Chinese food industry has been undergoing a regulatory reform in recent years. On 28th July, 2015, three new drafts on Chinese dietary supplement regulatory system were released by CFDA, namely "Administrative Measures on Dietary Supplement Registration and Notification (Draft)", "Administrative Measures on Dietary Supplement Function Directory and Food Raw Material Directory (Draft)" and "Administrative Measures on the labeling of Dietary Supplement (Draft)". With a view to assisting dietary supplement enterprises in entering Chinese market more smoothly, the articles in the draft regulations are researched in depth by CIRS food team. The interpretations for 12 significant changes of the reform are presented as following:
1. "Notification system" is included in dietary supplement management system
Dietary supplement notification is unprecedented in China, the new legislation stipulates that certain kinds of dietary supplement could be notified and others still required to be registered before selling in China. The notification system is developed with the goal of simplifying the procedures of administrative examination; from another point of view, it may lead manufacturers to producing similar dietary supplement products because of the restrictive food raw materials. Therefore, based on their own production scale and characteristics, dietary supplement enterprises are suggested to produce the products of which the food raw materials are in the Food Raw Material Directory or develop creative products of which raw materials are not listed in the Food Raw Material Directory.
Table 1: The Scope of Registration and Notification
1. "Notification system" is included in dietary supplement management system
Dietary supplement notification is unprecedented in China, the new legislation stipulates that certain kinds of dietary supplement could be notified and others still required to be registered before selling in China. The notification system is developed with the goal of simplifying the procedures of administrative examination; from another point of view, it may lead manufacturers to producing similar dietary supplement products because of the restrictive food raw materials. Therefore, based on their own production scale and characteristics, dietary supplement enterprises are suggested to produce the products of which the food raw materials are in the Food Raw Material Directory or develop creative products of which raw materials are not listed in the Food Raw Material Directory.
Table 1: The Scope of Registration and Notification
| Registration | The dietary supplement of which raw materials are not listed in the Food Raw Material Directory. |
| The dietary supplement which is imported to China for the first time. | |
| Notification | The dietary supplement of which raw materials are listed in the Food Raw Material Directory. |
| The dietary supplement which is imported to China for the first time and its functions are regarded as nutriment supplementation, like vitamins and minerals. | |
| Dietary supplement which is already notified but has information changed needs to be re-notified. |
2. The changes of the definition of "dietary supplement"
As same as the elder version of legislation, there are two styles of dietary supplements: I. the dietary supplements claiming functions. II. The dietary supplements supplying vitamins, minerals or other nutriments but not declaring functions, herein these dietary supplements are named "nutriment supplements".
However, slight changes appeared in the new legislation. I. "specific" is deleted before "function" in the new regulation, as dietary supplement enterprises are encouraged to apply new healthy functions with the purpose of developing innovative products. II. "And other nutriments" is added after "vitamins and minerals", thus the food raw materials of nutriment supplements are no longer limited to vitamins and minerals but including other nutriments such as amino acids, fatty acids etc. The directory of vitamins, minerals and other nutriments in the Dietary Supplement Food Raw Material Directory is expected to be published in follow-up new food regulations before 1st October, 2015.
3. The changes of the required qualification of the applicant
Table 2 The changes of the required qualification of the dietary supplement applicant
| Applicant of domestic dietary supplement registration |
I. Private citizen is not allowed to apply as the applicant. II. Even the product is developed by several organizations, applying together is forbidden and only one organization can acts as applicant. |
| Applicant of domestic dietary supplement notification | I. The production certificate is mandatory for the applicant, thus, if distributes or research institutes without the production certificate would like to obtain the dietary supplement certificate, the only method is to apply the registration. |
| Applicant of imported dietary supplement registration | As long as the applicant is the legal holder of the marketed product, it is allowed to apply registration. |
| Applicant of imported dietary supplement notification | As long as the applicant is the legal holder of the marketed product, it is allowed to apply notification. |
4. Registration procedure will be managed based on the risk grade
I. In the previous regulation, the on-the-spot inspection of manufacture quality management system is not required. However, in new draft, whether conduct the on-the-spot inspection or not, will depend on the result of the technical evaluation.
II. In the previous, after the acceptance of registration, the re-test and technical evaluation will be conducted at the same time, while, in new draft re-test could be exempted if no risk affirmed by CFDA after technical evaluation and (or) spot inspection. (Note: The re-test in the old regulation refers to product quality re-test such as hygienic items, active ingredients and other items listed in the quality standard. Whereas, the re-test in the new regulation includes toxicity test, function test and etc.)
5. The change of the required materials on dietary supplement registration and notification
I. For the materials of dietary supplement registration, the new regulation stipulates more detailed requirements on R&D materials and product formula materials, but there is no significant change on the overall required materials.
