The Guidance of Health Food Notification (Record) in China 2015

According to the New Food Safety Law of the People's Republic of China and the Administrative Permission Law of the People's Republic of China, CFDA issued the Administrative Measures of Health Food Registration and Notification (draft version for public comments) on 28 July 2015, in an attempt to regulate the registration and notification for dietary supplement. The public can present opinions and advice for the Measures before 28 August this year. CIRS speculated that the final version of the Administrative Measure of Health Food Registration and Notification will have slight modification compared with the draft version, and will be issued before 1 October 2015. It is said that there would be a transitional period. At the same time, the Administrative Measure of Health Food Registration (trial version issued on 30 April 2005) will be replaced.  

Compared with the Measure issued in 2005, the new Regulation has a tremendous change. The new law has unprecedented requirements on the health food notification in China. It is clearly demonstrated that if dietary supplements meet notification requirements, they have no need to be registered. Compared with registration, notification has simpler procedures, shorter period and costs less fee.

 

Due to the New Regulation, what kind of dietary supplement should be notified?

I. The dietary supplement of which raw materials are listed in the Catalogue of Raw Materials of Dietary Supplement.

II. The dietary supplement which is imported to China for the first time and its functions are regarded as nutriment supplementation, like vitamins and minerals.

III. Health food which is already notified but has information changed needs to be re-notified.

 

Who could be the legal notification applicant?

I. The qualified Chinese manufacturer and distributor of dietary supplement of which raw materials are listed on the Catalogue of Raw Materials of Dietary Supplement.

II. When notifying imported dietary supplement, applicant has to be the legal possessor of this product.

 

The procedures of the dietary supplement notification. 

 

 

 4The changes of required materials of dietary supplement notification.

 

NO.

Notification required materials

The differences between the law in 2015 and in 2005, and relevant comments.

1

The application form of dietary supplement notification

Registration form has been replaced as notification form.

2

The valid qualification certificate and its copies of applicant.

No big change.

 

3

Product formula materials

It is estimated that product formula materials will be simplified.

4

Product process materials

It is estimated that product process materials will be simplified.

5

Product labels and manual sample

 

The labels requirements has changed a lot in new law, which showed that Chinese governments will be stricter to the requirements of the unsuitable crowds, attentions and label formats of dietary supplement.

6

Quality standards

No big change.

7

Materials that certify the product safety, healthcare functions

Dietary supplement notification has no need to conduct toxicology safety testing and healthcare function testing, The simplified testing requirements showed that Chinese government will pay more attention to the R&D materials of dietary supplement, and inclined to using those materials to demonstrate the safety and function of dietary supplement.

 

NO.

The additional materials that required for imported health food notification

The differences between the law in 2015 and in 2005, and relevant comments.

1

The certificates which demonstrate that the applicant is the legal possessor of the product. The certificates should be issued by the countries or regions where manufacturer belong to

I. According to the new regulation, the report of safety situation of selling and consumption should be included. If a product has a good sale in overseas and has no any safety problem, it would be much helpful to its registration in China.

II. The imported dietary supplements have to be tested in all aspects before notified in China.

2

The certificate which certifies that manufacturer meets the local quality management standards. This certificate should be issued by original country and have the valid period on it.

3

The certificate which certifies that this product has been on sale for more than 1 year. This certificate should also be issued by original country.

4

The analyzing report about the sales and the consumption situation in original country.

5

The product-related standards from original country or international organizations.

6

Completed testing report issued by professional testing institutes, which should certify that the three batches of product all meet quality standards.

7

The package, labels and manual samples of the product in original country or region.

Notes: All foreign language materials provided by manufacturers need to be translated into Chinese. And Chinese document should be notarized by Chinese notary department. The certificates provided by foreign institutes should be notarized by local notary department and need to be confirmed by Chinese Embassy. The product quality standards (Chinese version) have to be in line with the format of Chinese quality standards of dietary supplement.

  

The Administrative Measures of Health Food Registration and Notification (draft version for public comments) demonstrated that the dietary supplements of which raw materials are listed in the Catalogue of Raw Materials of Dietary Supplement still need to be registered if they are imported into China for the first time. However, if their functions are regarded as nutriment supplementation, like vitamins and minerals, they only need to be notified. Notification may bring the impact of product homogeneity, therefore, CIRS advises enterprises to pay more attention to innovative R&D, and to find breakthroughs from new raw materials, new process, new standards and new functions.  

If you have any questions and comments on the regulations, please contact us as follows:

 

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