China CFDA Release 3 Special Foods Registration Approval Guidelines

On December 25, 2017, CFDA released 3 support documents about special foods registration approval effective from December 1, 2017. They are:

Service Guideline on the Approval of Infant and Young Children Milk Powder Formula Recipes Registration
Service Guidelines on the Approval of Health food with New Raw Materials and First Imported Health Food (Vitamins, Mineral Substances and other Nutrient Supplements Excluded) Registration
Service Guidelines on the Approval of Foods for Special Medical Purpose Registration

The contents of the guidelines are mainly from the previous management regulations like Food Safety Law, Administrative Measures for Registration and Filing of Health Foods, Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes and their attached documents.

These 3 guidelines also list some common mistakes found in registration dossiers. Below are some we selected regarding imported products that overseas enterprise should avoid.

Category	Registration application	Registration change or continuation application
Infant Formula	Use of non-standard Chinese characters or the name contains letters, graphics, symbols and so on, such as A, +, ®, etc. in product name; The English product name is not consistent with the Chinese one; The information filled is not consistent with the submitted qualification certificates; The name of the applicant is not in accordance with the Business License; The contact person and information are not the actual information of the person submitting materials for registration;	The product name is not same as the name on registration certificate.
Health food	The manufacturer’s name is not the actual one for sub-contract products; The function claim is not consistent with the Health Food Function Claim Directory; No signature of the legal representative and no stamp of the domestic applicant.	The product name, applicant and function claim are not same as the name on registration certificate; Contact information is not true.
FSMP	Product type is selected more than 1; Addresses of applicant and manufacture are not detailed.	The content and reason of change are not detailed enough; The original approved content is not consistent; Latest change content is not stated for non-first time change application; For continuation application, approved content changes are not stated during the validity of the registration certificate.

Different from infant formula and FSMP, health food also has the applications for transfer of technology and registration certificate replacement/reissue.

ChemLinked provides on-demand translation service for Chinese food regulations/standards, if you would like to have the English versions of these guidelines, feel free to contact with us.