Through a notification dated 10 November 2020 the has proposed draft Food Safety and Standards (Import) Amendment Regulation,2020 related to inclusion of registration and inspection of Foreign Food manufacturing facilities. The FSSAI has invited objections or suggestions if any, which may be addressed as per the attached format to the Chief Executive Officer, Food Safety and Standards Authority of India, Food and Drug Administration Bhawan, Kotla Road, New Delhi – 110002 or emailed to regulation@fssai.gov.in within 60 days of the above-mentioned date.
Draft regulations
These regulations may be called the Food Safety and Standards (Import) Amendment Regulations, 2020. They shall come into force with effective date for implementation to be either 1st January or 1st July subject to a minimum of 180 days from the date of their final publication in the official Gazette.
In the Food Safety and Standards (Import) Regulations, 2017 new chapter XIV has been added which is ad follows
Chapter XIV
Registration and inspection of Foreign Food manufacturing facilities
18 (1) Registration of Foreign Food manufacturing facilities-
- The Food Authority may from time to time based on the risk specify the categories of food products to be exported to India, for which inspection or audit of Foreign Food manufacturing facilities producing such categories of foods shall be mandatory.
- (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 importer 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 30 days from such notice. In case the applicant fails to furnish the required information within the stipulated time of 30 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 and issuance of registration or rejection of the application.
(3) Inspection of Foreign Food manufacturing facilities
- (a) Officials from FSSAI and relevant ministry/ organization/ department for the purpose of inspection of Foreign Food Manufacturing Facilities shall be nominated by the Food Authority
- (b) Foreign Food manufacturing facility (ies) may be inspected in a manner as specified by Food Safety and Standards Authority of India
- (c) Foreign Food manufacturing facility(ies) may also be inspected after the issuance of registration, as deemed necessary;
(4) Issuance of registration
- (a) Foreign Food manufacturing facility found to be in compliance of FSS Act rules and regulation made there-under shall be registered as Foreign Food manufacturing facilities for a period of five years and their registration number shall be communicated in Form 17;
- (b) Foreign Food manufacturing facility found to not be in compliance of FSS 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
- (d) Renewal of registration of Foreign Food manufacturing facility shall be made in Form 16, not later than 30 days prior to the expiry date indicated in the registration.
(5) Audit of Foreign Food manufacturing facility
- (a) Foreign Food manufacturing facility which requires mandatory audit shall get their facility audited by the auditing agency recognized by the Food Authority. Frequency of audit shall be specified by the Food Authority from time to time. Copy of the audit report/certificate issued by the auditing agency shall be submitted to the Food Authority.
(6) Suspension or cancellation of registration
- (a) If Foreign Food manufacturing facility or their food products are found not to be in compliance of FSS 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.
New Form-16 and Form-17 have been included in the amendment
FORM – 16
[See regulation 18(1)(b)]
Application for Registration/renewal of Registration of Foreign Food manufacturing facilities
- Name of the Company/Organization………………………………………………………………………………
- Registered Office Address…………………………………………………………………………………………………
- Address of Premise for which Registration is being applied………………………………………………….
- license/registration issued by concerned country’s government authority for food manufacturing/processing facility……………………………………………………………………………………………..
- E-mail ………………………………………………………………………………………………………….
- Contact no………………………………………………………………………………………………………
- Details of the product(s)……………………………………………………………………………….
- 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 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) Authorization in favour of importer (if applied through importer).
FORM – 17
[See regulation 18(4)(a)]
Registration/renewal of Registration of Foreign Food manufacturing facilities
- Name of the Company/Organization………………………………………………………………………………
- Registered Office Address…………………………………………………………………………………………………
- Address of authorized premise……………………………………………………….. …………………………….
- Registration no…………………………………………………………………………………..
- Details of the product(s)…………………………………………………………………………………………………..
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 ……………………………………………………..
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