FSSAI Notifies ‘Food Safety and Standards (Import) First Amendment Regulations, 2021’ vide Notification No. F. No. 4067/MOC-Trade/Reg-FSSAI/2017 (Part-1) Dtd. 03rd November, 2021.

The FSSAI has notified a new set of Regulations to amend the existing Food Safety and Standards (Import) Regulations, 2017. The said Regulations shall come into force on the date of their publication in the Official Gazette i.e., 06th November, 2021 and Food Business Operator (FBO) shall comply with all the provisions of these Regulations w.e.f. 1st June, 2022. 

Food Safety and Standards (Import) First Amendment Regulations, 2021

Vide this set of Amendment Regulations, the FSSAI has inserted a new chapter (Chapter XIV) after Chapter XIII, to provide for registration and inspection of Foreign Food manufacturing facilities.  

Sr. No. Regulation Comments
1 Regulation 18(1)

[Registration of Foreign Food manufacturing facilities]

(a) The Food Authority may from time to time based on the risk specify the categories of food products intended for export to India for further regulating control as specified in these regulations.

(b) Foreign Food manufacturing facilities falling under such categories and desirous to export such article of food to India shall register with the Food Authority before exporting to India:

(c) Foreign Food manufacturing facility either directly or through authorized representative may apply for registration in “Form 16” of these regulations along with documents specified in Annexure-1 and fee as specified by the Food Authority.

Vide this amendment, the FSSAI has provided that, it may from time to time specify the categories of food products intended for export to India for further regulating control. As a consequence, Foreign Food manufacturing facilities falling under such categories shall register with the Food Authority before exporting to India in Form-16 along with the documents specified in Annexure-1 and fee as specified, either directly or through an authorized representative.

2 Regulation 18(2)

[Processing of application for Registration of Foreign Food manufacturing facilities]

(a) If upon scrutiny of the application Food Authority requires any additional information with respect to an application or if the application is incomplete, the Food Authority shall advise the applicant, to furnish such additional information or complete the application, as the case may be, within thirty days from such notice. In case the applicant fails to furnish the required information within the stipulated time of thirty days, the application for Registration of Foreign Food Manufacturing Facility shall stand rejected;

(b) On receipt of a complete application including the additional information if asked for, the Food Authority may process the application for inspection, if required or issuance of registration or rejection of the application.

The Food Authority shall ask the applicant to furnish additional information or complete the application within 30 days from such notice if upon scrutiny any additional information is required or if the application is incomplete.

In case the applicant fails to furnish the required information within the stipulated time the application shall be rejected.

3

Regulation 18(3)

[Inspection of Foreign Food manufacturing facilities]

(a) Foreign Food manufacturing facility(ies) may be inspected, if required in a manner as specified by Food Safety and Standards Authority of India:

Provided that no inspection shall be required in case of such categories of food that are covered under mandatory Bureau of Indian Standards Certification Mark Scheme and where the Bureau of Indian Standards scheme of inspection includes the requirements specified under Schedule 4 of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

(b) Foreign Food manufacturing facility may also be inspected after the issuance of registration, as deemed necessary;

(c) Officials from FSSAI and relevant ministry or organization or department or recognized auditing agency shall be nominated by the Food Authority for the purpose of inspection of Foreign Food Manufacturing Facilities;

(d) Food Authority, if required may prescribe cost of inspection, which shall be borne by the Foreign Food manufacturing facility.

Self-explanatory.
4 Regulation 18(4)

[Issuance of registration]

(a) Foreign Food manufacturing facility found to be in compliance of Food Safety and Standards Act, rules and regulation made there-under shall be registered as Foreign Food manufacturing facilities for a period of two years and their registration number shall be communicated in Form 17;

(b) Foreign Food manufacturing facility found to not be in compliance of Food Safety and Standards Act, rules and regulation made there-under, the application made for registration shall be rejected;

(c) Foreign Food manufacturing facility whose application is rejected, after taking remedial action may apply for recognition again, and

(d) Renewal of registration of Foreign Food manufacturing facility shall be made in Form 16, not later than thirty days prior to the expiry date indicated in the registration.

