Chapter II The Registration and Filing Administration of New Cosmetic Ingredients

Section I Registration and Filing of New Cosmetic Ingredients

Article 12 Natural or artificial ingredients used in cosmetics for the first time in China are new cosmetic ingredients.

To adjust the purpose of use, safe dosage etc. of the existing cosmetic ingredients, registration application or filing shall be performed as required by the administration and filing of new cosmetic ingredients.

Article 13 To apply for registration of new cosmetic ingredients with functions such as preservative, sunscreen, colorant, hair dye, spot corrector and whitening, the application dossiers shall be submitted in accordance with the requirements of the NMPA. The service agency shall complete the format review of the application dossiers within 5 working days from the date of receipt, and deal with it separately according to the following circumstances:

(1) Where the application items do not require registration in accordance with law, a decision of non-acceptance shall be made and a notice of non-acceptance shall be issued;

(2) Where the application items do not fall within the scope of NMPA's terms of reference in accordance with law, a decision of non-acceptance shall be made, a notice of non-acceptance shall be issued, and the applicant shall be informed to apply to the relevant administrative organization;

(3) Where the application dossiers are incomplete or do not conform to the prescribed form, a notice of supplement shall be issued to notify the applicant of all the contents that need to be supplemented and corrected at one time. If no notice is made within the time limit, the application shall be deemed as accepted since the date of receipt; and

 (4) Where the application dossiers are complete and meet the prescribed form as required, or the applicant submits all supplementary documents as required, the registration application shall be accepted and a notice of acceptance shall be issued.

The service agency shall transfer the application dossiers to the technical assessment agency within 3 working days from the date of accepting the registration application of new cosmetic ingredients.

Article 14 The technical assessment agency shall, within 90 working days from the date of receiving the application dossiers, organize the technical evaluation in accordance with the requirements of the technical evaluation, and deal with it separately according to the following circumstances:

(1) If the application dossiers are authentic, complete, and able to prove the safety and quality control of the ingredient, and meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications, the technical assessment agency shall make an evaluation conclusion of approval;

(2) If the application dossiers are not authentic, and unable to prove the safety and quality control of the ingredient, and do not meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications, the technical assessment agency shall make an evaluation conclusion of disapproval; and

(3) Where supplementary documents are required from the applicant, the applicant shall be notified once of all the contents to be supplemented; the applicant shall provide supplementary documents at one time as required within 90 working days, and the evaluation time limit shall be recalculated after the technical assessment agency receives the supplementary documents; if the supplementary documents are not submitted within the specified timeline, the technical assessment agency shall make an evaluation conclusion of disapproval.

Article 15 If the evaluation conclusion is disapproval, the technical assessment agency shall notify the applicant and explain the reasons. If disagreements exist, the applicant may apply for re-evaluation within 20 working days from the date of receiving the evaluation conclusion. The content of the re-evaluation is limited to the original application items and application dossiers.

The technical assessment agency shall make a re-evaluation conclusion within 30 working days from the date of receiving the re-evaluation application.

Article 16 The NMPA shall, within 20 working days from the date of receipt of the technical evaluation conclusions, review the legality, standardization and completeness of the technical evaluation procedures and conclusions, and whether to grant approval to the registration.

The service agency shall issue to the applicant the registration license of the new cosmetic ingredient or a decision letter of disapproval of the registration within 10 working days from the date when the NMPA makes the administrative examination and approval decision.

Article 17 Before the technical assessment agency makes a technical evaluation conclusion, the applicant may withdraw the registration application. In the process of technical evaluation, if it is suspected that false documents have been provided or the new cosmetic ingredient has any safety issue, the technical assessment agency shall handle it in accordance with law, and the applicant shall not withdraw the application for registration.

Article 18 The filing of new cosmetic ingredient is completed when the filing person submits the dossiers as required.　　

