On August 31, 2023, the National Institute of Food and Drug Control (“NIFDC”) issued a notice on the “Technical Guidelines for Children’s Cosmetics” (the “Guideline”), which sets forth the product formula requirements and implementation standards for children’s cosmetics. This Guideline came into effect on the date of promulgation.  China issued specialized rules on children’s cosmetics in 2021 to strengthen oversight on safety aspects, including special rules on labeling and ingredients (available here).  Children’s cosmetics are defined as cosmetics that are suitable for children ages 12 and under and have cleaning, moisturizing, refreshing, or sunscreen functions (decided based on the product label claims and targeted users). Cosmetics registrants/filers should further subdivide their products by “for infants” (0-3 years old) and “for children” (>3-12 years old). Cosmetics that represent to be applicable to all groups or for use by the whole family are also regulated as children’s cosmetics.

The Guideline provides further guidance on requirements for children’s cosmetics’ names, product formulations, product standards, labeling, inspection reports, and safety assessment data, and requirements for imported children’s cosmetics whose formulations are designed specifically for the China market. In general, the Guideline provides that children’s cosmetics should follow three principles: safety first, efficacy required, and simplified formula. The Guideline recommends against using ingredients in children’s cosmetics that are prohibited in other regions and countries. The Guideline also states that imported products formulated for the China market must provide a formula design description based on skin type and consumer need (e.g., through consumer testing and market research), as well as safety and efficacy data derived from testing with Chinese consumers, to support the formula design and the product’s claims.

For further information or inquiries relating to this post, please email APACRegBlog@cov.com.

Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John BalzanoJulia PostMuyun Hu, Kaixin Fan, and Kexin Yang.