FAQs on Cosmetics Registration and Filing in China – Safety Assessments

We've translated a selection of some of the latest FAQs on cosmetics registration and filing in China with a focus on safety assessments to help you understand the current requirements.

Q: How do you conduct safety assessments for cosmetic products that must be used with instruments or tools?

A: According to Article 34 of the Provisions on the Management of Cosmetic Registration and Filing Data, the registrant and the filer shall conduct product safety assessments in accordance with the requirements of the technical guidelines related to the safety assessment of cosmetics and form a product safety assessment report. In terms of cosmetics that must be used with instruments or tools (those that only help to apply cosmetics to skin, including brushes and air cushions, as well as hair curling tools, are exempted), the safety under the use of instruments or tools should be evaluated. Information on whether the instrument or tool has the function of cosmetics during use, whether it participates in the reproduction of cosmetics, and whether it changes the mechanism of action between the product and the skin should be provided.

Q: What are the requirements for the submission of cosmetic safety assessment materials?

A: Based on the announcement of the National Medical Products Administration (NMPA) on the issuance of the Technical Guidelines for Cosmetics Safety Assessment (2021 Edition), from January 1, 2022, cosmetic registrants and filers must conduct cosmetic safety assessments and submit product safety assessment materials in accordance with the requirements of the Technical Guidelines before applying for the registration of special cosmetics or the filing of ordinary cosmetics. Before May 1, 2024, cosmetic registrants and filers may submit simplified product safety assessment reports in accordance with the requirements of the Technical Guidelines.

Q: How is the safety of fragrances evaluated?

A: The highest historical fragrance usage recorded in the Inventory of Existing Cosmetic Ingredients in China (2021 Edition) cannot be used as evidence for evaluation. Fragrance should be evaluated according to the principles and requirements of the Technical Guidelines for Cosmetics Safety Assessment, or the documents certifying that the fragrance used in the product meets the requirements of the International Fragrance Association (IFRA) practices or regulations, or the relevant national standards for China should be provided.

Q: What information should be provided when evaluating nanomaterials?

A: When conducting safety assessments on products containing nanomaterials, the raw material quality specification issued by the manufacturer, and the safety assessment materials based on the quality specification of the raw material and the amount of formula used must be provided.

Q: Is it possible for titanium dioxide to be used as both a sunscreen and a physical whitening agent during product declaration? What should we pay attention to when submitting the products for evaluation?

A: According to the Safety and Technical Standards for Cosmetics (2015 Edition), titanium dioxide is approved for use as a sunscreen and colorant. When it is used as a sunscreen, the concentration is limited to 25%. If titanium dioxide should be used both as a sunscreen and a physical whitening agent in a product, enterprises may refer to the limit requirements for sunscreen. However, it should be noted that if nano titanium dioxide is added, the safety of the ingredient must be further discussed.

Q: Is it possible to calculate the average daily consumption of hand and neck membranes? What documents can be used as a reference when calculating the average daily consumption of essential oils?

A: The average daily usage of the product mainly depends on the:

• use method – rinse-off or leave-on,
• frequency of use, and
• position of use.

Related enterprises may calculate the average daily consumption as per the design of the products, or the average exposed skin surface area, and average daily exposure level, issued by domestic and foreign authorities.

Common references include:

• SCCS Notes of Guidance for the testing of cosmetic awards and their safety evaluation;
• CFTA Safety Evaluation Guidelines; and
• Guidelines for Cosmetic Safety Assessment issued by Japan Cosmetic Industry Federation; Research data of the Netherlands National Institute of Public Health and Environment on cosmetic exposure.

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