This document discusses India's regulatory landscape for food safety. It notes the challenges with the previous fragmented regulatory system and the opportunities provided by the implementation of the Food Safety and Standards Act of 2006. The key points of the new system include consolidating various regulations under one authority (FSSAI), establishing science-based standards, improving enforcement through licensing and inspections, and holding food businesses accountable through requirements like adopting food safety management systems. The new system aims to drive self-regulation compliance and enable swifter resolution of enforcement issues through specialized tribunals.

1. India’s Regulatory Landscape
A Challenge or An Opportunity
February 2016
By - Sunil Adsule

2. • 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

3. EVERYONE HAS A ROLE TO PLAY

4. You Are Only
As Strong As
Your Weakest
Link…

5. Media Activism

6. NGO Activism

7. WHAT IS MAKING HEADLINES ………… YESTERDAY
Food 90% Safe

8. Enforcement Activism – Trial by Media

9. Enforcement Activism – Trial by Media

10. ………………FOUND SAFE …..?

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

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

13. ORGANIZED FOOD INDUSTRY IS EXPECTED
TO LEAD THE WAY-

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

15. 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

16. 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
16

17.  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
17
• 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”

18. 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

19. 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

20. 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.)
20

21. FSSAI - Structure - Central

22. FSSAI - Structure - States

23. FSSAI - Licensing
Framework

24. 24
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

25. 25
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

26. 26
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

27. • 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
27
New Act - Building Accountability
Onus on Food Business Operator (FBO)

28. • 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) Regulations
28
FSSA Rules & Regulations – August 5, 2011

29. Food Safety is BUILT IN
Licensing and Registration Requirements
29
• 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

30. Licensing and Registration
Schedule IV – GMP Standards
30
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

31. Thank You !!!