FSSAI Flavouring regulation

14 June 2019
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 What is a flavoring?
Codex: Flavorings (CAC/GL 66-2008 item 2.2) are products that are added
to food to impart, modify, or enhance the flavour of food…
FSSAI: Flavoring agents include flavour substances, flavour extracts or
flavour preparations, which are capable of imparting flavouring properties,
namely taste or odour or both to food.

A bottle of 10
gr of flavoring

100 bottles of 1 liter of beverage

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 Flavorings Vs Food Additive

FLAVORING SUBSTANCES FOOD ADDITIVES

• Many occurs naturally in Food • Only few derives from Natural
Sources
• Being identified with INS no.
• Being identified with their type –
Natural, NI or Art.
• Used in complex mixture of • Used in single or in combination
flavoring components.

• Concentration – regularized by
• Concentration varies with the the Authority
type of Flavor
• Each flavoring substance used at
• Usually not Self limiting
low levels – Self limiting – results
in low exposure
FSSAI Flavouring Regulation-India

• Flavours are standardized As per FSSAI Clause 3.3.1FLAVOURING AGENTS AND

RELATED SUBSTANCES:

• Types of Flavouring:

Natural •Are Flavour preparations and single substance ,

obtained exclusively by physical processes from
Flavouring vegetables.

•Substances chemically isolated from aromatic raw

Nature Identical materials or synthetically; they are chemically
flavouring identical to substances present in natural products.

Artificial •Substances which have not been identified in natural

flavoring products.

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India Suitable Flavour Formula Composition

Flavour or flavouring
shall be food grade not
permitted anti- Diethylene
11Flavoring adulterated,
oxidants, Glycol and
Restricted use: compound are misbranded,
emulsifying and Monoethyl
Silicon Dioxide - forbidden to use contaminated and safety
stabilising ether
2% in India evaluated under any of
agents and food Forbidden
( Negative List) regulatory agencies like
preservatives solvent.
FEMA GRAS,CODEX
JECFA,EFSA list .

Coumarin and dihydrococumarian

Tonkabean ( Dipteryl adorat)
β-Asarone and cinamyl anthracilate
Estragole
Ethyl Methyl Ketone
Ethyl -3-phenylglycidate
Eugenyl methyl ether
Methyl β napthyl Ketone
P.propylanisole
Saffrole and Isosaffrole
Thujone and Isothujone & β Thujone

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Flavouring (packaging & labelling)
FSSAI regulation clause no.2.2.2.5.

Addition of flavouring
Disclosure of In case both colour
agents need tobe In case of artificial
flavouring agent, in the and flavour are used in
mentioned on the flavouring substances
ingredients list the product
finished product label
•Dsclosure of •PRODUCT CONTAINS •CONTAINS •CONTAINS ADDED
Flavouring ingredients ADDED PERMITTED ADDED ARTIFICIAL FLAVOUR
not required on finish FLAVOUR(Specify type C0LOUR(INS) AND (Chocolate)
product label under of flavouring agent) ADDED FLAVOUR(S)
the list of ingredients

Other labeling declarations:

 Name of the Product
 Ingredient list
 Legal status
 Net Weight
 Manufactured by/Consignee add.
 Batch No. / Lot No.
 Best Before / Date of Expiry
 FSSAI logo with Lic. No.
 Not For Retail Sale
 Veg Logo
 Allergen declarations

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Major limitations of FSSAI Flavoring clause 3.3.1

Flavoring regulation is under

No reference list of globally
the Food additive regulation
Restriction on use of silicon accepted flavoring substances
which has limited
dioxide 2% in flavours. approved by FEMA GRAS,
clarifications(No Separate
Codex JECFA, EFSA
flavouring Regulation)

Flavour regulation lacks Additives like anti-oxidants,

information about thermal emulsifying and stabilizing Flavour Emulsion only
process flavorings, smoke agents, preservatives, allowed for Carbonated
flavorings & Flavor modifying anticaking mention but not water.
properties (FMP) addition in mention specific name of
flavorings. additive under these class

 Frequent reformulation – increasing cost

 Limiting Innovation
 Classification Issues (N/ NI /A) vs. global classification of N/A

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Expectation from Associations & Regulators
Sustained engagement and unified approach

Sustained engagement

Sustained engagement : Flavor Manufacturers, Trade Bodies & FAFAI

Continued efforts to align with stakeholders like SMEs via FAFAI

Unified approach on framing Flavor Regulation under FSSAI

Unified approach

Harmonized Officially accepted Clear guidelines on

flavouring Regulation globally approved flavoring terminology
as Additives & reference list of and, other than
Flavouring flavorings substances flavoring ingredients
substances are from FEMA GRAS, Codex suitability
different entities JECFA ,EFSA list.

