What’s new?

On February 12, 2024, the European Chemicals Agency (ECHA) announced that France plans to propose a new harmonised classification for Sodium Fluoride, including a classification as an endocrine disruptor for human health and reprotoxic, under the REACH regulation.

Sodium Fluoride is widely used in cosmetics as an antiplaque agent and in oral care and is currently restricted in Annex III/31 to the EU Cosmetics Regulation (EC) No. 1223/2009.

What now?

According to the EU Cosmetics Regulation No. 1223/2009, cosmetic ingredients classified as CMR (Carcinogenic, Mutagenic, Toxic to Reproduction) of categories 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, shall be prohibited. Additionally, cosmetic ingredients classified as CMR substances in category 2 may also face prohibition, unless they have undergone evaluation by the Scientific Committee on Consumer Safety (SCCS) within the new classification framework and have been deemed safe for use in cosmetic products.

Banning sodium fluoride could lead to the prohibition of all fluorinated agents in oral cosmetic products. Therefore, Cosmetics Europe invited interested companies to a consortium to “prepare a safety dossier for submission to the European Commission to support the continued use of Sodium Floride in cosmetics and personal care products.”

The restriction dossier is expected to be submitted on April 15 2025.

References:

European Chemicals Agency – Registry of restriction intentions until outcome

Cosmetics Europe – Call for interest to participate – Sodium Fluoride Consortium