On 10 February 2026, the European Chemicals Agency (ECHA) published the Response to Comments (RCOM) on the proposed classification of sodium fluoride. This document followed a three-month public consultation on France’s proposal to classify sodium fluoride as Repr. 1B under the Classification, Labelling and Packaging (CLP) of Substances and Mixtures Regulation. The proposal and consultation focused on how sodium fluoride should be classified under this regulation. The publication of the RCOM marks the next step in that process.
Regulatory status of sodium fluoride in cosm
etics
Sodium fluoride is currently allowed in oral hygiene products at a maximum concentration of 0.15%. This limit appears in Annex III of the Cosmetics Regulation. If the substance ends up classified as Repr. 1B, the situation changes. Article 15 would then apply, which bans CMR substances, meaning carcinogenic, mutagenic, or toxic for reproduction, in cosmetic products.
Industry position on sodium fluoride
In the RCOM, many industry associations from several sectors spoke up. These sectors include chemicals, cosmetics, and dental health. A number of EU Member States joined those views as well. Their position was that the proposed CMR classification is not supported by a sufficient weight of evidence. They pointed to the health benefits linked to sodium fluoride in oral care cosmetic products.
Sodium fluoride is widely recognised as a global standard for cavity prevention.
What comes next?
ECHA’s Risk Assessment Committee (RAC) now has time to review the proposed classification. The committee has until 4 April 2027 to adopt and publish its final opinion on the proposal.
