CSAR Subsidiary Regulations: China Unveils the Cosmetic Classification Rules and Catalogs

On July 29, 2020, China National Medical Products Administration (NMPA) opened a public consultation on draft Cosmetic Classification Rules and Catalog. ¹ On April 9, 2021, the finalized Cosmetic Classification Rules and Catalogs (hereinafter referred to as “the Catalogs”) was officially released and will come into force on May 1, 2021. ²

Notably, starting from the Catalogs’ effective date, cosmetic registrants or notifiers shall fill in the product classification code in accordance with the Catalogs when applying for registration of special cosmetics or notification of general cosmetics. For cosmetics that have been registered or notified before May 1, 2021, the cosmetics registrants and notifiers shall supplement product classification codes through the cosmetics registration and notification information service platform before May 1, 2022.

Highlights of the Finalized Catalogs

The Catalogs specify that the classification of cosmetics will adopt a coding system, which has five layers in order as follows:

5 Layers	Sub-categories	Range of Codes
1st Layer: Efficacy Claims	Includes 26 kinds of claims such as cleansing, makeup removing, moisturizing, sunscreen, deodorant, hair removal, etc.	01-26, A^*
2nd Layer: Application Areas	Includes 10 parts such as hair, body skin, head, face, etc.	01-10, B^*
3rd Layer: Target Users	Includes 3 types of target users, namely infants (between birth and the age of 3), children (aged between 3 and 12), and ordinary people.	01-03, C^*
4th Layer: Dosage Forms	Includes 11 dosage forms such as creams and emulsions, liquids, gels, powders, pastes, aerosols, sprays, etc.	00^◆, 01-11
5th Layer: Application Methods	Rinse-off and leave-on categories	01, 02
Note: **"": In any of the first three layers, products outside the prescribed sub-categories will be coded by letters and managed as cosmetics with new efficacies.* "◆": The code “00” of the fourth layer Dosage Forms means other forms that are not coved in the stipulated dosage forms.** For the detailed coding catalogs, please refer to our upcoming English translation (It is in urgent translation, and the English Version will be uploaded within these days).

As per the Catalogs, every cosmetic product will have a corresponding code composed of 5 layers of numbers. Each layer is connected by "-" and represented by a 2-digit number or a letter. For example, the classification code of moisturizing masks may be 11-05-03-10-02, indicating "Moisturizing-Face-General population-Patch and Mask-Leave-on" products.

If the product has multiple efficacy claims, application areas, target users, or dosage forms, multiple corresponding serial numbers can be selected for each layer. The serial numbers should be arranged in order and connected by "/." For example, the classification code of baby shampoo may be 09-01/04-01-02-01, indicating "Cleaning-Hair/Head-Infants and Toddlers-Liquid-Rinse-off" products.

Besides, efficacy claims of cosmetics shall be supported by a sufficient scientific basis. (Click here to see the requirements for efficacy claim)

Comparisons to the 2020 Draft

Compared to the previous draft released in 2020, the finalized Catalog, rather than being a massive overhaul, offers slight modifications to the previous provisions to add clarity and increase the logicality.

Specifically, the general classification rule of the finalized Catalog remains the same as that of the draft. Both indicate that cosmetics should be encoded based on efficacy claims, application areas, target user, dosage forms, and application methods. But the specific content of the first four layers is subject to minor adjustments, as shown below:

First Four Layers	Noteworthy Changes
Efficacy Claims	The kinds of efficacy claims are reduced from “28+A” to “26+A”. The two categories of claims, "freckle removing and whitening" and "freckle removing and whitening (physical coverage only)," are merged into one single category, namely " freckle removing and whitening." The "hair styling" claim is removed. It’s worth noting that this does not mean that products claiming "hair styling" efficacy do not belong to cosmetics. Those products may fall under the oversight of "beautifying and embellishing” categories.
Application Areas	The number of the application area is reduced from “13+B” to “10+B”. The application area of “eye” not only includes the skin around the eyes but also “eyelash” and “eyebrow."
Target Users	The sequence of the layer “target users” and “dosage forms” is exchanged.
Dosage Forms	The sequence of the layer “target users” and “dosage forms” is exchanged. The types of dosage forms are reduced from the “14+B” to “12”. As per the draft, the determining of cosmetics with new efficacies has to do with efficacy claims, application areas, target users, and dosage forms. But under the finalized Catalog, the determining of new efficacy cosmetics has to do solely with the first three items. Thus, cosmetic dosage forms beyond the scope of the prescribed 11 categories are considered as other forms and shall be coded as “00”. These products will not be regarded as cosmetics with new efficacies.

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CSAR Subsidiary Regulations: China Unveils the Cosmetic Classification Rules and Catalogs

Highlights of the Finalized Catalogs

Comparisons to the 2020 Draft

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