The Evolution Of FSSAI

November 15th, 2017

By - Sunil Adsule

How The Indian Regulator is

Upgrading Regulations

Disclaimer: All the Images used herein are for representation purpose only
 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
Integrated Food Bill 2003-04
o Prime Minister’s Council on Trade and
Industry Aug 1998 formed
o Six Special Subject Groups with
• Food & Agro-industries Management Policy
group under leadership of M/s Nulsi Wadia,
Ratan Tata and A.C. Muthiah
o Critical appraisal by the Group
o Recommendations made on spurring growth
in Food Sector
o “There is a need to streamline and harmonise
food laws in line with world-wide trends.
o No country can act in isolation as the world food
system has become quite interdependent”
 Food Safety & Standards Act-2006: Integrated
Vegetable Oil Edible Oils
Products Packaging
(Control) Order, (Regulation)
1947 Order, 1998
Solvent Extracted
Meat Food Oil, Deoiled Meal,
Products Order, and Edible Flour
1973 (Control) Order,
1967

Milk and Milk

Fruit Products
Products Order,
Order, 1955
1992

Food Any other order

Prevention of
Food Adulteration
Safety and under Essential
Commodities Act,
Act, 1954 Standards 1955 relating to
food
Act, 2006
4
Food Safety and Standards Authority of India
(FSSAI ) established in 2008

www.fssai.gov.in
 FSSA Rules & Regulations – August 5, 2011

• 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

6
 Food Safety and Standards Act – “The WHY”
MOVING FROM
• 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
To
 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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 PFA FSSA
Multiple Authorities Single Authority

Adulteration Safety

Critical Shifts Prescriptive Standards Categorized Standards

Inspection/ Control Monitoring & Surveillance

Insufficient Enforcement Full time district Officer, Food

Personnel Safety Officers under FSC

Poor Lab Network Goal of food Lab in each

District
 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.)

9
 New Act - Building Accountability
Onus on Food Business Operator (FBO)
• Offences and Penalties
– Graded penalties based on gravity of offence
– Monetary penalties up-to 10 L [$ 15,000]
– 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
 Standardized Food - Proprietary Food
• FSSAI’s Regulation classifies food & beverage
products in two major categories
• Standardized foods &
• Non-Standardized foods (Proprietary Foods)
• Standardized foods are those which are defined
under regulations (e.g.)
• Fruit Jam, Fruit Drinks, Sauces, Biscuits,
Carbonated Water
• Over 375 standards are defined
• Proprietary Foods are those which are not
standardized under regulations - may contain
• Primary ingredients and certain generic additives
• Examples : Ready to Serve Tea Based Beverages,
Custard powder (Starch, Dextrose, Flavour,
Colour)
 FSSAI - Structure - Central

Advisor - Advisor - Advisor - Director -

Chief Management Service Officer
Standards Codex & Regulation Quality Assurance Vigilance & Import

Director
FSMS
FSSAI - Structure - States
FSSAI - As per the Act’s
Mandate Food Authority (Apex Body)
(As per Sections 4 & 5 – FSS Act 2006)
Scientific Risk Assessment to 22 Member Body Headed by FSSAI Chairperson
Final Output
drive Regulation & Rule (Final Arbiter of All Regulatory Issues)
Regulation / Rule
Making Process Scientific Committee finally responsible for the general co-ordination
necessary to ensure consistency of the scientific opinion procedure

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

Scientific Opinion / Risk

Assessment
Food additives, flavourings, Functional foods,
processing aids and Pesticides and Genetically modified nutraceuticals, dietetic
materials in contact with organisms and foods products and other similar
food
Antibiotics Residues
products

Labeling, Method of
Contaminants in the
Biological hazards Advertising and sampling and
food chain
Claims analysis

Scientific Panels
 Regulatory Harmonization under FSSAI

• Food Additive Usage in Different Food Categories

• Labelling & Claims
 Regulatory Harmonization - Timelines
o Started during erstwhile PFA – 2004-05
onwards PFA
• INS Numbering for Food Additives - GSR 388
• Standards of Confectionery Products - GSR 184
• Standards of Fruit & Vegetable Products - GSR 185
• Standards of Milk & Milk Products - GSR 356
• Nutrition Labelling and QUID for key ingredients – GSR
491/GSR 664
o Integrated Food Bill 2004-05
o FSS Act was passed 2006
o FSSAI was established 2008
o FSS Regulations issued 2010-11
o Harmonization with FCS – 2012-16
 Harmonization – Aligning FSSR Standards and Additive Provisions
o FSSAI initiated harmonization exercise in May 2013
• Joint exercise – Scientists from Public Sector, Research Institutes, Academia, Private
Sector (Industry)
• Formed 80 plus eWGs to develop standards
• All Standards reviewed by FSSAI’s Scientific Panel
o Aligning Horizontal Standards - Worked to align Food Codex Category
System with current Food Product Standards from FSSR
o Harmonized Horizontal FCS Additive Standards with GMP Table –
Effective 16th Sep 2016 (FSS Seventh Amendment Regulations, 2016)
o FSSR Food Product (vertical) Standards aligned with Codex to be issued
o FCS provides framework for mapping these harmonized vertical
standards
o Aligning Vertical Standards – with existing Codex Commodity Standards
 FSSAI Labeling Regulation
• Food Safety and Standards (Packaging and Labelling)
Regulations, 2011
• Enlist mandatory labeling requirements for food
products
• Additional Labeling (Advisories)
• Mandatory
• Name of Product, Ingredient List, Veg / Non-Veg
Logo, Name/Address of Manufacturer (Importer – In
case of Imports), Net Content, FSSAI Logo with
License No., Nutrition Labeling (Big 4 plus sugar),
Best Before Date, Consumer Helpline & Email
• Flavour Labeling
• N, NI, A, Name of Fruit Flavour for all fruit containing
products & those with Artificial Flavours
• Ingredient / Additive / Product Specific Labeling
• Caffeine, Polyols, Polydextrose, Sat / Trans Fat
• Artificial Sweeteners – “Not Recommended for
Children”
Current Trends underpinning Future FSSAI Labelling Regulation
• HFSS Regulation and Labeling
• Safe and Nutritious Food @ Home
• Fortified Food
 Guideline Daily Amount (GDA) labeling
• Nutrition information of a Food Energy and other Nutrients

/Beverage
– In context to the daily dietary
requirement

• Informed choices on balancing

Percentage of Energy, Fat, Saturates, Sugars and Salt per portion of
their diet for consumers the Food vis-à-vis Daily Requirement

– by evaluating the energy and nutrient

contribution of a portion of a food
– as percentage of daily allowances for
these nutrients
 Draft Advertising & Claim Regulations - 2017
• Highlights
• Nutrition Claims
• Health Claims
• Non-Addition Claims
• Conditional Claims
• Prohibited Claims
• Approval of Claims
• FBOs need prior approval from FSSAI for
claims not defined
• Procedure outlined for submissions &
approval
• Noncompliance redressal Mechanism
• Food Advertising – will be under FSSAI’s
scrutiny
 Draft Packaging Regulations 2017
• Highlights
• Mandates safety requirements for all
primary food contact materials
• BIS Standards to be adopted under FSSAI
• OML / SML specified at par with global
norms
• Product – Packaging – Suggestive list
provided
• Expected inclusions
• Traceability of Packaging Materials
• Guidelines for FCM to be used by Food
Service (Home Delivery)
 Thank You
Emails: sadsule@coca-cola.com & sunilads2200@gmail.com