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Food Safety & Standards (Recognition & Notification of Laboratories) Reg. 2018

Ministry of Health and Family Welfare (Food Safety and Standards Authority of India) Notification dated 8th November 2018

F. No. 11/202/LAB REC/QA/FSSAI/2016.—Whereas the draft of the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2017 were published as required by section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the Food Safety and Standards Authority of India number F.No. 11/202/LAB REC/QA/FSSAI/2016, dated 27th December, 2017, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected thereby, before the expiry of the period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And Whereas, the copies of the said Gazette were made available to the public on the 9th January, 2018;

And Whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India;

Now, Therefore, in exercise of the powers conferred by clause (e) of sub- section (2) of section 16 read with section 43 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations , namely:-

1. Short title and Commencement.-

(1) These regulations may be called the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2018.
(2) They shall come into force on the date of their publication in the Official Gazette.

2. Definitions.-

(1) In these regulations, unless the context otherwise requires, --
 (a) “Act” means the Food Safety and Standards Act, 2006 (34 of 2006);
 (b) “accreditation” means a third party attestation of the competence of a food laboratory to carry out its function effectively;
 (c) “accreditation body” means an authority that performs accreditation;
 (d) “adequacy audit” means an audit conducted on site prior to notifying a laboratory to ensure that essential requirements of testing and other related facilities are available in a food laboratory;
 (e) “audit” means an audit conducted after notifying a food laboratory to ensure its overall competence to carry out testing of food items and maintenance of specified standards in accordance with the provisions of the Act and the rules and regulations made thereunder;
 (f) “notified food laboratory” means a food laboratory notified by the Food Authority under sub-section (1) of section 43;
 (g) “referral food laboratory” means a food laboratory established or recognized by notification by the Food Authority under sub section (2) of section 43;
 (h) “reference food laboratory” means a food laboratory referred to in regulation 3;
 (i) “section” means a section of the Act.

(2) All words and expressions used herein and not defined, but defined in the Act, rules or regulations made thereunder, shall have the meanings as assigned to them in the Act, rules or regulations, respectively.

3. Appointment of reference laboratories.-

(1) The Food Authority may recognise any notified food laboratory or referral food laboratory as reference laboratory for the purpose of developing methods of testing, validation, proficiency testing and training.

(2) The reference laboratory shall carry out the following functions, namely:-
 (a) be a resource center for provision of information for certified reference materials and reference materials;
 (b) develop standards for routine testing procedures and reliable testing methods;
 (c) provide technical support in the area of competence;
 (d) evaluate the performance of other notified laboratories;
 (e) coordinate exchange of information amongst notified food laboratories;
 (f) collaborate for data generation among the network of notified food laboratories and referral food laboratories and collate the data related to their specific domain; and
 (g) such other functions as may be specified by the Food Authority.

4. Criteria for notifying and recognising food laboratories.-

For being recognised and notified, every food laboratory shall have-
 (a) accreditation against ISO/IEC 17025 by the National Accreditation Board for Testing and Calibration Laboratories or such other equivalent accreditation agency as may be approved by the Food Authority;
 (b) adequate capability and competence for testing of food safety and quality parameters as per the requirements of the Act;
 (c) person possessing qualification and experience required for being appointed as Food Analyst under rule 2.1.4 (1) of the Food Safety and Standards Rule, 2011:
 Provided that a food laboratory accredited by an accreditation body having authorised signatory designated by such accreditation body, shall also be considered for being notified subject to the condition that such authorised signatory shall, within one year from the date of such notification, acquire the qualification and experience required for being appointed as Food Analyst under the said rule; and
 (d) the infrastructure and facilities including equipments required for carrying out the analysis as per the scope applied for.

5. Procedure for notification of food laboratories.-

(1) A food laboratory desirous of being notified under sub-section (1) of section 43 may, if it fulfills the criteria specified in regulations 4, submit an application in Form-A through online platform of the Food Authority along with the documents specified therein and a fee of rupees One thousand.

(2) A food laboratory owned or controlled by a Government institution including research institution or established by the Food Authority or any other statutory body and accredited by an accreditation body and desirous of being notified as referral laboratory under sub-section (2) of section 43 may apply in Form- A along with the documents specified therein.

(3) The Food Authority shall scrutinise all applications received under sub-regulations (1) and (2) and inform the deficiency, if any, to the applicant within thirty days from the date of such receipt and the applicant shall remove such deficiency within thirty days of receipt of the information, failing which the application shall stand rejected without any further reference and the fees so paid shall not be refunded.

(4) An application which is complete in all respect shall be registered by assigning a registration number which shall be used in all future correspondence with the laboratory concerned.

(5) The Food Authority may carry out adequacy audit of a laboratory and on being satisfied, decide to notify such laboratory.

(6) The Food Authority may reject an application for the reason to be recorded in writing.

(7) Where the Food Authority decides to notify a food laboratory, such laboratory shall execute an agreement with the Food Authority agreeing to comply with all the terms and conditions specified in such agreement.

