NIFDC Released FAQs on the Registration and Filing of New Cosmetic Ingredients

1. How to calculate the safety monitoring period for new cosmetic raw materials?

According to Article 19 of the Cosmetic Registration and Filing Management Measures, new cosmetic raw materials that have been registered and filed are subject to a safety monitoring system. The safety monitoring period is 3 years, starting from the date when the cosmetics that first use the new cosmetic raw materials are registered or filed.

2. During the safety monitoring period, what are the obligations of the registrant/filer of the new raw material and the registrant/filer of its cosmetics that uses the new raw material?

New raw material registrants and filers should establish a safety risk monitoring and evaluation system for new raw materials after they are launched, conduct follow-up research on their safety, and conduct continuous monitoring and evaluation of their use and safety.The use and safety of new raw materials should be summarized and analyzed, and an "Annual Report" should be submitted within the specified time limit as required; if new raw materials are found to have any of the conditions specified in Article 22 of the "Cosmetic Registration and Filing Management Measures", research should be carried out immediately, necessary risk control measures should be taken, and a "Risk Control Report" should be submitted in a timely manner.

Cosmetics registrants and filers who use new raw materials to produce cosmetics should promptly provide feedback on the use and safety of the new raw materials to the new raw material registrants and filers. When adverse reactions or safety issues in cosmetics that may be related to new raw materials occur, measures should be taken immediately to control the risks, the new raw material registrants and filers should be notified, and reports should be made to the local drug regulatory department of the province, autonomous region, or municipality directly under the Central Government in accordance with regulations.

3.When should new raw material registrants and filers submit their annual reports? What content should the annual reports include?

According to Article 21 of the Cosmetic Registration and Filing Management Measures, new raw material registrants and filers shall summarize and analyze the use and safety of new cosmetic raw materials within 30 working days before the first full year of new raw material safety monitoring, and submit an annual report to NMPA.

According to the "Cosmetics New Raw Materials Registration and Filing Data Management Regulations", the annual report should generally include: information on the cosmetics registrant, recorder or entrusted production enterprise that uses new raw materials to produce cosmetics; information on cosmetics produced using new raw materials; supervision, random inspection, investigation and recall of cosmetics produced using new raw materials; relevant information on adverse reaction monitoring; relevant information on risk monitoring and evaluation, etc. For specific compilation requirements, please refer to Appendix 7 of the "Cosmetics New Raw Materials Registration and Filing Data Management Regulations". The annual report is submitted through the "Cosmetics Smart Application and Review System".

4. Under what circumstances should new raw material registrants and filers submit risk control reports? What should the risk control reports include?

According to Article 22 of the Cosmetics New Raw Materials Registration and Filing Data Management Regulation, new raw material registrants and filers should immediately conduct research and report to the technical review agency if they discover the following situations:

(1) Other countries (regions) discover serious cosmetic adverse reactions or group adverse reactions that are suspected to be caused by the use of similar raw materials;

(2) Cosmetic laws, regulations and standards of other countries (regions) raise the use standards, increase use restrictions or prohibit the use of similar raw materials;

(3) Other situations related to the safety of new cosmetic raw materials. In addition, if there is evidence that new cosmetic raw materials have safety issues, the registrant or filer of the new raw material shall immediately take measures to control the risks and report to the technical review agency.

According to the Cosmetics New Raw Materials Registration and Filing Data Management Regulation, risk control reports should generally include: basic information on new raw materials; production and usage conditions; analysis of the causes of safety issues or emergencies; disposal measures taken and results, etc. disposal measures taken and the results of the treatment, etc. For specific preparation requirements, please refer to Appendix 8 of the Cosmetics New Raw Materials Registration and Filing Data Management Regulation. The risk control report is submitted through the "Cosmetics Smart Application Review System".

5. Is it possible to submit other information at the same time as submitting the annual report or risk control report?

According to the Cosmetics New Raw Materials Registration and Filing Data Management Regulation, some technical information can be submitted together with the annual report. For example, for new raw materials used for the first time at home and abroad, accelerated test data of at least 3 batches of raw materials or long-term storage test data of more than 1 year can be submitted when registering and filing. For the long-term storage test data of the remaining service life, it can be supplemented once or annually with the annual report.

Except for the circumstances permitted by the Cosmetics New Raw Materials Registration and Filing Data Management Regulation, the submission of other information not related to the annual report or risk control report will be deemed invalid.

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