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 IOFI-International Organization of Flavour Industry
 IOFI has Observer Status” at the WHO/FAO Codex Alimentarius Commission and its
subsidiary bodies.
 IOFI India Task Force- Givaudan Chair.
 It represents the interests of the global flavor industry and its partners by providing
leadership in safety, scientific and regulatory matters

 Global harmonization of Indian Flavoring regulation.

 IOFI has developed Global Reference List of >4000 Flavoring substnaces which is
combination of all together:

 Flavourings evaluated by the Joint FAO/WHO Experts Committee on Food Additives (JECFA)
 European Food Safety Authority (EFSA) or the Japanese Food Safety Commission (FSC).
 Expert Panel of the Flavor and Extract Manufacturers Association of the United States (FEMA
GRAS)
Flavour Advocacy track in India

Joint efforts
Meetings by IOFI- FICCI-IOFI
Development FAFAI on
with FAFAI, “Flavoring safety
work of GST (Goods
FICCI, CII Awareness”
industry & Services
[Jan 2018] Seminars
guidelines Tax) [2018] [2018 & 2019]
[2015~]

FSSAI Codex
harmonization
started
[2013]

Flavour Industry FSSAI Hearing Support development of

Workshop on ( flavoring flavoring regulation /
Harmonization scientific Global reference list
towards Codex panel) [2018~]
[2016] [Feb 2018]
 DRAFT - FOOD SAFETY AND STANDARDS
(FLAVOURINGS) REGULATIONS, 2019

Structure/Definition: based on Codex Guidelines for the Use of Flavourings.

Details: Refer to current Indian regulations/provisions whenever applicable.
Complemented by IOFI recommendations.

Adopting a positive list by reference to the following international lists :

I. Flavourings evaluated by the Joint FAO/WHO Experts Committee on Food

Additives (JECFA)

II. Flavourings materials that are deemed to be Safe or approved as published

by the independent Expert Panel of the Flavor and Extract Manufacturers
Association (FEMA)

III. Materials that have been evaluated by authoritative bodies such as the
European Food Safety Authority (EFSA)

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FEMA GRAS

 Flavor and Extract Manufacturers Association of the U.S.

 FEMA was established in1909 & working under FDA for flavour safety.

 The Expert Panel of FEMA is the primary body for the safety evaluation of food
flavouring for the flavour industry and the public through its "generally recognized as
safe" (GRAS) assessment of flavouring substances .

 Promots Global Harmonization of Flavourings & flavor safety in all global markets.

FEMA GRAS.mp4
Meeting with FSSAI Scientific Panel (Flavorings & Food Additives)
F2F meeting discussion:
)
 Existing FSSAI regulation Rule 3.3.1/ negative list/limitations
 Global list of flavoring which approved from FEMA GRAS/US FDA, Codex JECFA & EU
 Codex –Guidelines for the use of Flavorings CAC/GL 66-2008
Expectation from Associations & Regulators
FSSAI unlikely agree • Flavour houses along with  Best Option : Regulation on
to “Approval by Associations to lead the Flavouring Substances basis
Reference to discussion with Regulator to “Approval by Reference to FEMA
International list from push for “Approval by GRAS/US FDA, Codex JECFA & EU
FEMA GRAS/US FDA, Reference to FEMA GRAS/US Flavoring list”
Codex JECFA & EU FDA, Codex JECFA & EU
Flavoring list .”
- Perceived as loss of  Back Up Option: Regulation on
control Flavouring Substances basis
“Approval by Reference” for
existing molecules & “Approval by
Submission” for new substances
(Approval time frame 3-6 month)

India

Flavour
Industry

Regulator &
Associations

Consumers
Food
Industry
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Thank You
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