On February 10, 2026, the European Chemicals Agency (ECHA) published the Response to Comments (RCOM) regarding the proposed classification of Sodium fluoride. This document summarizes the feedback from a three-month public consultation on France’s proposal to classify Sodium fluoride as a Category 1B Reproductive Toxicant (Repr. 1B), in accordance with the Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP).
Regulatory Status of Sodium Fluoride in Cosmetics
According to Annex III of the EU Cosmetics Regulation, Sodium fluoride is currently permitted for use in oral care products (such as toothpaste and mouthwash) at a maximum concentration of 0.15%. If Sodium fluoride is ultimately classified as a Repr. 1B substance, its use in cosmetics would be subject to a comprehensive ban under Article 15 of the Cosmetics Regulation. This article prohibits the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) in cosmetic products.
Industry Stance
In the RCOM document, associations from the chemical, cosmetic, and oral health sectors, along with several EU Member States, pointed out that:
- The proposed CMR classification lacks sufficient scientific evidence.
- Sodium fluoride provides significant health benefits in oral care products, particularly its globally recognized efficacy in caries prevention.
Next Steps
ECHA’s Committee for Risk Assessment (RAC) is expected to issue its final opinion on the proposed classification of Sodium fluoride by April 4, 2027.
