Referral 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.
The first part of the Laboratory and Sample Analysis Regulations, 2011 gives the title and commencement, defines "notified laboratory" and "referral laboratory", says where samples of imported articles are sent, and lists what a referral laboratory must do in addition to its duties under the Act.
This article reads the text as amended up to 14 September 2026 (FSSAI Compendium Version III dated 01.03.2021; the Amendment Regulations, 2026 apply from 1 April 2027). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
A "notified laboratory" is one notified by the Food Authority under sub-sections (1) and (2) of section 43 of the Act, and a "referral laboratory" is one established and/or recognized by notification under sub-section (2) of section 43. The Authorised Officer sends the sample of any imported article to the food analyst of a laboratory notified under section 43(1), and a referral laboratory carries out eight listed functions, from analysing samples and issuing certificates to capacity building for food analysts. Importers, laboratories and State food safety teams are affected.
Regulation 1.1: title and commencement
Regulation 1.1.1 gives the title, the Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011. Regulation 1.1.2 says they come into force on or after 5th August, 2011.
Regulation 1.2: the two definitions
Regulation 1.2.1 prints two definitions, applying unless the context otherwise requires.
| No. | Term | Meaning as printed |
|---|---|---|
| 1 | "Notified laboratory" | any of the laboratories notified by the Food Authority under sub-sections (1) and (2) of section 43 of the Act |
| 2 | "Referral laboratory" | any of the laboratories established and/or recognized by the Food Authority by notification under sub-section (2) of section 43 of the Act |
Section 43 of the Act deals with recognition of laboratories; see our post on sections 43 and 44 of the FSS Act on recognition of laboratories and food safety audit agencies. The Regulations only name the section.
Regulation 2.1: notified laboratories for import
Regulation 2.1.1, substituted by the notification of 15 October 2020 (footnote 3), says the sample of any imported article will be sent by the Authorised Officer for analysis to the food analyst of any of the laboratories notified by the Food Authority under section 43(1) of the Food Safety and Standards Act, 2006.
Three points follow from the words. The sender is the Authorised Officer. The destination is the food analyst of a laboratory notified under section 43(1). And the regulation speaks of "any imported article", so it is not limited to a class of food. An importer whose consignment has been sampled and who needs to respond to the result can use FSSAI notice reply support. How the Authorised Officer draws and handles samples is dealt with in the Import Regulations, 2017, which this series covers in its articles on regulations 8 and 9 and regulation 10.
Regulation 2.2: the referral laboratory
Regulation 2.2.1: functions
In addition to the functions entrusted to it under the Act, the Referral Laboratory shall carry out the following functions:
| No. | Function as printed (summary of the words) |
|---|---|
| 1 | analysis of samples of food sent by any officer or authority authorized by the Food Authority, and submission of the certificate of analysis to the authorities concerned |
| 2 | investigation for the purpose of fixation of standard of any article of food |
| 3 | investigation, in collaboration with the laboratories of Food analysts in the various States and other laboratories and institutions the Food Authority may approve, for standardizing methods of analysis |
| 4 | ensuring that the laboratory follows the scientific protocols laid down for handling and testing the articles of food |
| 5 | maintaining high standards of accuracy, reliability and credibility in the operation of the laboratory and achieving and maintaining the required levels of accreditation and reliability |
| 6 | laying down a mechanism for ensuring that personnel of the laboratory adhere to high professional standards and discipline |
| 7 | such other conditions as the Authority may lay down for Referral Laboratories |
| 8 | capacity building by way of organizing professional training, workshops and seminars for the Food analyst and laboratory personnel in the states specified by the Food Authority |
Functions 1 to 3 concern analysis and standards work, 4 to 6 concern quality of the laboratory itself, and 7 and 8 are a general power and training duty. The certificate in function 1 is the document discussed in our post on the legal validity of the food analyst's certificate.
Regulation 2.2.2: State and Union Territory referral laboratory
Also substituted by the notification of 15 October 2020, regulation 2.2.2 says the Food Authority shall authorise laboratories to carry out the function of referral laboratory that are notified by the Food Authority under section 43(2) of the Act. An invented example: a State Government's laboratory at a regional centre is notified under section 43(2). Under regulation 2.2.2 the Food Authority may authorise it to carry out the referral laboratory functions in 2.2.1, so a food business receiving a report from it should check which notification applies to that laboratory.
How recognition of laboratories is handled
Recognition and notification of laboratories is itself governed by the Recognition and Notification of Laboratories Regulations, 2018. Those are covered in our articles on the criteria and definitions, procedure and renewal and audits, obligations and appeal. For a general overview of the testing system, see lab testing regulations under FSSAI.
What comes next in these Regulations
Regulation 2.3 deals with the sampling procedure and quantities, covered in our article on the procedure and quantity of sampling. Regulation 2.4 deals with rapid test kits, covered in the article on rapid test kits, methods and timelines.
Need help with a laboratory report or a sample?
Food businesses that receive an analyst's report or an import sample result can ask for guidance under FSSAI notice reply. A written response is easier to prepare when the reader knows which laboratory issued the report and under which provision.
Key takeaways
- Both definitions point to section 43 of the Act.
- Samples of imported articles go from the Authorised Officer to a food analyst of a laboratory notified under section 43(1).
- A referral laboratory has eight listed functions in addition to its Act functions.
- Recognition itself is under the 2018 Regulations; the 2026 amendment affects later regulations, not 1.1 to 2.2.
Read next
- Regulation 2.3: procedure and quantity of sampling
- Regulation 2.4: rapid test kits, methods and timelines
- Lab testing regulations under FSSAI
- Sections 43 and 44, FSS Act: recognition of laboratories and food safety 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.