The Provisions for Registration and Filing of Cosmetics

Order of the State Administration for Market Regulation

No. 35 

The Provisions for Registration and Filing of Cosmetics adopted at the 14th Executive Meeting of the State Administration for Market Regulation on December 31, 2020 is hereby promulgated and shall go into effect as of May 1, 2021.

                       Minister Zhang Gong

January 7, 2021

The Provisions for Registration and Filing of Cosmetics

(Announced by Order No. 35 of the State Administration for Market Regulation on January 7, 2021)

Chapter I General Provisions

Article 1 These Provisions are formulated for the purpose of regulating registration and filing of cosmetics, while ensuring the quality and safety of cosmetics in accordance with the Regulations on Supervision and Administration of Cosmetics.

Article 2 The registration and filing activities of cosmetics and new cosmetic ingredients and their supervision and administration within the territory of the People's Republic of China shall comply with these Provisions.

Article 3 The registration of cosmetics and new cosmetic ingredients refers to the activity that a registrant submits a registration application in accordance with legal procedures and requirements, and the drug regulatory department reviews the safety and quality control of the cosmetics and new cosmetic ingredients applied for registration and decides whether it agrees to the application.

The filing of cosmetics and new cosmetic ingredients refers to the activity that a filing person submits the dossier indicating the safety and quality control of the cosmetics and new cosmetic ingredients in accordance with legal procedures and requirements, and the drug regulatory department files the submitted dossier for reference.

Article 4 The State implements registration administration for special cosmetics and new cosmetic ingredients with high risks, and filing administration for general cosmetics and other new cosmetic ingredients.

Article 5 The National Medical Products Administration (NMPA) is responsible for the registration and filing administration of special cosmetics, imported general cosmetics and new cosmetic ingredients, and guiding and supervising the related cosmetic filing work undertaken by the drug regulatory departments of provinces, autonomous regions, and municipalities. The NMPA may entrust the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government that have corresponding capabilities to implement the filing administration of imported general cosmetics.

The cosmetic technical assessment agency of the NMPA (hereinafter referred to as the technical assessment agency) is responsible for the technical assessment of the registration of special cosmetics and new cosmetic ingredients, the technical verification of imported general cosmetics and the new cosmetic ingredients after filing, and the evaluation of the use and safety reports of new cosmetic ingredients.

The administrative affairs service agency of the NMPA (hereinafter referred to as service agency), the inspection agency, adverse reaction monitoring agency and information management agency shall be responsible for the registration acceptance, on-site inspections, adverse reaction monitoring, informatization and management respectively.

Article 6 The drug regulatory departments of provinces, autonomous regions and municipalities are responsible for the filing administration of domestic general cosmetics within their administrative areas, implementing the filing administration of imported general cosmetics in the name of the NMPA within the scope of entrustment, and assisting in the on-site inspection for registration of special cosmetics etc.

Article 7 The registrant and filing person of cosmetics and new cosmetic ingredients shall perform product registration and filing obligations in accordance with law and shall be responsible for the quality and safety of cosmetics and new cosmetic ingredients.

Registrants and filing persons of cosmetics and new cosmetic ingredients shall comply with the requirements of relevant laws, administrative regulations, mandatory national standards and technical specifications when applying for registration or filing for filing, and shall be responsible for the authenticity and scientificalness of the submitted dossiers.

Article 8 Overseas registrants and filing persons shall designate an enterprise legal person within the territory of China as the domestic responsible person. The domestic responsible person shall fulfill the following obligations:

(1) In the name of the registrants and filing persons, handling the registration and filing of cosmetics and new cosmetic ingredients;

(2) Assisting the registrants and filing persons in carrying out cosmetic adverse reaction monitoring, safety monitoring and reporting of new cosmetic ingredients;

(3) Assisting the registrants and filing persons in implementing the recall of cosmetics and new cosmetic ingredients;

(4) In accordance with the agreement with the registrants and filing persons, assuming corresponding quality and safety responsibilities for cosmetics and new cosmetic ingredients released in the domestic market; and

(5) Cooperating with the supervision and inspection of the drug regulatory department.

Article 9 The drug regulatory department under the State Council shall release the information on registration and filing of cosmetics and new cosmetic ingredients to the public for reference within 5 working days since the date when the registration is approved or the filing is filed.

Article 10 The NMPA shall strengthen informatization to provide convenient services for registrants and filing persons.

Registrants and filing persons of cosmetics and new cosmetic ingredients shall apply for registration and filing through the information service platform of registration and filing for cosmetics and new cosmetic ingredients (hereinafter referred to as the information service platform) in accordance with regulations.

The NMPA shall formulate the inventory of existing cosmetic ingredients, update it in a timely manner and make it public to facilitate enterprises for reference.

Article 11 The drug regulatory department may establish an expert consultation mechanism to listen to expert opinions on important issues in the process of technical evaluation, on-site inspection, supervision and inspection, and give play to the role of experts for technical support.