II. For the materials of dietary supplement registration, the biggest change is that the new regulation particularly points out that safety toxicology materials and function materials are required rather than the safety toxicology testing reports and function testing reports in the old regulation. Therefore, CIRS experts predict that in the near future enterprises could arrange toxicology testing and function testing in any qualified laboratory in China or oversea countries instead of in the assigned 58 (up to 10th August) laboratories in China.
III. For the materials of dietary supplement notification, the materials on product formula, production process etc. are simplified. As there is no any further required particular material about safety toxicology materials and function materials, a heroic assumption was made by CIRS that toxicology testing reports and function testing reports will be no longer needed to provide in dietary supplement notification.
IV. For the material of dietary supplement registration and notification, the required materials in new regulation and old regulation are similar.
V. For the more specific changes on dietary supplement registration, please kindly refer to the below two links:
6. The changes of the product name
I. Trade name which used to distinguish the product from other similar ones is a mandatory part of the product name, and this new added article may lead trend of brand name registration.
II. The new regulation stipulates that function name or relevant function claim in the product name is forbidden, the registered dietary supplement with function name may need to conduct the product name modification.
7. Dietary supplement function directory is added
I. There are only 27 healthy functions which are allowed to apply in the old regulation. With the publishing of Administrative Measures on the labeling of Dietary Supplement(Draft), related manufacturer, research institution and other organization are permitted to develop new functions with the goal of motivating industry innovation and enhancing enterprise competitiveness.
II. In fact, a large number of imported dietary supplements of which the function is outside of 27 functions list could not enter Chinese market previously. In the near future, enterprises could apply the new function and the dietary supplement function directory will be updated by CFDA.
8. Dietary supplement food raw material directory is added
I. The focus of dietary supplement regulatory supervision is shifted from the technical evaluation of the finished product to the food raw material of the product. Although the requirements of the notification system are reduced at the first glance appear, actually the application scope of the raw material is restricted by the directory in order to guarantee the safety of the finished product.
II. As the procedure of notification is much briefer and the cost of notification is much cheaper than of registration, a lot of dietary supplements of which the food raw materials are in the directory will be produced by domestic manufacturers. However, vast similar products will cause a limited range of products which will lead the vapidity in the Chinese market.
III. An important note is that if the extractive of the listed raw material in the directory is used as the ingredient, the product needs to registration not notification.
9. The authorized department for dietary supplements registration and notification:
Table 3 The authorized department for dietary supplements registration and notification
I. Trade name which used to distinguish the product from other similar ones is a mandatory part of the product name, and this new added article may lead trend of brand name registration.
II. The new regulation stipulates that function name or relevant function claim in the product name is forbidden, the registered dietary supplement with function name may need to conduct the product name modification.
7. Dietary supplement function directory is added
I. There are only 27 healthy functions which are allowed to apply in the old regulation. With the publishing of Administrative Measures on the labeling of Dietary Supplement(Draft), related manufacturer, research institution and other organization are permitted to develop new functions with the goal of motivating industry innovation and enhancing enterprise competitiveness.
II. In fact, a large number of imported dietary supplements of which the function is outside of 27 functions list could not enter Chinese market previously. In the near future, enterprises could apply the new function and the dietary supplement function directory will be updated by CFDA.
8. Dietary supplement food raw material directory is added
I. The focus of dietary supplement regulatory supervision is shifted from the technical evaluation of the finished product to the food raw material of the product. Although the requirements of the notification system are reduced at the first glance appear, actually the application scope of the raw material is restricted by the directory in order to guarantee the safety of the finished product.
II. As the procedure of notification is much briefer and the cost of notification is much cheaper than of registration, a lot of dietary supplements of which the food raw materials are in the directory will be produced by domestic manufacturers. However, vast similar products will cause a limited range of products which will lead the vapidity in the Chinese market.
III. An important note is that if the extractive of the listed raw material in the directory is used as the ingredient, the product needs to registration not notification.
9. The authorized department for dietary supplements registration and notification:
Table 3 The authorized department for dietary supplements registration and notification
| Domestic dietary supplement registration | CFDA |
| Domestic dietary supplement notification | provincial FDA |
| Imported dietary supplement registration | CFDA |
| Imported dietary supplement notification | CFDA |
10. Timeliness of the notification certificate
Applying the production license in the limited time is necessary after getting the notification certificate, otherwise the certificate will be invalid. Notification certificate and production license are different.
11. Registration certificate will be cancelled
If the registered dietary supplement has not been produced in 5 years' expiry date, the registration certificate will be cancelled by CFDA.
12. Administrative cost will be charged
Administrative cost of dietary supplement registration will be charged by CFDA. The specific fee will be published by CFDA in the near future.
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
