The FSSAI has drafted the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2017 and has asked all stakeholders for their objections, comments and suggestions which are to reach FSSAI office within 60 days beginning on 25 September, 2017.
The regulations begin with the definition of the terms used in the regulation like accreditation and accreditation body, adequacy audit, food analyst and food laboratory, notified and referral laboratory and sample.
Food Laboratories and their Functions
The Food Authority may recognize and notify food laboratories and research institutes as notified laboratory or referral laboratory to carry out the functions entrusted by the Act or any rules and regulations made thereunder
Functions of Notified Laboratories
These labs will carry out analysis of food samples sent by the
- Food Safety Officer or any other person authorized under this act, Food business operators and purchasers.
- Authorized officer or any other person authorized under this act
- For the purpose of surveillance
Functions of Referral Laboratory
- Analysis of food samples sent by any officer or authority authorized by the Food Authority for the purpose and submission of the certificate of analysis
- Investigation for fixing standards for any article of food
- Investigation for standardizing methods of analysis in collaboration with State and other laboratories and institutions the Food Authority may approve.
- Check to see laboratories follow scientific protocols laid down for handling and testing articles of food
- Ensure maintenance of high standards of accuracy, reliability and credibility in laboratory operations and achieve and maintain the required levels of accreditation and reliability
- Laying down mechanisms that ensure laboratory personnel adhere to high professional standards and discipline.
- Capacity building by way of organizing professional training, workshops and seminars for the Food analyst, laboratory personnel in the states specified by the Food Authority.
- Work as an appellate laboratory in case of any dispute over the results of analysis between two parties (Laboratories/ Food Business Operators) within the ambit of Food Authority.
- Carry out any such functions, as the Food Authority may lay down for Referral Laboratories, from time to time.
Functions of a Reference Laboratory
The Food Authority can also recognize the notified and referral laboratories as reference laboratories for the purpose of method development, method validation, proficiency testing and training. Their functions will be as such
- Develop country wide standards for routine testing procedures and reliable testing methods
- Work as resource centres for provision of information for certified reference materials (CRMs) or reference materials (RMs)
- Provide technical support in the area of competence.
- Evaluate the performance of other notified laboratories.
- Coordinate exchange of information amongst notified laboratories.
- Collaborate for data generation among their network and collate the data related to their specific domain.
- Such other functions, as may be specified by the Food Authority from time to time
Criteria for recognition and notification food laboratories
The food laboratories that seek recognition shall have
- implemented and maintained Quality Management System in accordance with the latest version of ISO/IEC 17025 ‘General requirements for the competence of testing and calibration laboratories.’ The laboratory must have the competence and capability to test foods as per the parameters laid down in the Food Safety and Standards Act 2006
- a valid accreditation certificate for the relevant scope against ISO/IEC 17025 by a national / international accreditation agency which is signatory to ILAC or APLAC for carrying out accreditation of laboratories
- all the infrastructure and facilities including equipment required for carrying out the analysis as per the scope applied for
- qualified Food Analysts as per Food Safety and Standards Rules for testing food samples received under Food Safety and Standards Act 2006
Private food laboratories, recognized by accreditation body, having authorized signatory as designated by the accreditation body in their lab, instead of Food Analyst as per FSS Rules shall also apply for the recognition. The recognition shall be subjected to the condition that the authorized signatory(s) of the laboratory shall clear the food analyst examination within one year of the recognition and notification by the Food Authority or as and when the food analyst examination is conducted by the Food Authority after the recognition and notification by the Food Authority, whichever is earlier.
- The Food Authority reserves the right to recognize and notify or curtail the scope of recognition or suspend or de-recognize a laboratory
The Recognition Process
The FSSAI has also outlined in detail the recognition process which begins by filling out Form A of Schedule 1 given in these regulations duly signed by authorised signatories and payment of non-refundable application fees. After scrutiny by the Food Authority, if the application is found to be complete then a registration number will be allotted. Rejected and closed applications will not be opened the laboratory will have to apply afresh along with the prescribed fees. After requite audit of the laboratory if inadequacy is detected it will be conveyed to the laboratory which can be set right within a given time frame. If no inadequacy is detected the FSSAI will grant recognition on the basis of the scope mentioned on the accreditation certificate. After the recognition has been granted the recognised laboratory will enter into agreement with the Food Authority wherein private laboratories need to deposit an interest free Security Deposit.
The Food Authority shall notify the recognized Food Laboratories in the Gazette of India and shall also update the directory of same along with their validity and scope of accreditation on its website.
The FSSAI has also outlined the
- kinds of audit that the laboratory can be subjected to even after notification
- length of time for recognition validity
- procedure for recognition
- addition and deletion in the scope of the recognition
- the procedure for suspension and cancellation of recognition
- revocation of suspension including time period of cooling period
Conditions for suspension or cancellation of recognition
The Food Authority may suspend the recognition of food laboratory by an order for following conditions if the laboratory has
- made an application to be declared an insolvent
- failed to carry out any orders issued by the Food Authority
- failed to observe terms and conditions and obligations of the agreement
- become incompetent to continue to be accredited as required under these regulations
- failed to provide access to their records and furnish necessary information to the Food Authority to conduct an assessment or investigation on them; if any.
- Shifted laboratory premises
- Changed in the name, proprietorship/ownership with/without the address of the laboratory
- Any other reason that the Food Authority deems fit and necessary.
The Food Authority may also cancel the recognition of food laboratory by an order for following condition
- The laboratory has committed a fraudulent act
- Cancellation of accreditation of laboratory by the concerned accrediting agency
- If the food laboratory after suspension still failed to rectify the defects or to comply with the requirements of these regulations or repeated suspension (more than two) during an operative period
In the case of expiry of accreditation, the Food Authority notification/recognition of the laboratory would be temporarily suspended till fresh accreditation. In case of cancellation the security deposit shall be forfeited.
The Regulations have also outlined in detail the
- responsibilities of the laboratory
- dispute resolution
- special situations like informing food authority of any changes to the address, change in the name of the laboratory etc.
This article is just a synopsis of the of the proposed draft on recognition and notification of laboratories