Introduction

On 17 September 2022, the Ministry of Health and Family Welfare (“MHFW”) issued the Handbook on Rapid Analytical Food Testing Kits (“RAFT Handbook”).¹ This initiative by the Food Safety Standards Authority of India (“FSSAI”) aims to provide a comprehensive policy framework for the new and improved Rapid Analytical Food Testing (“RAFT”) kits, equipment and methods. These tools serve as an alternative to conventional food testing methods, and enhance consumer healthcare by ensuring food safety and quality.² Traditional food testing methods are often expensive, labour-intensive, and time-consuming, posing significant challenges in India. However, food companies must conduct thorough testing before introducing products to the market to ensure consumer healthcare. This has prompted FSSAI to develop several RAFT kits, equipment, and methods to detect toxins, foodborne pathogens, and contaminants in food products. In comparison, RAFT kits, equipment, and methods are more affordable, specific, sensitive, robust, user-friendly, economically profitable and equipment-free.

The FSSAI plays crucial role in ensuring that food testing laboratory methods comply with the highest analytical performance standards. To this end, the FSSAI has also notified the Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011 (“FSS (LSA) Regulations”)³. The RAFT Handbook identifies biosensors as one of the prominent methods for rapid food testing. A biosensor is an analytical instrument which tests and analyses food particles using biochemical principles. Recently, using biosensors as a metric to analyse food is gaining popularity due to its reliability, easy usage, and efficiency.

Analysis of Raft Handbook

The FSS (LSA) Regulations were amended in 2020 to include a provision which outlines the approval process for using RAFT methods. The provision also mentions that the procedure for such approval must be in accordance with the guidelines framed by FSSAI.⁴ The RAFT Handbook details the policies, procedures, application formats and verification/validation criteria for approval of RAFT kits, equipment, and methods. These ‘rapid method’ are defined analytical techniques that reduce testing time and provide instantaneous results, useful for preliminary screening and surveillance purposes at the field level.⁵

The purpose of using RAFT kits, methods and equipment approved by FSSAI has been limited to screening and surveillance. For enforcement purposes, the methods specified in the manual for analysis of various food products as described in tables of Appendix B of Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 must be used.⁶

Application for RAFT approval must be submitted through FSSAI’s dedicated portal⁷, and a committee under the RAFT Handbook scrutinises these applications. Any decisions made by such committee are ratified by the Scientific Panel on Methods of Sampling and Analysis and approved by the competent authority before adoption/implementation. Once such approval is granted, FSSAI ratifies the decision as well.⁸

On 9 May 2022, FSSAI mandated that  all state food testing laboratories use only FSSAI-approved RAFT kits, equipment, and methods for screening and surveillance.⁹ An order issued on 31 October 2023, outlined the rights granted to applicants whose RAFT kits, equipment, or methods are approved. The order further mentioned that approved applicants will receive a certificate of conformance valid for 3 years from the date of issue, allowing them to use the “RAFT Logo” along with the certificate number, validity period and barcode on the approved RAFT kit, equipment or method. In case where RAFT kit, equipment or method is used to test multiple parameters but approval from FSSAI has been only provided for a few parameters, it is mandatory to mention the same as a disclaimer. The applicant must also ensure that the certificate number and validity are mentioned on the certificate. Further, the applicants must submit a self-declaration form (as given in Annexure II of the order) to FSSAI within 2 days of initiating the process to print the aforementioned information on the RAFT kit/equipment¹⁰. Additionally, the RAFT Handbook provides guidelines for the verification of microbiological analysis, chemical analysis, nucleic acid-based methods and enzyme-linked immunosorbent assay-based models.

Conclusion

The FSSAI’s adoption of RAFT kits, equipment and methods marks a significant advancement in the food testing space, enhancing consumer healthcare by ensuring food safety and quality. This involves including methods which are ingrained in modern science such as the use of biosensors. To give effect to such change, the RAFT Handbook serves as a supplementary guideline to be observed by companies in addition to FSS (LSA Regulations) which recognises such kits, equipment, and methods.

Ultimately, this will aid companies in accelerating the timeline for testing food products and cutting down on the cost which is involved in placing a product in the market. However, to do so, companies in the food industry must ensure that the legal compliance services provided to them for the usage of RAFT kits, equipment, and methods are according to the FSS (LSA Regulations) and RAFT Handbook. 

[1]https://fssai.gov.in/upload/uploadfiles/files/RAFT_Handbook_10_11_2022.pdf

[2] Regulation 2.4, Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011.

[3]https://www.fssai.gov.in/upload/uploadfiles/files/Compendium_Lab_Sample_Regulations_04_03_2021.pdf

[4] Regulation 2.4, Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011.

[5] Page 11, Handbook on Rapid Analytical Food Testing Volume 1.0

[6] Page 9, Handbook on Rapid Analytical Food Testing Volume 1.0

[7]https://fssai.gov.in/upload/uploadfiles/files/RAFT%20Portal-signed.pdf

[8] Chapter 2, Handbook on Rapid Analytical Food Testing Volume 1.0.

[9]https://fssai.gov.in/upload/uploadfiles/files/Annexure_Qa.pdf

[10]https://fssai.gov.in/upload/uploadfiles/files/RAFT%20Portal-signed.pdf.