China Released Two Important Official Catalogues as Supporting Documents of Full Version of Safety Assessment Report

Recently, China's National Institutes for Food and Drug Control issued two catalogs, including,

• The International Authoritative Cosmetic Safety Assessment Data Index; and
• Usage Information for Ingredients in Marketed Products

International Authoritative Cosmetic Safety Assessment Data Index

The catalog contains 3651 ingredients.

1. This index is an objective collection of ingredients used in cosmetics in China that are not included in the "Technical Guidelines for Cosmetics Safety Assessment", but for which the European Union’s Scientific Committee on Consumer Safety (SCCS) and the United States Cosmetic Ingredient Review (CIR) have published safety assessment reports. It serves as a reference for cosmetic safety assessments. Cosmetic registrants and filers may use, but are not limited to, the assessment conclusions published by the above-mentioned assessment bodies when conducting cosmetic safety assessments.

2. Cosmetic registrants and filers should fulfill their corporate responsibilities. When applying the assessment conclusions from cosmetic safety assessment bodies, they should analyze the relevant data and, if compliant with the relevant regulations of Chinese cosmetics law, may adopt the related assessment conclusions. In cases where different bodies have inconsistent assessment results, conclusions should be adopted based on the reliability and relevance of the data in a scientific and reasonable manner.

3. With the advancement of science and technology and the improvement of public awareness, the types of ingredients assessed and the conclusions drawn may change. When applying these, the most recent assessment conclusions should be used as the primary reference.

Usage Information for Ingredients in Marketed Products

The catalog contains 2234 ingredients.

1. This information on ingredient usage is an objective record of the amounts used in special cosmetics within the validity period of their approvals in China, which are not included in the "Safety and Technical Standards for Cosmetics" and for which there are no authoritative assessment reports. No systematic evaluation of the safety of the listed ingredients has been organized. Cosmetic registrants and filers, when using this ingredient information, must comply with relevant national laws, regulations, standards, and specifications, conduct cosmetic safety assessments, and assume responsibility for product quality and safety.

2. The specified amounts of ingredients can serve as a reference for cosmetic safety assessments. Cosmetic registrants and filers should use these amounts correctly in accordance with the product's method of use and area of application.

3. For the same ingredient used on the same area of application, if only the usage amount for leave-on products is available, rinse-off products may refer to the usage for leave-on products.

4. For the same ingredient used with the same method, it can be applied in the following order: (1) whole-body skin, torso, face, lips, eyes; (2) whole-body skin, torso, hands and feet, head, hair. Subsequent areas of application can refer to the ingredient usage amounts of earlier areas, but if the product is intended for use on the eyes and refers to usage amounts for other areas, an additional assessment of the ingredient's potential for eye irritation is required.

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