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Regulations 1–4 of the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2018: definitions, reference laboratories and the criteria for notifying and recognising food laboratories

A laboratory is notified by the Food Authority under section 43(1) or recognised as a referral laboratory under section 43(2). To be recognised and notified it needs accreditation...

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Last updated: October 2026Verified against: Government sources

Regulations 1 to 4 of the Recognition and Notification of Laboratories Regulations, 2018 give the commencement, define the kinds of food laboratory (notified, referral and reference), set the functions of a reference laboratory, and state the four criteria every laboratory must meet to be recognised and notified under the Act.

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. Businesses that rely on laboratory reports can begin with FSSAI compliance support.

Regulation 1: commencement

The Regulations may be called the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2018 and come into force on the date of publication in the Official Gazette. They were made on 8 November 2018 under section 16(2)(e) read with section 43 of the Act, after the draft of 2017 was published for objections and suggestions. See our article on sections 43 and 44 of the FSS Act.

Regulation 2: definitions

ClauseTermPrinted meaning
(b)accreditationa third party attestation of the competence of a food laboratory to carry out its function effectively
(c)accreditation bodyan authority that performs accreditation
(d)adequacy auditan audit conducted on site prior to notifying a laboratory to ensure that essential requirements of testing and other related facilities are available
(e)auditan audit conducted after notifying a food laboratory to ensure its overall competence to carry out testing of food items and maintenance of specified standards
(f)notified food laboratorya food laboratory notified by the Food Authority under sub-section (1) of section 43
(g)referral food laboratorya food laboratory established or recognised by notification by the Food Authority under sub-section (2) of section 43
(h)reference food laboratorya food laboratory referred to in regulation 3

Two timing ideas sit in the definitions: an adequacy audit happens before notification, an audit after it. Words not defined take their meaning from the Act, rules or regulations.

Regulation 3: reference laboratories

Regulation 3(1) says the Food Authority "may recognise any notified food laboratory or referral food laboratory as reference laboratory for the purpose of developing methods of testing, validation, proficiency testing and training". Regulation 3(2) lists the functions of a reference laboratory:

  1. be a resource centre for information on certified reference materials and reference materials;
  2. develop standards for routine testing procedures and reliable testing methods;
  3. provide technical support in the area of competence;
  4. evaluate the performance of other notified laboratories;
  5. coordinate exchange of information amongst notified food laboratories;
  6. collaborate for data generation among the network of notified and referral laboratories and collate data in its specific domain; and
  7. perform such other functions as the Food Authority specifies.

A reference laboratory is therefore a recognition added to an existing notified or referral laboratory, and it brings network duties such as evaluating other laboratories.

Regulation 4: criteria for notifying and recognising

"For being recognised and notified, every food laboratory shall have" the four items below.

ClauseCriterion
(a)accreditation against ISO/IEC 17025 by the National Accreditation Board for Testing and Calibration Laboratories, or such other equivalent accreditation agency as may be approved by the Food Authority
(b)adequate capability and competence for testing of food safety and quality parameters as per the requirements of the Act
(c)a person possessing the qualification and experience required for being appointed as Food Analyst under rule 2.1.4(1) of the Food Safety and Standards Rules, 2011
(d)the infrastructure and facilities, including equipment, required for carrying out the analysis as per the scope applied for

A proviso to clause (c) lets a laboratory accredited by an accreditation body with an authorised signatory designated by that body also be considered, on condition that the authorised signatory acquires within one year from the date of notification the qualification and experience required for a Food Analyst under that rule.

Note how clause (d) ties infrastructure to the "scope applied for". A laboratory is notified for a scope, not generally. The Food Analyst qualification itself is in the FSS Rules; our article on analysis by the Food Analyst explains the Analyst's role in the sampling chain.

An invented example: Deccan Analytical Services holds ISO/IEC 17025 accreditation from NABL for dairy and edible oil testing. It employs a chemist who meets the Food Analyst requirement and has a layout, equipment list and staff for those scopes. It meets all four criteria for those scopes. A second laboratory has accreditation from a foreign body with an authorised signatory who lacks the Analyst qualification; under the proviso it may be considered, but its signatory must acquire the qualification within one year of notification.

Where laboratories fit in the system

The laboratories matter at several points: sampling under the Laboratory and Sample Analysis Regulations (referral laboratories), imports and fortification quality assurance. For how to choose among accredited laboratories see choosing NABL accredited food testing labs. The procedure for notification is in the next article, regulations 5 to 7.

Need help with laboratory reports?

A lab report is only as useful as the laboratory's status and scope. Our FSSAI compliance support team can help you pick notified laboratories for your product range and read their reports against the standards.

Key takeaways

  • Notified laboratories are notified under section 43(1); referral laboratories are established or recognised under section 43(2).
  • The Food Authority may recognise any notified or referral laboratory as a reference laboratory.
  • Four criteria: ISO/IEC 17025 accreditation, capability and competence, a person qualified as Food Analyst, and infrastructure for the scope applied for.
  • A proviso gives a laboratory with a designated authorised signatory one year to acquire the Analyst qualification.

Read next

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.

Quick recapKey facts & short answers

Key Facts About Food Lab

  • Applies in: All states across India, under the relevant central law.
  • Mode: Mostly online via the official government portal.
  • Typical timeline: Ranges from a few days to a few weeks depending on the case.
  • Non-compliance: May attract penalties, interest or late fees.
  • Expert help: TaxClue completes the entire process end to end for you.

Which accreditation does a food laboratory need?

Accreditation against ISO/IEC 17025 by the National Accreditation Board for Testing and Calibration Laboratories, or an equivalent agency approved by the Food Authority.

What is a referral food laboratory?

One established or recognised by notification under section 43(2) of the Act.

Settle the facts first; the right section and the right form follow from them.

— TaxClue Compliance Desk

Food Lab: a key compliance topic in Indian tax and corporate law that businesses and individuals must understand to remain compliant.

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Disclaimer: This article is for general informational purposes only and does not constitute professional tax, legal or financial advice. Laws, rates and due dates change and can vary by individual case — always verify with the relevant government source (e.g. mca.gov.in, incometax.gov.in) or consult a qualified professional before acting. TaxClue accepts no liability for decisions taken based on this content.

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Questions, answered

Short, direct answers to the 6 questions readers ask most on this topic.

Accreditation against ISO/IEC 17025 by the National Accreditation Board for Testing and Calibration Laboratories, or an equivalent agency approved by the Food Authority.

One established or recognised by notification under section 43(2) of the Act.

It develops methods, validates, runs proficiency testing and training, and evaluates other notified laboratories, among the functions in regulation 3(2).

A person with the qualification and experience required for appointment under rule 2.1.4(1) of the FSS Rules, 2011.

An on-site audit before notification to ensure essential testing and related facilities exist.

No; the Regulations came into force on publication.