New Alternative Testing Methods in Cosmetic Ingredients Added to Safety and Technical Standards for Cosmetics (2015) - Regulatory News - Personal and Home Care Products

China,Cosmetic,Alternative Method,Safety and Technical Standards for Cosmetics,Ingredient

On 22^nd Mar, 2019, NMPA issued a Notice No.12 regarding 5 new testing methods added and 4 testing methods revised to Safety and Technical Standards for Cosmetics (2015). The 5 new testing methods are Determination of Free Formaldehyde in Cosmetics, Short Time Exposure In Vitro Test Method (STE), Skin Sensitization: Local Lymph Node Assay: DA (LLNA:DA), Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA) and In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA). The 4 revised testing methods are Determination of Cantharidin and Chlormethine in Cosmetics, Determination of 10 α-hydroxy acid in cosmetics, Bacterial Reverse Mutation Assay and Teratogenicity Test. From 1^st Jan 2020, these testing methods will be available to testing of cosmetics registration/filing and post market surveillance.

Status of Alternative Methods in China

Testing item	Testing method	Effective time	Applicable scope
Skin phototoxicity	In Vitro 3T3 Neutral Red Uptake Phototoxicity Assay (In Vitro 3T3 NRU PT)	11th Nov, 2016	cosmetic ingredient
Skin corrosion	In Vitro Skin Corrosion：Transcutaneous Electrical Resistance Test (TER)	21st Aug, 2017	cosmetic ingredient
Skin photoallergy	Skin Photoallergy Test	21st Aug, 2017	both cosmetic ingredient and cosmetic product
Skin sensitization	In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)	22nd Mar, 2019	cosmetic ingredient
Eye irritation or corrosion	Short Time Exposure In Vitro Test Method (STE)	22nd Mar, 2019	cosmetic ingredient
Skin sensitization	Skin Sensitization: Local Lymph Node Assay: DA (LLNA:DA)	22nd Mar, 2019	cosmetic ingredient
Skin sensitization	Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA)	22nd Mar, 2019	cosmetic ingredient

CIRS Comments

Only one alternative method of skin photoallergy adopted in cosmetics in China.
From 1^st Jan, 2020, 4 new alternative methods of skin sensitization and eye irritation/corrosion will be effective. It will be beneficial for the registration of new cosmetic ingredient then.

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Reference

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