ZMUni Compliance Centre

ZMUni Compliance Centre

China Cosmetic Compliance
China Cosmetic Compliance

Our Services

  • Cosmetic Product Registration and Filing

  • Cosmetic Formula & Label Review

  • Cosmetic Safety Assessment

  • Cosmetic Efficacy Evaluation

  • Chinese Domestic Responsible Person Representation

  • Toothpaste Compliance Services

 

Cosmetic in China

Cosmetics refer to daily chemical products that are applied to the skin, hair, nails, lips, or other areas of the human body through methods such as smearing, spraying, or similar means. They are used for cleaning, protecting, beautifying, and modifying the appearance.

 

Imported Cosmetics in China

Imported cosmetics are products where the final production process, which involves contact with the contents, is completed overseas. For products completed in Taiwan, Hong Kong, and Macau, they are also managed as imported products.

Products that are registered or filed under a specific product name, or products that are packaged together or in combination, where the final production process of any of the constituents is completed overseas, are managed as imported products.

 

Classification of Cosmetics in China

Special cosmetics: products used for hair dyeing, perming, spot whitening, sun protection, hair loss prevention, as well as cosmetics claiming new efficacy.

General cosmetics: cosmetics other than special cosmetics.

 

Cosmetics Regulatory Approach in China

Currently, apart from cosmetics sold through cross-border e-commerce channels, other cosmetics (excluding ordinary soaps) sold through other channels need to be registered or filed with the National Medical Products Administration (NMPA) or local drug regulatory authorities before they can be marketed.

Special cosmetics are subject to registration management, while general cosmetics are subject to filing management.

Imported cosmetics require the engagement of a domestic Registered Agent (Responsible Person) to complete the filing process, and the Responsible Person assumes the corresponding product safety and quality responsibilities.

After being marketed, the registration certificate for special cosmetics is valid for five years and needs to be renewed before expiration. General cosmetics need to submit annual reports.

 

Cosmetics Registration and Filing Process and Timeline in China

The filing process for general cosmetics takes around 4-6 months, involving steps such as authorization by the Responsible Person (RP), permission granting, testing, dossier compilation, and online submission.

The registration process for special cosmetics takes around 12-16 months, involving steps such as authorization by the Responsible Person (RP), permission granting, testing, dossier compilation, formal review, and technical review to obtain the registration certificate.

 

Cosmetics Registration and Filing Documents in China

Documents required for registration and filing include the "Cosmetic Registration and Filing Information Form" and related materials, product name information, product formula, applicable standards, product label drafts, product testing reports, product safety assessment materials, Certificate of Free Sale (CFS), testing samples, and relevant information.

 

Cosmetic Testing Requirements in China

The product testing report for registered or filed products should be issued by cosmetic registration and filing inspection institutions and comply with relevant regulations such as the "Cosmetic Safety Technical Specification" and the "Cosmetic Registration and Filing Inspection Work Specification." The product testing report includes microbiological tests, physicochemical tests, toxicological tests, human safety tests (for special cosmetics), and human efficacy test reports, among others.

 

Exemption from Animal Testing

Starting from May 1, 2021, general cosmetics meeting the following conditions may be exempted from toxicological tests in safety assessments:

-The production enterprise has obtained Good Manufacturing Practice (GMP) certification issued by the competent authorities of the country (region) of origin (Note: Multiple production locations are not accepted, and certification from third-party institutions is not accepted).

-The product is not marketed for infants and children.

-The product does not contain new cosmetic ingredients still under safety monitoring.

-Based on the results of quantitative grading, the applicant, Responsible Person, and production enterprise are not listed as key regulatory targets.

 

Requirements for Cosmetics Labels in China

Cosmetics labels refer to the text, symbols, numbers, patterns, and other markings used on the sales packaging of products to identify and provide information on the basic details, characteristics, and safety warnings of the products. This includes labels on packaging containers, boxes, and instruction manuals that contain the labeling information.

Imported cosmetics can use Chinese labels directly or attach Chinese labels. If Chinese labels are attached, the content should be consistent with the original labels.

