Food Safety and Standards (Food Safety Auditing) Regulations, 2018

Food Safety and Standards (Food Safety Auditing) Regulations, 2018[1]

[28th August, 2018]

Whereas, in exercise of the power conferred by clause (c) of sub-section (2) of Section 16 read with Section 44 of the Food Safety and Standards Act, 2006 (34 of 2006) the Draft Food Safety and Standards (Food Safety Auditing) Regulations, 2017, were published as required under sub-section (1) of Section 92 of the said Act, vide notification of the Food Safety and Standards Authority of India number File No. TPA/01/REG/FSSAI-2017 dated the 12th October, 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 Gazette containing the said notification were made available to the public;

And whereas, copies of the said Gazette were made available to the public on the 18th October, 2017;

And whereas, 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 (c) of sub-section (2) of Section 16 read with Section 44 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations, namely—

Regulation 1. Short title and commencement.

(1)     These regulations may be called the Food Safety and Standards (Food Safety Auditing) Regulations, 2018.

(2)     They shall come into force on the date of their publication in the Official Gazette.

Part I GENERAL

Regulation 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 related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment task;

(c)      “accreditation body” means an authority that performs accreditation;

(d)      “audit report” or “food safety audit report” means a written record of the observations, findings and conclusion of the audit;

(e)      “ auditing agency” means an auditing agency recognised by the Food Authority for undertaking food safety audit in accordance with these regulations;

(f)       “form” means a form appended to these regulations.

(2)     Words and expressions used herein and not defined in these regulations but defined in the Act, shall have the same meaning as assigned to them in the Act.

Part II RECOGNITION OF AUDITING AGENCY

Regulation 3. Criteria for granting recognition to auditing agencies.

(1)     Food Authority may, for the purpose of carrying out food safety audit, grant recognition to auditing agencies which conform to the following criteria, namely—

(a)      it is established or registered in accordance with the law for the time being in time;

(b)      it holds a valid accreditation on ISO/IEC 17020 or ISO/IEC 17021 or ISO/TS 22003 from National Accreditation Board for Certification Bodies for Management System Certification, for the required food categories specified by the Food Authority:

Provided that the Food Authority may consider auditing agency which are accredited by any other accreditation body which is a member of the International Accreditation Forum and signatory to the International Accreditation Forum Multilateral Recognition Arrangements for Management System Certification subject to the condition that they shall apply for National Accreditation Board for Certification Bodies accreditation. Such agency may be recognised provisionally till the time it has been so accredited.

Provided further that auditing agency which has applied for accreditation from National Accreditation Board for Certification Bodies may also apply for recognition, but it shall be granted recognition only after it has been so accrediated.

(c)      it has at least three auditors with the following qualifications and requirements, namely—

(i)       Bachelor's degree in Food or Dairy or Fisheries or Oil Technology or Biotechnology or Agriculture or Veterinary Sciences or Bio-chemistry or Microbiology or Chemistry or Hotel management or Catering technology from a recognised university;

(ii)      successful completion of Accredited Lead Auditor course in Food Safety Management System;

(iii)     knowledge of the Act and the rules and regulations made thereunder;

(iv)    sector specific knowledge of hygienic and sanitary practices, processing techniques, hazards identification and analysis and control and knowledge of contaminants and allergens;

(v)      work experience of two years with a minimum of ten audits carried out.

(2)     The criteria for recognition may be relaxed by the Food Authority for the reasons to be recorded in writing.

Regulation 4. Procedure for recognition.

(1)     Any auditing agency seeking recognition may make an application in Form A along with requisite documents and fees of rupees five thousands.

(2)     The Food Authority shall scrutinise the application and in case of any deficiency, call for rectification or supplementary information within thirty days from the date of receipt of such application.

(3)     The auditing agency concerned shall take necessary steps for rectification or furnishing of supplementary information within fifteen days of receipt of the communication failing which the application shall be rejected by the Food Authority.

(4)     The Food Authority shall constitute a Screening Committee for granting recognition to the auditing agency.

(5)     On being satisfied that the auditing agency fulfills all requirements as specified in these regulations, the Food Authority shall place the application before the Screening Committee for recommending to it on grant of recognition.

Regulation 5. Terms and conditions of recognition.

(1)     On the recommendation of the Screening Committee and after the deposit of recognition fees of Rupees Thirty thousands, the Food Authority may grant recognition to the auditing agency by issuing a Certificate of Recognition in Form ‘B’:

Provided that the screening committee may, if it deems necessary, conduct an assessment of the auditors of the auditing agency before recommending for recognition.

(2)     The Certificate of Recognition granted under sub- regulation (1) shall be valid for a period of three years.

(3)     Any recognised auditing agency seeking change in the scope may apply for the same in Form A along with requisite documents and fees of rupees five thousands.

(4)     The Certificate of Recognition may be suspended or cancelled by the Food Authority on any of the grounds specified in Regulation 7.

Regulation 6. Procedure for renewal.

(1)     The auditing agency may make an application for renewal of Certificate of Recognition not later than sixty days prior to the date of expiry specified in the Certificate of Recognition along with renewal fee of Rupees Five thousands.

