China New Regulations on Cosmetics (III): Detailed Rules on Registration and Filing

We have written a post last July when China initially published its overhauled new regulations on cosmetics “Regulation on Supervision and Administration of Cosmetics” (the “New Regulation“), setting out the regulatory framework on cosmetics industry.

Since then, China State Administration for Market Regulation (CSAMR), the government body in charge of cosmetic industry, has brewed and formulated the detailed implementation rules for the New Regulation. On January 7, 2021, CSAMR published its works on the implementation rules, entitled “Administrative Measures on Registration and Filings of Cosmetics” (the “Administrative Measures“).

Here are a few takeaways of this new Administrative Measures.

I. Online Platform Launched for Registration and Filing

“Internet+” has long been a strategy promoted by China governments in upgrading industries including government services.

Now to apply for registration for designated new raw materials (considered as having high hazards) and special cosmetics or filing for ordinary cosmetics and new raw materials other than those designated, the applicants shall resort to the so called “Information Service Platform” designed just for such registrations and filings. This platform is used for other purposes in regard of the administration of cosmetics.

(1) during the three-year safety-monitoring period for new cosmetic raw materials, if the raw materials are used in cosmetics, the applications for registration and/or filing of such cosmetics shall, through the information service platform, be confirmed by the registrants or filers of such new raw materials.

(2) applicants for registration and filing of cosmetics shall, on the platform, specify the source and related safety data of the raw materials used by such cosmetics.

(3) where registrants or filers of home-made cosmetics entrust their manufacturing to others, such entrustments shall be disclosed on the platform.

(4) registrants of special cosmetics shall upload onto the platform the picture of the labels of such special cosmetics for the review of the public before such cosmetics products are launched in market.

(5) where the regulatory agency is unable to reach the registrants, filers or domestic responsible persons as per the registration or filing information, the agency may designate and enlist on the platform such registrants, filers or domestic responsible persons as specially watched targets, and announce the same on the platform.

II. Registration of Listed Materials as New Ones

We have elaborated on the detailed rules in the New Regulation about the procedures and time limits of registering high-hazard new raw materials. But there is anything new and interesting.

Article 12 of Administrative Measures provided that when an already listed (as you may know, there is a Catalogue listing all items of raw materials duly approved and filed) raw material is adjusted in terms of its purpose of usage and safety dosage, then this material shall be considered as a new material subject to the same registration and filing rules.

第十二条   在我国境内首次使用于化妆品的天然或者人工原料为化妆品新原料。

调整已使用的化妆品原料的使用目的、安全使用量等的,应当按照新原料注册、备案要求申请注册、进行备案。

Article 12 of the Administrative Measures in Chinese

III. Definition of Home-made Cosmetics

Under the New Regulation and the Administrative Measures, home-made cosmetics are treated differently sometimes from imported cosmetics. So it is necessary to be clear about what are home-made cosmetics.

Article 61 of Administrative Measures defines home-made cosmetics as those whose last production process/step in contact with the contents of the products takes place within China. Otherwise, those products shall be imported cosmetics. Further, if a product, registered or filed in one name, comprises smaller units that should be used or packaged in combination and any last production process/step in contact with the contents of any unit thereof takes place outside China, such products shall be considered as imported products.

We will further update you on new rules on the testing requirements on new raw materials later on.

Jason Tian

Jason Tian, senior partner, specializes in foreign-related legal services ranging from foreign investment in China, banking and capital, real estate, M&A, corporate, international trade, estate planning, inheritance and divorce at his blog: https://www.sinoblawg.com.

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