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