Acceptance: Once the application is accepted, the registration shall be granted for a period of 2 years and registration number shall be communicated in Form-17.

Rejection: Application made by Foreign Food manufacturing facility which is found not in compliance with the Food Safety and Standards Act, rules and regulation shall be rejected which may after taking remedial action apply for recognition again.

Renewal: Application for renewal shall be made in Form-16 not later than 30 days prior to the expiry date indicated in the registration.

5

Regulation 18(5)

[Suspension or cancellation of registration]

(a) If Foreign Food manufacturing facility or their food products intended for export to India are found not to be in compliance of Food Safety and Standards Act, rules and regulation made there-under, their registration as Foreign Food manufacturing facilities shall be suspended or cancelled. However, Food Authority may review the same after giving opportunity for hearing or clarification, as deemed fit.

Self-explanatory.

*****

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA

NOTIFICATION

New Delhi, the 3rd November, 2021.

F. No. 4067/MOC-Trade/Reg-FSSAI/2017 (Part-1).—Whereas the draft of the Food Safety and Standards (Import) Amendment Regulations, 2020, were published vide notification of the Food Safety and Standards Authority of India number F.No. 4067/MOC-Trade/Reg-FSSAI/2017(part-1), dated the 10th November, 2020, in the Gazette of India, Extraordinary, Part III, Section 4 as required under sub- section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), inviting objections and suggestions from persons likely to be affected thereby, within a 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 16th November, 2020;

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 92 of Food safety and Standards Act,2006(34 of 2006) the Food Safety and Standards Authority of India, with the previous approval of the Central Government hereby makes the following regulations, further to amend the Food Safety and Standards (Import) Regulations, 2017, namely:—

1. (1) These regulations may be called the Food Safety and Standards (Import) First Amendment Regulations, 2021.

(2) They shall come into force on the date of their publication in the Official Gazette and Food Business Operator shall comply with all the provisions of these regulations with effect from 1st June, 2022.

2. In the Food Safety and Standards (Import) Regulations, 2017,—

(i) after “chapter XIII”, the following shall be inserted, namely,—

“Chapter XIV

Registration and inspection of Foreign Food manufacturing facilities

18 (1) Registration of Foreign Food manufacturing facilities.—(a) The Food Authority may from time to time based on the risk specify the categories of food products intended for export to India for further regulating control as specified in these regulations.

(b) Foreign Food manufacturing facilities falling under such categories and desirous to export such article of food to India shall register with the Food Authority before exporting to India:

(c) Foreign Food manufacturing facility either directly or through authorised representative may apply for registration in “Form 16” of these regulations along with documents specified in Annexure-1 and fee as specified by the Food Authority.

(2) Processing of application for Registration of Foreign Food manufacturing facilities—(a) If upon scrutiny of the application Food Authority requires any additional information with respect to an application or if the application is incomplete, the Food Authority shall advise the applicant, to furnish such additional information or complete the application, as the case may be, within thirty days from such notice. In case the applicant fails to furnish the required information within the stipulated time of thirty days, the application for Registration of Foreign Food Manufacturing Facility shall stand rejected;

(b) On receipt of a complete application including the additional information if asked for, the Food Authority may process the application for inspection, if required or issuance of registration or rejection of the application.

(3) Inspection of Foreign Food manufacturing facilities- (a) Foreign Food manufacturing facility (ies) may be inspected, if required in a manner as specified by Food Safety and Standards Authority of India:

Provided that no inspection shall be required in case of such categories of food that are covered under mandatory Bureau of Indian Standards Certification Mark Scheme and where the Bureau of Indian Standards scheme of inspection includes the requirements specified under Schedule 4 of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

(b) Foreign Food manufacturing facility may also be inspected after the issuance of registration, as deemed necessary;

(c) Officials from FSSAI and relevant ministry or organization or department or recognised auditing agency shall be nominated by the Food Authority for the purpose of inspection of Foreign Food Manufacturing Facilities;

(d) Food Authority, if required may prescribe cost of inspection, which shall be borne by the Foreign Food manufacturing facility.

