The Supporting Document for Change of Health Food Registration Certificate Issued for Public Comments: Interpretation of the Key Points

With the release of the new regulations for health food registration, the State Administration for Market Regulation (SAMR) 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 (Draft) on December 27, 2023, for public comments, to standardize the health food registration certificates with no validity period and technical requirements issued by the former Ministry of Health (MOH). The deadline for public comments is January 26, 2024.

According to our previous analysis, as many as nearly ten thousand such products have been approved. CIRS has summarized and analyzed the general procedures and key points of registration certificate replacement, to assist enterprises in completing the process under the new regulations.

Products subject to Certificate Change

Health food products with no validity period and technical requirements should change their certificate during the transition period (from August 31, 2023, for 5 years).

Procedures and Requirements

1. The provincial-level market regulatory authorities issue opinions on reissuing the certificate.

• The provincial-level market regulatory authorities where the production license is located issue details and a confirmation opinion on the product’s valid production license, the product formula, the production process, and technical requirements used in the actual production; and
• The provincial market regulatory authorities where the registrant is located issue a statement confirming that there are no abnormal self-inspection findings regarding the registrant’s entity qualifications, along with a confirmation opinion from the provincial-level bureau.

2. Apply for the change of health food registration certificate

• Change of health food registration certificate application form and commitment letter;
• Copies of valid entity registration certificates for all registrants;
• Copies of approval certificates and related documents for changes; and
• Opinion on certificate replacement and annex issued by the provincial-level market regulatory authorities, etc.

3. 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.

4. Administrative approval

• If it meets the requirements, the registration number will be updated as “国食健注G/J Year number+serial number” (“Year number+Serial number” remains unchanged). The remark section of the certificate should note the original product registration number, product name, and the expiration of the original registration certificate; and
• If it does not meet the requirements, the application for the change of certificate will be disapproved and the registrant may reapply.

5. Reissue the registration certificate

• The reissued registration certificate or disapproval decision shall also be sent to the provincial-level market supervision department where the registrant is located and where the production license is issued; and
• Health food registrants and manufacturers shall strictly organize production according to the new registration certificate within 6 months. Products produced before can still be sold until the expiration date.

Key Focus

(1) Product name: The product name shall comply with the current regulations. Products may still retain the original name with reasonable grounds.

(2) In addition to 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 the amount of use exceeds current regulations.	Adjust the formula according to current regulations (including replacing the raw materials), and re-conduct tests for toxicology, function, hygiene, stability, and other validation tests for re-registration of the product.
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).
The formula contains two or more new health food raw materials, and the safety evaluation documentation for those raw materials was not provided when it was registered.	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).
The product technical requirements involve the addition or revision of quality control indicators.	Submit the revision notes along with relevant materials of hygiene and stability tests, and test reports of function or characteristic components.
The product technical requirements involve amendments to the function/characteristic components indicators, and the registrants develop the testing methods for physiochemical indicators by themselves.	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.

(3) Regarding imported health food: Exempted 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 Opinion

According to statistics from relevant authorities, approximately 1,800 health food products with no validity period and technical requirements have obtained production licenses. During the transition period, the SAMR will focus on the certificate replacement for these products. It is recommended that enterprises subject to certification change prepare the necessary materials in advance following the requirements outlined in the draft for public comments if their products are currently in production and sale, striving to complete the process within 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 (in Chinese)

China Officially Released the Function Evaluation Methods for Health Food: Summary of Key Changes