FAQs on the Replacement of Health Food Registration Certificate in China (Vol. 1)

1. What is the scope of replacement of health food registration certificate ? What is the application category?

According to the Key Points for the Review of the Change of Registration Certificate for Health Foods with No Validity Period and No Technical Requirements in Production and Sale (hereinafter referred to as the Key Points), during the transition period, for domestic products with no validity period and no technical requirements in production and sale (hereinafter referred to as “Dual No” health food), when they are currently in production and on sale, the registrant should submit a re-certification application as required. For imported products that are currently in production and on sale, if the relevant materials meet the requirements, the registrant can directly submit a re-certification application. The review body may conduct on-site inspections overseas if necessary. The application category for re-certification is a change of registration application.

2. What is the procedure for handling the “Dual No” health food re-certification application?

According to the Directory of Permissible Health Functions for Health Food (2023 Edition) and the Key Points, the registrant should prepare the re-certification materials as required and apply for re-certification under the change of registration process. Provincial market regulatory departments will propose re-certification opinions based on the actual production technical requirements and supervision conditions of the product, and submit these to the State Administration for Market Regulation (SAMR), with a copy sent to the registrant. The review body will conduct the re-certification review in accordance with relevant laws and standards, and send the review conclusion to SAMR for approval. The re-certification opinions issued by the provincial market regulatory departments are an important basis for the re-certification approval process. Applicants should ensure that their application materials are in line with these opinions. For matters related to re-certification opinions from provincial market regulatory departments, please consult the relevant provincial departments that issue the product manufacturing license.

3. For products produced by cross-provincial entrusted manufacturing, should the re-certification opinion be issued by the provincial market regulatory department where the applicant is located, or the department where the entrusted manufacturer is located?

According to the Key Points, the re-certification opinion should be issued by the provincial market regulatory department that issued the production license.

4. Should the change of registration application for products be processed separately, or can it be handled together with the re-certification application?

According to the Guide for Health Food Registration Application (2016 Edition), registrants can apply for multiple change of registration items simultaneously. If, for objective reasons, these cannot be handled together, the review body should notify the registrant in writing and explain the reason. If no objections are raised within 10 working days, the change application will automatically terminate. During the registration process, if there are changes to the registrant’s name or address, the registrant can submit a supplementary change application. For multiple change requests made at different times, the review deadline for the last received change request will apply to all changes.

According to the Announcement on Matters Related to Name and Address Changes for Health Food Registrants and the Announcement on Categorizing Health Food Registration Change Applications, if the registrant’s name or address changes, or if there are changes such as reducing health functions, changing product names, or modifying labels (limited to deleting prefaces, reducing health functions, expanding inapplicable groups, standardizing specifications, etc.), the registrant can apply for change separately or combine it with the re-certification application.

For changes that fall under the specific requirements in the Key Points, these should be included in the re-certification application and should not be separately applied for.

5. How should the transfer of technology for health food be handled?

According to the Regulations on the Registration and Filing Management of Health Food, if the registrant of health food transfers technology, the transferee must submit a new product registration application under the guidance of the transferor. The product technical requirements should be consistent with the original application materials. If the application meets the requirements, SAMR will issue a new health food registration certificate to the transferee and cancel the registration of the transferor.

According to the Guide for Health Food Registration Application (2016 Edition), if the Dual No health food is in the process of applying for other registration matters, the transfer of technology application will not be accepted until those matters are completed. During the transfer process, the registrant may also submit change or renewal registration applications, but if the technology transfer application is being processed, the change or renewal registration application will be terminated.

The Key Points clearly states that the “Dual No” health food re-certification is considered a change of registration application.

The re-certification application for “Dual No” products involves verification of the actual production formula, process, and technical requirements, and may involve adjustments to the product name, formula, function, and other aspects. On the other hand, technology transfer applications involve changes to the certificate holder and rights between the transferor and transferee, which can lead to disputes. Therefore, it is recommended that registrants first complete the “Dual No” re-certification before applying for technology transfer.

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