AMENDMENT REGULATION ON FOREIGN FOOD MANUFACTURING FACILITIES

The draft of the Food Safety and Standards (Import) Amendment Regulations on 10th November 2020, published vide notification of the Food Safety and Standards Authority of India number F.No. 4067/MOC-Trade/Reg-FSSAI/2017(part-1), invites objections and suggestions. Primarily, it will be accepted within a period of thirty days from the date on which the copies of the Official Gazette of the same notification were made available to the public.

Significantly, 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) . Notably, the copies of the said Gazette were made available to the public on the 16th November, 2020.  Moreover, the objections and suggestions received from the public as per the draft regulations have been considered by the Food Safety and Standards Authority of India.

 Notably, 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 has made 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 Operators 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 articles of food to India shall register with the Food Authority before exporting to India.

 (c) Foreign Food manufacturing facility either directly or through authorised representatives 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 facilities 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, the Food Authority may review the same after giving the 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…………………………

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 …………………………………………………………………………………………

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.

Source: FSSAI