The Food Safety and Standards Authority of India (FSSAI) has issued updated guidelines for the Rapid Analytical Food Testing (RAFT) Scheme. A notice of these guidelines was issued on 31st October, 2023.
The new guidelines provide detailed instructions for manufacturers and method developers wishing to apply for RAFT approval.
These guidelines supersede the previous FSSAI notice dated 9th January, 2023.
The key aspects highlighted in the updated guidelines are as follows:
- Online Application Process: Desirous manufacturers and method developers are encouraged to apply for RAFT approval through the Online Portal. FSSAI will only accept duly filled, complete, and signed applications submitted via the online RAFT Portal. Any other mode of application will not be accepted. Incomplete or unsigned applications will be summarily rejected, and no fees will be refunded.
- Data Validation and Verification: Applications should include complete and accurate data for validation and verification. The RAFT Secretariat may request additional information and supporting documents in case of incomplete or insufficient data.
- Timely Submission: Applicants must submit all requested information within a period of thirty days. Failure to do so will result in the summary rejection of the application. Applicants may request an extension, providing written reasons for the delay.
- Mandatory Validation: Validation of the rapid food testing kit, equipment, or method in accordance with international guidelines by a third party is mandatory for approval. This validation consists of two phases: a single laboratory validation of parameters and a collaborative ring trial involving multiple laboratories.
- Commercial Manufacturers: FSSAI will consider applications under the RAFT Scheme from commercial manufacturers of rapid kits, equipment, or methods, rather than innovators, researchers, institutes, or organizations. If technology is transferred and kits are commercially manufactured, revalidation is required.
- Justification and Documentation: Applications should include proper justifications for each product individually, accompanied by all necessary supporting documents, including validation certificates and product manuals.
- Exclusions: Applications for instruments used for general parameters or routine laboratory equipment and accessories will not be accepted and will be summarily rejected. However, kits capable of detecting a class of antibiotics as per FSSR will be considered.
- Separate Applications: Applicants should submit separate applications for each kit, equipment, or method. Each application should be accompanied by a separate application processing fee, payable through the online RAFT Portal.
- Renewal Process: In case of renewal of RAFT applications, applicants must apply for renewal on the online RAFT Portal at least 60 days before the certificate’s expiration date, following the renewal procedure guidelines. Other modes of renewal applications will not be accepted.
The updated guidelines aim to streamline the application process for the RAFT Scheme, ensuring that manufacturers and method developers adhere to strict standards and procedures for food testing and surveillance in India.
