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 Dietary Supplement Registration and Notification (draft version for public comments) on July 28th 2015, in an attempt to regulate the registration and notification for dietary supplement. The public can present opinions and advice for The Measures before Aug 28th this year. CIRS speculated that the final version of the Administrative Measure of Dietary Supplement Registration and Notification will have slight modification compared with the draft version, and will be issued before Opt 1st 2015. It is said that there would be a transitional period. At the same time, the Administrative Measure of Dietary Supplement Registration (trial version issued on Apr 30th 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 dietary supplement 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. Dietary supplement 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.
Compared with the Measure issued in 2005, the new Regulation has a tremendous change. The new law has unprecedented requirements on the dietary supplement 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. Dietary supplement 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.
The 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 dietary supplement 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 Measure of Dietary Supplement Registration and Notification (exposure draft) demonstrated that the dietary supplements of which raw materials are listed on 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 problem or comment on this new guideline or the draft, please don’t hesitate to contact us. We are ready to offer help or convey your comments to CFDA.
Contact us:
Ms. Cathy Yu Team Leader of Food Safety and Regulatory Affairs Department, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel : +86 571 8720 6538 | Fax : +86 571 8720 6533
Email: cathy.yu@cirs-group.com