The following information should be included on cosmetics labels:

  • Chinese product name and special cosmetics registration certificate number

  • Name and address of the registrant or filer; if the registrant or filer is a foreign company, the name and address of the responsible party within the country should also be included

  • Name and address of the manufacturer; for domestically produced cosmetics, the production permit number of the manufacturer should also be included

  • Standard number that the product complies with

  • Complete list of ingredients

  • Net content

  • Expiration date

  • Instructions for use

  • Necessary safety warnings

  • Other information required by laws, regulations, and mandatory national standards

For products with packaging boxes, the Chinese product name and expiration date should also be indicated on the packaging containers that directly contact the contents.

 

Cosmetic Product Safety Report (CPSR) in China

  • Product information

  • Product testing reports

  • Physical and chemical stability evaluation of the product

  • Microbiological evaluation of the product

  • Formulation design principles

  • Preservative challenge test report

  • Packaging materials

  • Risk control measures or recommendations

  • IFRA certificate for fragrances (if applicable)

  • Safety assessment conclusion

  • Signature and resume of the safety assessor

  • Reference literature and appendices

 

List of Relevant Regulations in China

  • Regulations on the Supervision and Administration of Cosmetics

  • Measures for the Registration and Filing Administration of Cosmetics

  • Regulations on the Management of Registration and Filing Information of Cosmetics

  • Measures for the Management of Cosmetics Labels

  • Regulations on the Supervision and Administration of Children's Cosmetics

  • Rules and Catalogs for the Classification of Cosmetics

  • Technical Specifications for the Safety of Cosmetics (2015 edition)

  • Specifications for the Inspection of Cosmetics Registration and Filing

  • Guidelines for the Evaluation of Efficacy Claims of Cosmetics

  • Technical Guidelines for the Safety Evaluation of Cosmetics (2021 edition)

  • Inventory of Existing Cosmetic Ingredients in China (2021)

  • Technical Guidelines for the Submission of Cosmetics Registration and Filing Information (Trial)

 

China Cosmetic Regulatory FAQ

How to distinguish the registrant, filer, and responsible person in China?

If a brand wants to apply for special cosmetics, it needs to register the cosmetics, and in this case, the brand is the registrant. If a brand wants to apply for general cosmetics, they need to file the cosmetics, and in this case, the brand is the filer.

The responsible party within the country is limited to foreign registrants or filers. According to Article 8 of the "Measures for the Registration and Filing Administration of Cosmetics," if the registrant or filer is located overseas, they should designate a domestic corporate entity as the responsible party within the country.

 

What is the difference between cosmetics registration and filing?

Cosmetics registration refers to the process where the applicant submits a registration application in accordance with the legal procedures and requirements. The competent drug regulatory authority examines the safety and quality controllability of the applied cosmetics and new cosmetic ingredients and decides whether to approve the application.

Cosmetics filing refers to the activity where the filer submits data that demonstrates the safety and quality controllability of the cosmetics and new cosmetic ingredients in accordance with the legal procedures and requirements. The competent drug regulatory authority archives and keeps the submitted data for future reference.

 

For products filed before May 1, 2021, if the efficacy evaluation result does not support the product name, can the product name be changed?

For cosmetics that have been registered or filed before May 1, 2021, if the efficacy evaluation result, according to the "Guidelines for the Evaluation of Efficacy Claims of Cosmetics," does not support the efficacy claims mentioned in the product name or label, the registrant or filer can submit a change application before the end of the transition period. The product's classification code can be adjusted based on its actual properties, and the product name or related content on the label can be modified to comply with regulatory requirements. Additionally, according to the announcement (No. 50 of 2021) issued by the National Medical Products Administration regarding the release of the "Guidelines for the Evaluation of Efficacy Claims of Cosmetics," "For cosmetics that have obtained registration or completed filing before May 1, 2021, the registrants or filers should evaluate the efficacy claims of the cosmetics according to the requirements of the guidelines and upload a summary of the basis for the efficacy claims of the products before May 1, 2023."

Therefore, for products filed before May 1, 2021, if the efficacy evaluation result does not support the product name, a change in the product name can be made under the aforementioned conditions.

 

If a new formula product still uses the name of a discontinued old formula product, can the term "upgraded version" or similar wording be added to differentiate them?

Considering that the new product with an adjusted formula still uses the name of a discontinued product, and both the new and old products may coexist in the market, to protect consumers' right to information, objective terms such as "new formula" or "formula adjusted" can be indicated on the label of the new product for differentiation. The use of terms like "upgraded version" lacks clear criteria and may potentially mislead consumers.

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