3 Aug 2017
Enquiry: What is the Difference between the Registration and Record-filing of Imported Health Foods?
According to the Administrative Measures for the Registration and Record-Filing of Health Food issued by the China Food and Drug Administration (CFDA), as from 1 July 2016, health foods produced domestically and foreign health foods imported into China for the first time must meet the requirements for registration and record-filing.
1. Registration of health foods: When an applicant applies for registration of health foods, CFDA departments would review the application materials with regard to the safety, health functions and quality controllability of the health food in question and then determine whether registration is granted.
2. Record-filing of health foods: This refers to the procedure whereby the health food production enterprise submits materials with regard to the safety, health functions and quality controllability of the health food in question to CFDA departments in accordance with statutory procedures, conditions and requirements for filing, public disclosure and inspection.
The applicant can visit the website of CFDA or CFDA’s Centre for Health Food Evaluation, log on to the health food registration application system and fill in the application for registration, application for change of registration, application for re-registration, or application for registration of technology transfer products.
The materials for application for health food registration must comply with the requirements set out in the Administrative Measures for the Registration and Record-Filing of Health Food, Administrative Measures for the Registration, Inspection and Review of Health Food, Technical Specification for the Inspection and Evaluation of Health Food, and Rules for the Registration, Evaluation and Approval of Health Food. Materials to be submitted in the application for registration of new products produced domestically include:
- Application for registration of health food and pledge of legal responsibility for the truthfulness of the materials submitted
- Report of product research and development
- Information on the ingredients of the product
- Information on the production processes of the product
- Information on safety and health function evaluation of the product
- Samples of product labelling and manual
- Three samples of the smallest product package
For foreign health products imported into China for the first time, in addition to the above materials, the following materials also have to be submitted in the application for registration:
- Qualifications certificates of the offshore manufacturer of the health food in question issued by the competent government department or legal service agency of the country where production is carried out
- Documentary proofs of the sale of the health food in question on the market for at least one year or safety reports of the product sold outside the mainland for human consumption issued by the competent government department or legal service agency of the country where production is carried out
- Original of the technical regulations and/or standards of the producing country or international organisation regarding the health food in question
- Samples of the packaging, labelling and manual of the product on sale in the market of the producing country
- For applications handled by the China resident representative office of an offshore applicant, a copy of the Registration Certificate of the China Resident Representative Office of Foreign Enterprises has to be submitted
As for record-filing of imported health foods, according to the Guidelines on the Record-Filing of Health Foods (Trial Implementation) which came into effect on 2 May 2017, the individual(s) submitting the filing application should be the offshore manufacturer of the health food concerned. The filing applicant must bring along the qualifications certificates of the offshore manufacturer of the health food concerned issued by the competent government department or legal service agency of the producing country as well as a letter of authorisation and go to CFDA’s administrative service centre to apply for an account number for logging on to the record-filing management information system. The log-on account number will be issued to the filing applicant after approval has been granted by the administrative service centre.
After obtaining the login account number, the applicant must log on to the health food record-filing management information system and print out the auto-generated record-filing application form (with barcode and check code), product ingredients, label manual, product technical requirements etc. Then the applicant must stamp its official seal on each and every page of the printouts as well as on any other record-filing application materials required. After that, the applicant should scan all the print materials required for record-filing and upload their colour electronic versions (in PDF file) onto the system, before verifying and submitting them. A full set of the original record-filing application materials should also be submitted to CFDA’s administrative service centre.
For further details, please refer to:
Administrative Measures for the Registration and Record-Filing of Health Foods (Chinese)