(4) Issuance of registration.—(a) Foreign Food manufacturing facility found to be in compliance of Food Safety and Standards Act, rules and regulation made there-under shall be registered as Foreign Food manufacturing facilities for a period of two years and their registration number shall be communicated in Form 17;

(b) Foreign Food manufacturing facility found to not be in compliance of Food Safety and Standards Act, rules and regulation made there-under, the application made for registration shall be rejected;

(c) Foreign Food manufacturing facility whose application is rejected, after taking remedial action may apply for recognition again, and

(d) Renewal of registration of Foreign Food manufacturing facility shall be made in Form 16, not later than thirty days prior to the expiry date indicated in the registration.

(5) Suspension or cancellation of registration.—(a) If Foreign Food manufacturing facility or their food products intended for export to India are found not to be in compliance of Food Safety and Standards Act, rules and regulation made there-under, their registration as Foreign Food manufacturing facilities shall be suspended or cancelled. However, Food Authority may review the same after giving opportunity for hearing or clarification, as deemed fit.”

(ii)  after “Form 15”, the following form shall be inserted, namely:—

“FORM – 16

[See regulation 18(1)(b)]

Application for Registration/renewal of Registration of Foreign Food manufacturing facilities

1. Name of the Company/Organisation………………………………………………….

2. Registered Office Address………………………………………..

3. Address of Premise for which Registration is being applied…………………………………..

4. license/registration issued by concerned country’s government authority for food manufacturing/processing facility…………………………………………………………………………………….

5. E. mail…………………………………………………………………………………….

6. Contact no………………………………………………………………………………….

7. Product(s) name and description…………………………………………………

8. All information and particulars furnished here by me are true and correct to the best of my knowledge.

Date ………………………………………………………………. Signatures and seal of authorized signatory

Place ……………………………………………………………… Name and address…………………………….

Annexure-1

List of documents to be enclosed with Application for Registration/renewal of Registration of Foreign Food manufacturing facilities:—

(1) license/registration or similar document issued by concerned country’s government authority for food manufacturing/processing facility;

(2) Consent of owner of Foreign Food manufacturing facility for inspection by Food Safety and Standards Authority of India officials;

(3) Detail composition of products;

(4) Authorisation in favour of authorised representative (if applied through of authorised representative).

(5) Any other documents/ information as may be required by the food Authority.

FORM 17

[See regulation 18(4)(a)]

Registration/renewal of Registration of Foreign Food manufacturing facilities

1. Name of the Company/Organisation……………………………………………………………………………………….

2. Registered Office Address……………………………………………………………………………………………………

3. Address of authorised premise………………………………………………………………………………………………

4. Registration no………………………………………………………………………………………………………………….

5. Product(s) name and description……………………………………………………………………………………………

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

Date ………………………………………………………………….. Signatures of CEO, FSSAI/representative

authorised by him

Place ………………………………………………………………….. Name …………………………………………. ”

ARUN SINGHAL, Chief Executive Officer

[ADVT.-III/4/Exty./404/2021-22]

Note: The Food Safety and Standards (Import) Regulations, 2017 were published in the Gazette of India, Extraordinary, Part III, Section 4, vide notification number F. No. 1/2008/Import safety/FSSAI, dated the 9th March, 2017 and was subsequently amended vide notification numbers—

(i) F. No. REG/11/25/Import amendment/FSSAI-2017, dated the 7th February, 2018; and

(ii) F. No. 1-1275/FSSAI/Import/2015, dated the 20th October, 2020.

******

Disclaimer: The author is based in Jabalpur and is a Practicing Company Secretary dealing in Corporate, Legal & Taxation services. The information contained in this write up, as provided by the author, is to provide a general guidance to the intended user. The information should not be used as a substitute for specific consultations. Author recommends that professional advice is sought before taking any action on specific issues.

The author can also be reached at [email protected]

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