Food21 means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption; and includes primary food, genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting.

Legal Framework

In India, the food industry was earlier governed by various laws and regulations. The first legislation which dealt with food safety in India was the Prevention of Food Adulteration Act, 1954. It regulated the laws of the food industry along with other laws and regulations viz. the Fruit Product Order of 1955, the Meat Food Products Order of 1973, the Vegetable Oil Products (Control) Order of 1947, the Edible Oils Packaging (Regulation) Order of 1998, the Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order of 1967 and the Milk and Milk Products Order of 1992. Different laws relating to food were enacted under different Ministries, GOI, each having its own rules and regulations. This created many confusions in the minds of consumers, traders, manufactures and investors. There was a strong need for a comprehensive law to deal with such confusions and complexities in laws governing food industry in India. Accordingly, in order to bring uniformity and a single reference point for all issues in relation to food industry, the Food Safety and Standards Act, 2006 (FSS Act) was enacted in the same year. The FSS Act overrides all existing laws relating to food industry which were in force prior to 2006.

The FSS Act has been enacted with a purpose to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India (FSSAI) with primary objective of laying down science=based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, in order to ensure availability of safe and wholesome food for human consumption.

In addition to the FSS Act, the Food Safety and Standards Rules, 2011, and several Regulations as listed below, are also applicable to food industry in India:

  1. Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011
  2. Food Safety and Standards (Packaging and Labelling) Regulations, 2011
  3. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011
  4. Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011
  5. Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011
  6. Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011

Compliances under the FSS Act and rules & regulations made thereunder

Any person carrying on the business of manufacture, packing, sale, storage or transport of food is called as Food Business Operator (FBO). Such FBOs are responsible for ensuring the compliances of the FSS Act, rules and regulations made thereunder. The summary of such compliances under the FSS Act are as under:

  1. Compliance with respect to Licensing and Registration:

    • Any person carrying on the business of manufacture, packing, sale, storage or transport of food i.e. Food Business Operators require either a Registration or a License under the FSS Act to carry on the business of manufacture, packing, sale, storage or transport of food.
  2. Food Business Operators need to comply with the following conditions at all times during the course of Food Business:

    • To display a true copy of the license granted in Form C at a prominent place in the premises where Food Business is carried on.
    • To give necessary access to licensing authorities and/or their authorized personnel to the premises.
    • To inform authorities about any change or modifications in activities relating to Food Business.
    • To employ at least one technical person to supervise the production process.
    • To furnish periodic annual return i.e. for the period 1st April to 31st March, on or before 31st May of each year.
    • To ensure that no product other than the product indicated in the license /registration is produced in the unit.
    • To maintain factory's sanitary and hygienic standards as prescribed.
    • To maintain daily records of production, raw materials utilization and sales separately.
    • To ensure that the source and standards of raw material used are of best quality.
    • To ensure clean-in-place system (whatever necessary) for regular cleaning of machines & equipments.
    • To ensure testing of relevant chemical and/ or microbiological contaminants in food products in accordance with the regulation to ensure production and delivery of safe food through own or NABL accredited /FSSAI recognized laboratories at least once in every six month.
    • To ensure that as much as possible the required temperature shall be maintained throughout the supply chain from the place of procurement or sourcing until it reaches the end consumer including chilling, transportation, storage etc.
  3. Compliances with respect to Sanitary & Hygiene Requirements:

    • Premises to be clean, adequately lighted, ventilated
    • Floor, walls, ceiling to be in sound condition
    • Floor and skirted walls to be washed daily with disinfectant
    • Lay-out of the premises should be such that there is no cross-contamination
    • Floor, walls to be made of impervious, non-absorbent, washable material
    • Premises to be kept free from all insects
    • Water used in manufacturing (food handling, washing, processing, cooking) to be potable, meeting BIS standards
    • Workers in processing and preparation to use clean aprons, hand gloves, head wears
    • No person employed should be suffering from infectious disease
    • Workers to have finger nails trimmed, clean.
    • Vehicles used to transport food must be kept in good repair and kept clean.
    • Display board mentioning do's and don'ts to be displayed
    • Segregation of raw material, processed, rejected, recalled products – suitable marking
    • FIFO norms to be followed for raw material, ingredients, WIP, finished products
    • Detailed SOP to be developed for proper management
  4. Ensuring Compliance that the food is Not

    • Unsafe;
    • Misbranded; or
    • Substandard.
  5. Compliance with respect to Label Declaration.

    • Every FBO to ensure that the labelling of foods should conform to the regulations and does not mislead the consumers.

Offences and Penalties

Where an offence under the FSS Act has been committed by a company and/or every person (who at the time the offence was committed) in charge of and responsible to the company for the conduct of the business of the company, such persons and the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly as per provisions of the FSSA. However, in case it is proved that the offence has been committed without the consent or connivance of or is not attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall not be deemed to be guilty of that offence and shall not be liable to be proceeded against and punished accordingly.

Penalties and punishments under the FSS Act are presented below :

Penalty for selling food not of the nature or substance or quality demanded Upto Rs. 2 Lakhs
Penalty for sub-standard food

Upto Rs. 5 Lakhs

Penalty for  misbranded food Upto Rs. 3 lakhs
Penalty for misleading advertising Upto Rs. 10 Lakhs
Penalty for food containing extraneous matter Upto Rs. 1 Lakh
Penalty for failure to comply with the directions of Food Safety Officer Upto Rs. 2 Lakhs
Penalty for unhygienic or unsanitary processing or manufacturing of food Upto Rs. 1 Lakh
Penalty for possessing adulterant Upto Rs. 2 Lakhs (in case adulterant is not injurious to health) Upto Rs. 10 Lakhs (in case adulterant is injurious to health)
Penalty for contraventions for which no specific penalty is provided Upto Rs. 2 Lakhs
Punishment for unsafe food Imprisonment upto 6 months and fine upto Rs. 1 lakh (for non- injurious)

Imprisonment upto 1 year and fine upto Rs. 3 lakh (for non-grievous injury)

Imprisonment upto 6 years and fine upto Rs. 5 lakh (for grievous injury)

Imprisonment for term not less than 7 years but can extend to imprisonment for life and fine not less than Rs. 10 lakh (in case such failure or contravention results in death)
Punishment for interfering with seized items Imprisonment upto 6 months and fine upto Rs. 2 lakh
Punishment for false information Imprisonment upto 3 months and fine upto Rs. 2 lakh
Punishment for obstructing or impersonating a Food Safety Officer Imprisonment upto 3 months and fine upto Rs. 1 lakh
Punishment for carrying  out a business without license Imprisonment upto 3 months and fine upto Rs. 1 lakh
Punishment for subsequent offences twice the punishment which might have been imposed on a first conviction; and a further fine on daily basis which may extend upto Rs. 1 Lakh where the offence is continuing one; and cancellation of license.

In addition to the punishment and penalties provided under the FSS Act, Section 272 of the Indian Penal Code also provides penalties for Adulteration of food or drink intended for sale. Accordingly, if any person who adulterates any article of food or drink, so as to make such article noxious as food or drink, intending to sell such article as food or drink, or knowing it to be likely that the same will be sold as food or drink, shall be punished with imprisonment of either description for a term which may extend to 6 months, or with fine which may extend to Rs.1000/-, or with both.


21. As per definition provided under the Food Safety and Standards Act, 2006

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.