currently under review with FSSAI’s Additive Panel

Labelling Regulations for the User Industry

o FSSR – Packaging & Labelling Regulation• Several declarations required such as • CONTAIN ADDED FLAVOURS• Several terms used – Class, Type, Common Name etc.• E.g.

• Resulted in labelling such as Natural (Milk) Flavour, Nature Identical (Cinnamon) Flavour and Artificial (Butter Scotch) Flavour

• Due to lack of uniform guidelines resulting in cases of labelling breach in Enforcement

Labelling of Added Flavour NEEDs Harmonization with Codex GuidelineCAC/GL 66-2008 & Labelling of Prepackaged Foods (CODEX STAN 1-1985)

• Import was not under PFA – but is now covered under FSSAI• In absence of regulation FSSAI issued series of advisories to govern

Food Imports• FSSAI Operationalization Notice for Food Import Regulation issued

from 14th Jan 2016– Documentation requirement for Imports & Customs House Agent (CHA)– Compliance expected for Packaging and Labeling Regulations– Certain articles of food not to be referred to Food Authority for clearance

Clause 5.1– Import of Food for the purposes of Research and Development - Clause 5.3

– Defined procedures - Storage, Sampling, Analysis of Imported Food26

Imports under FSSAI Lens

Consumer Safety – Consumer Information – Balancing Trade

o FSSAI has a significant role to play in ensuring a safe food supply by maintaining robust evidence based processes for developing food standards and responding to food safety issues which enables consumers to make informed choices and maintain public confidence in the safety of foods

Safety First…. – Trade Comes Later….

o Important to harmonize with Global Practices to balance Consumer Safety-Information while ensuring Vibrant Food trade

Harmonization of Regulatory FrameworkFor Flavour Regulations

Codex Standard CAC/GL 66-2008 as starting point• Definitions -• General Principles for the Use of Flavourings• Develop Lists of

• Flavouring – JECFA-IOFI-FEMA GRAS lists • Non-Flavouring Food Ingredients – as permitted

• Simplify Labeling (Labelling of Prepackaged Foods-CODEX STAN 1-1985 – Updated 2010) For Flavourings Labeling of Food Stuffs with Flavours

Thank You