India’s Regulatory Landscape A Challenge or An Opportunity

February 2016

By - Sunil Adsule

• Increasing scales of operation will enhance affordability of Quality and Safety of Processed Food

• Greater sophistication in food service sector – popularity of Quick Service Restaurants (QSRs)

• Credibility issues in established systems • Self regulation • Legal enforcement weaknesses, • Accreditation systems, • Either no mechanism or recall failures in crisis situations

“Certain things only Government can do”

• Increasing Consumer & Media focus on Food Safety • Understanding pathogenicity and control strategies driving Good

Manufacturing Practice (GMP) Standards

• Shift from 100% Inspection to Food Surveillance & Monitoring Systems

Current Trends

EVERYONE HAS A ROLE TO PLAY

You Are Only

As Strong As

Your Weakest

Link…

Media Activism

NGO Activism

WHAT IS MAKING HEADLINES ………… YESTERDAY

Food 90% Safe

Enforcement Activism – Trial by Media

Enforcement Activism – Trial by Media

………………FOUND SAFE …..?

SAFETY - PROCESSED OR PACKAGED FOOD ………..?

SOCIAL MEDIA: TWITTER .BLOGS…. PERCEPTIONS DRIVERS IN TODAY’S WORLD

ORGANIZED FOOD INDUSTRY IS EXPECTED TO LEAD THE WAY-

Food Safety and Standards Authority of India (FSSAI ) established in 2008

www.fssai.gov.in

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 & 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 penalties

depending 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 alignment

with global regulatory practices

MOVING FROM To

Food Safety and Standards Act – “The WHY”

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

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-ordinationnecessary to ensure consistency of the scientific opinion procedure

Final OutputRegulation / Rule

Eight Scientific Panels

Key Features of FSS Act

• Comprehensive definition of unsafe food

• Technical breach separated from deemed adulteration

– Graded penalties based on gravity of offence

• Licensing requirements enhanced to include GMP

– Manufacturing Hygiene Requirements – Schedule IV

– India – Hazard Analysis & Critical Control Points (HACCP) Code under development - proposed to be used for certification

• Food Safety Management Systems - Food Safety Audit

– FSMS Audits by FSSA enforcement officers

– Focus on Plant Certifications (ISO 22000 etc.)

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FSSAI - Structure - Central

FSSAI - Structure - States

FSSAI - Licensing Framework

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FSS Act - State Enforcement Machinery - C F S

Commissioner of Food Safety (CFS)

Heads the Enforcement Machinery in state

Empowered to sanction prosecution for offences punishable with imprisonment under the act

Powers and Duties

Prohibit in the interest of public health, the manufacture, storage, distribution, or sale of any article of food.

Carry out survey of the food processing units in the state to find out compliance of standards.

Conduct training program for the personnel engage in the food safety.

Ensure efficient and uniform implementation of the standards and other requirements.

Sanction prosecution for offences punishable with imprisonment under this Act.

Commissioner of

Food Safety

Designated

Officer

Food Safety

Officer

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FSS Act - State Enforcement Machinery – D O

CFS shall appoint Designated Officer (DO – equivalent to current LHA – Local Health Authority under PFA)

Powers and Duties

Issue or cancel license of Food Business Operator.

Prohibit sale in contravention of this Act.

Receive report and samples of articles of food from Food Safety Officer and get them analyzed.

Make recommendation to the Commissioner of Food Safety for sanction to launch prosecutions

Sanction prosecution

Maintain record of all inspections made by Food Safety Officers

Get investigated complaints in respect of any contravention of the provision of this Act or against FSO

Commissioner of

Food Safety

Designated

Officer

Food Safety

Officer

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FSS Act - State Enforcement Machinery – F S O

Food Safety Officer (FSO) (Will be appointed by CFS or by the State Government)

Powers and Duties

Power to take a samples of any food or any substance, to

be intended for sale or to have been sold for human

consumption

Seize any articles of food which appears to be in

contravention of this Act.

Enter and inspect any place where the food is

manufactured, or stored for sale

May after giving notice to the food business operator

cause the food to be destroyed which is unfit for human

consumption

Seize any adulterant found in possession of a manufacture

or distributor of any article of food

Penalty for harassment of business operator and also for

false complaint

Commissioner of

Food Safety

Designated

Officer

Food Safety

Officer

• Offences and Penalties

– Graded penalties based on gravity of offence

– Monetary penalties up-to 10 L [$ 15K]

– More trained Food Safety Officers in the field to ensure more frequent visits & inspections

• Tribunals expected to fast track resolution of enforcement issues / cases

– Provision of Adjudication and Food Safety Appellate Tribunal

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New Act - Building Accountability Onus on Food Business Operator (FBO)

• 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) Regulations28

FSSA Rules & Regulations – August 5, 2011

Food Safety is BUILT IN Licensing and Registration Requirements

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• FSS (Licensing & Registration) Regulations – Annexure 2 • Food Safety Management System Plan

• Ingredients and Water Analysis Report

• Food Recall Plan

• Routine examination of Food Handlers Medical Reports

• Conditions for License include• Technically Competent Person MUST to supervise the production

process

• Cleaning & Sanitation Systems for the machine & equipment

• Routine testing of relevant chemical - microbiological contaminants

• Purchase From & Sale To – Only FSSAI Licensed/Registered vendors

Licensing and Registration Schedule IV – GMP Standards

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1. Location and Surroundings

2. Layout and Design of Food Establishment Premises

3. Equipment & Containers

4. Facilities

5. Food Operations and Controls

6. Management and Supervision

7. Food Testing Facilities

8. Audit, Documentation and Records

9. Sanitation and Maintenance of Establishment Premises

10. Personal Hygiene

11. Product Information and Consumer Awareness

12. Training

Thank You !!!