(8) The food laboratory to be notified shall deposit rupees one lakh as interest-free security deposit at the time of signing the agreement:

 Provided that no such security deposit shall be payable by a laboratory owned or controlled or funded or operated by any statutory body or Government institution or Government-aided or funded institution including research institution or University recognised under the University Grants Commission Act, 1956 (3 of 1956).

(9) The Food Authority shall, by notification in the Official Gazette, notify the food laboratory and also upload on its website the details of notified laboratories including scope of accreditation of such laboratories.

(10) The agreement executed under sub-regulation (7) shall come into force with effect from the date of notification under sub-regulation (9) and shall be valid till the validity of accreditation certificate issued by an accreditation body or till the recognition and notification is continued by the Food Authority, whichever is earlier.

6. Renewal of agreement.-

(1) A notified food laboratory or, as the case may be, a referral food laboratory, desirous of continuing recognition and notification, shall make an application for renewal of agreement in Form- A, sixty days prior to the date of expiry of the agreement in the same manner as specified in sub-regulations (1) and (2) of regulation 5.

(2) Where, on the basis of audit reports and other relevant records, the Food Authority is satisfied that the food laboratory continues to meet with all the requirements as specified in these regulations; it may renew the agreement for a further period till the validity of renewed accreditation certificate of such laboratory.

7. Change in name, address, scope, etc. .-

Any change in the name, address, constitution or scope of accreditation of a notified food laboratory or referral food laboratory, as the case may be, shall be brought to the notice of the Food Authority through its online platform within fifteen days of such change along with the following documents, namely :-

 (a) relevant document with respect to change of address, change of name of food laboratory and change of constitution and change in the scope of accreditation, as the case may be.

 (b) revised accreditation certificate or communication from the accreditation body regarding change of address, change of name of food laboratory, change of constitution or change in scope of accreditation, as the case may be.

8. Audit and investigation.-

(1) The Food Authority may conduct the following audits, namely :-
  (a) a surprise audit to monitor or review the functioning of a food laboratory;
  (b) a scheduled audit which shall be at least once every year; and
  (c) an annual surveillance audit.

(2) On receipt of a complaint regarding the functioning of a food laboratory, the Food Authority may carry out investigation of such compliant.

9. Obligation of food laboratories.-

(1) A food laboratory shall have the following obligations, namely:-
 (a) it shall perform all tests in the approved premises as per the valid scope of recognition:
 Provided that such laboratory may get tests carried out through sub-contracting with any other food laboratory with prior permission of the Food Authority.
 (b) it shall inform any change in its name, address, constitution or scope of accreditation to the Food Authority as specified in regulation 7;
 (c) it shall inform the Food Authority of any change in the Quality Management System within a period of fifteen days along with the communication forwarded to the accreditation body and seek approval of the Food Authority for such change and it shall not carry out sampling or accept any sample for testing, till such approval is given;
 (d) it shall inform any change in key personnel in relation to quality assurance, key technical functions or senior management of to the Food Authority through its online platform within a period of fifteen days;
 (e) it shall inform the Food Authority immediately about the major changes or breakdown in the equipment which may affect testing of the relevant products or compliance with the requirements of the Act and rules or regulations made thereunder with reasons thereof, and it shall not carry out sampling or accept any sample for testing during such breakdown;
 (f) it shall inform the Food Authority within five working days about the suspension or withdrawal of accreditation from relevant accreditation body;
 (g) it shall treat the test report with strict confidentiality and no information regarding the sample or its results shall be divulged to any person including the food business operator who may deliver the sample for testing on behalf of Food Authority:
 Provided that in case sample is submitted by the food business operator or consumer for testing within the scope of recognition for the purpose of self monitoring or for monitoring or certification by Food Authority, the details of testing shall be made available to Food Authority through its online platform;
 (h) it shall share the record of observations and upload the test report on the online platform of the Food Authority and maintain a copy for a minimum period of three years;
 (i) it shall participate in Proficiency Testing or Inter-Laboratory Test Comparison programmes organized by any national or international laboratories for demonstrating technical competence of the personnel of such laboratory, as laid down by the accreditation body;
 (j) it shall permit access to the Food Authority or any of its officials deputed for the purposes of audit, surveillance or investigation and give access to all relevant records, documents and equipments for the purposes of verifying details;
 (k) it shall share all analytical data on the online Laboratory Information Management System with the Food Authority;
 (l) it shall , as and when required by the Food Authority, submit monthly or quarterly or annual statement pertaining to- (i) number of sample received for testing and number of samples tested; (ii) number of samples failed, specifying the parameter or test and other details;
 (m) it shall not make any misrepresentation or carryout any activity which may bring disrepute to the Food Authority; and
 (n) it shall adhere to the testing charges as fixed by the Food Authority.

