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The revised Food Safety Law of the People’s Republic of China mandates rigorous supervision and management of health foods. To standardize health food management, the State Administration for Market Regulation (SAMR, formerly the China Food and Drug Administration) has introduced a series of legal frameworks, including the Administrative Measures on Health Food Registration and Filing, the Guide for Health Food Registration and Application, and the Detailed Rules for the Review and Approval of Health Food Registration, among others. Additionally, the process of health food re-registration has been adjusted to health food registration renewal, with specific requirements outlined for this purpose.

What is health food registration renewal?

Health food registration renewal refers to the process in which the food and drug regulatory authority evaluates an applicant’s request to extend the validity period of the health food certificate in accordance with legal procedures, conditions, and requirements.

Materials required

1. Domestic health food registration renewal

Application form for health food registration renewal , along with a legal liability commitment from the applicant confirming the authenticity of the application materials;
Copies of the applicant’s entity registration certificate;
Copies of the health food registration certificate and its attachments;
The production and sales conditions of the health food within the validity period of the registration certificate, as verified by the provincial food and drug regulatory department (For applicants of imported health food unable to provide this documentation, a written explanation should be submitted, accompanied by copies of the business license, import customs declaration form, and sales invoices stamped with the official seal of the domestic distributor (or importer) or signed by the legal person;
Analysis report on the consumption patterns among target populations;
Self-inspection report on the operation of the production quality management system; and
A one-batch full-item test report for product technical requirements within the validity period of the registration certificate, issued by a legally qualified food inspection agency

2. Imported health food registration renewal

In addition to submitting the required materials for domestic products, the following should also be provided:

Qualification documents issued by the competent government department or legal service institution in the product’s country (or region) of production, certifying that the applicant is an authorized overseas producer of listed health foods;
Documentation from the competent government department or legal service institution in the product’s country (or region) of production proving that the health food has been on the market for more than one year, or a safety report on the product’s overseas sales and consumption by the population;
If the product is approved for export by the country (or region) of export, a certificate from the relevant authority in the exporting country (or region) permitting the product to be marketed should be provided;
Original texts of technical regulations or standards related to health foods from the country (region) of production or international organizations;
Actual samples of packaging, labels, and instructions of the products marketed in the country (or region) of production; and
If the applicant handles registration affairs through a permanent representative office in China, a copy of the Registration Certificate of Foreign Enterprises’ Permanent Representative Offices in China should be submitted. If the applicant entrusts it to a domestic agency, the original notarized power of attorney and a copy of the business license of the commissioned agency should be provided.

What are the considerations to keep in mind?

The applicant should apply for registration renewal prior to the expiration date of the health food registration certificate, generally six month in advance. If no renewal application for is submitted after the certificate expires, the original certificate will be cancelled;
If raw materials have been listed in the health food raw material directory and comply with relevant technical requirements, an application for health food registration to filing should be made;
The safety, health functions, and quality controllability of the product applied for registration renewal should meet the requirements, and the product should have a history of production and sales within the validity period of the registration certificate;
If the registration transfer and change application for products proposed for registration renewal has been accepted before December 31, 2016, and the review process has not yet concluded, the applicant should submit the renewal application within 30 working days after the previous application has been approved;
The types and amount of health food raw materials should remain unchanged;
Product technical requirements should comply with current regulations and remain unchanged. Necessary adjustments should be made according to the current provisions, however, supplementary test data and other application materials need to be re-submitted; and
Drafts of product labeling and instructions should be adjusted according to current regulations, and a revision description along with the standardized drafts should be submitted.

Related regulations

Food Safety Law of the People’s Republic of China and its Implementing Regulations
Administrative Measures on Health Food Registration and Filing
Guide for Health Food Registration Application
Detailed Rules for the Review and Approval of Health Food Registration
Key Points for Technical Evaluation of Health Food Re-registration