Regulations 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 1 to 3 of the Food Safety Auditing Regulations, 2018 give the title and commencement, define the terms used, and list the criteria an agency must meet before the Food Authority may recognise it to carry out food safety audits. Part II of the Regulations then deals with the recognition procedure, covered in the next article.
These Regulations are read as amended up to 28 August 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. Food businesses that face mandatory or voluntary audits can start from FSSAI compliance support.
The Food Authority may grant recognition to auditing agencies that conform to criteria in regulation 3: lawful establishment, a valid ISO/IEC 17020, ISO/IEC 17021 or ISO/TS 22003 accreditation from NABCB for the food categories specified, and at least three auditors with the printed qualifications. The criteria may be relaxed for reasons recorded in writing. The Regulations were made under section 16(2)(c) read with section 44 of the Act.
Regulation 1: title and commencement
The Regulations may be called the Food Safety and Standards (Food Safety Auditing) Regulations, 2018 and come into force on the date of publication in the Official Gazette. Unlike several other FSSAI regulations, no later date is fixed for compliance. The notification is F.No. TPA/01/REG/FSSAI-2017 dated 28 August 2018; its preamble records that the draft Regulations, 2017 were published on 12 October 2017 and that objections and suggestions were considered. They were made under section 16(2)(c) read with section 44 of the Act; see our article on sections 43 and 44 of the FSS Act.
Regulation 2: definitions
| Clause | Term | Printed meaning |
|---|---|---|
| (b) | accreditation | a third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out a specific conformity assessment task |
| (c) | accreditation body | an authority that performs accreditation |
| (d) | audit report or food safety audit report | a written record of the observations, findings and conclusion of the audit |
| (e) | auditing agency | an auditing agency recognised by the Food Authority for undertaking food safety audit under these Regulations |
| (f) | form | a form appended to the Regulations |
Clause (a) defines the Act, and regulation 2(2) gives words not defined here the meaning in the Act.
Regulation 3: criteria for recognition
Regulation 3(1) says the Food Authority "may" grant recognition to auditing agencies that conform to the following criteria. The word "may" matters: meeting the criteria makes an agency eligible, not entitled.
- (a) Lawful existence. The agency is established or registered in accordance with the law for the time being in force.
- (b) Accreditation. It holds a valid accreditation on ISO/IEC 17020 or ISO/IEC 17021 or ISO/TS 22003 from the National Accreditation Board for Certification Bodies (NABCB) for Management System Certification, for the required food categories specified by the Food Authority.
- (c) Auditors. It has at least three auditors who satisfy five requirements, listed below.
Two provisos to clause (b) soften the NABCB requirement. First, the Food Authority may consider an agency accredited by any other accreditation body that is a member of the International Accreditation Forum and a signatory to its Multilateral Recognition Arrangements for Management System Certification, on condition that the agency applies for NABCB accreditation; such an agency may be recognised provisionally until it is so accredited. Second, an agency that has applied for NABCB accreditation may also apply for recognition, but is granted recognition only after it has been accredited.
The auditor requirements in clause (c)
| Item | Requirement |
|---|---|
| (i) | Bachelor's degree in Food, Dairy, Fisheries or Oil Technology, Biotechnology, Agriculture, Veterinary Sciences, Bio-chemistry, Microbiology, Chemistry, Hotel management or Catering technology from a recognised university |
| (ii) | Successful completion of an Accredited Lead Auditor course in Food Safety Management System |
| (iii) | Knowledge of the Act and the rules and regulations made under it |
| (iv) | Sector specific knowledge of hygienic and sanitary practices, processing techniques, hazards identification and analysis and control, and knowledge of contaminants and allergens |
| (v) | Work experience of two years with a minimum of ten audits carried out |
Regulation 3(2) adds that the criteria for recognition may be relaxed by the Food Authority "for the reasons to be recorded in writing". The Regulations do not say which criterion may be relaxed or by how much.
An invented example: SafePlate Assurance, a company registered under the Companies Act, holds a valid ISO/IEC 17021 accreditation from NABCB for dairy and bakery categories and employs four auditors, each with a food technology degree, an Accredited Lead Auditor certificate, two years of experience and ten audits. It meets clauses (a), (b) and (c). Another agency, accredited abroad by an IAF member body, can be considered under the first proviso, but only provisionally and on condition that it applies for NABCB accreditation.
What the criteria do not say
The Regulations do not name the food categories; clause (b) leaves them to be "specified by the Food Authority". They do not say how many audits an agency must have carried out as an agency, only the experience of its individual auditors. The Regulations print the application fee, the recognition fee and other amounts in the next Part; this article does not state fees, which should be read from the Regulations themselves.
How this fits with the rest
Part II continues with the application, the terms of recognition, renewal and cancellation: see our article on regulations 4 to 7. The audit itself, the auditor's duties and the report are in regulations 8 to 12, and monitoring, disputes and forms are in regulations 13 to 15. The overview post is third party food safety auditing.
Need help with food safety audits?
Whether an audit is mandatory for a business, or optional but useful, depends on the Food Authority's order. Our FSSAI compliance support team can help a food business prepare for an audit and work with a recognised agency.
Key takeaways
- The Regulations came into force on publication in the Gazette; no later compliance date is printed.
- Recognition is at the Food Authority's discretion ("may") among agencies meeting the criteria.
- The agency needs ISO/IEC 17020, ISO/IEC 17021 or ISO/TS 22003 accreditation from NABCB, with provisos for other IAF-member bodies.
- At least three auditors with a degree, an Accredited Lead Auditor course and two years' experience with ten audits.
- The criteria may be relaxed for reasons recorded in writing.
Read next
- Regulations 4–7: recognition, renewal and cancellation
- Regulations 8–12: audit process, auditors and reports
- Third party food safety auditing under FSSAI
- Sections 43 and 44, FSS Act: recognition of laboratories and audit agencies
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.