Regulations 1 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.
The first three regulations of the Non-Specified Food Regulations, 2017 say when they apply and who needs permission. A person may not manufacture or import any non-specified food or food ingredient except with the prior approval of the Food Authority. "Non-specified food" is any food, or any food ingredient including additives, processing aids and enzymes, for which no standard has been specified in any regulation under the Act.
This article reads the text as amended up to 11 October 2022 (FSSAI Compendium Version I dated 14.10.2022). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
Under regulation 3(1), no person shall manufacture or import any non-specified food or food ingredient except with the prior approval of the Food Authority. "Approval" is a permission to manufacture or import food or a food ingredient, intended directly or indirectly for human consumption, that has not been specified under any other regulation made under the Act. The Regulations are in addition to, and not in derogation of, other rules or regulations under the Act. Manufacturers and importers of new products and ingredients are affected. For help with approvals see food product approval support.
Regulation 1: title and commencement
Regulation 1 gives the title, the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, and says they come into force from the date of their publication in the Official Gazette. The principal notification is dated 11 September 2017, and the compendium's Note lists one amendment, the notification of 11 October 2022, which substituted regulation 4 on the procedure.
Regulation 2: the definitions
Regulation 2(1) defines four terms.
| Clause | Term | Meaning as printed |
|---|---|---|
| (a) | "Act" | the Food Safety and Standards Act, 2006 (34 of 2006) |
| (b) | "Approval" | a permission to manufacture or import any article of food or food ingredients, intended directly or indirectly for human consumption, that has not been specified under any other regulation made under the Act |
| (c) | "Food Authority" | the Food Safety and Standards Authority of India established under section 4 of the Act |
| (d) | "Non-specified food" | any food other than proprietary food or food ingredients, including additives, processing aids and enzymes, for which standards have not been specified in any regulation made under the Act |
Regulation 2(2) adds that words not defined but defined in the Act, rules or regulations carry those meanings.
Reading definition (d) closely
Definition (d) has three parts. It starts from "any food", then carves out proprietary food, and then brings in food ingredients, "including additives, processing aids and enzymes", for which standards have not been specified in any regulation under the Act. The test, in short, is whether a standard has been specified. A food with a standard in the Food Products Standards and Food Additives Regulations is not a "non-specified food" on that ground; a food with no standard anywhere in the regulations is.
Our post on section 22 of the FSS Act deals with proprietary food and related categories under the Act. The Regulations here name proprietary food only to exclude it from the definition, and say nothing more about it.
An invented example: Raagini Bakes develops a new bakery ingredient blend for which no regulation specifies a standard, and plans to manufacture it in India. Regulation 3(1) requires the prior approval of the Food Authority before it manufactures it. If the same blend was already covered by a standard in the Food Products Standards and Food Additives Regulations, it would not be a non-specified food and these Regulations would not be the route.
Regulation 3: prior approval
Regulation 3 is headed "Prior approval for manufacture, storage, sale, distribution, import, etc.". The operative text is shorter than the heading:
- 3(1) No person shall manufacture or import any non-specified food or food ingredient, as the case may be, except with the prior approval of the Food Authority.
- 3(2) The provisions of these Regulations are in addition to, and not in derogation of, any other rules or regulations made under the Act.
Two features are worth noting. The verbs in 3(1) are "manufacture or import". The heading mentions storage, sale and distribution as well, but the printed sub-regulation names only manufacture and import. And 3(2) means approval under these Regulations does not displace other requirements: the product must still meet the other rules, such as labelling and licensing. Regulation 4(12), explained in our next article, says the food business operator shall, after grant of approval, apply for a licence under the Licensing and Registration Regulations, 2011.
What happens after regulation 3
Regulation 4 sets the procedure for the application, scrutiny, expert review, decision, appeal and revocation; see our article on the approval procedure under regulation 4. Form I is the application and Form II the decision; both are described by heading in our article on Form I and the dossier. An FSSAI office order of 6 May 2026 provides that applications of this kind go through the ePAAS single window; the order is administrative and changes none of the text of these Regulations.
Who is affected
- Manufacturers of foods or ingredients with no specified standard.
- Importers of such foods or ingredients, who must also hold the import licence described in the Import Regulations, 2017; see our article on the import licence.
- Additive, processing aid and enzyme suppliers whose products have no standard in the regulations.
For a general overview see approval for non-specified food and ingredients. For novel food, see the topic post on the novel food approval process.
Need help with prior approval?
Working out whether a product is "non-specified" is the first and often the hardest step. Our food product approval service helps manufacturers and importers test their product against the definition and prepare for the approval route.
Key takeaways
- Manufacture or import of a non-specified food or ingredient needs prior approval of the Food Authority.
- "Non-specified food" is food or an ingredient, including additives, processing aids and enzymes, for which no standard has been specified in any regulation under the Act; proprietary food is carved out.
- The Regulations are in addition to other rules and regulations.
- Regulation 4 (procedure) was substituted by the notification of 11 October 2022.
Read next
- Regulation 4: approval procedure
- Form I and Annexures: the application dossier
- Approval for non-specified food and ingredients under FSSAI
- Section 22, FSS Act: genetically modified, organic, functional and proprietary foods
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.