On 10 February 2026, the European Chemicals Agency (ECHA) published the Response to Comments (RCOM) on the proposed classification of Sodium fluoride. The document follows 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.
Regulatory status of sodium fluoride in cosmetics
Sodium fluoride is currently permitted in oral hygiene products at a maximum concentration of 0.15%, as listed in Annex III of the Cosmetics Regulation. Should the substance be classified as Repr. 1B, it would become prohibited for use in cosmetic products pursuant to Article 15, which bans CMR (carcinogenic, mutagenic, or toxic for reproduction) substances in cosmetics.
Industry position on sodium fluoride
In the RCOM, numerous industry associations across multiple sectors – including chemicals, cosmetics, and dental health – and several EU Member States argued that the proposed CMR classification is not supported by a sufficient weight of evidence. They also highlighted the significant health benefits of 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) has until 4 April 2027 to adopt and publish its final opinion on the proposed classification.
Do you have questions on compliance of cosmetics in the EU, UK, USA, and Canada? Contact us here or at coslaw@obelis.net.
References
ECHA. (2026). Compiled Comments on CLH Consultation: Sodium Fluoride. Retrieved on 11 February 2026.
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