FSSAI issues notice on approval of RAFT kit superseding previous one
The FSSAI has issued a notice regarding approval of rapid analytical food testing (RAFT) kit by the food authority superseding the previous one wherein a revised application format has been issued.
The application format seeks technical information including contents to be submitted with the dossier for pre-evaluation by FSSAI wherein the applicant should clearly state which parts of the application are claimed to be confidential/proprietary and provide verifiable justification.
Also, the applicant was asked to provide details of the conventional method/equipment/test kit with which the said product should be compared along with technical specifications on rapid testing kits/device/method, which is only indicative that all necessary information to support and strengthen the application must be submitted.
The format also seeks info on operational characteristics for kits/devices. Meanwhile, according to the FSSAI, only duly filled complete and signed application will be accepted by the apex food regulator and incomplete or unsigned applications will be summarily rejected and no fee shall be refunded. In case of applications with incomplete or insufficient data on validation and verification, the RAFT Secretarial may direct the applicant to submit additional information with supporting documents within stipulated time.
The notice states that validation of the rapid food testing kit equipment/method in accordance with international guidelines by a third-party such as an authorised FSSAI laboratory or international organisations like AOAC, AFNOR, MICKOVAL etc., is mandatory for approval.
Validation of a method consists of two phases: 1) a single laboratory validation of all of the parameters viz. scope. Limit of Detection (LoD) and Limit of Quantitation (LoQ), trueness, precision, selectivity, sensitivity, efficiency, linear dynamic range and robustness, repeatability, standard deviation, reproducibility, standard deviation and 2) a collaborative ring trial (at least 5-7 laboratories), the main outcome of which is a measure of the repeatability and reproducibility together with detailed information on the transferability of methods between laboratories,” reads the notice.
The notice added that FSSAI will only consider the application under RAFT Scheme by commercial manufacturers of the rapid kit equipment/method and not through the innovator/ researcher/institute organisation. However, if the technology is transferred and the kit is manufactured commercially, the manufacturer will have to validate the kit again as per the guidelines and apply to FSSAI.