Harmonization of FSSAI Regulations for Flavouring Substances

1. Harmonization of Flavour Regulations
Perspective of Food & Beverage Industry
March 2016
By - Sunil Adsule
IOFI India Task Force Workshop –
2nd March 2016

2. 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 Sector
o “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

3. 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

4. Food Safety and Standards Authority of India
(FSSAI ) established in 2008
www.fssai.gov.in

5. 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
5

6.  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 penalties
depending on gravity of offence
 Alignment with international regulatory
guidelines
 Integrated response on strategic
issues – Novel / GM foods, Global
trade
6
• 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 alignment
with global regulatory practices
MOVING FROM To
Food Safety and Standards Act – “The WHY”

7. 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

8. 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 belonging
or affiliated to any of the Scientific Panels
Food additives, flavourings,
processing aids and
materials in contact with
food
Contaminants in the
food chain
Genetically modified
organisms and foods
Labeling,
Advertising and
Claims
Functional foods,
nutraceuticals, dietetic
products and other similar
products
Method of
sampling and
analysis
Scientific Opinion / Risk
Assessment
Scientific Committee finally responsible for the general co-ordination
necessary to ensure consistency of the scientific opinion procedure
Final Output
Regulation / Rule
Eight Scientific Panels

9. 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 formulated
9

10. • 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
10
FSSA Rules & Regulations – August 5, 2011

11. • 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

12. 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)

13. 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

14. Product Approval – Major Issues
Product Approval
o Complex procedure
o Adverse impact on
o New Product Introductions
o Business Continuity for some
companies
o Unpredictability of whole mechanism
o No defined timeframe for approvals
o Very Slow & Inconsistent approach leading
to long hold-ups & delay in getting license
o Disclosure of product composition

15. PA – Legal & Regulatory Developments …………
o Litigation in Mumbai HC
o FSSAI held back approval of PA applications pending
litigation & HC Order
o SLP filed in SC by FSSAI
o 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

16. India’s Tryst with Regulatory Harmonization

17. 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 2004-05
o FSS Act was passed 2006
o FSSAI was established 2008
o FSS Regulations issued 2010-11
o Harmonization with FCS – 2012-15
P F A

18. 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 Standards
o 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 2015
o FSSR Food Product (vertical) Standards aligned with Codex to be issued
o FCS provides framework for mapping these harmonized vertical
standards

19. • 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

20. 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 flavouring
effect.
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.

21. 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

22. • 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); and
3. ß asarone and cinamyl anthracilate
4. Estragole
5. Ethyl Methyl Ketone
6. Ethyl-3-Phenylglycidate
7. Eugenyl methyl ether
8. Methyl ß napthyl Ketone
9. P.Propyl anisole
10. Saffrole and Isosaffrole
11. 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

23. 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

24. Review of Existing Standards to Align with Codex
o Definitions of N, NI and A
o Specify list of permitted flavouring and non-
flavouring additives, permitted solvents
o Review Negative list
• Guidance if the restricted substance present naturally
(E.g. Saffrole)
o Review of applicability of NOTS
o Contaminants – Realistic Limits depending on
• Exposure
• Local Practices
Example :-
FSSR Standard For Colorants
Sunset Yellow and other colours
states
“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

25. 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 Guideline
CAC/GL 66-2008 & Labelling of Prepackaged Foods (CODEX STAN 1-1985)

26. • 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 Food
26
Imports under FSSAI Lens

27. 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

28. Harmonization of Regulatory Framework
For 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

29. Thank You