MK体育·(国际)官方网站-mksport

The revised Food Safety Law of the People’s Republic of China mandates strict 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 issued 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. These documents specify the detailed requirements for health food change registration.

What is health food change registration?

Health food registration refers to the approval process in which the food and drug supervision department evaluates and reviews an applicant’s request to alter the contents of a health food registration certificate and its attachments. This systematic evaluation is conducted according to legal procedures, conditions, and requirements to determine whether to grant the registration.

Requirements for applicants

If the contents of the health food registration certificate and its attachments are to be changed, the registrant should apply for the changes along with written reasons and basis.
In the case of a change in the registrant’s name, the new registrant should apply for the change.

Materials required

1. Domestic health food change registration

Application form for health food change registration, along with a legal liability commitment statement 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; and
The specific items before and after change, reasons, and basis.

2. Imported health food change registration

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 production country (or region), certifying that the applicant is an authorized overseas manufacturer of listed health foods;
Documentation from the competent government department or legal service institution in the product’s production country (or region) 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 after change;
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; and
Documentation from the competent government department or legal service agency of the product’s production country (region) confirming changes to the application, along with relevant documents.

3. Depending on specific changes, the following materials should also be provided:

S.N.	Change item	Materials required
		Domestic health food	Imported health food
1	Change of applicant name and address	Documentation issued by the local Administration for Industry and Commerce confirming that the applicant’s name and address has been changed	Documentation issued by the competent government authority or legal service agency of the product’s country (region) of manufacture proving that the production site has not been changed
2	Change of product name	Searchable materials demonstrating that the generic name after change does not duplicate any registered drug names Searchable materials proving that the generic name after change does not duplicate any registered health food names If the generic name of the product includes words other than the raw material or its abbreviation to indicate the product’s characteristics, a naming explanation should also be provided
3	Add health functions	Demonstration report of the health function added Test evaluation materials of the health function added; if it involves human feeding trials, the ethical review approval certificate and population consumption evaluation materials should be provided as well Hygienic test report of the test sample of the health function added Draft of revised labeling instructions
4	Change of product specifications, storage methods, shelf life, excipients, production processes, and other technical requirements	Reports on efficacy or characteristic components, hygiene, and stability tests for three batches of samples (if the referenced standards in product technical requirements are updated or replaced without substantial changes, these reports can be omitted) Revised materials should be provided if there are changes to the product formula, label draft, product technical requirements, or production process materials For changes in the production process, provide supporting literature, experimental data, and a comparative analysis of the pre- and post-change processes to confirm that the product’s safety, health function, and quality control are substantially equivalent to those of the originally registered product
5	Changes of of suitable and unsuitable population range, precautions, consumption method, and consumption levels	Draft of revised labeling instructions Regarding changes in the suitable and unsuitable population, precautions, consumption method, provide the following: Justification that the changes do not impact the product’s safety or health function If the original safety and function evaluation tests, and hygiene and stability tests, do not adequately support the changes regarding the suitable and unsuitable population, consumption method, or precautions, additional tests should be conducted. For a reduction in consumption level, provide the function evaluation test report conducted according to the proposed consumption level For an increase in consumption level, provide the following: Test report on toxicological safety assessment conducted according to the proposed consumption level Function evaluation test report comparing the proposed consumption level and the original level

The following items apply only to domestic health food change registration:

S.N.	Change item	Materials required
1	Absorption and merger, or new merger between the applicant and another company	Copies of the business license of the applicant before and after the merger Merger and cancellation documentation issued by the local Administration for Industry and Commerce Statement of no dispute and notarized document regarding the ownership of the product approval certificate from the applicant and the related company
2	The applicant undergoes a corporation split and establishes a wholly-owned subsidiary	Copies of the business licenses of the applicant and the wholly-owned subsidiary Documentation issued by the local Administration for Industry and Commerce confirming the applicant’s establishment of a wholly-owned subsidiary Capital verification documentation issued by a verification agency, confirming the transfer of all relevant health food production workshops, equipment, facilities, production personnel, and product approval certificates to the wholly-owned subsidiary after the split Board resolution or approval documents from relevant authorities agreeing to transfer all health food-related production workshops, equipment, facilities, production personnel, and product approval certificates to the wholly-owned subsidiary Commitment statement ensuring that cconditions related to product quality and safety, such as production workshops, equipment, facilities, production processes, quality standards, and production personnel, remain unchanged

The following items apply only to imported health food change registration:

S.N.	Change item	Materials required
1	Change of overseas production site (without changing the country or region of production)	Documentation issued by the competent government department or legal service agency of the new production site country (region) allowing the production and sale of the product in that country (region) Actual samples of the product’ packaging, labels, and instructions as marketed in the new production site country (region), along with drafts of the updated labels and instructions Reports on efficacy or characteristic component, hygiene, and stability tests for three batches of samples produced at the new production site, issued by a legally qualified inspection agency Documentation issued by the competent government department of the sample production country (region) or the department designated by the government to bear legal responsibility, confirming compliance with good manufacturing practices Statement from the overseas production companu ensuring that health foods exported to China comply with China’s relevant laws, regulations, and national food safety standards Other materials related to product registration review
2	Change of overseas production site (change the country or region of production)	Documents provided by the licensee for the application to cancel the original registration certificate Product formula materials Production process materials Reports on efficacy or characteristic components, hygiene, and stability tests for three batches of samples Types, names, and standards of packaging materials in direct contact health foods Drafts of labels and instructions: Searchable materials demonstrating that the generic name in product name does not duplicate any registered drug names, and that the product name does not duplicate any registered health food names Product technical requirement documents 3 minimum retail packaging samples Other materials related to product registration review

What are the considerations to keep in mind?

If the raw materials have been included in the health food raw material directory and comply with relevant technical requirements, an application for health food registration to filing should be made;
Changes in the application should be limited to the content specified in the approval certificate and its attachments, and must not result in substantial changes to product quality;
The composition and quantities of ingredients in the product formula must remain unchanged, except in cases where alterations are necessitated by changes in current regulations or mandatory standards, rendering the content of the registration certificate and its attachments non-compliant;
The applicant may submit multiple change requests for the same product at the same time. However, if there are ongoing change requests under evaluation, the applicant must provide a written statement regarding these pending changes along with the acceptance numbers. For change requests accepted before December 31, 2016, the applicant should await the completion of these before submitting other requests; and
Should there be any alterations to the applicant’s name or address during the registration process, the applicant can submit a supplementary change application.

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

Procedures for health food change registration

Our Services

Other Services

Further Information

FAQs on Health Food Registration and Filing in China

Analysis on Health Food and Dietary Supplement Product Registrations in China in 2022

China Health Food Change Registration