On 10 February 2026, the European Chemicals Agency (ECHA) shared its latest Response to Comments (RCOM) regarding the sodium fluoride classification proposal. This announcement followed a 90-day public review of France’s submission to classify sodium fluoride as a Repr. 1B substance under the Classification,Labelling and packaging (CLP) Regulation for Substances and Mixtures. The focus was on whether sodium fluoride should fall under strict hazard classification within this framework. issuing the RCOM sets a new stage in the regulatory process.
Sodium Fluoride: Rules and Limits in cosmetic Products
Current EU Regulation
EU law currently permits sodium fluoride in oral care products up to 0.15%, according to Annex III of the Cosmetics Regulation. If a Repr. 1B classification is confirmed, Article 15 will come into force. This article bans the use of CMR substances-carcinogenic,mutagenic,or toxic to reproduction-in cosmetic formulations.
Industry’s Viewpoint: Scientific Debate and Public Health
During the RCOM consultation, organisations from the chemical, personal care, and dental sectors contributed. A few EU countries echoed these perspectives. industry stakeholders argued the current evidence does not support labelling sodium fluoride as a CMR substance. They cited its positive role in oral health and its established importance in oral hygiene cosmetic products.
Globally, sodium fluoride remains the leading anti-cavity agent in toothpastes and mouthwashes.
Next Steps in the Regulatory Process
the ECHA’s risk Assessment Committee (RAC) is now in the process of evaluating the classification proposal. RAC must deliver and publish its official opinion by 4 April 2027.
