Regulations 11 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.
Regulation 11 of the Advertising and Claims Regulations, 2018 requires prior approval from the Food Authority for reduction of disease risk claims that are not already defined, with criteria, in these or other regulations. Regulation 12 sets out what the application must contain, the periods for scrutiny and reply, the speaking order, and what happens if a claim is rejected.
The text is read as amended up to 13 December 2022 (FSSAI Compendium Version IV dated 14.12.2022). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in. An FSSAI office order of 6 May 2026 provides that applications for approval of claims are submitted through the ePAAS single window system from 1 June 2026; this article does not describe the portal. Claim dossiers can be prepared through food product approval support.
A food business operator or marketer shall seek prior approval for reduction of disease risk claims other than those for which criteria are laid out in the Regulations (Schedule III) or elsewhere. The application goes with the applicable fees prescribed by FSSAI; deficiencies are informed within ninety days and the applicant replies within thirty days. The Food Authority passes a speaking order; a rejected claim cannot be used.
Regulation 11: which claims need approval
"The food business operator or marketer shall seek prior approval from the Food Authority for reduction of disease risk claims other than those that are defined and for which criteria are laid out under these regulations or any other regulations made under the Food Safety and Standards Act, 2006." So the approval route is for disease-risk claims that are not in Schedule III or another regulation. Health claims within the Schedules and other claims that meet the conditions in the Regulations do not need it. See our article on regulation 7 and the Schedules.
Regulation 12: the procedure
| Sub-reg. | What it says |
|---|---|
| 12(1) | The food business operator submits an application along with the applicable fees as prescribed by FSSAI, with seven items of information (below) |
| 12(2) | The Food Authority itself, or an agency or panel it appoints, carries out preliminary scrutiny |
| 12(3) | Deficiencies, if any, are informed to the applicant within ninety days from the date of receipt of the application; the applicant provides the information within thirty days of receipt of the communication, failing which the application is rejected without further reference |
| 12(4) | The fees paid shall not be refunded under any circumstances |
| 12(5) | After scrutiny the Food Authority may pass a speaking order for approval or rejection of the claims and may suggest an amendment to the claim |
| 12(6) | The amended claim may be submitted to the Food Authority within thirty days for reconsideration |
| 12(7) | In case of rejection, the food business operator or marketer shall not use that claim in advertising and marketing communication for articles of food offered for sale or for promotion of sale, supply, use or consumption |
The Regulations do not state the fee, and this article does not either.
What the application must contain (12(1))
- the claim to be made;
- the name of the ingredient, nutrient or substance on the basis of which the claim is made;
- the validated method of analysis of the ingredient or substance;
- scientific information or materials substantiating the claim;
- how the claim is clear and meaningful and helps consumers comprehend the information provided;
- well-designed human intervention studies in the case of health claims, conducted by or under guidance of established research institutions; and
- any other useful information.
These items track the general principles in regulation 4: truthful, meaningful, scientifically substantiated by validated methods. See general principles for claims.
Reading the periods
The periods point in different directions. The Food Authority has ninety days to inform deficiencies; the applicant then has thirty days to provide the information. The applicant has a further thirty days, after a speaking order that suggests an amendment, to resubmit the amended claim. The Regulations print no period within which the Food Authority must pass the speaking order itself, and this article does not supply one. The Regulations do not give any calendar computation and none is attempted here.
An invented example: Oat Valley wants to claim that its oat bran product reduces the risk of a particular disease in a way not listed in Schedule III. It prepares an application with the claim, the substance, a validated analysis method, scientific material and human intervention studies, and pays the prescribed fees. The Food Authority writes within ninety days about a missing study; Oat Valley replies within thirty days. The speaking order approves the claim with a suggested amendment in wording; Oat Valley resubmits the amended claim within thirty days if it wishes the Authority to reconsider it. If the claim is rejected, Oat Valley may not use it in any advertising or marketing communication.
Other approval routes
Claims are one of several prior approvals. For approval of non-specified food and ingredients, see our articles on regulation 4 of the Non-Specified Food Regulations and how to apply for product approval. The corrective advertisement and redressal provisions, which follow in the Regulations, are in regulations 13 to 15. The overview post is health and nutritional claims on food labels.
Need help with a claim approval?
A claim dossier is mostly evidence work: the method of analysis, the studies and the wording. Our food product approval team can help assemble the application and track it through scrutiny.
Key takeaways
- Prior approval is needed for reduction of disease risk claims not already defined with criteria.
- The application carries the prescribed fees and seven items of information.
- Deficiencies: informed within ninety days; reply within thirty days, or the application is rejected.
- A speaking order approves or rejects; an amended claim may be resubmitted within thirty days.
- A rejected claim cannot be used; fees are not refunded.
Read next
- Regulation 7 and Schedules II–IV: health claims
- Regulations 13–15: misleading claims and corrective advertisement
- Regulation 4 of the Non-Specified Food Regulations: approval procedure
- How to apply for product approval
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.