New Alternative Testing Methods in Cosmetic Ingredients Added to Safety and Technical Standards for Cosmetics (2015)

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

On 22nd 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 1st 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

  1. Only one alternative method of skin photoallergy adopted in cosmetics in China.
  2. From 1st 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

NMPA News