Last May, China released the Administrative Measures for Notification of Non-special Use Cosmetics (Draft) and proposed a possibility that imported general cosmetics will be exempt from mandatory animal testing.
Starting from the finalization of China’s overarching regulation – Cosmetics Supervision and Administration Regulation (CSAR) on June 29, whether China will move away from animal testing for imported general cosmetics has been the most burning question in the industry. However, the CSAR gives no clear and specific answer as it only regulates the underlying cosmetic regulatory framework.
The final answer will only be revealed after the promulgation of Standards for Dossiers of Cosmetic Registration and Notification. It will detail the dossiers requirements for the registration/notification of domestic/imported general and special cosmetics as well as new cosmetic ingredients. According to ChemLinked’s internal news source, it will be released before 2021.
Possible regulatory mode for imported general cosmetics
As per the Administrative Measures for Notification of Non-special Use Cosmetics (Draft), animal testing can be replaced by risk assessment documents for imported general cosmetics manufactured under certified GMP conditions, except in any of the following circumstances:
1. The product is for specific use by children or infants
2. The product uses new cosmetic ingredients that have been registered or notified but have not been included in the IECIC
3. The notifier, the domestic responsible person and the actual manufacturing enterprise are listed as the key supervision targets according to the results of credit rating
4. The notifier, the domestic responsible person, and the actual manufacturing enterprise have been investigated and punished due to quality or safety issues within the past three years
However, the draft didn’t specify the requirements for the risk assessment documents. At present, domestic general cosmetics are subject to a similar exemption of animal testing. The risk assessment documents for domestic general cosmetics, which was called Cosmetic Product Safety Report (CPSR), mainly refer to the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation in the EU. And they are acceptable by the provincial MPAs during the post-market substantial review. But whether such a CPSR is applicable for imported general cosmetics remains to be seen.
Supervision progress on animal testing in China
In the past few years, China has made significant progress in moving towards a cruelty-free cosmetics sector.
In 2013, the previous CFDA issued Requirements for Notification of Domestic Non-Special Use Cosmetics stipulating that mandatory animal testing could be avoided for domestic non-special use cosmetics if reliable safety assessment reports were provided. The announcement came into force from June 30, 2014.
On November 10, 2015, the previous CFDA released a Guidance for Cosmetic Safety Risk Assessment for public consultation, which provides for the first time a complete technical standard on risk assessment of cosmetics in China.
On November 12, 2018, cosmetic Industries opened a public consultation on the draft group standard of Guidelines on Cosmetic Safety Assessment.
On November 21, 2018, the CBEC transitional policy was officially extended. Cosmetics imported in this mode shall be supervised as personal articles, exempt from customs import license, and not subject to cosmetic registration/notification which includes animal testing.
Until March 2019, China NMPA has approved seven alternatives to animal testing methods for cosmetic ingredients.
On July 29, 2020, China released the draft Technical Guidelines for Cosmetic Safety Assessment for public consultation. The draft is likely to become the basis for the expert review of general cosmetics safety assessment.
In recent years, a larger number of domestic organizations such as the National Institutes for Food and Drug Control and Zhejiang Institute for Food and Drug Control have developed a partnership with the international non-profit organization Institute for In Vitro Sciences.
One expert commented that the removal of mandatory animal testing for imported general cosmetics is a very definite possibility considering the recent years of great efforts that China has made to phase out animal testing. The removal should be China’s other new step to end animal testing.