United States Notifies New Regulation Restricting Formaldehyde in Cosmetics, Effective September 28, 2025

On August 27, 2025, the United States notified the WTO of an addendum to the 173-339 Washington Administrative Code (WAC) COSMETIC PRODUCTS RESTRICTIONS (Formaldehyde in Cosmetics) (G/TBT/N/USA/2187/Add.2).

This regulation restricts the manufacture, sale, and distribution of cosmetic products in the state of Washington that contain intentionally added formaldehyde or formaldehyde releasers. The objective is to reduce consumer exposure to formaldehyde through the use of cosmetic products, due to its known health risks. The regulation will enter into force on September 28, 2025.

Key Provisions of the Regulation

1. WAC 173-339-110 lists 25 restricted formaldehyde releasers, which have been updated in this addendum compared to the original notification (G/TBT/N/USA/2187). The intentional addition of these substances in cosmetic products will be prohibited starting January 1, 2027. The specific substances are listed in the table below.

2. The regulation clarifies the definition of “intentionally added”, in order to interpret the restriction provisions on toxic chemicals under the Toxic-Free Cosmetics Act (RCW 70A.560.020).

Methods of Addition:

• Direct addition of formaldehyde to cosmetics or their ingredients.
• Addition of formaldehyde releasers, which are chemicals that gradually release formaldehyde over time.

Formaldehyde is considered "intentionally added" in cosmetics when used for the following purposes:

• Antimicrobial
• Preservative
• Denaturant
• Cross-linker
• Other purposes

Toxic-Free Cosmetics Act (TFCA)

In 2023, the Washington State Legislature passed the Toxic-Free Cosmetics Act (TFCA) to enhance the safety of cosmetics and personal care products while protecting the health of Washington State residents and the environment from exposure to toxic chemicals.

Transition Period: Starting January 1, 2025, the manufacture, distribution, and sale of cosmetics containing the following nine categories of substances will be prohibited in Washington State. Existing products containing these substances may continue to be sold until January 1, 2026.

Our Services

• The United States Agent;
• The United States FDA Cosmetic Facility Registration;
• The United States FDA Cosmetic Product Listing;
• The United States FDA OTC Drug Registration;
• The United States Color Additive Batch Certification;
• The United States Cosmetic/OTC Drug Labeling Review; and
• International Cosmetic Ingredient Name (INCI) Application

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

https://members.wto.org/crnattachments/2025/TBT/USA/final_measure/25_05758_00_e.pdf