New Labelling Requirements for Cosmetic Products in China
The new Cosmetics Supervision and Administration Regulation (CSAR) was enacted in China. The National Medical Products Administration (NMPA) has released standards for the testing of cosmetic products' safety profile and efficacy claims. The NMPA has also published the Administrative Measures on Cosmetics Labelling, an updated set of requirements for the label of cosmetic products made available in the Chinese market.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate


The implementation of a new Cosmetics Supervision and Administration Regulation (CSAR) has come into force on 1st of January (2021). On the 4th of March (2021) the National Medical Products Administration (NMPA) released the final versions of the two regulations: Provisions for Management of Cosmetic Registration and Notifications Dossiers (previously called as Instructions for Cosmetic Registration and Notification Dossiers) and Provisions for Management of New Cosmetic Ingredient Registration and Notifications Dossiers. The key goal of these regulations is to standardize and guide the registration and filing of new cosmetic materials and products, specifying The documentation requirements for application, modification, renewal and cancellation of a cosmetic registration and notification.

On the 3rd of June, NMPA published the Administrative Measures on Cosmetics Labelling (also called the “Measures”), unifying the contents of regulations, standards and normative documents on cosmetic labelling management. It sharpened up the requirements in accordance with the new CSAR, implementing certain conditions for the labelling and prohibiting specific cosmetic claims.


Labelling plays a main role in cosmetics. It needs to be clear, true and give all the essential information to the consumer. It is a powerful and essential tool of marketing. The NMPA had already issued standards for testing the cosmetic products’ safety profile and efficacy of claims: “Cosmetics Efficacy Claim Evaluation Standards” and “The Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)”, explained in our previous post.

The Chinese new labelling regulation (Administrative Measures on Cosmetics Labelling) introduced five main changes regarding the ingredient list, Chinese labelling (sticker), requirements for claiming specific ingredients and efficacy of ingredients, executive standard number, and extension of words not allowed. The Measures apply to words, symbols, numbers, patterns and other markings on the packaging and containers of cosmetic products.

The label will now need to contain the full ingredients list. The ingredients shall be listed in descending order of concentration if they are present at a concentration above 0.1% (w/w). Ingredients with content under 0.1% (w/w) should be labelled separately, under the term “other trace ingredients”.

According to the new Measures, cosmetic products that enter in China shall bear Chinese labels, using standard Chinese characters. Exceptions are made for trade names, websites, names and addresses of foreign companies and conventional technical terms (e.g., Colour Index number, SPF value, etc.). A visible panel on the sales packaging with standard Chinese characters shall be used in order to explain other symbols or characters that might be used.

Chinese stickers can be used in imported cosmetics but product’s safety information and efficacy claims on these stickers need to be consistent with the contents present in the original labels. This means that the Chinese sticker cannot contain any claim that was not originally placed on the product’s label, nor it can add any new information related to product’s safety or efficacy. Moreover, the font size of the Chinese characters on the labels needs to be at least as large as the font size of other characters (exception of registered trademarks). Claims need to be in compliance with Chinese cosmetic regulation requirements.

Claiming particular ingredients or the efficacy of certain ingredients has become stricter. For example, if a product claims to have a determined ingredient or indicates the category of the ingredient, it needs to be consistent with the product’s formula. Brand names cannot imply effects or raw materials/ingredients that the product does not contain.

Cosmetic products available in the Chinese market need to indicate the product’s executive standard number in its label. This number is automatically generated in the notification of ‘general cosmetics’ (preparatory notification number received by the applicant).

Requirements were also set for the expansion of words that are not allowed to use on cosmetic labels or in claims. Medical terms/effects (explicit or implicit), guarantee of safety or efficacy, false/exaggerated/misleading information are some of the features that cannot be used in the labelling of cosmetic products in China.

In sum, the Chinese label must contain the following information:

  • Chinese name of the product and registration certificate number of special cosmetics
  • Name and address of the registrant/filling person or of the person responsible in China (for foreign company)
  • Name and address of the manufacturer (if manufactured in China, it also needs the manufacturer’s production license number)
  • Product implementation number
  • Full ingredient list
  • Net content
  • Use period/expiry date
  • Instructions of use and safety warnings
  • Other content as required by relevant laws, administrative regulations and national standards.

The Chinese product name and the expiration date need to be indicated in the outer package (e.g. box).

Although the Measures are scheduled to be implemented on 2022 (May 1st), companies should start to comply with the requirements as soon as possible.

The Chinese legal framework on cosmetics can be tricky and hard to understand, but Critical Catalyst has a team of experts that can help you. Please feel free to contact us using our email


  1. Technical Guidelines for Cosmetic Safety Assessment. 2021. (Chinese).
  2. Interview Vol. 4. Interpretation of China’s New Cosmetic Labeling Regulation. Chemlinked. Jul 09, 2021. Available from:
  3. CSAR Subsidiary Regulations: China Finalizes Requirements for Cosmetic Labeling. Chemlinked. Jun 04, 2021. Available from:


medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »