The Food Safety and Standards Authority of India (FSSAI) has issued a notice regarding the approval of the Rapid Analytical Food Testing (RAFT) kit superseding all the previous notices on the same. As per the notice, FSSAI will only contemplate the application under RAFT Scheme.
This means application only by commercial manufacturers of the rapid kit/equipment/method will be considered and not through the innovator, researcher, institute or organisation. However, FSSAI also states that if the technology is transferred to some other party and the kit is manufactured commercially then the manufacturer of the same will have to validate the kit again as per the guidelines and apply to FSSAI.
According to the Food Authority, the validation of a method will have two phases. The first one is a single laboratory validation of all the parameters namely scope, Limit of Detection (LOD) and Limit of Quantitation (LOQ), trueness, precision, selectivity, sensitivity, efficiency, linear dynamic range and robustness, repeatability, standard deviation and reproducibility standard deviation.
The second phase includes a collaborative ring trial at laboratories (at least 5-7 labs). The main outcome of this will be a measure of repeatability and reproducibility together with detailed information on the transferability of methods between laboratories.
In relation to it, FSSAl has asked the manufacturers and method developers to follow prescribed points issued in the notice to submit the application for the approval of the RAFT kit (or equipment or method). The Food Authority would accept the duly filled, complete and signed application received on the online RAFT Portal only. No other mode of application shall be accepted.
Further, FSSAI can also seek additional data along with supporting documents before the approval. If the required information and documents are not submitted within 30 days, the application shall be rejected. However, applicants can request an extension of timeline beyond 30 days.
Besides the above conditions, the validation of the Rapid Food Testing kit/equipment/method in accordance with international guidelines by a third-party, including an authorised FSSAl laboratory or international organisations like AOAC, AFNOR and MICROVAL is mandatory for approval as well.