(2)     The Food Authority shall before renewing the Certificate of Recognition, have regard to the following, namely—

(a)      the auditing agency continues to meet the criteria specified in Regulation 3;

(b)      the performance of the auditing agency during the previous validity period;

(c)      the complaints, if any, received during the period of validity.

(d)      the recommendation of the Screening Committee for evaluation.

(3)     On being satisfied and after depositing of recognition fees of rupees thirty thousands, the Food Authority shall renew the Certificate of Recognition for a further period of three years.

Regulation 7. Suspension or cancellation of recognition.

(1)     The Food Authority may suspend or cancel the recognition granted to the auditing agency on any of the following grounds, namely,—

(i)       the auditing agency has been declared insolvent by a competent authority;

(ii)      the auditing agency has failed to performs its duties satisfactorily or in accordance with these regulations;

(iii)     the auditing agency has suppressed material information or committed fraud;

(iv)    the auditing agency has become incompetent to continue to be accredited as auditing agency;

(v)      the auditing agency has failed to provide access to their records and furnish necessary information to the Food Authority to conduct the assessment or investigation;

(vi)    the auditing agency has failed to take timely and necessary corrective measures, if any, as directed by the Food Authority;

(vii)   the recommendation of the Screening Committee on of the complaints received regarding conduct of the auditing agency;

(viii)  the auditing agency has provided false information with regard to conflict of interest.

(3)     Where the Food Authority is satisfied that the recognition granted to an auditing agency is liable to be suspended or cancelled may issue a show cause notice to such auditing agency for suspension or cancellation of recognition.

(4)     The auditing agency shall file its reply to the Food Authority within fifteen days from the date of receipt of the show cause notice,failing which the decision to cancel or suspend recognition shall be taken by the Food Authority.

(5)     The Food Authority shall consider the reply filed by the auditing agency and pass such order as it deems fit, within thirty days of the receipt of the reply of the auditing agency.

(6)     Where the Food Authority has suspended recognition, it may revoke the suspension if the auditing agency has taken necessary corrective measures in accordance with these regulations.

(7)     Where the Food Authority has cancelled the recognition, the auditing agency shall make a fresh application to the Food Authority for grant of recognition after a period of six months from the date of such cancellation.

(8)     The recognition of the auditing agency shall be deemed to be suspended or cancelled, if its accreditation is suspended or cancelled by its accreditating body.

(9)     The auditing agency may file an appeal to the Central Government, if it is aggrieved by the order of suspension or cancellation of recognition.

Part III AUDITING PROCEDURE

Regulation 8. Audit process.

(1)     The Food Authority shall specify the category or type of food businesses which shall be subject to mandatory food safety auditing, on the basis of their risk classification.

(2)     For the purpose of sub-regulation (1) the classification of food businesses shall be made having regard to the major risk factors including food type, intended customer use, nature of activity of the business, volume of the business, method of processing and such other factors as the Food Authority may deemed necessary.

(3)     A Food business which is subject to mandatory food safety auditing under sub-regulation (1) shall get its business audited by a recognized auditing agency of such intervals as the Food Authority may by order specify.

(4)     A Food business which is not subject to mandatory food safety auditing, but desirous of getting audited by a recognized auditing agency, may opt for the same.

(5)     A Food business having satisfactory food safety audits report may be subject to less frequent inspections by the Central licensing authority or the State licensing authority:

Provided that in case of any complaints against the food businesses or when it comes to the knowledge of the Food Authority that the public health and safety is at risk, the Food Authority shall undertake more frequent inspections.

(6)     The audit process for assessing the food safety management system of a Food Business Operator shall be based on IS/ISO 19011:2011 (Guidelines for auditing management systems).

Regulation 9. Audit examination.

(1)     An audit examination shall include collection of objective evidence and recording of audit observations collected or made through interviews, examination of documents and activities.

(2)     The deficiencies or non-conformities observed by the auditing agency shall be recorded clearly and concisely, pointing out the regulatory requirements that are being contravened.

(3)     During the audit process, the auditing agency shall verify the compliance not only with the food safety measures, but also with the provisions of the Act and the rules and regulation made thereunder, except those which require specific sampling and laboratory analysis of the products and also verify relevant documents relating to laboratory reports maintained by the Food Business Operator.

Regulation 10. Duties of auditors.

The auditor shall perform the following duties, namely,—

(i)       conduct food safety audit of Food Business Operator;

(ii)      verify the compliance by the Food Business Operator of the provisions of the Act and the rules and regulations made thereunder;

(iii)     conduct pre-commissioning inspection of newly established food business unit, as and when directed by the Food Authority;

(iv)    maintain confidentiality in respect of commercial-in-confidence materials, which may include process and product formulation information, food safety programme information and audit outcomes;

(v)      forward the audit report to the Food Authority within fifteen days of the conduct of food safety audit;

(vi)    carry out necessary follow-up action, including further audits, to verify if any corrective action has taken to remove any deficiency of such food safety program identified during the audit;

(vii)   maintain confidentiality of food safety audit;

(viii)  such other duties as may be directed by the Food Authority.

