Since April 2010 and the publication of new texts concerning the registration of cosmetic products, no new approval was granted by the Chinese authorities for the marketing of “special function” cosmetics [1]. The presentation of the new arrangements for the registration that members of the SFDA made on the occasion of the conference on “Cosmetics Regulations in Asia” organized by Premium Beauty News on October 14, was therefore eagerly awaited.

New administrative organisation

Mr. Huang Jiansheng, Director of the Center for Health Food Evaluation of the SFDA, presented the outline of the new regulation and its objectives, as well as the new organization of the administration responsible to approve imported cosmetic products before their sale in China. He particularly emphasized the central role to be played, by the Committee of Experts charged of the technical evaluation of the application files of “special function” products.

This committee, which will meet monthly, will consist of twenty members, and will assess the compliance of products with chemical, toxicology and labelling requirements. Its expert members are currently being recruited.

On the contrary, as far as “ordinary cosmetic” are concerned, the appraisal of the Committee of Experts is not required.

Registration procedure

Mr. Liu Baojun, Director of the Cosmetic Division, of the Centre for Health Food Evaluation, entered more in depth into the details, and recalled the main technical requirements for the regulatory compliance of cosmetic products imported into China: testing to perform, toxicological data to provide, detection of hazardous materials, etc. Then, Ms. Françoise Yidan Li, consultant specializing in the registration of cosmetic products, proposed a very comprehensive overview of the components of a registration file, as well as the new regulatory requirements, including the approval of new ingredients.

New Ingredients

The approval of new ingredients, one of the main new items of the modified procedure, raised many questions from the audience.

For the SFDA, China’s regulation is clear: new ingredients are those that have not yet been marketed in China and, where appropriate, it is to the company responsible for placing the product on the market (manufacturer or supplier) to provide evidence of an earlier marketing. The administration is currently drawing up the list of substances already known in China and should publish it on its website. “But the process is long,” has warned Mr. Liu Baojun, who declined to give deadline for this publication.

Traces of dangerous substances

Another sticking point: the search for traces of dangerous substances, which is an important element of the new registration rules. Mr Liu Baojun recalled that according to the Chinese regulations, these substances are defined as substances that are brought by impurities in cosmetic raw materials, or through the manufacturing process, and that may pose a risk to human health.

The implementation of this provision has also raised many questions as the scope of investigation seems immense while the risks are extremely low or nonexistent below a certain threshold.