Use. Sodium fluoride is a key active ingredient in dentistry. It is used in:
- Toothpaste & Gels,
- Professional Varnish (highly concentrated, usually 5% sodium fluoride)
It is also used in various other applications including in water fluoridation, as a treatment for osteoporosis, and as a protective agent against radiation in certain industrial settings.
New hazards. Following assessments carried out under the CLP Regulation (for Classification, Labelling and Packaging of Products), the French Health Agency ANSES is proposing to classify sodium fluoride as an endocrine disruptor for human health (Category 1) and a reproductive toxicant (Category 1B).
This would not lead to a ban but to a possible new product labelling.
The scientific dossier was submitted for public consultation on the website of the European Chemicals Agency (ECHA) until 16 January 2026.
Scientific basis. « Experimental studies in rodents and epidemiological studies in human health have shown that sodium fluoride has effects on neurodevelopment following exposure during pregnancy, and that it alters thyroid function. These effects were observed following oral exposure. In addition, studies on animal models have shown impaired fertility. »
In light of its assessment, the Agency therefore recommends extending the harmonised classification of sodium fluoride to the following hazard classes:
- endocrine disruptor for human health, Category 1 (EU H380, may cause endocrine disruption in humans, as reported in the dossier with evidence on adverse effects of altered thyroid function);
- reproductive toxicity, Category 1B (EU H360F, may damage fertility, as reported on male and female rodents).
Current CLP classification. Like all medications, sodium fluoride is not without its side effects and contraindications. Sodium fluoride is already classified for the following hazards:
- acute toxicity (oral), Category 3 (H301, toxic if swallowed);
- skin irritation, Category 2 (H315, causes skin irritation);
- eye irritation, Category 2 (H319, causes serious eye irritation).
Its use in dentistry has not been hampered by this current classification.
Next step. The European Chemicals Agency’s decision on the proposed classification should be adopted this year.
Consequence 1 – Justification use. CLP Regulation is directly applicable across EU Member States, mandating that suppliers classify, label, and package hazardous substances/mixtures before placing them on the market. So is the Medical Devices Regulation.
According to Annex 1, para.10.4.1 of the Medical Devices Regulation, the use of CMR substances of categories 1A and 1B which are present in a medical devices in a concentration that is above 0,1 % weight by weight (w/w) must be scientifically justified (in other words : demonstration must be brought of no available & alternative solutions)
Consequence 2 – Labelling. Their presence must be appropriately labelled on the device itself or on the packaging (Annex 1, para.10.4.5). Pictogram to use for category 1B : GHS06 (Skull and Crossbones) marks substances toxic or fatal if swallowed, inhaled, or in contact with skin. Pictogram to use for category 1 : GHS08 (Health Hazard) marks carcinogenic, mutagenic, reproductive toxic, or organ-damaging substances.
Dentistry & Internal Market Commissioner. In September 2025, when replying to a parliamentary question (E-002751/2025), the Internal Market Commissioner stated “The Commission is fully aware of the role of fluoride in preventing dental caries, as underlined by the World Health Organization and national health authorities.” and underlined “The Commission remains committed to supporting public health and promoting access to effective preventive care across the EU.”.
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