Section II Safety Monitoring and Reporting

Article 19 New cosmetic ingredients that have been registered or filed shall follow a safety monitoring system. The period of safety monitoring is 3 years, starting from the date when cosmetics using new cosmetic ingredients for the first time are registered or filed.

Article 20 During the safety monitoring period, registrants and filing persons of new cosmetic ingredients may use the new cosmetic ingredient to produce cosmetics.

If cosmetic registrants and filing persons use new cosmetic ingredients to produce cosmetics, the relevant cosmetic registration application and filing shall be associated and confirmed by the registrant or filing person of the new cosmetic ingredient through the information service platform.

Article 21 Registrants and filing persons of new cosmetic ingredients shall establish a safety risk monitoring and evaluation system after the launch of new cosmetic ingredients, conduct follow-up research on the safety of new cosmetic ingredients, and continue to monitor and evaluate the use and safety of new cosmetic ingredients.

Registrants and filing persons of new cosmetic ingredients shall, within 30 working days before a year period of safety monitoring of new cosmetic ingredients, prepare an annual report summarizing and analyzing the use and safety conditions of new ingredients, and submit it to the NMPA.

Article 22 If the following situations are found, the registrants and filing persons of new cosmetic ingredients shall immediately conduct research and report to the technical assessment agency:

(1) Where serious cosmetic adverse reactions or group adverse reaction incidents suspected to be caused by using similar ingredients are found in other countries (regions);

(2) Where the laws, regulations and standards for cosmetics of other countries (regions) raise the ingredient standards, increase the restriction condition or prohibit the use of similar ingredients; and

(3) Other circumstances related to the safety of new cosmetic ingredients.

If there is evidence showing that the new cosmetic ingredient has any safety issues, the registrant and filing person of the new cosmetic ingredients shall immediately take measures to control the risks and report to the technical assessment agency.

Article 23 The registrant and filing person of cosmetics who use new cosmetic ingredients to produce cosmetics shall give prompt feedback on the use and safety of the new cosmetic ingredients to the registrant and filing person of new cosmetic ingredients.

If there is any cosmetic adverse reaction or safety issue that may relate to new cosmetic ingredients, the cosmetic registrant and filing person shall immediately take measures to control risks, notify the registrant and filing person of the new cosmetic ingredient, and report to the drug regulatory department of province, autonomous region, or municipality where it is located as prescribed.

Article 24 After receiving reports of adverse reactions or safety issues of cosmetics using new cosmetic ingredients, the drug regulatory departments of provinces, autonomous regions, and municipalities shall carry out research, judgment and analysis, and if the new cosmetic ingredients may have safety risks that cause body injury or health hazard, measures shall be taken to control the risks in accordance with relevant provisions, and the technical assessment agency shall be immediately informed.

Article 25 The technical assessment agency shall, after receiving the feedback or report from the drug regulatory department of the province, autonomous region, or municipality, or the registrant and filing person of new cosmetic ingredients, assess the situation in accordance with the annual statistical analysis results of cosmetic adverse reactions from the adverse reaction monitoring agency. When believing that the safety risks can be eliminated by adjusting technical requirements of the new cosmetic ingredients, the technical assessment agency may propose opinions of adjustment and report to the NMPA; when believing that there are safety issues, the technical assessment agency shall report to the NMPA and request to revoke the registration or nullify the filing. The NMPA shall make decisions in a timely manner.

Article 26 After three-year safety monitoring period for new cosmetic ingredients, the technical assessment agency shall submit an opinion on whether the new cosmetic ingredients meet the safety requirements to the NMPA.

For new cosmetic ingredients with safety issues, the NMPA shall revoke the registration or nullify the filing; if no safety issues are found, the NMPA shall include them into the inventory of existing cosmetic ingredients.

Article 27 During the safety monitoring period, if a new cosmetic ingredient is ordered to suspend the use, the cosmetic registrant and filing person shall also suspend the production and operation of cosmetics using the new cosmetic ingredient at the same time.