Cosmetics enterprises quality and safety responsibilities have been addressed in the draft regulation issued by the China National Medical Products Administration (NMPA) on November 29, 2022.
General provisions
Article 1 – Basis and purpose
In order to urge enterprises to implement the main responsibility of cosmetics quality and safety, strengthen the awareness of enterprise quality and safety responsibility, standardize cosmetics quality and safety management behavior, and ensure the quality and safety of cosmetics, in accordance with the CSAR, the Measures for the Supervision and Administration of the Production and Operation of Cosmetics, the Cosmetic Production Quality Management Standards and other laws and regulations.
Article 2 – Scope of application
These provisions shall apply to cosmetics registrants, filers, and entrusted manufacturers (hereinafter collectively referred to as “enterprises”) within the territory of the People’s Republic of China in implementing the responsibility for the quality and safety of cosmetics in accordance with the law and their supervision and management.
Article 3 – Responsible entity
Cosmetics registrants and filers are responsible for the quality, safety and efficacy claims of cosmetics, and manage the quality and safety of the cosmetics registered or filed in the whole process from research and development, production and operation.
Where a cosmetics registrant or filer entrusts the production of cosmetics, it shall supervise the entire process of production activities and be responsible for the quality and safety of the cosmetics commissioned for production. The entrusted production enterprise is responsible for the production activities and accepts the supervision of the entrusted party.
Article 4 – Quality and safety responsibility system
Enterprises shall establish a cosmetics quality and safety responsibility system and clarify the responsibilities of cosmetics quality and safety related positions.
Requirements for key positions in quality and safety
Article 5 – Responsibility framework
The legal representative (or main responsible person, the same below) of the enterprise is fully responsible for the quality and safety of cosmetics.
Enterprises shall appoint a person in charge of quality and safety. The person in charge of quality and safety shall, in accordance with the requirements of the quality and safety responsibility system, assist the legal representative in organizing and leading relevant personnel of enterprise quality and safety management to perform quality and safety management duties in accordance with law.
Article 6 – Entrusted performance of duties by the legal lepresentative
According to the operation needs of the quality management system of the enterprise, the legal representative of the enterprise may entrust other personnel of the enterprise to perform the comprehensive management of the quality and safety of cosmetics on his behalf. The legal representative shall supervise the performance of duties on behalf of the legal representative, and the legal responsibility that he shall bear shall not be transferred to the entrusted person.
Article 7 – Enhancement of the capacity of the legal representative
The legal representative of an enterprise or the entrusted person entrusted by him to perform the overall management of the quality and safety of cosmetics shall strengthen the study of the quality and safety management of cosmetics and the knowledge of relevant laws and regulations, and have the ability to make correct decisions on major issues of cosmetics quality and safety.
Article 8 – Requirements for the person in charge of quality and safety
The person in charge of quality and safety of the enterprise shall have professional knowledge of the quality and safety of cosmetics, such as cosmetics, chemistry, chemical industry, biology, medicine, pharmacy, food, public health or law, be familiar with relevant laws and regulations, mandatory national standards and technical specifications, and have more than 5 years of experience in cosmetics production or quality management.
Article 9 – Job responsibilities of the person in charge of quality and safety
The person in charge of quality and safety set up by enterprises engaged in cosmetics production activities shall assist the legal representative to undertake the following corresponding product quality and safety management and product release duties:
- Establish and organize the implementation of the enterprise’s quality management system, implement the responsibility for quality and safety management, and regularly report the operation of the quality management system to the legal representative;
- Decision on product quality and safety issues and issuance of relevant documents;
- Audit and management of product safety assessment reports, formulas, production processes, material suppliers, product labels, etc., as well as the review of cosmetics registration and filing materials (except for entrusted manufacturers);
- Material release management and product release;
- Monitoring and management of adverse reactions of cosmetics.
The person in charge of quality and safety set up by the registrant or filer for the commissioned production of cosmetics shall assist the legal representative of the enterprise to undertake the following corresponding product quality and safety management and product release duties:
- Establish and organize the implementation of the enterprise’s quality management system, implement the responsibility for quality and safety management, and regularly report the operation of the quality management system to the legal representative;
- Decision on product quality and safety issues and issuance of relevant documents;
- Review cosmetics registration and filing materials;
- Where the entrusting party purchases or provides materials, the review and management of material suppliers and material release;
- Listing and release of products;
- Supervision and management of the selection of entrusted production enterprises and production activities;
- Monitoring and management of adverse reactions of cosmetics.
Article 10 – Ability of the person in charge of quality and safety to perform duties
The person in charge of quality and safety of an enterprise shall have the following ability to perform his duties:
(1) Ability to apply professional knowledge.
(2) Ability to apply legal knowledge.
(3) Organizational and coordination capabilities.
(4) Ability to study and judge risks.
(5) Other cosmetics quality and safety management capabilities that should be possessed.
Further information
According to the draft guidelines, the provisions shall take effect as of March 2023, however, subject to the final implemented version.
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