(Issued by Announcement No. 31 of the NMPA on February 26, 2021; revised by Announcement No. 59 of the NMPA on June 25, 2026; effective as of July 15, 2026)

Article 1 This Provision is formulated in accordance with the requirements of the Regulations on Supervision and Administration of Cosmetics and the Measures for the Administration of Cosmetics Registration and Filing, for the purpose of standardizing the administration of registration and filing of new cosmetic ingredients.

Article 2 The documents submitted by registrants and filing persons of new cosmetic ingredients when applying for registration or conducting filing of new cosmetic ingredients shall comply with the requirements of this Provision.

Article 3 The registration and filing documents of new cosmetic ingredients shall be based on scientific research and describe the properties, characteristics, and safe use requirements of new cosmetic ingredients in a comprehensive, authentic, accurate, and standardized manner.

Registrants and filing persons of new cosmetic ingredients shall be responsible for the authenticity, accuracy, completeness, legality, and traceability of the submitted documents.

Article 4 Registrants, filing persons of new cosmetic ingredients, or domestic responsible persons shall apply for registration or conduct filing through the cosmetic registration and filing information service platform (hereinafter referred to as the "information service platform") in accordance with relevant provisions. The electronic version of the registration and filing documents filled in and uploaded to the information service platform shall be consistent with the corresponding paper version.

Article 5 Before applying for registration or conducting filing of new cosmetic ingredients, registrants and filing persons of new cosmetic ingredients shall fill in the following information through the information service platform to complete user information registration: (1) Information of registrants and filing persons of new cosmetic ingredients; (2) Overview of the safety risk monitoring and assessment system of registrants and filing persons of new cosmetic ingredients; (3) Where the registrant or filing person of new cosmetic ingredients is an overseas entity, the domestic responsible person shall fill in the information and submit the originals of the letter of authorization for the domestic responsible person and the notarial certificate thereof.

Where a domestic enterprise holds multiple identities, such as registrant, filing person, or domestic responsible person of new cosmetic ingredients at the same time, or is authorized as the domestic responsible person for multiple overseas registrants or filing persons of new cosmetic ingredients, it may obtain corresponding user permissions after submitting all relevant documents at one time. Existing users may supplement relevant documents and adjust user authorities according to actual conditions.

Article 6 The letter of authorization for the domestic responsible person shall at least specify the following contents and information: (1) Names of the registrant, the filing person, and the domestic responsible person of new cosmetic ingredients; (2) Scope of authorization; (3) Term of authorization.

The same new cosmetic ingredient shall not be authorized to more than one domestic responsible person. The domestic responsible person shall carry out the registration or filing of new cosmetic ingredients within the scope of authorization. The domestic responsible person shall submit a letter of authorization for extending the authorization term before the expiration of the authorization term specified in the letter of authorization. Where it fails to submit as required, the corresponding permissions of the domestic responsible person's account shall be frozen upon expiration and shall be restored after such submission.

Article 7 When the following information and documents of registrants, filing persons of new cosmetic ingredients, or domestic responsible persons change, they shall be updated in a timely manner to ensure that the relevant information and documents on the information service platform are authentic and accurate: (1) When information such as the legal representative and contact information of the registrant, filing person, or domestic responsible person changes, the user shall update it on the information service platform by itself; (2) When other basic information of the registrant, filing person, or domestic responsible person, the overview of the safety risk monitoring and assessment system for new cosmetic ingredients, or the scope and term of authorization of the domestic responsible person changes, an information update form for registrants and filing persons of new cosmetic ingredients shall be submitted, and relevant documents shall be submitted as required to complete the update of relevant information and documents.

Where the name or address of an overseas registrant or filing person changes, the original relevant certification document issued by the competent government department or relevant institution of the country (region) where it is located, certifying that the entity remains unchanged, shall be provided. If the original cannot be submitted, a copy notarized by a Chinese notary office or confirmed by the Chinese embassy (consulate) shall be provided. Where the name or address of a domestic responsible person changes, the original relevant certification document issued by the competent government department or relevant institution of China, certifying that the subject remains unchanged, shall be provided.

