Food Laboratory 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 8 to 11 of the Recognition and Notification of Laboratories Regulations, 2018 cover the life of a laboratory after notification: the audits the Food Authority may conduct, the obligations a laboratory carries, the grounds and steps for suspension and de-notification, and the appeal to the Central Government.
These Regulations are read as amended up to 8 November 2018 (the Regulations as notified; FSSAI lists no amendment as at 2 October 2026). The Gazette text prevails. Later notifications should be checked on fssai.gov.in. Where a laboratory report is disputed, a food business can read these provisions alongside its notice reply under FSSAI notice reply support.
The Food Authority may conduct surprise, scheduled (at least once every year) and annual surveillance audits and investigate complaints. A laboratory has the fourteen obligations in regulation 9, including confidentiality of test reports, uploading reports and keeping a copy for a minimum of three years. Grounds for de-notification are in regulation 10, and an aggrieved laboratory may appeal to the Central Government within thirty days.
Regulation 8: audit and investigation
Regulation 8(1) says the Food Authority may conduct (a) a surprise audit to monitor or review the functioning of a food laboratory; (b) a scheduled audit "which shall be at least once every year"; and (c) an annual surveillance audit. Regulation 8(2) allows an investigation on receipt of a complaint about the functioning of a laboratory. The audits are post-notification audits, as distinct from the adequacy audit before notification (see our article on regulations 1 to 4).
Regulation 9: obligations of food laboratories
| Clause | Obligation, in short |
|---|---|
| (a) | perform all tests in the approved premises as per the valid scope of recognition; sub-contracting to another food laboratory only with the prior permission of the Food Authority |
| (b) | inform any change in name, address, constitution or scope of accreditation as specified in regulation 7 |
| (c) | inform any change in the Quality Management System within fifteen days with the communication to the accreditation body and seek approval; no sampling or accepting samples until approval is given |
| (d) | inform any change in key personnel (quality assurance, key technical functions, senior management) through the online platform within fifteen days |
| (e) | inform the Food Authority immediately of major changes or breakdown in equipment which may affect testing, with reasons; no sampling or accepting samples during the breakdown |
| (f) | inform the Food Authority within five working days of suspension or withdrawal of accreditation |
| (g) | treat the test report with strict confidentiality; no information about the sample or its results to any person including the food business operator who delivers the sample on behalf of the Food Authority |
| (h) | share the record of observations and upload the test report on the Food Authority's online platform and maintain a copy for a minimum period of three years |
| (i) | participate in Proficiency Testing or Inter-Laboratory Test Comparison programmes as laid down by the accreditation body |
| (j) | permit access to the Food Authority or its officials for audit, surveillance or investigation, with access to records, documents and equipment |
| (k) | share all analytical data on the online Laboratory Information Management System |
| (l) | submit monthly, quarterly or annual statements as required: samples received and tested; samples failed, specifying the parameter or test |
| (m) | not make any misrepresentation or carry out any activity which may bring disrepute to the Food Authority |
| (n) | adhere to the testing charges fixed by the Food Authority |
A proviso to clause (g) says that where a sample is submitted by a food business operator or consumer for testing within the scope of recognition, for self monitoring or for monitoring or certification by the Food Authority, the details of testing shall be made available to the Food Authority through its online platform. Clause (g) matters to a food business: a laboratory testing an official sample must not tell the operator the result, while a laboratory testing a business's own sample reports to the business and also makes the details available to the Food Authority. The Regulations do not fix testing charges; clause (n) leaves them to the Food Authority.
Regulation 10: de-notification and de-recognition
Regulation 10(1) lists nine grounds on which the Food Authority may de-notify or de-recognise a laboratory.
- The laboratory has been declared insolvent.
- It has failed to comply with the Act or any rules or regulations.
- Its accreditation has been suspended or cancelled by the accreditation body.
- It has failed to follow the terms and conditions of the agreement.
- It has failed to perform its obligations in regulation 9.
- It has failed to provide access to records and information for an audit or investigation.
- Its accreditation has expired and no step has been taken to renew it.
- The audit report or investigation of a complaint proves that its technical competency, integrity or confidentiality is not satisfactory.
- It has committed a fraudulent act.
The remaining sub-regulations set out the steps.
- 10(2) Before initiating action for de-notification under grounds (ii), (iii), (iv), (v) or (vi), the Food Authority may suspend the laboratory's activities by order for a period of not less than six months.
- 10(3) If satisfied that the shortcomings have been rectified, it may revoke the suspension.
- 10(4) If the laboratory fails to rectify the shortcomings, or has been suspended more than two times within the period of validity of its accreditation, or on grounds (i), (vii), (viii) and (ix), the Food Authority may de-notify or de-recognise it by notification in the Official Gazette.
- 10(5) A laboratory so de-notified or de-recognised is not eligible to be notified, and shall not apply, for at least two years from the date of de-notification.
Regulation 11: appeal
A laboratory aggrieved by (a) an order rejecting its application under regulation 5(6), (b) an order of suspension under 10(2) or (c) an order of de-notification or de-recognition under 10(4) may appeal to the Central Government within thirty days from the date of the order (11(1)). The Central Government may entertain the appeal after that period if satisfied that the appellant was prevented by sufficient cause from filing in time (11(2)), and shall dispose of the appeal after giving the appellant an opportunity of being heard (11(3)).
Form A
Form-A is the application for notification of a food laboratory, covered in our article on regulations 5 to 7. It is not described further here.
An invented example: Bay Food Labs is found, on a surprise audit, to have accepted samples during an equipment breakdown without informing the Food Authority. That is a failure of obligation 9(e). The Food Authority may suspend its activities for not less than six months under 10(2), and if Bay Food Labs does not rectify, it may be de-notified by Gazette notification, after which it cannot reapply for at least two years. Bay Food Labs may appeal to the Central Government within thirty days of the suspension or de-notification order.
What it means for food businesses
When a food sample's result is questioned, one line of enquiry is the laboratory's status and scope on the date of testing. The Food Authority's website lists notified laboratories and their scope under regulation 5(9). The sampling and analysis side is in the Laboratory and Sample Analysis Regulations; see our article on rapid test kits, methods and timelines, together with the Act's section on laboratories.
Need help with a laboratory report you dispute?
A challenge to a laboratory report should start from the laboratory's notification, scope and the sampling record. Our FSSAI notice reply team can review the report and prepare the reply to the authority.
Key takeaways
- Surprise, scheduled (at least once every year) and annual surveillance audits; complaints can be investigated.
- Fourteen obligations, including confidentiality, uploading reports, three years' record keeping and reporting changes.
- Nine grounds for de-notification; suspension of not less than six months may come first; two years' bar after de-notification.
- Appeal to the Central Government within thirty days.
Read next
- Regulations 5–7: procedure and renewal
- Regulations 1–4: reference laboratories and criteria
- Regulation 2.4: rapid test kits, methods and timelines
- Choosing NABL accredited food testing labs
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.