8. FSSAI Act and Rules: A Complete Guide to Food Safety and Standards Authority of India

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA (FSSAI): A TEACHER’S COMPREHENSIVE GUIDE TO FSS ACT, RULES, AND REGULATIONS

Welcome, future pharmacists and healthcare professionals!

As a pharmacy law and ethics educator with years of experience teaching food safety regulations, I have observed that understanding the Food Safety and Standards Authority of India (FSSAI) is essential for anyone involved in the food and pharmaceutical industries. 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.

In this comprehensive guide, I will take you through the duties and functions of FSSAI, the Food Safety and Standards Act, 2006, manufacture and storage of food supplements, sale of food supplements, labelling requirements, Food Safety and Standards Rules, 2011, and the role of the Food Safety Officer. By the end of this article, you will have a thorough understanding of the food safety regulatory framework in India. Let us begin.

DUTIES OF FSSAI

The Food Safety and Standards Authority of India performs several important duties to ensure food safety in the country:

1. Prescribing Standards and Guidelines for food and appropriate enforcement systems.
2. Specifying limits for Additives, Contaminants, Pesticides and 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

The FSSAI performs several key functions to regulate the food industry:

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

A TEACHER’S REGULATORY INSIGHTS

Over my years of teaching food safety regulations, I have developed a few key insights that I always share with my students:

• FSSAI plays a crucial role in ensuring food safety in India. Understanding its functions and duties is essential for anyone involved in the food or pharmaceutical industries.
• The Food Safety and Standards Act, 2006, provides a comprehensive framework for food regulation, covering everything from manufacturing standards to labelling requirements.
• Food supplements are regulated under specific regulations, and manufacturers must comply with documentation, production, storage, and labelling requirements.
• The Food Safety Officer plays a critical role in enforcing food safety regulations through inspections, sampling, and investigations.

FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is FSSAI?

FSSAI is the Food Safety and Standards Authority of India, established in 2008 under the Ministry of Health and Family Welfare to regulate food safety and standards in India.

2. What is the Food Safety and Standards Act, 2006?

The FSS Act, 2006 is the governing legislation that establishes FSSAI and provides the regulatory framework for food safety and standards in India.

3. What are the main functions of FSSAI?

FSSAI’s main functions include creating rules and standards for food manufacturing, issuing licenses, testing food quality, conducting audits, raising public awareness, and maintaining records.

4. What is required on the label of pre-packaged foods?

Pre-packaged food labels must include food name, ingredients list, nutrient information, veg/non-veg declaration, manufacturer’s name and address, quantity, batch identification, manufacturing date, expiry date, and country of origin for imported food.

5. What are the qualifications of a Food Safety Officer?

A Food Safety Officer must have a degree in Food Technology, Dairy Technology, Biotechnology, Oil Technology, Agricultural Science, Veterinary Sciences, Bio-Chemistry, Microbiology, or Masters Degree in Chemistry, or a Degree in Medicine from a recognised university.

6. What are the powers of a Food Safety Officer?

A Food Safety Officer can seize adulterant or unsafe food, seal premises for investigation, and cause examination of persons suspected of harbouring infectious disease.

7. What are the labelling requirements for food supplements?

Food supplements must be labelled with “HEALTH SUPPLEMENT” or “NUTRACEUTICAL”, advisory warning “NOT FOR MEDICINAL USE”, disclaimer “NOT A SUBSTITUTE FOR A BALANCED DIET”, and other specific information.

SUMMARY

The Food Safety and Standards Authority of India (FSSAI) plays a crucial role in ensuring food safety in India through the Food Safety and Standards Act, 2006, and the Food Safety and Standards Rules, 2011. FSSAI prescribes standards, specifies limits for contaminants, lays down labelling standards, and promotes food safety awareness. The manufacture, storage, and sale of food supplements are regulated under specific regulations. Food Safety Officers enforce these regulations through inspections, sampling, and investigations. Understanding the FSSAI regulatory framework is essential for anyone involved in the food and pharmaceutical industries.

As I always tell my students: “Food safety is not just about compliance—it is about protecting public health. Every food business operator has a responsibility to ensure that the food they produce or sell is safe for consumption.”

REFERENCES AND FURTHER READING

• Food Safety and Standards Act, 2006. Government of India.
• Food Safety and Standards Rules, 2011. Government of India.
• Food Safety and Standards Authority of India (FSSAI). (2022). Food Safety Regulations and Guidelines. Retrieved from https://www.fssai.gov.in.
• Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016. FSSAI.
• Ministry of Health and Family Welfare. (2022). Food Safety Resources. Government of India.

Disclaimer: This article is for educational purposes only and does not constitute legal advice. Always refer to the latest regulatory guidelines and consult legal experts for compliance matters.