Food Industry need regulatory harmonization to achieve global parity and growth.

1. Make In India:
Perspective on Regulatory Enablers
for
Food Industry
January 2016
By - Sunil Adsule

2. 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

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

4. 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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5.  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
5
• 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”

6. 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

7. • Brought regulations under the new framework – in a single
integrated document
– Final Food Safety & Standards Regulations- Aug 5, 2011
– Same Regulations were brought under one umbrella
– Proprietary Food definition and provisions continued
FSSAI Regulations – August 5, 2011
PFA FSSAI

8. Proprietary Food - Background
• FSSAI’s Regulation classifies food & beverage
products in two major categories
• Standardized foods &
• Non-standardized foods (or Proprietary
Foods)
• Standardized foods are those which are
defined under regulations
• Fruit Jam, Fruit Drinks, Sauces, Biscuits,
Carbonated Water
• Approx. 377 standards are defined
• Proprietary Foods are those which are not
standardized under regulations - may contain
• Primary ingredients and certain generic
additives
• Usage of additives is restricted
• Examples : Energy Drinks, Custard
powder – Starch, Dextrose, Flavour,
Colour

9. 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

10. 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

11. PA - Legal 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 Industry is still awaiting further directions
from FSSAI on licensing of Proprietary Foods
o Some New proprietary food awaiting
licenses since over 12 to 18 months now

12. 12
Food Industry in India – Grappling with

13. oProduct – Regulation-Content
• Relevant – Balances Consumer Safety and Fair Trade Practices
• Fair - at par with Global standards
oProcess –of Making Regulation
• Transparency – clarity on how stakeholder’s concerns were
considered
• Speed – match up with global best in time-bound manner
oDelivery – Implementation of Regulations
• Level playing field – recognize and reward self regulation
• Building Trust – interactive sessions between industry and State
Enforcement Agencies
Core Areas of Emphasis in 2016
Product – Process - Delivery

14. Regulatory Enablers – Food & Beverage Industry
• Harmonization of FSSAI Regulations with Global Best Practices
– Codex Alimentarius – Regulatory Guidelines developed for Food Trade with
global participation and acceptance
– Recommendation - Harmonize standards at par with Codex
• Simplify of Proprietary Food Regulation
– Products waiting for over 12 to 18 months pre-market approval
– Recommendation – Onus of safety to rest with manufacturer. Build in
penalties as safeguard in case of violations. Proprietary Food License
issuance within 60 days or less is needed
• Standard Setting Process - Industry Support-Participation
– will speed up the consultative process
– Recommendation - Industry members as Observers / Invitees on Panels
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15. Thank You