Global Cosmetic Compliance
Intelligence & Solutions
In Chemico Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA)
Local Title:
体外皮肤变态反应 氨基酸衍生化反应试验方法
Country/Region:
Chinese Mainland
Competent Authority:
National Medical Products Administration
Type:
Regulation
Status:
In force
Release Date:
2023-08-28
Implementation Date:
2023-08-28
Document
Language Source Title Access
ZH
Official In Chemico Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA)
In Chemico Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA)
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Summary

On August 28, 2023, China National Medical Products Administration (NMPA) announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The key updates include the addition of a new prohibited ingredient, the clarification of benzene limit in cosmetics, the revision of 5 testing methods, and the introduction of 14 additional testing methods. Notably, except that the revised methods are scheduled to come into force on March 1, 2024, all other new contents will take immediate effect upon release. 

The new testing method “In Chemico Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA)” specifies the basic requirements and procedures for conducting an amino acid derivative reaction assay. This method is applicable for evaluating the potential allergenicity of ingredients used in cosmetics, either as single known components or as components with known compositions in multi-component cosmetics.

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