Perspective on Regulatory Enablers for Food Industry-4th Jan 2016

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