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Registration of Foreign Food Manufacturing Facilities (ReFoM)

tag icon Regulation/Guidelines
category icon Food,
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Summary:

Registration of Foreign Food Manufacturing Facilities (ReFoM) intending to export Egg powder; Nutraceuticals; Meat & meat items, including fish, poultry & their products; Infant food


As per the order dated 10th October 2022, FSSAI notified that registration of Foreign Food Manufacturing Facilities (ReFoM) intending to export Egg powder; Nutraceuticals; Meat & meat items, including fish, poultry & their products; Infant food; and/or Milk & milk products to India is mandatory. This order is effective from 1 Feb 2023.

The FSSAI has requested all competent authorities of exporting nations to provide the list of current manufacturers and those who are aiming to export such products to India. Based on the list provided by competent authority, registration would be done by FSSAI on its portal.

Such facilities can apply for Registration through an authorised representative or directly. 

Around 1760 companies from 33 countries have already registered as on 19 April 2023.

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Documents required for registration of Foreign Food Manufacturing Facilities

  • Registration or License or similar document granted by the concerned country’s authority;
  • Owner’s consent of the Foreign Food Manufacturing Facility for the verification by the FSSAI Officials;
  • Detail compositions of products or items;
  • Authorisation for the authorised representative (in case applied through an FSSAI authorised representative);
  • Any additional documents or details that may be needed by Food Authority or FSSAI.

Process of ReFoM:

  • First, the Foreign Food Manufacturing Facility, either directly or through an Authorised Representative (AR), may apply for Registration in the application form (Form-16) along with all the relevant documents specified above and the fee for the Registration which is yet to be specified by FSSAI. As of now this process has been made free of charge and FSSAI may call upon for the fee as and when gazetted or notified through circular.  
  • If upon scrutiny of the application form, the FSSAI requires any additional details regarding the application or if the application for the Registration is incomplete, it shall inform the applicant to provide such additional information or complete the application form, as the case may be, within 30 days from such notice. If the applicant fails to provide the required details within the stipulated time, the application for the Registration of Foreign Food Manufacturing Facilities shall be rejected.
  • On receipt of the application, including the additional details, if asked, the FSSAI may process the application for the examination and issue the Registration or rejection of the application.
  • If required, the Foreign Food Manufacturing Facilities may be inspected by FSSAI. However, no inspection shall be needed in case such food categories are covered under the mandatory BIS Certification Mark Scheme ^ where the BIS inspection comprises the requirements specified under Schedule 4 of the Food Safety & Standards (Licensing & Registration of Food Businesses) Regulations, 2011. As of now the audits are yet to be initiated by FSSAI.
  • These facilities may also be examined after the issuance of the Registration Certificate, as considered necessary from time to time. A process is expected to be brought in later stages.
  • FSSAI Officials and the relevant Ministry or Department or Organisation or recognised auditing agency shall be nominated by the FSSAI to examine such facilities.
  • FSSAI, if required, may prescribe inspection costs, which shall be borne by the Foreign Food Manufacturing Facility.
  • The Foreign Manufacturing Facility (Food Manufacturing) found to be compliant to the FSS Act & Rules and Regulations made thereunder shall be registered for 2 years & their Registration No. shall be communicated in Form-17.
  • Such manufacturing facility whose application is rejected or refused, after taking remedial action, may apply for Registration again.
  • Renewal of Registration of Foreign Food Manufacturing Facilities shall be made in Form-16, not later than 30 days before the expiry date indicated in the registration approval.

Note: The Registration of such facilities is valid for only 2 years and renewal of the Registration shall be made at least 30 days prior to the expiry date. The Registration of Foreign Food Manufacturing Facilities shall be cancelled or suspended if such facilities or food items exported to India are not in compliance with the FSS Act, Rules and Regulations.

Saurangi is a food regulatory expert with 8 years of experience. She shares her knowledge and insights on regulatory updates, food trends, best practices, and news. Follow her for expert insights and practical advice on all things for food regulatory

Saurangi Shah

CliniExperts Services Pvt. Ltd.


Tags Registration Form 16 Form 17 Foreign manufacturers Infant foods Nutraceuticals

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