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CSAR Subsidiary Regulations: China Finalizes Requirements for Cosmetic Labeling

On June 3, 2021, China NMPA released the finalized Administrative Measures on Cosmetics Labeling, spelling out the requirements for the labeling and prohibited claims of cosmetics under China’s new cosmetic regulations. The most significant change relates to the full ingredient listing. Ingredients with content more than 0.1% (w/w) shall be listed in descending order while ingredients less than 0.1% (w/w) shall be labeled separately under “other trace ingredients”. Chinese stickers can be affixed for imported cosmetics. The contents related to product safety and efficacy on Chinese stickers are required to be consistent with the contents on the original labels.

On June 3, 2021, China National Medical Products Administration (NMPA) released the finalized Administrative Measures on Cosmetics Labeling (hereinafter referred to as the Measures). The Measures spells out the requirements for the labeling and prohibited claims of cosmetics (including cosmetics provided to consumers in the form of trial, gift, exchange, etc.) under China's new cosmetic regulations.

The Measures is scheduled to be implemented on May 1, 2022. Starting from the implementation date all cosmetics to be registered or notified shall comply with the Measures.  However, companies are encouraged to label cosmetics in accordance with the Measures from now on. For cosmetics that have been registered or notified before May 1, 2022, but not complied with the Measures, the registrants or notifiers shall update the labels by May 1, 2023.

Basic Requirements for Cosmetic Labeling

Cosmetics are required to bear Chinese labels with all contents using standard Chinese characters except for trade names, websites, names and addresses of overseas companies, and conventional technical terms (e.g. CI number, SPF value and series No.). If other characters or symbols are used, standard Chinese characters should be used on a visible panel on the sales packaging to explain the corresponding meaning.

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

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

No.

Required Information

Noteworthy Requirements

1

Chinese product name, and special cosmetic registration certificate number

A product name legally consists of three parts: a trade name, a generic name, and an attribute name. The Measures adds requirements for the trade name and generic name considering that products using the name of a certain ingredient to highlight its existence and its function are quite popular in the Chinese market:

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 a visual panel of the sales packaging.

  • If the ingredient is not contained, it shall be clearly labeled on a 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 in formula 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 can be exempted from being used in the formula.

2

The name and address of registrant or notifier

The name and address shall be consistent with those on the product registration/notification certificates.

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

3

The name and address of manufacturing enterprise

Manufacturing enterprise refers to the enterprise that completes the last process of contacting the contents. If there are more than one manufacturing enterprises, all of them can be marked.

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

4

The product executive standard number

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

5

Full ingredients listing

The full ingredients listing is subject to significant changes:

  • It is required to label the standard Chinese names of ingredients with content more than 0.1% (w/w) in descending order.

  • For ingredients with content less than 0.1% (w/w), their standard Chinese names shall be labeled separately under "other trace ingredients". There is no need to list the ingredients in descending order.

  • If a compound is contained, each ingredient's content in the compound shall be used to judge whether it is a trace ingredient or shall follow the descending order.

6

Net content


7

Durability

The following two methods can be used on sales packaging:

  • production date and shelf life

  • production batch number and expiry date

For products with packaging boxes, the primary packaging can use production batch number and period after opening to indicate the durability apart from the above two methods.

8

Application method


9

Necessary safety warnings


10

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


Note 1:For products with a net content of no more than 15 g or 15 mL, only items 1, 2, 6 and 7 shall be labeled on a visible panel of the sales packaging. Other required labeling information can be indicated in the leaflet.

Note 2:The Chinese product name and durability shall be labeled on the primary package for all products with packaging boxes.

Prohibited Claims

The Measures specifies 12 kinds of prohibited claims on cosmetic labels, shown as below:

  1. Use medical terms, names of medical celebrities, words describing medical function and effects or approved drug names to express or imply that the product has medical effects;

  2. Use false, exaggerated, or absolute wordings to describe falsely or misleadingly;

  3. Use trademarks, patterns, font color sizes, color differences, homophonic or suggestive words, letters, Chinese pinyin, numbers, symbols, etc. to imply medical effects or make false claims;

  4. Fabricate concepts by using terminology and mechanism that have not been widely accepted by the scientific community;

  5. Fabricate false information, or talk down other legal products, etc. to mislead consumers;

  6. Use fictitious, forged or unverifiable scientific research results, statistical data, survey results, abstracts, quotations and other information to mislead consumers;

  7. Claim the function of the ingredient contained to imply the efficacy that is not allowed to claim, or the product does not actually have;

  8. Use labels, rewards, etc. that have not been recognized by relevant competent authorities as cosmetic safety and efficacy-related claims and wordings;

  9. Utilize the names and images of state agencies, public institutions, medical institutions, public welfare institutions, etc., and their staff and appointed experts for proof or recommendation;

  10. Use wordings of assertions or guarantees expressing efficacy and safety;

  11. Mark vulgarity, feudal superstition or other content that violates social public order and good customs;

  12. Other contents prohibited by laws, administrative regulations and mandatory national standards for cosmetics.

For innovative terminologies that have not been widely used by the industry and not in the above scope of prohibited claims, they can be used but their meanings shall be put by for consumers to understand. 

ChemLinked Comments

  • Compared with the draft version released on Sep. 21, 2020, the finalized Measures is more simplified, deleting some contents related to efficacy claims, product executive standard number, electronic labels, the list of prohibited claim examples and legal liability. ChemLinked estimates that the government may further clarify these matters by releasing supporting documents or measures.

  • It should be noted that cosmetics samples and gifts are also subject to the Measures, and the primary packaging of all cosmetics shall bear the Chinese product name and durability. For most existing imported cosmetics and cosmetics samples and gifts in the Chinese market, their primary packaging may still bear the original labels. Overseas cosmetic companies are advised to check their products and make corresponding changes.

  • The most significant change is relating to the full ingredient listing. The Measures newly stipulates that for ingredients with content less than 0.1% (w/w), their standard Chinese names shall be labeled separately under "other trace ingredients". Therefore, the labels and packaging of all existing cosmetics are subject to adjustments of the ingredient listing this time. Another impact of the change is that products adding tiny amounts of a certain ingredient but greatly promoting its function or efficacy may be no longer attractive to consumers as the ingredient will be clearly listed as a trace ingredient.

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