8. FSSAI ACT AND RULES

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA (FSSAI)

Food Safety and Standards Authority of India was established in 2008 under the aegis of the Ministry of Health and Family Welfare with the mandate for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption. The Chairperson and Chief Executive Officer of FSSAI are appointed by the Central Government. The Head office is located at FDA Bhawan, Kotla Road, New Delhi.

DUTIES OF FSSAI

1. Prescribing Standards and Guidelines for food and appropriate enforcement systems.
2. Specifying limits for Additives, Contaminants, Pesticides & Veterinary Drug Residues, Heavy Metals, Processing Aids, Mycotoxins, Antibiotics, and Irradiated Foods.
3. Laying down food labelling standards including health/nutrition claims, special dietary uses, and food category systems.
4. Laying down methods of sampling, analysis, and exchange of information among enforcement agencies.
5. Taking up, summarising, and analysing scientific/technical data on biological/emerging risks and residues.
6. Promoting general awareness about food safety and standards, and coordinating international work on food standards.

FUNCTIONS OF FSSAI

1. Creating Rules and Standards for food manufacturing enterprises.
2. Issuing License – certificate and license for any food-related business.
3. Testing the Food Standard and quality produced by registered businesses.
4. Conducting Regular Audits of food manufacturing and production companies.
5. Raising Public Awareness of Food Safety and hygienic food.
6. Maintaining Records and Data of all registered organisations.
7. Keeping the Government Updated on any threat pertaining to food safety.

FOOD SAFETY AND STANDARDS ACT, 2006

Salient Features of FSS Act

1. Decentralisation of licensing; empowers States to issue Registration and State license.
2. Effective, transparent and accountable regulatory framework with well-defined functions, powers and responsibilities.
3. Emphasis on shifting from regulatory regime to self-compliance.
4. Regulation of food imported into the country.
5. Provision for food recall.
6. Surveillance mechanism.
7. Large network for food laboratories.
8. Novel justice dispensation system for fast track disposal of cases.
9. Consistency between domestic and international food policy measures.
10. Training and awareness programs for food safety.

MANUFACTURE OF FOOD SUPPLEMENTS

Documentation

• Product-Specific Documentation: Master Formula, Master Method/Master Manufacturing Instructions, and related Standard Operating Procedures.
• General Manufacturing Documentation: Plant operating instructions, procedures for stoppages/breakdowns, and procedures for foreign body contamination.

Production

• Work area and equipment must be clean before manufacturing.
• Production staff must follow well-defined authorised procedures.
• Deviations require prior agreement and must be recorded.
• Personnel should immediately report contamination incidents.
• Operation details recorded in Lot Manufacturing Record or Lot Packaging Record.
• Materials and equipment must be labelled with product name, strength, lot number, and status.
• Status labels must show previous product manufactured and cleaning status.

STORAGE OF FOOD SUPPLEMENTS

Key Requirements

• Items conveniently available for load assembly.
• Aisles and assembly areas designed for unrestricted access.
• Proper stock rotation (First In, First Out – critical for short-life products).
• Maximum use of available space.
• Proper stacking considering safety.
• Aisles kept clear; no temporary material storage.
• Pallets placed systematically with adequate distance for ventilation.
• Regular visual inspection of pallets for structural integrity.
• Corner boards for visibility and impact protection.
• All materials/products correctly tagged with identification/lot number for traceability.

Damaged Goods Storage

• Damaged goods must be deposited in a designated area immediately.
• Avoid exposure to contamination or infestation.
• Damaged items that cannot be repackaged must be handled to prevent re-entry into distribution chain.
• Repackaging allowed only after thorough inspection.
• Multiple manufacturing codes repackaged together must be labelled with the oldest “Best Before” date.

SALE OF FOOD SUPPLEMENTS

A licence is required for a Food Business Operator (FBO) who wants to manufacture or sell food supplements under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016.

Key Points

• Food supplements available in powder, capsule, tablet, and syrup forms.
• Plants or botanicals in natural state NOT considered food supplements.
• Supplements must be formulated according to established medical principles with reliable data support.
• Hormones, steroids, and psychiatric medicines are PROHIBITED.

Labelling Requirements

• “HEALTH SUPPLEMENT” or “NUTRACEUTICAL” (as applicable)
• “FOOD FOR SPECIAL DIETARY USE” / “FOOD FOR SPECIAL MEDICAL PURPOSE” / “PROBIOTIC FOOD” (as applicable)
• Advisory warning: “NOT FOR MEDICINAL USE”
• Goal, substance, and target age group of supplement
• Disclaimer: “NOT A SUBSTITUTE FOR A BALANCED DIET”

LABELLING OF PRE-PACKAGED FOODS

Required Information

• Food name (trade name or description)
• Ingredients list
• Nutrient information
• Veg or Non-veg declaration
• Food additives used
• Manufacturer’s name and complete address
• Total quantity
• Lot/Code/Batch identification
• Manufacturing or packaging date
• Expiry date (Best Before and Use By date)
• Country of origin for imported food
• Useful instructions

Specific Restrictions on Product Labels

• No references to the Act or conflicting laws.
• No terms suggesting medical advice.
• No terms showing imitation without permission.
• Fruit products must contain prescribed amounts of fruit juice/pulp.
• Products without prescribed fruit content must be labelled “ADDED (NAME OF FRUIT) FLAVOURED”.
• Products with only fruit flavours shall use “(NAME OF FRUIT) FLAVOUR”.
• Carbonated water without fruit juice shall not mislead as fruit product.
• Vitamin C enriched fruit/vegetable products must contain at least 40mg ascorbic acid per 100gm.
• Imitations shall not be labelled as “pure”.

FOOD SAFETY AND STANDARDS RULES, 2011

The Food Safety and Standards Act, 2006 under Section 91 empowers the Central Government to make rules by notification in the Official Gazette. The Central Government notified the Food Safety and Standards Rules in 2008 and subsequently comprehensive Food Safety and Standards Rules 2011 to regulate various subjects.

FOOD SAFETY OFFICER (FSO)

Qualifications of FSO

• Degree in Food Technology / Dairy Technology / Biotechnology / Oil Technology / Agricultural Science / Veterinary Sciences / Bio-Chemistry / Microbiology
• OR Masters Degree in Chemistry
• OR Degree in Medicine from a recognised University
• OR any other equivalent/recognised qualification notified by Central Government
• Has successfully completed training as specified by the Food Authority

Powers of FSO

• Seize adulterant or unsafe/sub-standard/misbranded food
• Seal premises for investigation after taking sample
• Cause examination by qualified medical professional of persons suspected of harbouring infectious disease

Duties and Functions of FSO

1. Inspect all food establishments in assigned area.
2. Ensure licence conditions are complied with and report to Designated Officer.
3. Procure and send samples for analysis of food in contravention of the Act.
4. Draw samples for surveillance, survey, and research (not for prosecution).
5. Investigate complaints in writing regarding contravention of the Act.
6. Maintain database of all Food Business within assigned area.
7. Recommend Designated Officer to issue improvement notices.
8. Maintain record of all inspections and action taken.
9. Make inquiries and inspections to detect contravention of the Act.
10. Stop and inspect vehicles suspected to contain unsafe food intended for sale.

SUMMARY TABLE

Particular	Details
Establishment Year	2008
Parent Ministry	Ministry of Health and Family Welfare
Head Office	FDA Bhawan, Kotla Road, New Delhi
Governing Act	Food Safety and Standards Act, 2006
Rules	Food Safety and Standards Rules, 2011
Regulations (2016)	Health Supplements, Nutraceuticals, FSDU, FSMP, Functional Food, Novel Food