Supporting Document of Replacement of Health Food Registration Certificate Issued Officially in China: Interpretation of the Key Points

The State Administration for Market Regulation (SAMR) officially issued 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) on November 1, 2024, to standardize the health food registration certificates of products with no validity period.

According to our previous analysis, nearly ten thousand such products have been granted approval. CIRS summarizes and analyzes the general procedures and key points of registration certificate change, aiming to assist enterprises in completing the process under the new regulations.

Scope of Change of Health Food Registration Certificate

Health food products with no validity period and technical requirements possessing valid production permits during the transition period (from August 31, 2023, for a period of 5 years).

Product category	Certificate Change Requirement
Domestic products	Applicants submit the application as required by the Key Points.
Imported products	Applicants submit the application directly if the related materials conform to the requirement of the Key Points. The review body can carry out on-site verification.

Procedures and Requirements

Applicants who apply for a change of registration certificate must submit the following:

• application form for replacement and commitment letter;
• duplicate of valid documents proving the registration subject;
• duplicate of the approval certificate and duplicate of the documents proving the transfer of the certificate;
• specific matters, reasons, and basis for the change;
• the valid production license nationwide (imported products do not need to provide this); and
• the registrant's declaration that there are no legal disputes or ownership controversies regarding the product registration certificate and that the products for certificate change are not involved in unresolved law enforcement cases.

Provincial-level market supervision departments issue opinions on certificate renewal

First, review the production license issued by the provincial market supervision departments, the product formulations during actual production, production technology, and product technical requirements. Then report them to the SAMR, and send a copy to the registrant.

Technical review

The review agency conducts the review in accordance with current laws, regulations, and standards, and submits the review conclusions to the SAMR for approval.

Administrative approval

• If the product meets the requirements, the registration number will be updated to “国食健注G/J Year number+Serial number” (“Year number+Serial number” remains unchanged). The certificate remarks section should indicate the original product registration number, product name, and that the original registration certificate is invalid due to a change of registration certificate.
• If the product does not meet the requirements, the change of certificate application will be disapproved and the registrant may reapply.

Change the registration certificate

• The newly issued registration certificate or disapproval decision shall also be sent to the provincial market supervision department where the registrant is located and where the production license is issued.
• Health food registrants and manufacturers shall produce according to the new registration certificate within six months from the date of approval for certificate change. Products produced before the change of certificate can be sold until the end of their shelf life.

Key Points

About the product name: The product name must comply with the current regulations. Retaining the original name is allowed with a valid reason.

Besides the eight categories of functions that are required to redo or supplement the function tests, the following scenarios are also listed in the draft:

Scenarios	Requirements
There is no basis for the use of the raw material, or its use level exceeds current regulations.	Based on the safety assessment report on the long-term consumption of the product, which covers the theoretical and documentary basis for the product formulations and the safety dosage, product safety evaluation reports on the safety of consumption after marketing, comprehensively evaluate the safety of the product after long-term consumption.
	Through evaluation, if the product needs to reduce the usage of raw materials, the certificate change application will be denied. The registrant can reapply for a certificate change after decreasing the raw material usage as per existing regulations. In the reapplication, it is not necessary to submit safety evaluation test materials for the product with reduced raw material usage. However, documentation for health function evaluation and test reports on hygiene, stability, and the analysis of active/characteristic components must be provided to demonstrate the product's health function and quality control.
The formula contains new health food raw materials, while the safety evaluation documentation for the raw materials was not provided when it was registered.	Conduct the safety evaluation and relevant inspections of the new raw material and product according to the Guidelines on the Safety Toxicological Inspection and Evaluation of Health Food and Its Raw Materials (2020 Edition) (hereinafter referred to as the Guidelines). If the formula contains two or more new health food raw materials, should also be carried out product 90-day oral toxicity test and teratogenicity test in accordance with the Guidelines, and combined with the history of consumption of new raw materials, the use of new raw materials, products on the market after the evaluation of the safety of crowd consumption report to assess the safety of long-term product consumption
The product technical requirements involve the addition or revision of quality control indicators.	Conduct the acute oral toxicity, three genotoxicity, 90-day oral toxicity, and teratogenicity tests for each new raw material and product, as well as the associated inspections according to the Guidelines on the Safety Toxicological Inspection and Evaluation of Health Food and Its Raw Materials (2020 Edition).
Product technical requirements involve the updating, and revision of physical and chemical, microbiological, and efficacy of the ingredients/indicators of the signature ingredient.	Submit the revision notes along with the relevant materials of hygiene and stability tests, and test reports of function or characteristic components.
The product technical requirements related to the updating of the efficacy of the ingredients / iconic ingredients indicators, as well as physical and chemical indicators of the test method for the registrant to develop their own research.	Provide methodological validation for testing and relevant research materials
Adjustments are made to the raw material quality standards, involving substantial changes to the material foundation of the product.	Re-conduct tests for toxicology, function, hygiene, stability, function/characteristic components, and other validation tests for re-registration of the product.
Adjustment of product formulations (including substitution or removal of raw materials) in accordance with current regulations	In accordance with the current requirements for registration of new products, should submit product formulations, production processes, samples of labels and instructions, product technical requirements and other research and development materials, safety, health functions, hygiene, stability, the efficacy of the ingredients/signature ingredients testing and other test reports, to demonstrate that the product's safety, health functions, and quality controllability.

Imported health food: is exempt from providing the opinion on the change of registration certificate issued by the provincial-level market supervision department where the production license is located. Qualification certificates and other materials as per regulations are required.

CIRS Comments

According to statistics from authorities, there are approximately 1,800 health food products with no validity period and technical requirements that have obtained production licenses. During the transition period, the SAMR will focus its certificate replacement efforts on these products. It is recommended that enterprises with certification replacement needs and products currently in production and sale prepare the necessary materials in advance following the requirements outlined in the Key Points, and strive to complete the process during the transition period. For those products that do not hold a valid production license, the change of registration certificate can be applied following the proper procedures once they obtain the production license.

If you need any assistance or have any questions, please get in touch with us via service@hfoushi.com.

Further information

SAMR Announcement

Change of Health Food Registration Certificate Service in China