Announcement of the State Food and Drug Administration on Issues concerning Encouraging Innovation and Standardizing Management of New Raw Materials for Cosmetics (No. 143 of 2023)

release time:2023-12-12


In order to encourage and support the research and innovation of new cosmetic raw materials, standardize the research, development, use, registration and filing management of new raw materials, ensure the quality and safety of raw materials and products, protect the health of consumers, and promote the healthy development of the cosmetics industry, in accordance with the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations), the Measures for the Administration of Cosmetics Registration and Filing (hereinafter referred to as the Measures) and other regulations, the relevant matters concerning strengthening the management of new raw materials for cosmetics are hereby announced as follows:

  Encourage and support research and innovation of new raw materials 1. strengthening technical guidance services

The research and innovation of new cosmetic raw materials is the basis of cosmetic technology innovation, and the safety of new cosmetic raw materials is the source of product quality and safety. The State Food and Drug Administration continued to promote the construction of a technical support system for new cosmetic raw materials, organized relevant technical departments to study the establishment of a communication and exchange mechanism for new cosmetic raw materials, accelerated the revision of technical guidelines for the research of new cosmetic raw materials, and strengthened technical guidance services for the registration and filing of new cosmetic raw materials.

Encourage the development of new cosmetic raw materials in combination with China's traditional advantageous projects and characteristic plant resources, and support the use of modern science and technology for research and innovation of cosmetic raw materials. When developing new raw materials for cosmetics, registrants and filers should conduct sufficient scientific research on the source, performance, purpose of use, preparation process, quality control and other related safety of the raw materials, and fully verify the expected purpose, scope of application and safe use of the raw materials in cosmetics. To adjust the use purpose and safe use of used cosmetic raw materials, registration or filing shall be applied for in accordance with the relevant requirements of the new raw materials. The improvement and innovation of used cosmetic raw materials can be carried out by optimizing the preparation technology and production process, changing the material basis of raw materials and other aspects of substantive innovative research, so as to improve the safety, stability and quality controllability of raw materials.

 2. implement the main responsibility of enterprises to ensure the quality and safety of raw materials and products

As the main body responsible for the quality, safety and safety monitoring of new raw materials, registrants and filers of new raw materials for cosmetics shall strengthen the standardized management of the research, production and use of new raw materials, ensure the authenticity, scientificity and traceability of the registration and filing materials and data of new raw materials, and continuously track the correct use and safety monitoring of new raw materials in cosmetics, Ensure the quality and safety of new raw materials and related products.

The registrant and the filing person of the new raw material of cosmetics shall provide the safety-related information of the new raw material registration and filing to the cosmetics companies that use the new raw materials objectively, truthfully, completely and accurately, and supervise and guide the cosmetics companies to use the new raw materials correctly to ensure that the new raw materials are used in the cosmetic formula. The role played is consistent with the purpose and scope of application of the new raw material registration and filing.

The person who records the new raw materials of cosmetics shall implement the main responsibility of the enterprise, and carry out self-examination on the filing of new raw materials in accordance with the regulations and measures and relevant technical specifications, technical guiding principles and other relevant requirements. if the self-examination finds that the filing of new raw materials of cosmetics does not fall within the scope of filing, it may propose to the State Drug Administration to take the initiative to cancel the filing of new raw materials.

Cosmetic registrants and filers who use new raw materials to produce cosmetics shall implement the main responsibility for product quality, safety and efficacy claims, review and evaluate the raw material safety information provided by the new cosmetic raw material registrants and filers, and check the performance and quality of the new raw materials used. Safety is verified to ensure that the role of new raw materials in cosmetic formulations is consistent with the purpose and scope of application of the new raw material registration.

 3. Strengthening Supervision and Management to Promote the Healthy Development of Cosmetic Industry

Strengthen the safety risk assessment and prevention and control of the whole chain of new raw materials for cosmetics to ensure the quality and safety of cosmetics using new raw materials. The drug regulatory department shall, in accordance with the requirements of relevant laws, regulations and technical specifications, strengthen the supervision and management of new raw materials and related products, strengthen the monitoring and evaluation of the registration and filing management, use and safety of new cosmetic raw materials, and urge the implementation of the main responsibility of enterprises.

After the new raw material is used in the product and associated with the cosmetics registration information service platform, the State Food and Drug Administration shall organize the post-filing technical verification of the new raw material, and organize on-site verification and extended inspection when necessary, and find that quality and safety issues are involved, Immediately take corresponding risk control measures for new raw materials and cosmetics using new raw materials, and investigate and deal with violations of laws and regulations in accordance with the law.

The provincial drug regulatory departments shall urge the cosmetics enterprises using new raw materials to implement the responsibilities of the registration and filing of new raw materials for cosmetics, the establishment of safety monitoring and risk prevention and control system after the product is put on the market, and the disposal and reporting of adverse reactions. Focus on strengthening the supervision and management of the use of new raw materials for ordinary cosmetics, organize technical audits and on-site inspections of related products, and immediately organize research and analysis if adverse reactions or quality and safety problems involving the use of new raw materials are found or received, And take corresponding risk control measures for new raw materials and cosmetics using new raw materials in accordance with relevant regulations based on the research and judgment, and find violations of laws and regulations, and be investigated and dealt with in accordance with the law.

The State Food and Drug Administration will further strengthen the encouragement of innovation and supervision and management of new raw materials, and provide timely guidance on the research and development, use and management of new raw materials for cosmetics by establishing a communication mechanism for new raw materials for cosmetics and issuing technical guidelines.

It is hereby announced.

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