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Make In India:Perspective on Regulatory Enablers
for Food Industry
January 2016
By - Sunil Adsule
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
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”
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
• 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
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
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 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 Advisorieso 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
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Food Industry in India – Grappling with
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 2016Product – Process - Delivery
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 Licenseissuance 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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Thank You