On March 4, 2021, the NMPA announced the Provisions for the Management of Cosmetics Registration and Filing Dossiers (No.32-2021) and the Provisions for the Management of New Cosmetic Ingredient Registration and Filing Dossiers (No.31-2021) to support the implementation of the Cosmetic Supervision and Administration Regulation (CSAR). Both provisions will come into force from May 1, 2021 onwards.
The Provisions for the Management of Cosmetics Registration and Filing
Since 2018, the NMPA began drafting the provisions for the management of cosmetics regulatory documents and launched two public consultations. Based on the 2,033 comments solicited, the NMPA revised the drafts and formulated the final version of this provision.
The provisions consist of 6 chapters and 60 articles focusing on the format and standard requirements of the registration and filing information. The provisions address the details of what needs to be noticed or completed in the 24 annexes including the application form, the domestic responsible agent’s (DRA) letter of authorization, related standards, etc.
- The provisions listed the conditions to rollout the exemption for submitting the toxicological test reports (animal testing) of “general” cosmetics. Overseas manufacturers will be required to present:
i) a safety risk assessment report
We are still waiting for the NMPA to announce the details on how the reports should be written, which is expected at the earliest by April 2021; ii) the GMP (Good Manufacturing Practice) certificate or comparable certification of the quality management system issued by the local competent authorities of the country (region) where the manufacturers are located. Even so, the exemption may not apply if:
i) the product is considered to be used by infants and children;
ii) the product contains new cosmetic ingredients that are still under the 3 years of required monitoring; or
iii) the NMPA quantitative rating system indicates that the filer, DRA or manufacturers are targets for market supervision
- The provisions addressed the registration and filing dossier requirements in accordance with the CSAR and specified the technical safety requirements.
- Although the “special” cosmetics and “general” cosmetics are being managed differently (registration and filing), both of them still share the same basic principles for the standard of product quality and safety. Therefore, the registration and filing requirements for imported cosmetics and domestics cosmetics would be the same to remain consistent and fair.
- Avoid new drastic changes made to the existing submission requirements that would become a burden to enterprises. The provisions provided templates instead to help prepare for the registration and filing requirements.
- Utilize and promote the online platform for government services that would facilitate and streamline the registration and filing process whilst strengthening the market surveillance on applicants, DRAs, domestic manufacturers, etc. In addition, electronic submissions will save the extra time and effort used for paper submissions.
Provisions for the Management of New Cosmetic Ingredient Registration and Filing Dossiers
Since the implementation of the CSAR, significant adjustments have been made to how new cosmetic ingredients were managed. Based on the risk classification management model, the registration of high-risk new raw materials was required whilst filing was only needed for lower-risk raw materials. A three-year monitoring period was set for registrant and filers to report annually to ensure the safe use of new raw materials.
However, the NMPA also noticed the need to develop an all-rounded and detailed dossier submission requirement for the registration and filing of new cosmetic ingredients. Hence the NMPA initiated the plan to draft the provisions and launched two public consultations to solicit comments. Field research and special meetings were also held before improvements have been made to finalize the provisions.
The provisions consist of 20 articles focusing on the format and standard requirements of the registration and filing information. The provisions address the details of what needs to be noticed or completed in the 8 annexes including the application form, toxicological safety evaluation, quality control standards, risk control reports, other technical documents, etc.
- The provisions addressed the registration and filing dossier requirements in accordance with the CSAR.
- The provisions encourage the use of innovative technology to research and develop new cosmetic ingredients as long as the relevant information is provided to meet the safety risk requirements.
- Accept alternative methods to replace animal testing whilst the exemption of animal testing has been announced on conditional terms.
- Save resources by accepting electronic submission for the registration and filing of new cosmetic ingredients, and no longer requiring enterprises to submit new raw material samples, but to keep it for future inspection when needed.
Industry Responds to Animal Testing Exemption
Many cosmetics companies presently only receive GMP certificate from their home country industry organization. But because the animal testing exemption requirements announced by NMPA require issuance of GMP certificate by a competent authority of the country, many companies will not be in a position to comply. The French industry body FEBEA has, however, announced that the French health authorities are working closely with the cosmetic brands in France to ensure they meet the new conditions required by the China authorities for importing cosmetic products into China. Read the FEBEA announcement (in French) published on January 14, 2021.
By Jacky Li. Contact Cisema if you would like to learn more.