FAQs Vol. 10 | Most Up-to-date Guidance on Cosmetic Registration and Notification under China’s CSAR

Starting from May 1, 2021, when applying for registration and notification, registrants and notifiers shall fill in the source and the trade name of ingredients used in the formula. Among them, if the ingredients have quality specifications as per the Safety and Technical Standards for Cosmetics 2015 (STSC 2015), quality specification certificates or safety-related information of the ingredients shall be submitted as well.

These specified ingredients include but not limited to Polyacrylamides, Trialkylamines, Trialkanolamines and their salts, Dichloromethane, Fatty acid Dialkylamides and Dialkanolamides, Monoalkylamines, Monoalkanolamines and their salts, etc. The specification requirements for these ingredients can be found under "Other Restrictions and Requirements" in the "Restricted Ingredients for Cosmetics" (List 3) of STSC 2015.

There are 17 ingredients newly defined as prohibited ingredients in Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021) since May 28, 2021, including Formaldehyde, Boric Acid, Sodium Borate, 2-Chloro-p-penylenediamine, 2-Chloro-p-phenylenediamine Sulfate, Cannabis Sativa Fruit, Cannabis Sativa Seed Oil, Cannabis Sativa Leaf Extract, Tagetes Erecta Flower Extract, Vinyl Acetate, etc. Cosmetics manufacturers shall not manufacture or import cosmetics containing these prohibited ingredients. 

In Inventory of Existing Cosmetic Ingredients in China 2015 (IECIC 2015), there are cases where the same ingredient has multiple Chinese names. Therefore, IECIC 2021 standardizes and unifies the names of the same ingredient. The ingredients subject to the name change are compiled in the table below. From May 1, 2021, when applying for registration and notification, registrants and notifiers shall use the updated ingredient names as per IECIC 2021.

The changes are shown in red:

It has been found that the ingredient submission code provided for some cosmetics' notification application on the Cosmetics Registration and Notification Platform is inconsistent with the data stored in the Cosmetic Ingredient Safety Information Submission Platform (the submission platform). Notifiers need to confirm with ingredient manufacturers or suppliers about:

(1) Whether the ingredient submission code corresponds with the target ingredient;

(2) Whether the specific ingredients in cosmetic formula, such as the composition and proportion of compound ingredients, are consistent with the information provided on the submission platform.

Yes. The Cosmetics Registration and Notification Platform accepts multiple submission codes for one ingredient. 

Article 23 of Cosmetic Supervision and Administration Regulation (CSAR) stipulates that overseas cosmetics registrants and notifiers shall designate an enterprise legal person in the territory of China to handle cosmetics registration and notification, and assist in monitoring of cosmetics adverse reactions and implementing product recalls. For general cosmetics entrusted to be produced in China, overseas cosmetic notifiers shall designate an enterprise legal person in the territory of China as the domestic responsible person (RP). The RP shall register an account on the Cosmetics Registration and Notification Platform prior to handling the notification of entrusted produced cosmetics on behalf of the overseas notifiers. 

As required by Article 37 of Provisions for Management of Cosmetic Registration and Notification Dossiers (Provisions), special cosmetics and general cosmetics for export only shall be notified on the Cosmetics Registration and Notification Platform. Cosmetics manufacturers shall submit the following documents:

(1) Product name;

(2) The country (region) to be exported to;

(3) Product's label pictures, including the front stereoscopic display diagram of the product sales packaging, the product packaging plan, and the product leaflet (if any).

According to Standards for Cosmetic Efficacy Claim Evaluation, cosmetic registrants and notifiers can carry out cosmetic efficacy claim evaluation by themselves or by entrusting an evaluation institution with required capabilities. Institutions that undertake the cosmetic efficacy claim evaluation shall establish good laboratory practices, complete the efficacy claim evaluation and issue the reports, and be responsible for the authenticity and reliability of the reports. 

Cosmetics with freckle-removing and whitening, sunscreen or anti-hair loss efficacy shall undergo the human trial carried out by cosmetics registration and notification testing institutions in accordance with the requirements of mandatory national standards and technical norms, with a report issued.

Yes. The Provisions specifies that, when filling out the formula table on the Cosmetics Registration and Notification Platform, cosmetic registrants and notifiers shall indicate the contents of all ingredients, which are calculated by the mass percentage. In addition, all ingredients shall be listed in descending order as per the contents’ mass percentage. Subject to this requirement, ingredients whose content are less than 0.1% shall also be arranged in descending order. 

However, when label the product formula, according to Administrative Measures on Cosmetics Labeling, cosmetic registrants and notifiers shall label ingredients whose content is no more than 0.1% (w/w) separately with "other trace ingredients" as the guide language, and these ingredients do not have to be listed in descending order of content in formula.

No. Article 30 of the Provisions states that the main procedures of the actual production process shall be briefly described, including feeding, blending, filling, etc. If there is a freeze-drying process involved, it shall be described based on the actual production process as well.