10. De-notification and de-recognition of food laboratories.-

(1) The Food Authority may de-notify or derecognise any food laboratory on any of the following grounds, namely:-
 (i) the food laboratory has been declared an insolvent;
 (ii) the food laboratory has failed to comply with the provisions of the Act or any rules or regulations made thereunder;
 (iii) the accreditation granted to a food laboratory has been suspended or cancelled by the concerned accreditation body;
 (iv) the food laboratory has failed to follow the terms and conditions of the agreement;
 (v) the food laboratory has failed to perform its obligation as specified in regulation 9 ;
 (vi) the food laboratory has failed to provide access to their records and furnish necessary information to the Food Authority to conduct an audit or investigation;
 (vii) the accreditation of food laboratory has expired and no step has been taken by such food laboratory to renew accreditation ;
 (viii) the audit report or the investigation of complaint proves that the technical competency , integrity or confidentiality of the food laboratory is not satisfactory; and if:
 (ix) the food laboratory has committed a fraudulent act.

(2) The Food Authority may, before initiating action for de-notification or de-recognition of a food laboratory under clause (ii), (iii), (iv), (v) or (vi) of sub-regulation (1), suspend, by order, the activities of such laboratory for a period of not less than six months.

(3) The Food Authority may on being satisfied that the food laboratory whose activities have been suspended under sub-regulation (2) has rectified it shortcomings, it may revoke such suspension.

(4) In case the food laboratory fails to rectify its shortcomings for which its activities have been suspended under sub-regulation (2) or where a food laboratory has been subjected to suspension for more than two times within the period of validity of its accreditation or on ground specified under clause (i), (vii), (viii) and (ix) of sub-regulations (1), the Food Authority may de-notify or, as the case may be de-recognise such food laboratory by notification in the Official Gazette.

(5) A food laboratory which has been de-notified or de-recognised under sub-regulation (4) shall not be eligible to be notified as notified food laboratory or referral laboratory, as the case may be, and shall not apply for period of at least two years from the date of such de-notification or de-recognition as the case may be.

11. Appeal.-

(1) A food laboratory which is aggrieved by the order of rejection of application under sub-regulation (6) of regulation 5 or by the order of suspension of its activities under sub-regulations (2) or by the order of de notification or de-recognition under sub-regulation (4), of regulation 10, may prefer an appeal to the Central Government within a period of thirty days from the date of such order,

(2) The Central Government may entertain the appeal after the expiry of the said period, if it is satisfied that the appellant was prevented by sufficient cause from filing in appeal in time.

(3) The Central Government shall dispose of the appeal after giving an opportunity of being heard to the appellant.



Form-A
(See regulation 5)
APPLICATION FOR NOTIFICATION OF FOOD LABORATORY

To
The Chief Executive Officer
Food Safety and Standards Authority of India
FDA Bhawan, New Delhi – 110002

APPLICATION FOR NOTIFICATION OF FOOD LABORATORY

Signature of Head/Authorised Representative of Laboratory with Seal

List of document to be enclosed with the application

 a) Application fee receipt/DD or pay order;
 b) Certificate of accreditation along with copy of scope;
 c) Certificate of signatory to Asia Pacific Laboratory Accreditation Cooperation (APLAC) or International Laboratory Accreditation Cooperation (ILAC) for accreditation as per ISO/IEC 17025;
 d) Copy of quality manual;
 e) Certificate of all Analysts;
 f) List of the food items tested in laboratory, with testing parameters of products as per relevant FSSR, 2011 as amended from time to time;
 g) List of test equipments with their least count and range against the parameters tested as per relevant standards;
 h) Capacity of analysis of food samples on weekly basis (Enclose a list);
 i) List of all Proficiency Testing and Inter Laboratory Comparison Programs attended and organized with schedule of next two years;
 j) List of employees with their designation, educational qualification and experience in the relevant area of work;
 k) Layout plan of the laboratory with measurements of areas; and
 l) in case application is signed by Authorised Representative of laboratory, the Authority Letter of its Proprietor/Partner/Director showing such authorisation.

Verification

I ____________________w/s/d/o ______________________do hereby solemnly affirm and verify that to the best of my knowledge and belief the information given in the application and the annexures/ statements accompanying with it, is correct and complete. I clearly understand that the application is liable to be rejected by Food Authority, if any information or data, submitted with the application is found to be incorrect or false at any stage.

I further declare that I am making this application in my capacity as ___________ in …… (name of the laboratory) and that I am competent to make this application and verify it by virtue of Authorization issue by the competent authority a photo/ attested copy of which is enclosed herewith.

Place:
Date:                                                                                 Signature with seal


Note : The application form, including the verification portion and Supplementary Information Form, must be signed in case of an individual, by the individual himself or a person duly authorized by him; in case of Hindu Undivided Family, by the Karta; in case of a partnership firm, by the managing partner; in case of a company, by a person duly authorized in the behalf by the Board of Directors; and in any other case, by a person in charge of or responsible for the conduct of the business.

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