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

The Food Safety and Standards Act, 2006

Official text

MINISTRY OF HEALTH AND FAMILY WELFARE

(Food Safety and Standards Authority of India)

NOTIFICATION

New Delhi, the 28

August , 2018

F.No. TPA/01/REG/FSSAI-2017.—Whereas, in exercise of the power conferred by clause (c) od 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 12

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 18

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:-

Regulations

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.

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Part-I

GENERAL

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;

(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

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.

(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.

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.

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(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.

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.

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 regulation3;

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

(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.

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.

(2) 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.

(3) 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.

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(4) 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.

(5) 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.

(6) 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.

(7) 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.

(8) 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

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).

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.

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;

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

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.

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

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.

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.

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.

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SCHEDULE

Form A

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

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

1) Name of auditing agency:

2) Name of contact person:

3) Address(with Pin Code):

4) Contact Details:

a) Tel No.(with STD code)

b) E-mail of the contact

person/Website address of the

Organization (if any)

5) Legal Entity Status (attach

documentary evidence):

6) Detail of accreditation certificate

( attach copy):

Certificate No:

Validity up to:

7) Specialised areas of work:

8) Detail of auditors enrolled ( attach

copy):

9) Educational qualification of auditor

10) Training details of auditor (copy of

certificate)

S. No Title of course Conducted/Organized

by(Name and

Address)

Dates

From To

Photo

(Authorised

signatory in case

of auditing

agency)

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11) Details of Inspection/audit conducted

in last two years (food category wise)

12) Any other information regarding food

safety audit competency

13) Recognition number : (in case of

renewal)

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.

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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

18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4)

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 personnel/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 personnel/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 personnel/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

PAWAN AGARWAL, Chief Executive Officer

[ADVT.-III/4/EXTY/205/18]

Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-110054.

brief note

gazette