The FSSAI has issued a notice dated 18th September 2019 related to Approval of Rapid Analytical Food Testing (RAFT) Kit / Equipment / Method by the FSSAI. The FSSAI has suppressed the earlier notice dated 23 March 2019 as it has revised the guidelines for approval of Rapid Analytical Food Testing (RAFT) Kit / Equipment / Method for the purpose of testing food.
The FSSAI has asked all desirous manufacturers/ method developer to apply to the FSSAI on the revised application format. These applicants are requested to follow the below mentioned points on submission of the application.
- Duly completed and signed application will only be accepted by FSSAI. Incomplete or unsigned applications will be summarily rejected and no fee shall be refunded.
- Applicants should submit separate application for each kit/equipment/method and each application should be accompanied by separate application processing fee. This shall be applicable to the applications which have already been scrutinized.
- Application should be submitted with proper justification for each of the product separately along with all necessary/supporting documents (validation certificate/data and manual/product insert).
- No application for general parameters like pH, density or routine laboratory equipment and accessories etc. will be accepted. Such applications, if received will be summarily rejected and payment received will be forfeited by FSSAI.
- Applicant to ensure that their kit/equipment/method should be able to test the parameter(s) mentioned in Food Safety and Standard Regulations (FSSR).
The requisite fee structure and the decision-making process for RAFT Application are annexed for kind information.
Brief of Process
To recognise the rapid test kits or equipment or method of analysis
a) Common requirements-
i.) Duly filled application in the prescribed format
ii.) Application processing fee of Rs.2,000 (not included in the fees prescribed against each category) per application/product in favour of Sr. Accounts Officer, FSSAI payable at New Delhi by Demand Draft.
b) For hand held or portable equipment-
i.) At least 20 instruments- can be taken back by the manufacturer after the trials;
ii.) Details of method/technology on which the equipment is based;
iii.) Validation/scrutiny fee of Rs.10,000 per laboratory who will undertake process of validation of the test kit/equipment/method.
c) For test kit(s)-
i.) At least 25 kits with clear details of instruction;
ii.) Details of method/technology on which the kit is based;
iii.) Validation/scrutiny fee of Rs.25,000 per laboratory who will undertake process of validation of the test kit/equipment/method.
d) For method(s)/protocols-
i.) Bound copies of methods clearly specifying different steps involved;
ii.) Details of relevant conventional method(s)/protocol(s) for which the rapid method is alternative; and, sources of reference materials;
iii.) Validation/scrutiny fee of Rs.2.5 to 5.0 lakhs depending on the chemicals involved per laboratory who will undertake process of validation of the test kit/equipment/method.
e) For issuance of certificate by FSSAI
i.) The manufacturer/method developer shall pay a fee of Rs.25,000 for the issuance of the conformance Certificate (CC);
ii.) Subsequent renewal, if recommended by MRG & SPMSA and approved by the competent authority, will attract a renewal fee of Rs.10,000.
Timeline for Scrutiny of application
Validity of Conformance Certificate
The Conformance Certificate will be valid for three years from the date of its issuance
Withdrawal of Conformance Certificate
FSSAI may withdraw or suspend the Conformance Certificate issued to applicant on the basis of its own investigation or complaint received in this regard.
APPLICATION FORM FOR APPROVAL OF RAPID ANALYTICAL FOOD TESTING (RAFT) KIT/ EQUIPMENT/ METHOD BY FSSAI
A. Application for (tick whichever is appropriate)
Rapid food testing kit/media
Any other, please specify
B. General Information
1. Details of Applicant
(a) Name of Principal manufacturer/OEM
(b) Name of authorized person/dealer in India (attach Authorization letter from principal manufacturer)
(c) Mobile No/Phone No
(d) Email (all communication will be through provided email/phone number)
(e) Name of the organization/manufacturer
(f) Address of the organization/registered office
(g) Manufacturing License number in India if any
(h) Name of the Rapid test/media/device/method
(i) Proposed regulatory use(specific product testing/analytical method)
C. Technical Information – Contents to be submitted with the Dossier for pre-evaluation by FSSA(I)
NOTE: The applicant should mark any proprietary information
1. Product Information
(a) Market name, product name and product code
(b) Names and corporate address of manufacturers
(c) Country of Origin
(d) Address (es) of manufacturing site(s)
(e) whether approved/verified by regulatory bodies/organizations
(f) If yes, name of regulatory bodies/organizations and validity of approval
(g) If validated by international bodies (e.g. ISO/AOAC etc.)
(h) If yes, attach documents/certificates/approvals etc.
(i) Bar code scanner, power source, data storage capacity (if applicable)
(h) Evidence that manufacturers have a certified quality management system of Good Manufacturing Practice (GMP) certification
2.Provide details of the conventional method/equipment/test kit with which the said product should be compared with
3.Technical Specifications on rapid testing kits/device/method (this list is only indicative all necessary information to support and strengthen the application must be submitted)
(a) The principle and detailed methodology
(b) Specify Food Category/Matrix for which approval is sought
(c) Test procedure, including the time needed to run the test
(d) Qualitative/Semi Quantitative /Quantitative
(e) Range and Reporting Units (if applicable)
(g) Sensitivity (wherever applicable)
(h) Specificity (including where the studies were performed to generate these values and 95% confidence intervals with supporting documents)
(i) Reproducibility across multiple test kit lots (e.g. including number of samples, type of food, number of different lots/devices)
(j) Inclusivity/exclusivity (applicable for microbiology kits/ methods/ device etc.)
(k) Robustness of the kit/ method
(l) Details of inter-laboratory validation of method/multiple users of device
(m) Demonstration of stability throughout the shelf life of the product under recommended storage conditions (not applicable to devices and methods)
(n) If device, warranty period, availability of maintenance service/spare parts etc
(o) Evidence of satisfactory test performance for kits from users within India (not applicable to devices and methods)
4. Operational characteristics for kits/devices
(a) Number of steps (from starting to results)
(b) Total run time (sample preparation to final result)
(c) Ease of data interpretation
(d) Overall ease of use
(e) Training requirements
(f) Recommended storage conditions
(g) Shelf life of rapid analytical food testing kit
(h) Kit size/ Device (hand-held/table top/portable/non-portable)
(i) Minimum quantity of sample required for one analysis
(j) Number of Individual tests/packages
(k) Required accessories necessary for operation that are not provided
(l) Availability of Certified Reference Material/Standard Reference Material/Quality Control material provided
(m) Advantages and disadvantages over the conventional technique/method/device
(n) Amount and type of waste generated (e.g. chemical/biological hazard)
(o) Cost/Kit and Cost/Test, cost/device
5. Any additional specific information
I/We understand that incomplete submissions, submission not conforming to the prescribed format, and applications containing excessive errors will be summarily rejected. I/We undertake that requisite material/content will be submitted to FSSAI as desired in case the pre-evaluation document is approved by FSSAI and FSSAI will provide the applicant with instructions for further action. If the documentation is not approved, FSSAI will notify the applicant with reasons.
Name of the authorized personnel ……………………….
Contact details ………………………
FSSAI has also taken out this Corrigendum
Subject: Application for Rapid Analytical Food Testing (RAFT) Kit/Equipment/Method
In continuation to this office Notice no.11014/05/2019-QA dated 20.03.2019 on the subject cited above, it is informed that the application processing fee of Rs.2000/- (Rupees two thousand) can also be paid through online mode, in the bank account mentioned below
Name: Senior Accounts Officer, FSSAI, New Delhi
Bank: Bank of Baroda, Nirman Bhawan
Account No: 26030100008653
IFSC Code: BARBON1RDEL