China Announces Revisions to Cosmetic Safety Technical Standards, Including pH Measurement Method for Oil-in-Water cosmetics

The National Medical Products Administration (NMPA) has issued a notice (No. 41 of 2023) regarding the incorporation of 21 revised items, including the pH measurement method for oil-in-water cosmetics, into the Cosmetic Safety Technical Standards (2015 edition). This move signifies a significant update in the regulations governing the cosmetics industry in China.

The NMPA organized the drafting of 21 revised items, such as the "pH Measurement Method for Oil-in-Water Cosmetics," and formulated corresponding testing methods. These revisions were reviewed and approved by the Cosmetic Standards Expert Committee during a full committee meeting.

Among the changes, five testing methods, including "Acrylamide Testing Method in Cosmetics," "Chlorpheniramine and 51 Other Raw Materials Testing Method," "8 Raw Materials Testing Method, Including Mercaptoacetic Acid," "Formaldehyde Testing Method in Cosmetics," and "4 Raw Materials Testing Method, Including Alpha-Arbutin," have been revised and will replace the existing testing methods outlined in the Cosmetic Safety Technical Standards (2015 edition). These changes will take effect from March 1, 2024. Cosmetic registration, filing, and sampling inspections must adhere to the testing methods specified in this notice.

Additionally, 14 new testing methods have been added to the Cosmetic Safety Technical Standards (2015 edition), including "In Vitro Skin Sensitization Human Cell Activation Test," "In Vitro Skin Sensitization Amino Acid Derivative Reaction Test," "Fluorescein Leakage Test for Chemical Ingredients in Cosmetics," "Acute Oral Toxicity Test with Up-and-Down Procedure," "Acute Oral Toxicity Test with Fixed Dose Procedure," "Acute Oral Toxicity Test Classification," and "In Vivo Comet Assay."

The notice also introduces a newly prohibited cosmetic ingredient, listed under Chapter 2, Cosmetic Prohibited and Restricted Ingredients, Table 1, Serial Number 1285 of the Cosmetic Safety Technical Standards (2015 edition). This prohibition will be enforced immediately upon publication.

Furthermore, a management limit of 2 mg/kg for benzene as an impurity in cosmetics has been added, stating that "if benzene cannot be avoided as an impurity in cosmetics for technical reasons, its limit should not exceed 2 mg/kg." This regulation is now included in Chapter 2, Cosmetic Prohibited and Restricted Ingredients, Table 1, Note (3) of the Cosmetic Safety Technical Standards (2015 edition) and will also be enforced immediately.

This comprehensive update to the Cosmetic Safety Technical Standards aims to enhance the safety and quality of cosmetics in the Chinese market, ensuring the protection of consumer health. Detailed information regarding the revisions can be found in the attached document, "Summary of 21 Revised Items in Cosmetic Safety Technical Standards."

For further inquiries and detailed guidelines on compliance with these revisions, cosmetic manufacturers and industry stakeholders are encouraged to refer to the official NMPA communication.

The following attachments are available:

1. Summary of 21 Revised Items in Cosmetic Safety Technical Standards
2. pH Measurement Method for Oil-in-Water Cosmetics
3. Testing Method for 40 Raw Materials, Including Ethyl Acrylate, in Cosmetics
4. Testing Method for 11 Raw Materials, Including CI 10020, in Cosmetics
5. Testing Method for 13 Raw Materials, Including CI 11920, in Cosmetics
6. Testing Method for 15 Raw Materials, Including 2-Amino-4-Hydroxyethylaminoanisole Sulfate  , in Cosmetics
7. Testing Method for 11 Raw Materials, Including  Magnesium Ascorbyl Phosphate, in Cosmetics
8. Testing Method for 5 Raw Materials, Including Sodium 2,2'-Methylenebis(4,6-Dimethylphenyl) phosphate, in Cosmetics
9. In Vitro Skin Sensitization Human Cell Activation Test
10. In Vitro Skin Sensitization Amino Acid Derivative Reaction Test
11. Fluorescein Leakage Test for Chemical Ingredients in Cosmetics
12. Acute Oral Toxicity Test with Up-and-Down Procedure
13. Acute Oral Toxicity Test with Fixed Dose Procedure
14. Acute Oral Toxicity Test Classification
15. In Vivo Comet Assay
16. Testing Method for Acrylamide in Cosmetics
17. Testing Method for 51 Raw Materials, Including Desloratadine, in Cosmetics
18. Testing Method for 8 Raw Materials, Including Mercaptoacetic Acid, in Cosmetics
19. Testing Method for Formaldehyde in Cosmetics
20. Testing Method for 4 Raw Materials, Including Alpha-Arbutin, in Cosmetics