China Approves New Alternative Non-Animal Testing Methods for Cosmetic Raw Materials One new additional test, four new alternative testing methods, as well as four substitution testing methods have been approved by NMPA in March 2019 effective from 1. January 2020

In March 2019, China’s National Medical Product Administration (NMPA) has approved a total of 9 testing methods; 4 new alternative testing methods, 1 new additional test and 4 substitution testing methods under “Safety and Technical Standards for Cosmetics 2015”.

Knudsen&CRC has prepared an overview below of the testing methods, as well as the original alternative testing methods launched during the period of 2016-2019:

Since 2019, one new additional test with an applied testing method for cosmetic finished products has been added:

  1. “Determination of free formaldehyde in cosmetics” – NO ANIMAL TESTING INVOLVED; only applicable for finished product

The following four new alternative testing methods for the existing testing items have been approved:

  1. “Local lymph node assay: daicel adenosine triphosphate (LLNA-DA)” – ANIMAL TESTING INVOLVED; only applicable for raw materials
  2. “Local lymph node assay: 5-bromo-2-deoxyuridine enzyme-linked immunosorbent assay (LLNA-BRDU Elisa)” – ANIMAL TESTING INVOLVED; only applicable for raw materials
  3. “In chemico skin sensitisation: direct peptide reactivity assay (DPRA)” – NO ANIMAL TESTING INVOLVED; only applicable for raw materials
  4. “Eye irritation or corrosion: short time exposure in vitro test method (STE)” – NO ANIMAL TESTING INVOLVED; only applicable for raw materials

The following four new testing methods for the existing testing items have replaced the original testing methods:

  1. “Determination of Cantharidin and Chlormethine in cosmetics” – NO ANIMAL TESTING INVOLVED; only applicable for finished products
  2. “Determination of 10 α-hydroxy acid in cosmetics” – NO ANIMAL TESTING INVOLVED; only applicable for finished products
  3. “Bacterial reverse mutation assay” – NO ANIMAL TESTING INVOLVED; applied for both finished products and raw materials
  4. “Teratogenicity Test” – ANIMAL TESTING INVOLVED; only applicable for raw materials

The new alternative testing methods include two non-animal testing methods for cosmetic raw materials:

  • “In chemico skin sensitisation: direct peptide reactivity assay (DPRA)”
  • “Eye irritation or corrosion: short time exposure in vitro test method (STE)”

Following the release of the notice, effective from 1 January 2020, the newly approved and revised testing methods will be available for use in testing of cosmetic raw materials and/or cosmetic finished products.  Some testing methods (“Determination of Cantharidin and Chlormethine in Cosmetics” and “Determination of 10 α-hydroxy acid in cosmetics”) can be applied for cosmetic filing/registration and post-market surveillance.

Alongside the newly approved testing methods there are three alternative testing methods, that were approved during the period of 2016-2017, and still in effect:

  1. “Skin phototoxicity” – NO ANIMAL TESTING INVOLVED; only applicable for raw materials
  2. “Skin corrosion”– ANIMAL TESTING INVOLVED; only applicable for raw materials
  3. “Skin photoallergy” – ANIMAL TETSING INVOLVED; applied for both finished products and raw materials

The above three tests are accepted for use on cosmetic raw materials, and the skin photoallergy test is also accepted for use on cosmetic finished products.