Newsletter

Regulatory News in the U.S. and China

Shereen Aboarkaba
December 18, 2025

U.S. FDA Proposes to Add New Sunscreen Ingredient Bemotrizinol

On 11th December 2025, the U.S. FDA (Food and Drug Administration) announced that it is proposing to add bemotrizinol as a permitted active ingredient in sunscreens. DSM Nutritional Products LLC submitted a request for the Agency to add bemotrizinol as a new active ingredient in OTC Monograph M020 for Sunscreens at concentrations up to 6%. The FDA is now seeking public comments on the proposed order and, if it is finalised, bemotrizinol will be regarded as generally recognised as safe and effective by the FDA for use by adults and children 6 months of age and older.

California OEHHA Updates Prop 65 List

Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires the state of California to maintain and update the list of chemicals subject to the law’s requirements. The latest Proposition 65 list was released on 8th December 2025 by the OEHHA (Office of Environmental Health Hazard Assessment) and may be found here.

China NIFDC Issues Technical Cosmetic Guidelines

On 15th December 2025, China's NIFDC (National Institutes for Food and Drug Control) announced the release of the 'Technical Guidelines for Updating Filing Information of New Cosmetic Raw Materials'. On the same day, to aid registrants of new raw materials, the 'Technical Guidelines for Updating Filing Information of New Cosmetic Raw Materials' was released.

On 16th December 2025, the NIFDC also released 'Technical Guidelines for Research on Anti-Hair Loss Cosmetics' and 'Technical Guidelines for Research on Raw Materials Related to the Efficacy of Anti-Hair Loss Cosmetics'.

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