China’s National Medical Products Administration’s (NMPA) has finalized Provisions for Management of Cosmetic Registration and Notification Dossiers (previously Instructions for Cosmetic Registration and Notification Dossiers) and will waive its requirements for pre-market animal testing for imported, general use cosmetics from May 1, 2021.

This exemption will only apply to general use products, which make up most of the cosmetic market in China and are commonly used in hair, skin, and nail products as well as perfume and makeup.

Toxicological tests can be exempted for general use cosmetics if a manufacturer has official certification (ISO or good manufacturing practices (GMP) compliance certificates) of the product’s manufacture using a quality management system (QMS) and safety risk assessment results that demonstrate the safety of the product. This means safety assessments can now be accepted in place of animal testing.

This however may be a challenge for some importers as many countries do not issue official QMS certificates.

In January 2021, France’s National Agency for the Safety of Medicines and Health Products (ANSM) developed an online platform to allow French cosmetic manufacturers to apply for a GMP certificate to comply with the China’s safety requirements.

Products Not Exempt

Special use cosmetics (ex. hair dyes, sunscreen, whitening products, anti-hair loss products etc.) and new ingredients will not be exempt from toxicological testing in the new regulations. For general cosmetics, animal testing is required if:

  • the product is for use by infants and children;
  • a product contains new ingredients that are not listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2015)

quantitative and grading scoring results show that the filing person, the domestic responsible person, or the actual production enterprise are listed as key regulatory target objects.

Update Nov 2021:

Testing Methods for Cosmetics in China

China’s National Institutes for Food and Drug Control (NIFDC) is holding a public consultation for five testing methods for cosmetic products and ingredients. The comment period will end on November 25, 2021.

NIFDC lists five test methods, these are:

  • Fluorescein leakage in vitro test method – assesses the effects of water-soluble cosmetic ingredients on the integrity/permeability of epithelial cells and therefore may be useful as a measure of eye irritancy potential.
  • in chemicoskin sensitization – amino acid derivative reactivity assay (ADRA) – this is used to test single cosmetic ingredients for the potential to cause skin sensitization.
  • Human cell line activation test –a cell-based assay that identifies skin sensitizers by examining changes in the expression of cell surface markers associated with the process of activation of monocytes and dendritic cells.

The other two methods cover pH testing and mammalian alkaline comet assay, which is used to evaluate DNA damage in cells.

If approved, the five methods will be added to the cosmetic safety and technical guidelines and can be used for the registration of cosmetic products and new cosmetic ingredients.

To ensure your product is compliant under the current cosmetic regulations and for any inquiries regarding the proposed amendments, Contact Nexreg today!