Official Interpretation: Administrative Measures of Health Food Registration and Filing

On 1 March, 2016, China Food and Drug Administration (CFDA) issued the Administrative Measures of Health Food Registration and Filing (CN version free download), which will come into force on 1 July 2016. Meanwhile, CFDA released a comprehensive interpretation on this measure (original link). Highlights are listed as follows by CIRS:

1. What is the legislative basis of this measure?

This measure was developed in accordance with the relevant provisions in Article 74, 75, 76, 77, 78, 82 of Food Safety Law of China.

2.What is the application scope of this measure?

Health food registration, filing and supervision in China should in accordance with this measure.  

3. What is the meaning of health food registration in this measure?

According to the registration application, in accordance with legal procedures, conditions and requirements, FDA departments conduct systematic evaluation and review on the application materials, then decide whether to approve the registration or not.

4. What is the meaning of health food filing in this measure?

In accordance with legal procedures, conditions and requirements, health food manufacturers submit relevant required materials to FDA departments for archiving, exposure and future reference.

5. Who is the health food registration acceptance department?

CFDA administrative accepting institution is in charge of the health food registration.

6. Who is the health food filing material receiving department?

CFDA administrative accepting institution is in charge of receiving imported health food filing materials.

Provincial FDA department is in charge of receiving health food filing materialswithin the district.

7. What are theresponsibilities of FDA departments at different level?

I. CFDA department is in charge of the health food registration, and imported health food (nutrition supplement)filing, and guide provincial FDA to conduct relevant work.

II. Provincial FDA department is in charge of health food filing within the district, and cooperate with CFDA in relevant work.

III. FDA department under provincial level is in charge of the supervision on health foodwithin the district.

8. What are the main responsibilities of applicant, review agency and administrative department?

I. The applicant should be responsible for the authenticity, integrity and traceability of application materials, and the safety, quality and effectiveness of the product.

II.The review agency is in charge of application materials review, on-site inspection, and check testing. The agency should complete the technical evaluation within 60 days, and submit the review conclusions and recommendations to CFDA.

III.The administrative department is in charge of health food registration and filing.

9. What are the important adjustments on the supervision of health food registration and filing?

Compared with the old version, the new measure conduct classification management on health food registration and filing.

S.N.

Products

Measures

1

Domestic health food of which raw materials are not listed in the health food raw material directory.

Registration

2

Health food which is imported to China for the first time.

3

Domestic health food of which raw materials are all listed in the health food raw material directory.

Filing

4

Health food which is imported to China for the first time and its functions are regarded as nutriment supplementation, like vitamins and minerals. The nutriments should be listed in the health food raw material directory.

The functionsclaimed should have been listed in health food function directory.

10. What are the important adjustments on the registration procedure of health food?

CFDA administrative accepting institution is in charge of health food registration application. The on-site inspection and check testing are integrated intotechnical evaluation procedure. The evaluation content, procedure, duration, and judgment basis are all specified.

11. What are the adjustments on the supplementary materials of technical evaluation?

The applicant should submit the required materials all together within 3 months after getting the notice. If the applicant does not submit the materials in time or upon request, the review agency can terminate the review, and suggest refusing the registration.

12. What are the adjustments on the health food technical transformation procedures?

If the registranttransferredthe technology, the transferee should re-submit an application for health food registration.The technical requirements should be in accordance with the original application materials. And the review agency should simplify the review procedures according to relevant regulations.

13. What are the important points on health food filing?

S.N.

Key points

1

When received the filing materials,

I. If the materials are satisfactory, the filing should be conducted on site.

II. If the materials are unsatisfactory, FDA department shouldinform the applicant at once.

2

FDA departments should provide filing certificate to the applicant, and public the filing information on their website.

14. What are the qualification requirements on the registration applicants?

S.N.

Qualification requirements on registration applicants

1

Domestic health food registration

Applicant should be the legal person or other organizations in China

2

Imported health food registration

I. Applicant should be the oversea manufacturer of the listed products.

II. The application should be conducted by the manufacturer’s office in China or just entrusted other agency in China to conduct.

15. What are the qualification requirements on the filing applicants?

I. For domestic health food filing, theapplicant should be the health food manufacturers in China, and the original registrant can act as the filing applicant.

II. For imported health food filing, the applicant should be the oversea manufacturer of the listed products.

16. What is the key corresponding work on the implementation of this measure?

The health food function directory and raw material directory arerequired when implementing this measure. For the moment, CFDA is formulating relevant measures.

For the further information on the draft of relevant measures interpreted by CIRS, please kindly refer to below links:

I.How to Apply New Healthy Function and New Food Raw Material of Dietary Supplement (health food)

II.CFDA Released the First Batch of Health Food Raw Materials for Record (filing) Nutrition Supplements

17. What are the measures on registered health food?

CFDA will recheck the already registered health food, and require them to regain thecertificate. And relevant regulations will be released in the future.

18. How to name the health food?

I.On25August 2015, CFAD issued the Notice on Further Stipulates the Health Food Naming. For furtherinformation of this notice interpreted by CIRS, please kindly click here.

II. On26 February 2016, CFAD issued the Notice on Health Food Naming to strengthen the supervision of health food naming.

For the moment, CFDA is carrying out the health food naming guidelines as well as the detailed rules, to specify health food naming, and CIRS will still continue to focus on this matter.