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CSAR Subsidiary Regulations: China Deletes One Exceptional Circumstance for Animal Testing Exemption

Nov 06, 2020
Winnie Xu
China is soliciting feedback on the second draft of the Instructions for Cosmetic Registration and Notification Dossiers, which made several significant amendments to the cosmetic registration and notification dossiers.

The supervision over children cosmetics will be strengthened going forward.

The exceptional circumstances of animal testing exemption are reduced from 4 to 3.

Less than three months after China’s National Institutes for Food and Drug Control released the draft Instructions for Cosmetic Registration and Notification Dossiers, an updated version was drafted for public comments by the NMPA on November 5, 2020 [1]. The new draft of the Instructions for Cosmetic Registration and Notification Dossiers includes a total of 6 chapters, 57 articles, and 25 attachments, with aims to further clarify and refine the provisions in the previous draft, and shift the focus of cosmetic supervision from pre-market assessment to in-and post-market management.

The second round of consultation will close at the end of November. Any suggestions can be mailed to ChemLinked ([email protected]) before November 29, 2020, and we will submit to the NMPA.

Note: Text in red indicates changes in comparison to the first draft. Strikethrough indicates a removal from first draft. 

Key Points

Compared to the first draft released on August 28, 2020, the major updates of the new draft are concerned with cosmetic pre-market application dossiers, such as product testing report, safety assessment document, product executive standard and etc.

Specifically, the new draft revises the naming of some documents, as shown below.

Cosmetic Registration and Notification Dossiers

First Draft

Second Draft

  1. Registration application form or notification information form and related documents (including information on registration applicant or notifier, production enterprise, and domestic responsible person);

  2. Information on the product name;

  3. Product formula;

  4. Product executive standard;

  5. The label sample manuscript of the registered product or the sales packaging pictures of the notified product;

  6. Product testing report;

  7. Product safety assessment documents.

  1. “Cosmetic Registration and Notification Information Form” and related documents;

  2. Naming basis of the product name;

  3. Product formula;

  4. Product executive standard;

  5. Product label sample manuscripts;

  6. Product testing report;

  7. Product safety assessment documents.

Besides, the requirements for each of the above mentioned dossiers are further modified and refined in a bid to add clarity and increase the logicality of the regulation. Among them, the following are of great significance:

1. Product Testing Report

In this new draft, China reiterates that the relevant toxicological test items of general product can be exempted provided that the production enterprise has obtained the GMP certifications from the local government, and the product safety risk assessment results can fully verify the product safety. 

However, the exceptional circumstances of animal testing exemption are reduced from 4 to 3. And the regulatory scope of the first exception is expanded to include products claimed to be used by infants.

First Draft

Second Draft

The relevant toxicological test items of the product can be exempted, except for the following situations:

(1) The product is claimed to be intended for children;

(2) The product uses new cosmetic ingredients that are in the monitoring period;

(3) The notifier, domestic responsible person, or production enterprise are listed as the key regulatory objects according to the quantitative grading results;

(4) The notifier, domestic responsible person, or production enterprise is investigated and punished for cosmetics' quality and safety issues according to law.

The relevant toxicological test items of the product can be exempted, except for the following situations:

(1)   The product is claimed to be intended for infants and children;

(2)   The product uses new cosmetic ingredients that are in the safety monitoring period;

(3)   The notifier, domestic responsible person, or production enterprise are listed as the key regulatory objects according to the quantitative grading results.

In addition, the document requirements for qualification certification of the production quality management system are specified.

  • For general cosmetics that are eligible for toxicological test exemption, the notifiers shall submit the original of the qualification certificate or certification document of production quality management system or GMP issued by their local government;

  • If the original is not available, the copy notarized by the notary offices in China can be used;

  • If the qualification certificate or certification document is in foreign languages, the translation shall be provided, and the consistency of the translation shall be notarized.

2. Product Safety Assessment

The new draft amends the document requirements for general cosmetics that are eligible for animal testing exemption and adds the regulatory requirements for baby and children cosmetics.

If general cosmetics can be exempted from animal tests when applying for notification, they shall submit safety assessment reports rather than the abstracts of safety assessment. While for products claimed to be used by infants and children, both the toxicological test reports and product safety assessment reports should be submitted when applying for registration.

First Draft

Second Draft

1. Special Cosmetics:

Toxicological Test Report + Abstract of the Safety Assessment Report

2. General Cosmetics:

  • Approach 1: Toxicological Test Report + Abstract of the Safety Assessment Report

  • Approach 2: Application for Toxicological Test Exemption + Abstract of the Safety Assessment Report

1. Special Cosmetics:

Toxicological Test Report + Abstract of the Safety  Assessment

2. General Cosmetics:

  • Approach 1: Toxicological Test Report + Abstract of the Safety Assessment

  • Approach 2: Application for Toxicological Test Exemption + Safety Assessment Report

3. Cosmetics claimed to be used by infants and children:

Safety Assessment Report + Toxicological Test Report

3. “Cosmetic Registration and Notification Information Form” and Related Documents

The requirements for products specifically designed for the Chinese market are refined. According to the new draft, the following two types of documents shall be submitted for imported products whose formula is specially designed for the Chinese market when filling in the Cosmetic Registration and Notification Information Form:

  1. Explanatory materials indicating that the product formula design is tailored to the skin types and consumer needs of Chinese consumers;

  2. Materials indicating that Chinese consumers have been used to conduct consumer test research or human efficacy test in China.

4. Naming Basis of the Product Name

The product naming basis shall specify the trademark name, generic name, and attribute name, as well as their specific meanings. Under the new draft, if the trademark name uses letters, Chinese pinyin, numbers, symbols, etc., in the Chinese name of a product, a trademark registration certificate shall be provided. The trademark authorization certificate can’t support the registration or notification of the product.

First Draft

Second Draft

Where it is stated in the product naming basis that the registered trademark name is used as the Chinese name of a product, a trademark registration certificate or trademark authorization certificate shall be provided.

If the trademark name uses letters, Chinese pinyin, numbers, symbols, etc., in the Chinese name of a product, a trademark registration certificate shall be provided.

5. Product Executive Standard

The new draft modifies the expressions of some items in the executive standard and deletes the regulatory requirements for packaging material.

First Draft

Second Draft

Product executive standards include:

  • Product name,  

  • Product formula,  

  • Production technique,

  • Sensory indicators, microbiological and physicochemical indicators and their testing methods,

  • Product use methods,

  • Product storage conditions,  

  • Shelf life,

  • Packaging materials, etc.,

Product executive standards include:

  • Product name,  

  • Product formula,  

  • Brief description of production technique,

  • Sensory indicators, microbiological and physicochemical indicators and their quality control measures,  

  • Use methods,

  • Storage conditions,  

  • Durability, etc.,

*Note: English translations of the Instructions will be uploaded to ChemLinked soon.

Related Resources:

In order to keep up-to-date on all news concerning CSAR (and the CSAR subsidiary regulations) remember to bookmark and tune in to ChemLinkeds’ comprehensive, and detailed CSAR homepage.

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Tags : Chinese MainlandChildren CosmeticsPre-market ApprovalIngredientsAnimal TestingSafety AssessmentCSAR
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