China’s cosmetic safety technical specifications (2015 Edition) have incorporated 21 revision items upon the announcement of National Medical Products Administration (NMPA) on August 28, 2023. Notably, Benvitimod has been added to the list of prohibited cosmetic ingredients.
Among these revisions, 5 testing methods have been updated, including:
- “Testing methods of acrylamide in cosmetics”
- “Testing methods of 51 raw materials such as desloratadine in cosmetics”
- “Testing methods of 8 raw materials such as mercaptoacetic acid in cosmetics”
- “Testing methods of free formaldehyde in cosmetics”
- “Testing methods of 4 raw materials such as α-arbutin in cosmetics”
These revised testing methods will replace the original ones found in the “Safety and Technical Specifications for Cosmetics (2015 Edition)”. Effective from March 1, 2024, all cosmetics registrations and inspections related to filings and sampling shall adhere to the testing methods outlined in this circular.
Additionally, the following new test methods have been introduced and are now incorporated into the Safety and Technical Specifications for Cosmetics (2015 Edition):
- “pH determination method of water-in-oil cosmetics”
- “Testing method of 40 raw materials such as ethyl acrylate in cosmetics”
- “Testing method of 11 raw materials such as CI 10020 in cosmetics”
- “Testing method of 13 raw materials such as CI 11920 in cosmetics”
- “Testing method of 15 raw materials such as 2-amino-4-hydroxyethylaminoanisole sulfate in cosmetics”
- “Testing method of 11 raw materials such as ascorbyl phosphate and magnesium ascorbate in cosmetics”
- “Test method of 5 raw materials such as styrenic diphenyldisulfonate disodium in cosmetics”
- “In vitro skin allergy human cell line activation test”
- “In vitro skin allergy amino acid derivatization reaction test method”
- “Cosmetic chemical raw material fluorescein leakage test method”
- “Acute oral toxicity test, up and down dose increase and decrease method”
- “Acute oral toxicity test fixed dose method”
- “Acute oral toxicity test Acute toxicity classification method”
- “In vivo comet test”
These new test methods come into effect upon their publication date.
Key revisions and implications for China’s cosmetic industry
One of the most notable changes is the addition of “Benvitimod” as a prohibited cosmetic ingredient. This inclusion is effective immediately upon promulgation, hence cosmetic manufacturers and importers must ensure their products comply with this new restriction.
Additionally, the regulation introduces a management limit for benzene at 2mg/kg. It states that if benzene unavoidably enters cosmetics as an impurity, its concentration should not exceed this limit. These changes underscore the importance of rigorous quality control and testing procedures in the cosmetic industry. This adjustment is also effective from the date of issuance.
Further information
Read the original NMPA announcement on 21 revision items incorporated into China’s cosmetic safety technical specifications (2015 Edition).
Entering the Chinese cosmetics market requires a keen understanding of the intricate regulatory landscape. Cisema specializes in deciphering ever-changing cosmetic ingredient regulations, and we are dedicated to helping clients adapt to these significant regulatory changes. Take a read to find out our service support for cosmetics and cosmetics ingredients in China, or should you need assistance navigating these regulatory changes, we are here to provide expert guidance tailored to your business needs.
