[Updated] CSAR Subsidiary Regulations: China Released Two Regulations on Cosmetic Supplementary Testing Methods

On Apr. 28, 2021, China NMPA released two regulations on cosmetic supplementary testing methods: Working Rules for Management of Cosmetic Supplementary Testing Methods (formerly named as Measures for the Management of Cosmetic Supplementary Testing Methods, a draft) and Technical Guidance for Studying and Drafting Cosmetics Supplementary Testing Methods (formerly an attachment of the draft Measures). The implementation date for the Working Rules is July 1, 2021, while no implementation date is set for the Technical Guidance as it only serves as a reference.

The Working Rules is subject to very subtle changes compared with the draft Measures. Companies may refer to the following contents for the detailed requirements for cosmetic supplementary testing methods. You may contact at [email protected] if a translation is needed.

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On November 12, 2020, China NMPA released the draft Measures for the Management of Cosmetic Supplementary Testing Methods for public consultation. Any suggestions can be mailed to ChemLinked ([email protected]) before December 10, 2020, and we will submit it to the NMPA.

This draft Measure consists of 6 chapters, 29 articles and an attachment. It specifies the application scope, competent authorities, drafting procedures, technical guidelines and compilation rules of cosmetic supplementary testing methods.

The key points of the draft are as follows:

1. Definitions

Cosmetic supplementary testing methods refer to the test methods that are not included into the existing national standards, which will be used for cosmetic sampling inspection, cosmetics quality and safety cases investigation and handling, as well as adverse reaction investigation and disposal once published. The testing results can be directly used as the basis for law enforcement.

2. Application Scope

The supplementary testing methods formulated by the NMPA apply to the cosmetics that may be adulterated or produced with prohibited cosmetic ingredients, and cannot be tested in accordance with the testing items and testing methods prescribed by the national cosmetic standards and technical specifications.

3. Related Administration Departments

NMPA

Responsible for the management of cosmetic supplementary testing methods, including the organization of project establishment, drafting and verification, as well as the method review, approval and release, etc.

Cosmetics Supplementary Testing Method Review Committee

Responsible for offering review comments on cosmetic supplementary testing method project establishment and method draft. The committee consists of a secretariat and an expert panel.

Expert panel: Composed of personnel from the medical product administration departments, cosmetic testing institutions, etc., it is mainly responsible for the technical review of the cosmetic supplementary testing method project establishment and method draft.
Secretariat: It is mainly responsible for the format review of the cosmetic supplementary testing method project establishment and method draft, the organization of expert review, the submission of draft methods, etc.

4. Development Process

1) Project Establishment	Submit the application	Technical units such as cosmetic testing institutions, scientific research institutes, universities and colleges can apply for the establishment of a cosmetic supplementary testing method on their own. The medical products administration departments of municipal level and above or the NMPA will also organize or entrust relevant technical units to apply for the project establishment.
	Review the application	The secretariat shall conduct a format review on the completeness and normativeness of the application materials within five working days from the date of receipt.
	Review the application	The secretariat shall submit the application materials to the expert panel for a technical review within 15 working days from the date of completing the format review.
	Issue review results	The secretariat shall reply to the units of project establishment within ten working days from the date of completing the review. The review conclusion includes two situations: (1) The project is approved by review; (2) The project is not approved, and the reasons should be explained.
2) Drafting and Validation	After the cosmetic supplementary testing method has passed the project establishment review, the drafting unit shall draft the cosmetic supplementary testing method, prepare a compilation instruction, and select no less than two cosmetic supplementary testing method verification units to perform inter-laboratory verification of the method, in line with the attached "Technical Guidelines for the Research and Drafting of Cosmetic Supplementary Testing Methods".
3) Draft Review and Submission	Submit the finished draft and other materials	The drafting unit shall submit the draft, compilation instruction, and other related materials online. Paper materials with consistent content shall be provided at the same time.
	Review the draft	The secretariat shall conduct a format review on the completeness and normativeness of the application materials within five working days from the date of receipt.
	Review the draft	The secretariat shall submit the draft and the application materials to the expert panel for a technical review within 15 working days from the date of completing the format review.
	Issue review results	The secretariat shall reply to the drafting units within five working days from the date of completing the review on the draft. The review conclusion includes three situations: (1) Pass the review, and recommend approval. (2) Pass the review in principle, but it is recommended to return to the drafting unit for modification within a time limit. (3) Fail to pass the review, and the reasons should be explained.
	Submit the reviewed draft to the NMPA	For the draft cosmetic supplementary testing method that passes the review, the secretariat shall submit the draft method, review conclusions, meeting minutes and other materials to the NMPA within ten working days from the date of approval.
4) Approval and Release	Once the draft cosmetic supplementary testing method is reviewed and approved by the NMPA, it will be released to the public in the form of an announcement. The cosmetic supplementary testing method (abbreviated as “BJH”) is numbered according to the rule of "BJH + four-digit year number + two-digit serial number".

ChemLinked Comments
Currently, there does exist the absence of testing methods for some risk substances in the national cosmetic standards, leaving regulatory loopholes that unscrupulous manufacturers can exploit to make adulterated cosmetics, or add prohibited ingredients to the product.
These Measures, which can supplement the testing items and testing methods for new risk substances in the future, are released to make up for the loophole and provide an essential reference for regulators to conduct cosmetic post-market supervision. The industry can expect a significant crackdown on the illegal activities mentioned above by the NMPA in the coming year.

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