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Will China Remove Mandatory Animal Testing for Imported General Cosmetics?

Last May, China released Administrative Measures for Filing 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.

According to ChemLinked's internal news source, the final answer will only be revealed after the promulgation of detailed requirements for application dossiers supplementing the Administrative Measures on Registration of Cosmetics, which has integrated the articles in the Administrative Measures for Filing of Non-special Use Cosmetics (Draft)

Possible Regulatory Mode for Imported General Cosmetics

As per the Administrative Measures for Filing 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 one 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 filed but have not been included in the IECIC

  3. The filer, 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 filer, 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 mainly refer to the Guide for Risk Assessment of Possible Substances with Safety Risks in Cosmetics. And they are acceptable by the provincial MPAs during the post-market substantial review. But whether the requirement for imported general cosmetics will be the same 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 former competent authority - CFDA (now NMPA)  issued Requirements for Filing 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 former 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. The draft group standard is likely to become the basis for the expert review of domestic non-special use cosmetics 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/filing which includes animal testing.

  • Until March 2019, China NMPA has approved seven alternatives to animal testing methods for cosmetic ingredients.

  • 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 could be China's other new step to end animal testing. As for a full ban on animal testing in China, there is still a long way to go.

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