Fortified Food explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulations 5 to 8 of the Fortification of Foods Regulations, 2018 impose the general obligations on those who fortify food: a twice-yearly quality assurance undertaking, compliance with the rest of the food law, packaging and label requirements (the "fortified with" words, the logo and an iron statement), and a promotion role for the Food Authority.
The text is read as amended up to 22 September 2021 (FSSAI Compendium Version V dated 01.06.2022). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in. Brand owners can have the label checked through FSSAI label compliance.
Every manufacturer and packer of fortified food must give an undertaking on quality assurance twice a year, backed by laboratory certification and records. Every package must carry the words "fortified with ... (name of the fortificant)" and the logo specified in Schedule-II, except iodised salt fortified with iodine. Iron-fortified food must carry a statement for people with thalassemia and sickle cell anaemia.
Regulation 5: quality assurance
Regulation 5(1): every manufacturer and packer of fortified food shall give an undertaking on quality assurance and submit evidence of steps taken to the Food Authority or such other authority as it designates. Regulation 5(2) says the undertaking "shall be given twice a year" and shall include:
| Clause | Content |
|---|---|
| (a) | certification by a food laboratory notified by the Food Authority that the fortified food complies with the Act and the regulations and standards |
| (b) | up-to-date record keeping and continuous inventory of fortificants used, including the source of procurement |
| (c) | appropriate monitoring procedures at different stages of manufacturing or packing |
| (d) | random testing of fortificants and fortified food |
| (e) | regular audit of technical equipment and processes |
| (f) | such good manufacturing practices as the Food Authority may specify from time to time |
| (g) | provisions for the reference of the purity criteria of micronutrients generally accepted by pharmacopoeias (Indian Pharmacopoeia, British Pharmacopoeia, Food Chemical Codex, the Joint FAO/WHO Expert Committee on Food Additives or Codex Alimentarius), which food business operators may adopt |
Clause (a) turns on a notified laboratory; our article on recognition of laboratories explains how laboratories are recognised and notified.
Regulation 6: the rest of the law
All fortified food, "whether voluntarily fortified or required to undergo mandatory fortification", must be manufactured, packed, labelled, handled, distributed and sold, "whether for profit or under a Government-funded programme", only in compliance with the standards under the Act and its regulations. So fortification does not displace the product standard of the food being fortified.
Regulation 7: packaging and labelling
- 7(1) All fortified food shall be packaged in a manner that takes into consideration the nature of the fortificant added and its effect on the shelf life of the food.
- 7(2) Every package shall carry the words "fortified with ………… (name of the fortificant)" and the logo specified in Schedule-II on its label. It may also carry a tag line "Sampoorna Poshan Swasth Jeevan" under the logo. A proviso says sub-regulation (2) is not required for iodized salt when fortified with iodine.
- 7(3) The provisions of the Packaging and Labelling Regulations, 2011 shall also apply to fortified foods. Those Regulations have been replaced by the Packaging Regulations, 2018 and the Labelling and Display Regulations, 2020; see our articles on packaging and labelling.
- 7(4) (inserted) Every package of food fortified with iron shall carry the statement "People with Thalassemia may take under medical supervision and persons with Sickle Cell Anaemia are advised not to consume iron fortified food products."
- 7(5) Manufacturers and packers complying with the law on fortified food are permitted to make a nutrition claim for an article of fortified food under the (2011) Packaging and Labelling Regulations; the current claims rules are in our article on advertising and claims.
The logo itself is a graphic shown in Schedule-II, with the printed words "Fortified with ...." and "Sampoorna Poshan Swastha Jeevan" in the compendium image; the Labelling and Display Regulations also deal with fortified-food logos, covered in our article on Schedule I: fortified and organic logos. The text of regulation 7 does not describe the logo's shape or size.
Regulation 8: promotion by the Food Authority
Regulation 8(1) directs the Food Authority to take steps to encourage production, manufacture, distribution, sale and consumption of fortified food, including fortification through conventional breeding or hybridization, in cooperation with the Government of India and State and Union Territory departments. Regulation 8(2) lists what it shall endeavour to do: advise and promote fortified food in Government-funded food distribution programmes; organise awareness and advocacy campaigns; give technical assistance to small manufacturers; and equip notified laboratories and research institutions to analyse the nutrients in fortified food. These are duties of the Authority and create no direct obligation for a business.
An invented example: Surya Edible Oils fortifies its refined oil and sells it in retail packs. Each pack must carry the "fortified with" words naming the fortificants, the Schedule-II logo, and the usual labelling. Surya's plant gives its quality assurance undertaking twice a year, attaching a notified laboratory's certificate and the fortificant inventory. If it also sold double fortified salt with iron, the iron statement in 7(4) would apply to that pack.
Practical points
The quality assurance duty is by manufacturers and packers, so a brand owner that outsources packing should check what undertaking each packer gives. The Food Authority decides to whom the undertaking is sent. The Regulations do not print a format or fee, and this article states none. For the standards that the undertaking is judged against, see the first part of the series on regulations 1 to 4 and the Schedule I article.
Need help with fortified food labels?
A fortified pack carries more than a usual one: the fortificant words, the logo, any iron statement and the nutrition claim rules. Our FSSAI label compliance service can review the artwork and the quality assurance file together.
Key takeaways
- A quality assurance undertaking is due twice a year from every manufacturer and packer of fortified food.
- Labels carry "fortified with ... (name of the fortificant)" and the Schedule-II logo; iodised salt (iodine) is exempt from this requirement.
- Iron-fortified packs carry the statement on thalassemia and sickle cell anaemia.
- The Food Authority's promotion duties are in regulation 8.
Read next
- Regulations 1–4: principles and micronutrient standards
- Schedule I: salt, oil, milk, atta, maida and rice
- Schedule I of Labelling and Display: fortified and organic logos
- Food fortification and the plus F logo
Disclaimer: Based on the FSSAI regulations named above as consolidated in FSSAI's compendium versions or as published in the Gazette, with the later notifications the article names (consulted on fssai.gov.in on 2-3 October 2026). Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.