Last August and November, China released the first and second draft Instructions for Cosmetic Registration and Notification Dossiers which proposed that general cosmetics could be exempted from animal testing.
General cosmetics refer to all the products complying with the definition of cosmetics within the Cosmetic Supervision and Administration Regulation (CSAR), except for the special cosmetics namely hair dyes, hair perming products, freckle-removing and whitening products, sunscreens, anti-hair loss products and cosmetics claiming new efficacy.
On Mar. 4, 2021, China NMPA finally released the finalized Instructions for Cosmetic Registration and Notification Dossiers (renamed as Provisions for Management of Cosmetic Registration and Notification Dossiers). As per the finalized regulation, imported general cosmetics will be permitted to exempt from animal testing from May 1, 2021.
But it should be noted that there are two preconditions and three exceptions for the animal testing exemption:
Only by fulfilling both of the following two conditions can companies of general cosmetics apply for the exemption of animal testing:
1. General cosmetic manufacturers have obtained the GMP; certificates issued by the competent authority of the country (region) where they are located;
2. The safety assessment results can fully confirm the safety of products.
As long as one of the following 3 conditions applies, companies are still required to conduct animal testing:
1. Products claim to be used by infants/children;
2. Products using new cosmetic ingredient during their 3 years of required monitoring;
3. The notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA.
For the first precondition-submission of GMP certificates, ChemLinked commented that "some overseas cosmetic companies may face a barrier for the animal testing exemption as they may fail to submit the GMP certificate granted by the local government cosmetic authority. In some regions, like the EU, the government cosmetic authority won't issue an official GMP certificate due to the local cosmetic regulatory scheme. The GMP certificates that can be provided are generally issued by cosmetic associations or international standardization organizations.”
However, the official GMP certificates may not be a barrier now. In January France ANSM (National Agency for the Safety of Medicines and Health Products), the French health authority, announced that it would issue the GMP certificates for local cosmetic manufacturers and has already launched an online platform for them to obtain the certificates.
Additionally, more countries in Europe are considering joining the league. “The U.K. government is working closely with industry to create a certification system that will satisfy new Chinese regulations on cosmetics, following the removal of the requirement for animal testing on imported cosmetics,” said a U.K. Department of International Trade spokesperson.
The authorities are also connecting with China's competent authority to confirm if their GMP certificates can be recognized.
Apart from the GMP certificates, safety assessment is also a mandatory condition for the animal testing exemption.