On 27. May 2019, NMPA issued the draft regulation “Administrative Measures for Non-Special Use Cosmetics”. Comments to the new draft regulation from the public were submitted before the 15 June 2019
PLEASE NOTE THAT THE NEW DRAFT REGULATION IS A SUGGESTED LAW – AND NOT IN EFFECT.
In sum, the new regulation is based on the 2 cosmetics filing systems for domestic and imported non-special use cosmetics, that came into effect in 2015 and 2018, respectively. The important change is that the new regulation draft now governs both imported and domestic non-special use cosmetics under the same regulatory framework. In this way imported non-special use cosmetics may be exempt from the mandatory animal test under the special conditions listed below, which was not the case before.
Important points and conditions you must comply with for the possible exemption from toxicology test proposed in the draft regulation:
- The manufacturer shall provide the certification of compliance to the production quality management system issued by the authority
- The manufacturer shall conduct the relevant product safety risks assessment testing confirming the safety of the product
- The filing products are not aimed at children or infants
- The filing products do not contain any new raw materials that are not included in the approved list of cosmetic raw materials
- The domestic filing applicant, the responsible person in China, as well as actual manufacturing facility should not be target of additional supervision by the Chinese authorities (due to the score of the quantitative classification grading system).
- The domestic filing applicant, the responsible person in China, as well as actual manufacturing facility have not been investigated and prosecuted for cosmetic quality and safety issues over the past 3 years
Please note even domestic non-special use cosmetics manufacturers should comply with the above conditions; otherwise animal testing will potentially be required.
The possible implications of the above conditions for the potential toxicology test exemption are as follows:
It’s not clear what kind of qualification certificate of the production quality management system will be recognized by the Chinese authority. Some of the possible assumptions are as follows:
- The Chinese government will create a new certificate (if this option is chosen, then all domestic and foreign manufacturers will need to do animal testing, or apply for the new certificate
- The Chinese government will recognise the ISO/GMP certificate (if this option is chosen, it means that most of the domestic manufacturers will need to do animal testing, until they can obtain these certificates)
- The Chinese government will recognise manufacturing license (if this option is chosen, then everyone, both domestic and foreign manufacturers, can avoid animal testing)
- It’s not clear how the Chinese authorities are going to grade the overseas manufacturing facilities
It is not possible to predict when the new law will come into effect. Comments to the new draft regulation should be submitted to the NMPA before 15. June 2019. Following the evaluation of the public comments to the law, NMPA may announce a second draft – and following a new round of public opinion, NMPA may announce the final regulation. Knudsen&CRC is confident that the Chinese authorities are moving towards ending mandatory animal tests for foreign cosmetics, while still ensuring consumer safety as a top priority.