Where the scope of authorization of the domestic responsible person changes, the new scope of authorization shall cover the original scope of authorization. Where only the authorization term is updated, other contents of the letter of authorization shall not be changed.

Where the domestic responsible person is changed, a letter of authorization meeting the requirements of Article 6 of this Provision, as well as a letter of commitment by the proposed new domestic responsible person to assume all relevant responsibilities of the original domestic responsible person, shall be submitted.

Article 8 To apply for registration or conduct filing of a new cosmetic ingredient, the registrant or filing person shall submit the following documents: (1) Name, address, and contact information of the registrant, filing person, and domestic responsible person; (2) Research and development report of the new ingredient; (3) Research documents on the preparation process, stability, and quality control standards of the new ingredient; (4) Safety assessment documents of the new ingredient.

Registrants and filing persons of new cosmetic ingredients shall formulate and provide the technical specifications for the new cosmetic ingredient based on the relevant technical information in the registration and filing documents. The technical specifications shall include basic information, purpose of use, safe usage amount, precautions, period of use, and other contents.

Article 9 The toxicological and human safety reports of new cosmetic ingredients submitted by registrants and filing persons shall be issued by institutions that have obtained China Inspection Body and Laboratory Mandatory Approval (CMA) for relevant items, obtained accreditation from the China National Accreditation Service for Conformity Assessment (CNAS) for relevant items, or comply with Good Clinical Practice (GCP) or Good Laboratory Practice (GLP).

Article 10 Where the registration matters of a registered new cosmetic ingredient change, the registrant of the new ingredient shall submit corresponding documents to complete the change in accordance with the provision before the ingredient is put into use.

Where the filing matters of a filed new cosmetic ingredient change, the filing person of the new ingredient shall update them in a timely manner to ensure that the relevant information and documents on the information service platform are authentic and accurate.

Article 11 The specific technical requirements for registration and filing documents of new cosmetic ingredients, and the specific technical requirements for the change and update of new ingredient information, shall be formulated by the cosmetic technical review authority.

Article 12 Registrants, filing persons of new cosmetic ingredients, or domestic responsible persons shall keep samples of new ingredients on file for inspection. When the cosmetic technical evaluation authority needs to inspect samples of new ingredients during technical evaluation or technical verification, registrants, filing persons, or domestic responsible persons shall provide samples as required in a timely manner.

Samples of new cosmetic ingredients shall have complete packaging and labels. The labels shall include information such as the name of the registrant, filing person, or domestic responsible person, the Chinese name of the ingredient, production date and period of use, and storage conditions.

Article 13 For registered and filed new cosmetic ingredients, registrants, filing persons, or domestic responsible persons shall collect and sort out the following information and documents in accordance with the relevant requirements of the safety monitoring period for new ingredients, and submit the annual safety monitoring report for new ingredients through the information service platform within 30 working days before the expiry of each full year of the safety monitoring period: (1) Information of cosmetic registrants, filing persons, and entrusted manufacturers that use the new ingredient; (2) Information of cosmetics produced with the new ingredient, including product name, product registration certificate number or filing certificate number, and production or import and sales volume of the products; (3) Information on sampling inspection, case filing and investigation, and product recall of cosmetics produced with the new ingredient; (4) Statistical analysis of adverse reactions of cosmetics produced with the new ingredient by cosmetic registrants and filing persons, and the measures taken.

Article 14 Where registrants, filing persons of new cosmetic ingredients, or domestic responsible persons find circumstances that shall be reported to the cosmetic technical evaluation authority as specified in the Measures for the Administration of Cosmetics Registration and Filing during the use of new ingredients, they shall collect and sort out information in a timely manner, such as basic information of the new ingredient, production or import, sales and use conditions, cause analysis of safety problems or emergencies, disposal measures taken, and handling results, and submit a safety risk control report for new cosmetic ingredients to the cosmetic technical evaluation authority through the information service platform.

Article 15 This Provision shall come into force on July 15, 2026. The Announcement of the National Medical Products Administration on Issuing the Provision on the Administration of the Dossier for Registration and Filing of New Cosmetic Ingredients (No. 31, 2021) shall be repealed simultaneously.