Regulation 11. Audit report.

(1)     The auditor shall after the completion of the audit, inform the Food Business Operator of the deficiencies or the non-conformities observed during the audit and give an opportunity to provide any further information or clarification required for completion of audit finding and reflect the same in the audit report.

(2)     When there is a major non-conformity which is a serious failure in the food safety management system of the Food Business Operator and may result in adverse health consequence possibly even fatal, the auditor shall report such findings to the Central Licensing Authority or State Licensing Authority within twenty four hours.

(3)     When there is a minor non-conformity which is shortcoming in the food safety management system or regulatory contravention of the Food Business Operator and may not cause any adverse health consequence, the auditor shall set up an appropriate timeframe of not more than 30 days for its rectification and follow up, so that the non-conformance could be rectified.

(4)     Failure by food business operator to rectify the minor non conformity within the specified timeframe shall be referred to the Central or State Licensing Authorities, as the case may be.

(5)     The auditing agency shall submit a copy of audit report to the Food Business Operator immediately after completion of the audit and forward audit report to the Central Licensing authority or State Licensing authority, as the case may be within fifteen days clearly bringing out the findings or non-conformities or concerns and observations for improvement.

(6)     The auditor may recommend in writing the reasons for the change in audit frequency of the food business operator to the Central Licensing Authority or State Licensing Authority based on the audit.

Regulation 12. Conflict of interest.

(1)     The auditing agency shall give a declaration in Form ‘C’ of the schedule before accepting food safety audit of a Food Business Operator.

(2)     The recognition of any auditing agency shall be suspended or cancelled immediately by the Food Authority on the event of providing false information on conflict of interest.

Part IV AUDIT MONITORING SYSTEM

Regulation 13. Audit monitoring.

(1)     The Food Authority shall monitor the performance of the recognized auditing agency in the following manner, namely—

(i)       The monitoring mechanism shall include review of the audit reports and performance; on site assessment of the auditors to ensure their competency of auditing the food safety management systems and the regulatory requirements; assessment of auditing agency on the basis of report of the accreditation body and any other mechanism as specified by the Food Authority.

Regulation 14. Handling disputes.

(1)     The Central or the State Licensing Authorities shall be the contact point for Food Business Operator to engage in case of any dispute or disagreement with auditors.

(2)     In case of any non-cooperation or resistance to the working of the auditing agencies or auditors by food business operator, the same shall be referred to the Central or the State Licensing authorities for resolution.

Regulation 15. Record keeping.

(1)     The final conformance report and all other documents related to the audit conducted including the first audit report, actions taken and successive communications on rectification measures shall be preserved by the auditing agencies at least for a period of five years and full confidentiality of the documents shall be maintained.

(2)     Food Business Operator shall maintain all records of audit findings and rectification for a period of five years.

SCHEDULE

Form A

(See sub-regulation 4(1), 5(3) and 6(1))

Application Form for Recognition/Renewal/Change in scope of Auditing Agency

 

I (authorised signatory) _________________________S/o, D/o_____________________ R/o___________________________________________________do hereby solemnly affirm and declare that all information and particulars furnished here by me are true and correct to the best of my knowledge. I further declare that the food safety auditing to be conducted by me or through my auditor shall conform to the requirements of the Food Safety and Standards (Food Safety Auditing) Regulations, 2017.

Signature of authorised signatory with stamp

List of documents to be enclosed:

(a)      Application fee receipt/DD or pay order

(b)      Certificate of accreditation

(c)      Educational qualification certificate of all auditors.

(d)      Lead auditor course certificate.

(e)      Confidentiality agreement

(f)       A copy of the last assessment report by the accreditation body

(g)      Details of industry auditing experience of all auditors.

Form ‘B’

Recognition Number………………

Certificate of Recognition

(See Regulation 5)

this is to certify that ………………..(name of auditing agency) has been recognised by the Food Safety and Standards Authority of India for the purpose of auditing of food business operators licensed under Food Safety and Standards Act, 2006 and subject to the Food Safety and Standards ( Food Safety Auditing) Regulations, 2018.

Name and address of auditing agency	Issued on/ renewed on	Valid up to	Scope

Note: This certificate must not be altered in any way. Intentional misuse of this certificate will result in cancellation without prior intimation.

Signature of Director with stamp

Form C

Declaration

[See sub-regulation (i) of Regulation 12]

I________________________________S/o, D/o ___________________________state that the food safety audit of M/s_________________________________having license number ____________ has been audited by my auditing agency. In this context, I hereby declare that:

(a)      my auditing agency or its personne1/auditor have not provided any training, guidance, Food Safety Certification or consultancy to and not carried out internal audits of the above said food business operator or any of its parent or subsidiary for last two years.

(b)      my auditing agency or its personne1/auditor does not own or have financial interest in, manage or otherwise control to the above said food business operators or any of its affiliate, parent or subsidiary.

(c)      my auditing agency or its personne1/auditor have not been employed by the above said food business operator for last two years.

(d)      my auditing agencyhas not carried out the food safety audit of the above said food business operator for more than three consecutive timesaudit.

Signature of authorised signatory/Auditor with stamp