ZMUni Compliance Centre

On November 4, 2024, China's National Medical Products Administration (NMPA) approved a new cosmetic ingredient, Isobutylamido Thiazolyl Resorcinol (Thiamidol 630), marking the first ingredient registered since the implementation of Cosmetic Supervision and Administration Regulation (CSAR) in 2021. Synthesized chemically, this new ingredient has undergone safety and efficacy verification and is approved as a whitening agent for leave-on products (excluding those posing inhalation risks).

It is noted that this is the third application submitted by the applicant Beiersdorf, following two previous rejections. This approval will facilitate Beiersdorf's relevant cosmetic products (containing this new ingredient) to smoothly enter China through major trade. This approval also offers a new opportunity for the development of freckle removal and whitening cosmetics in China.

New Cosmetic Ingredients Compliance in China

Under China's CSAR implemented in 2021, companies must register or notify new cosmetic ingredients (NCI) not listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021). Changes to the usage purpose or safe usage levels of existing ingredients also require submission.

In this framework, high-risk NCI, such as preservatives, UV filters, colorants, hair dyes, and whitening or freckle-removal agents, undergo a detailed NMPA registration process that includes format and technical reviews. Other ingredients only require notification.

Approved or Used Whitening Agents in China

Currently, China has approved four new cosmetic ingredients with wrinkle-removal and whitening effects, including three before the CSAR Implementation in 2021 (Dimethoxy-tolyl-4-propylresorcinol, Phenylethyl Resorcinol (SymWhite® 377) and Potassium Methoxysalicylate), and the latest Isobutylamido Thiazolyl Resorsinol (Thiamidol 630).

Although China has not yet published the list of approved whitening agents, companies may refer to the ingredients provided by the China NMPA, as outlined in the documents Determination of L-Ascorbic Acid 2-Phosphate Magnesium Ester and Other Ten Components in Cosmetics and α-Arbutin and Other 3 Kinds of Components in Cosmetic. Key ingredients include Magnesium Ascorbyl Phosphate, Ascorbyl Glucoside, Phenylethyl Resorcinol, Butylresorcinol, Potassium Methoxysalicylate, Ferulic Acid, Niacinamide, Kojic Acid, and others.

 It is anticipated that there will be more applications for the registration of new cosmetic ingredients in the future. ZMUni Compliance Centre provides services for the registration and notification of new cosmetic ingredients in China. If you have any compliance inquiries, please feel free to contact us at info@zmuni.com.