Regulations 11 and 12 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 lets the Food Authority adopt a risk-based framework for clearing imported food: it profiles importers and products, sets sampling frequency, may introduce a Pre-Arrival Document Review, issues food alerts and requires every importer to file a recall plan. Regulation 12 gives the Authority power to prohibit or restrict import of any article of food on risk perception or outbreak of disease.
This article reads the text as amended up to 27 October 2025 (FSSAI Compendium Version VII dated 06.11.2025). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
The Food Authority may review the risks associated with food imports from time to time and adopt a risk-based framework and inspection process. Every importer shall submit a recall plan as per the Food Recall Procedure Regulations, and if he fails to do so the licence may be cancelled or suspended; the Food Authority may prohibit or restrict the import of any article of food based on risk perception or outbreak of disease, and a Food Importer who does not comply with an order may have the import licence cancelled. Importers, customs agencies and exporters to India are affected. For help with licensing and compliance see FSSAI import licence support.
Regulation 11: the risk-based framework
| Sub-reg. | Rule as printed (summary) |
|---|---|
| (1) | the Food Authority may review risks associated with food imports from time to time and adopt a risk-based framework and risk-based inspection process for clearance |
| (2)(a) | the Authority shall profile the importer, custom house agent, manufacturer of the imported product, imported product, country of origin, source country of the consignment, port of entry, history of compliance and any other parameters it deems fit for assessing risk |
| (2)(b) | the importer shall submit a certificate of sanitary export from authorised agencies in exporting countries for the categories of food the Authority may specify |
| (3) | the Authority may specify the sampling frequency for different categories of food products |
| (4) | the Authority may introduce Pre-Arrival Document Review for regulating imports |
| (5) | in consultation with the concerned Ministry, the Authority may enter into a Memorandum of Agreement with relevant agencies in exporting countries on a reciprocal basis to facilitate ease of doing business and accelerated clearance |
| (6) | the Authority may identify laboratories in exporting countries for prior testing of samples before the food is imported into India |
| (7) | the Authority may issue food alert notifications, including time-bound prohibition on articles of food or prohibiting a source, or recalls, based on risk |
| (8) | every importer shall submit a recall plan as per the regulations on food recall procedures, specifying the contingency plan for traceability, failing which the licence may be cancelled or suspended |
| (9) | the food alert notification shall immediately be informed to the Risk Management System of the customs department |
| (10) | the alert remains in force until the Authority is satisfied the risk is no longer prevailing or control measures are in place and confirmed by test reports |
| (11) | during the alert, the Authority may order additional tests at the point of entry, mandatory certification from the exporting countries or channelisation, as it deems fit |
| (12) | Government agencies shall conduct post clearance surveillance of all food imports, including random checks and providing relevant documents to support the declarations to Customs |
Sub-regulation (2) was inserted by the notification of 7 February 2018 (footnote 1). "Pre-arrival document scrutiny" and "risk based random sampling" are defined in regulation 2; see our article on the definitions.
What the framework means in practice
The framework is permissive for the Authority: most sub-regulations say "may". The firm duties fall on the importer in sub-regulation (2)(b) (a sanitary export certificate for categories the Authority specifies) and (8) (a recall plan). The consequence of a missing recall plan is stated: the licence may be cancelled or suspended. The recall plan itself is covered in our article on regulations 5 to 8 of the Food Recall Procedure Regulations.
An invented example: Orchard Gate Foods has a long history of compliance and imports regularly. The Authority's profile under (2)(a) can take in that history, the product, the country of origin and the port. A food alert for a product from a particular source, under (7), can then shift the position, since during an alert (11) lets the Authority order additional tests at the point of entry, certification from the exporting country or channelisation.
Regulation 12: prohibition and restriction on imports
12(1) The Food Authority may prohibit or restrict the import of any article of food based on risk perception or outbreak of disease, and issue orders as it deems fit.
12(2) The Authority may issue an order, advisory or guideline as it deems fit, from time to time, for ensuring the safety and wholesomeness of imported food, and such prohibitions and restrictions shall be informed to customs immediately.
12(3) Every Food Importer to whom an order or direction is issued under the Regulations shall comply, and if the importer fails to comply the Authority may cancel the import licence.
12(4) Customs authorities, port authorities or any other agency involved in the clearance, rejection, auction or destruction of imported food in the customs area shall provide all such statistics to the Food Authority on a quarterly basis.
Regulation 2 defines "prohibited article of food" as an article declared by the food authority from time to time as prohibited and published on its website, and "prohibited location or origin" as a location for which conditional or absolute restrictions are specified on the website. The Act's own import provision is in section 25 of the FSS Act on imports, and the penalty for contravention is in section 67.
How the licence connects
Regulation 4(2)(a) allows cancellation of an import licence after a hearing for attempting to import prohibited articles or food from prohibited sources. Regulations 11(8) and 12(3) add two more routes: no recall plan, and failure to comply with an order. See our article on the import licence and its cancellation.
Where this sits
The previous article covers analysis of imported food samples. The next covers the officers who clear imports and the no objection certificate. For the practical steps at the port see clearance of imported food at the port and NOC.
Need help with import compliance?
A risk-based system rewards a clean compliance record and punishes a missing recall plan. Our FSSAI import licence service helps importers prepare the recall plan, keep records, and respond to alerts or orders.
Key takeaways
- The Authority may adopt a risk-based framework, profile importers and products and set sampling frequency.
- Every importer must submit a recall plan; failure can lead to cancellation or suspension of the licence.
- Food alerts can bring additional tests, certification from the exporting country or channelisation.
- The Authority may prohibit or restrict imports on risk perception or outbreak of disease.
- Failure to comply with an order can lead to cancellation of the import licence.
Read next
- Regulation 10: analysis of imported food samples
- Regulations 13 and 14: authorised officers and the no objection certificate
- Section 25, FSS Act: imports of food
- FSSAI compliance for food importers
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.