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CSAR Subsidiary Regulations: China Consults on the Draft Administrative Measures on Cosmetics Labeling

China is consulting on the draft Administrative Measures on Cosmetics Labeling for public consultation, which spells out the requirements for cosmetic labeling and claims.

On Sep. 21, 2020, China NMPA released the draft Administrative Measures on Cosmetics Labeling for public consultation, one of the subsidiary regulations of Cosmetic Supervision and Administration Regulation (CSAR).
Any suggestions can be mailed to ChemLinked ([email protected]) before Oct. 18, and we will submit it to the NMPA.

1. Basic Requirements for Cosmetic Labeling

As per the draft, the following information shall be marked on cosmetic labels:

No.

Required Information

Noteworthy Requirements

1

Product name, and special cosmetic registration license number

A product name legally consists of three parts: a trade name, a generic name, and an attribute name. The draft adds requirements for the trade name and generic name:

1)  For the trade name using an ingredient name or a terminology implying that a certain ingredient is contained,

  • If the ingredient is contained, its purpose of use shall be explained on the visual panel of the sales packaging.

  • If the ingredient is not contained, it shall be clearly labeled on the visible panel of the sales packaging that the product does not contain the ingredient, and the ingredient name is only used as a trade name.

2) In regards to the generic name,

  • If it uses an ingredient name or an ingredient category name, the related ingredient shall be contained and its actual efficacy shall be consistent with the efficacy claim.

  • If it uses the name of animals, plants or minerals for the purpose of describing the aroma, color or shape of the product, the related ingredient may not be contained.

2

The name and address of registrant or notifier

If the registrant or notifier is an overseas enterprise, the name and address of its domestic responsible person shall also be labeled.

3

The name and address of production enterprise

For domestic cosmetics, the production license number shall also be labeled.

4

The product executive standard number

The standard number is required for both domestic and imported cosmetics.

  • If the executive standard is a national/industry standard, the standard number shall be the number of the national/industry standard.

  • If the executive standard is a standard specially formulated for registration or notification, the standard number shall be the number stated in the product registration license or notification certificate.

5

Full ingredients listing

  • It is required to label all ingredients with content more than 0.1% (w/w).

  • For ingredients with content less than 0.1% (w/w), they shall be labeled separately with "Other trace ingredients" as the guiding word. If a compound is contained, the content of   each ingredient in the compound shall be used to judge whether it is a trace ingredient.

6

Net content


7

Durability

Production date and period after opening can be used to indicate the durability of products apart from the current 2 methods:

  • production date and shelf life

  • production batch number and expiry date

If using the production date and period after opening, companies shall guarantee that the shelf life of products shall be no less than 36 months.

8

Application method


9

Safety warnings


10

Other content prescribed by laws, administrative regulations and mandatory national standards


Note 1:For products with packaging boxes, at least items 1 and 7 shall be labeled on the primary package.

Note 2:For products with a net content of no more than 15 g or 15 mL, only items 1 (registration certificate number excluded), 2, 6 and 7 shall be labeled on the visible panel of the sales packaging. The items 1 (registration certificate number excluded) and 7 shall also be labeled on the primary package. Other required labeling information can be indicated in the leaflet or electronic label.

2. Highlights of the Draft

1) Labeling of Imported Cosmetics

For imported cosmetics, Chinese labels can be directly used or affixed. The contents related to product safety and efficacy on Chinese stickers are required to be consistent with the contents on the original labels.

While the actual contents related to product safety remain to be clarified by the NMPA. ChemLinked estimates that they may refer to the formula, application method and warnings.

2) Efficacy Claims

Efficacy claims on cosmetic labels shall be supported by a sufficient scientific basis. The abstract of the scientific basis will be open to the public for reference and supervision. The required contents of the scientific basis are stipulated in the China Guidelines for Cosmetic Efficacy Claim Evaluation. Efficacy claim evaluation shall also be conducted in accordance with the Guidelines.

Provided that the efficacy claim of a product has been evaluated and validated by human trials and the evaluation results are objective and effective, the product can claim "the efficacy has been evaluated and validated".

In the case that a product claims the efficacy of an ingredient contained, the efficacy claim shall be in line with the purpose of use of the ingredient, and the ingredient shall reach the effective amount of efficacy.

3) Prohibited Claims

The draft specifies 13 kinds of prohibited claims, which can be summarized as below:

  • Indicating medical effects implicitly or explicitly

  • Indicating misleading information implicitly or explicitly

  • Including absolute/exaggerated/false descriptions

  • Including other claims that are contrary to law, cosmetic regulations, public order or good customs

For the details of the 13 kinds of prohibited claims, please click here.

According to the draft, there may be a list of examples of prohibited claims, and the NMPA will dynamically update the examples based on the actual cosmetic supervision situation. However, the list isn’t included in the draft and will most likely be published separately by the NMPA.

In addition, innovative terminologies (that have not been widely used by the industry) are permitted for use on labels if they are not in the scope of prohibited claims, but their meanings shall be given in adjacent positions for consumers to understand.

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