New Rules for China Cosmetic Ingredient Safety Information Submission are Coming!
- Chaileedo Press
- May 8, 2023
- 3 min read
National Institute for Food and Drug Control issued the Technical Guidance for Submission of Cosmetic Ingredient Safety Information (consultation draft), in the safety information of the same raw materials filled by the same registrant or filer in cosmetic registration and filing, the composition of the raw materials should be consistent.
The China National Institute for Food and Drug Control issued the Technical Guidance for Submission of Cosmetic Ingredient Safety Information (consultation draft), which consists of 11 parts focusing on basic information of raw materials, production process descriptions, quality control requirements, and risk substance limit requirements.
The consultation draft summarizes the technical points and principles that need to be considered in the process of filling in safety information for raw materials. The public opinion solicitation period will end on May 20th.
In the registration and filing information of cosmetics, the safety information of raw materials that is self-filled and submitted by the cosmetic registrants or filers should be signed and endorsed by them, and they should take responsibility for the content.
Cosmetic registrants or filers should keep relevant information and materials for future reference, and they are responsible for the authenticity, accuracy, completeness, and traceability of the safety information of raw materials.
According to the consultation draft, in the safety information of the same raw materials filled by the same registrant or filer in cosmetic registration and filing, the composition of the raw materials should be consistent.
Due to different technical understandings, different registrants or filers of cosmetics may have differences in the filling of trace components that are not subjectively added. Such differences should not affect the safety evaluation of cosmetics and can be explained through reasonable interpretation.
Cosmetic registrants or filers should conduct safety assessments based on the principles and procedures of cosmetic safety assessment, considering all ingredients, and known risk substances in the formula, as well as relevant information such as the product's usage method, usage site, and exposure level. They should also be responsible for the safety and effectiveness of using raw materials in cosmetics.
According to the consultation draft, as for the basic information of raw materials. The composition of raw materials is an important part of the safety information, and cosmetic registrants or filers should truthfully and scientifically fill in the composition of raw materials based on the information provided by the raw material suppliers and other information such as the source and production process of the raw materials.
To fully evaluate the safety of cosmetics, the filling of raw material components should be as detailed and clear as possible. In principle, components that are intentionally or deliberately added and ultimately exist in the raw materials, as well as components generated during the production process that occupy a certain proportion in the raw materials, should generally be truthfully filled in as raw material components.
For raw materials composed of different components, the percentage range of each component should be filled in. The filled component content should reflect the composition and quality control of the raw materials and can be theoretically calculated based on the production process or obtained through monitoring data over a longer period or representative data. The relevant numerical values should be based on facts and should not be too broad.
As for the quality control requirements, consultation draft pointed that indicators and methods should be established to effectively control the quality of raw materials. To evaluate the quality and safety of cosmetic raw materials, relevant content on quality control requirements should be truthfully filled in the safety information of raw materials, focusing on identification methods, control indicators, and testing methods of raw materials, as well as other key information closely related to the quality of raw materials.
Unless otherwise specified, cosmetic registrants or filers should generally fill in the relevant content on quality control requirements based on the information provided by the raw material suppliers. If cosmetic registrants or filers set their own control indicators or other requirements, they should ensure that the relevant raw materials meet the quality control standards through agreements with the raw material suppliers and acceptance inspection of raw materials.
In Addition, in the safety assessment of cosmetics, data or risk assessment materials published by internationally authoritative organizations are an important technical reference, and cosmetic registrants, filers, and raw material manufacturers should strengthen the collection and use of relevant data. Common technical organizations include the European Commission's Scientific Committee on Consumer Safety (SCCS), the Cosmetic Ingredient Review (CIR), the International Fragrance Association (IFRA), the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), etc.
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