FSSAI (Food Safety and Standards Authority of India) Act and Rules: brief overview and aspects related to the manufacture, storage, sale, and labeling of Food Supplements. Subject Pharmacy Law and Ethics.

FSSAI (Food Safety and Standards Authority of India) Act and Rules: brief overview and aspects related to the manufacture, storage, sale, and labeling of Food Supplements

FSSAI (Food Safety and Standards Authority of India) Act and Rules: brief overview

Aim:

1. To regulate the manufacture, storage, distribution, sale, and import of food articles,

2. To ensure the availability of safe and wholesome food for human consumption

The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards, 2006. FSSAI has been created to frame science-based standards for food and to regulate their manufacture, storage, distribution, sale, and import.

A brief overview of the Food Safety and Standard Act, 2006, and Rules 2011.

It consolidates various acts & orders that handled food-related issues in various Ministries and Departments such as Various central Acts like the 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 1988, Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control) Order, 1967, Milk and Milk Products Order, 1992 etc. These all are included in Food Safety and Standards, 2006.

Establishment of the Food Safety and Standards Authority of India:

The Central Government established the Food Safety and Standards Authority of India to exercise the powers and functions assigned to it under this Act. The head office of the Food Authority is in Delhi. The Food Authority may establish its offices at any other place in India.

Composition and Qualification: It consists of a Chairperson and the following twenty-two members. Out of them, one-third shall be women.

1. Ex Officio members: Seven Members, not below the rank of a Joint Secretary to the Government of India. They will be appointed by the Central Government from the following departments: Agriculture, Commerce, Consumer Affairs, Food Processing, Health, Legislative Affairs, Small Scale Industries,

2. Two representatives from the food industry of which one shall be from small-scale industries;

3. Two representatives from consumer organizations;

4. Three eminent food technologists or scientists;

5. Five members to be appointed by rotation every three years, representing the States and the Union territories;

6. Two persons to represent farmers’ organizations;

FSSAI under Food Safety and Standards, 2006 (FSS Act, 2006) performs the following functions:

1. Standards and guidelines: Lay down the Standards and guidelines about articles of food.

2. Accreditation of certification bodies: Lay down mechanisms and guidelines for accreditation of certification bodies issuing certification of food safety management systems for food businesses.

3. Accreditation of laboratories: Lay down procedure and guidelines for accreditation of laboratories.

4. Advice and Technical Support: Provide scientific advice and technical support to Central Government and State Governments in the matters of framing the policy and rules related to food safety and nutrition.

5. Collect data regarding food consumption, the incidence of biological risk, contaminants in food products, identification of emerging risks and introduction of rapid alert system.

6. Information Network: Create an information network across the country to receive rapid, reliable, and objective information about food safety.

7. Training programs: Provide training programs for persons involved or who wish to be involved in food businesses.

8. International Technical Standards: Contribute to the development of international technical standards for food and sanitary standards.

9. Food standards: Promote general awareness about food safety and food standards.

Aspects related to the manufacture, storage, sale, and labeling of Food Supplements

GENERAL PROVISIONS AS TO ARTICLES OF FOOD: Use of food additive or processing aid.

• 1. No article of food shall contain any food additive or processing aid unless it is by the provisions of this Act and regulations.

• 2. Contaminants, naturally occurring toxic substances, heavy metals, etc.: No article of food shall contain any contaminant, naturally occurring toxic substances toxins, hormones, or heavy metals in excess of such quantities as may be specified by regulations.

• 3. Pesticides, veterinary drug residues, antibiotic residues, and microbiological counts: No article of food shall contain insecticides or pesticide residues, veterinary drug residues, antibiotic residues, solvent residues, pharmacologically active substances, and micro-biological counts over tolerance limit as may be specified by regulations.

• 4. No insecticide shall be used directly on an article of food except fumigants registered and approved under the Insecticides Act, 1968 (46 of 1968)

• 5. Genetically modified foods, organic foods, functional foods, proprietary foods, etc.– No person shall manufacture, distribute, sell, or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify in this behalf.

• 6. Packaging and labeling of foods. No person shall manufacture, distribute, sell, or expose for sale or dispatch or deliver to any agent or broker for sale, any packaged food products which are not marked and labeled in the manner.

  • · The labels shall not contain any statement, claim, design, or device which is false or misleading.

  • · Every food business operator shall ensure that the labeling including their shape, appearance, or packaging, the packaging materials used, and the information does not mislead consumers.

  SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY:

• 1. Every food business operator shall ensure that the articles of food satisfy the requirements of this Act and the rules at all stages of production, processing, import, distribution, and sale within the businesses under his control.

• 2. No food business operator shall himself or by any person on his behalf manufacture, store, sell, or distribute any article of food

  • · Which is unsafe; or which is misbranded or sub-standard or contains extraneous matter; or for which a license is required, or

  • · Which is for the time being prohibited by the Food Authority or the Central Government or the State Government in the interest of public health; or

  • · In contravention of any other provision of this Act or of any rule or regulation

• 3. No food business operator shall employ any person who is suffering from an infectious or contagious disease.

• 4. No food business operator shall sell or offer for sale any article of food to any vendor unless he also gives a guarantee in writing the nature and quality of such article to the vendor. Bill, cash memo, or invoice of the sale of any article of food given by a food business operator to the vendor shall be deemed to be a guarantee even if a guarantee is not included in the bill, cash memo, or invoice.

• 5. Any unsafe food is part of a batch, lot, or consignment of food, it shall be presumed that all the food in that batch, lot or consignment is also unsafe.

  Liability of manufacturers, packers, wholesalers, distributors, and sellers.

• 1. The manufacturer or packer of an article of food shall be liable if it does not meet the requirements of this Act and the rules.

• 2. The wholesaler or distributor shall be liable under this Act for any article of food which is

  • · Supplied after the date of its expiry; or

  • · Stored or supplied in violation of the safety instructions of the manufacturer; or

  • · Unsafe or misbranded; or

  • · Unidentifiable manufacturer from whom the food has been received; or

  • · Stored or handled or kept in violation of the provisions of this Act, the rules or

  • · Received by him with knowledge of being unsafe

• 3. The seller shall be liable under this Act for any article of food which is

  • · Sold after the date of its expiry; or

  • · Handled or kept in unhygienic conditions; or

  • · Misbranded; or

  • · Unidentifiable of the manufacturer or the distributors from whom such articles of food were received; or

  • · Received by him with knowledge of being unsafe.

  Food recall procedures.

• 1. If a food business operator has reasons that a food processed, manufactured, or distributed does not comply with this Act or the Rules, he shall immediately initiate procedures to withdraw the food from the market and consumers indicating reasons for its withdrawal and inform the competent authorities.

• 2. A food business operator shall immediately inform the competent authorities and co-operate with them if he has reasons that a food that he has placed on the market may be unsafe for the consumers.

• 3. The food business operator shall inform the competent authorities of the action taken to prevent risks to the consumer.

• 4. The food business operator shall not prevent or discourage any person from co-operating, to prevent, reduce, or eliminate a risk arising from a food.

• 5. Every food business operator shall follow conditions and guidelines relating to food recall procedures as the Food Authority may specify by regulations.