CSAR subsidiary regulations: Latest draft detail how China hopes to streamline ingredient registration process

The first is draft Administrative Measures on Cosmetic Registration, which specifies requirements for filing and registration.

The latter, draft Supervision and Administration Measures on Cosmetics Manufacture and Operation, details the obligations of cosmetic manufacturers and operators.

The publication of these drafts follows the June 29 release of the final version of CSAR, which will take effect on January 1, 2021.

Both drafts will be open for public consultation until August 20, 2020

New registration and notification requirements

Among the changes, the draft Administrative Measures on Cosmetic Registration stated that new cosmetic ingredients will now be classified and managed according to their risk to reduce barriers for entry for cosmetic companies.

The draft proposes that new low-risk cosmetic ingredients will need to complete notification after dossiers submission.

Hedy He, an analyst with regulatory consultancy Chemlinked said China was responding to the demands of the industry to simplify the process of ingredient registration.

“The complicated and time-consuming new ingredient registration procedures suppress the enthusiasm of enterprises to register new ingredients. The new classification management for cosmetic new ingredients reduces the entry barriers for low-risk ingredients.”​

She added that China may increase the notification numbers of low-risk ingredients in the future, especially for ingredients that have been proven safe and already widely used internationally.

Additionally, the state said it would protect the patents of newly registered and notified cosmetic ingredients.

The draft also detailed several new requirements on cosmetic registration and notification.

The draft proposes that the registrant and notifier shall be responsible for the ingredient safety and clarify the ingredient source and quality specification.

Imported cosmetics specially produced for China must submit relevant research and test data for Chinese consumers.

Additionally, a summary of cosmetic efficacy claims must be submitted at the time of registration and filing. Finally, packaging of special cosmetics must be disclosed to the public.

He added: “The disclosure of a summary of the basis of efficacy claims will guide companies to increase R&D investment. Notification of general cosmetics and low-risk new ingredients will speed up the market entry efficiency of innovative ingredients.”​

Animal testing not mentioned

Both drafts did not mention any regulation related to animal testing.

However, the Administrative Measures on Cosmetic Registration draft stated that the government will be releasing the Standard for Dossiers of New Cosmetic Ingredient Registration and Filing and Standard for Dossiers of Cosmetic Registration and Filing this year.

He said: “Look forward these two dossiers standards as it will specify cosmetics and new ingredients animal testing requirements.”​