On June 11, 2025, the European Chemicals Agency (ECHA) relayed France’s proposal for harmonized classification and labeling (CLH) of Sodium Fluoride, commonly used in oral care, notably as a reprotoxic and endocrine-disrupting substance.
Sodium fluoride (CAS No.7681-49-4, EC No.231-667-8, INCI: Sodium Fluoride) is an ingredient listed in the Cosing, with the functions: Antiplaque, Oral care.
The substance is included in Annex III/62 du Règlement Cosmétiques européen 1223/2009, which limits its use at 0.15% in oral products, with warning statements.
It is also listed in Annex VI/009-004-00-7 of European CLP Regulation 1272/2008, with the following classifications.
• Acute Tox. 3* - H301 - Toxic if swallowed.
• Eye Irrit. 2 - H315 - Causes skin irritation.
• Skin Irrit. 2 - H319 - Causes serious eye irritation.
France proposes to classify the substance as follows.
• Acute Tox. 3, H301 - Toxic if swallowed.
• Acute Tox. 3, H331 - Toxic if inhaled.
• Skin Irrit. 2, H315 - Causes skin irritation.
• Eye Irrit. 2, H319 - Causes serious eye irritation.
• Repr. 1B, H360F - May damage fertility.
• ED HH 1, EUH380 - May cause endocrine disruption in humans.
France also proposes the following specific concentration limits. • Oral: ATE=149 mg/kg bw
• Inhalation: ATE=0.64 mg/L
If the process is completed and the classifications as “Reprotoxic” and “Endocrine disruptor” become effective, Sodium Fluoride could eventually be banned from …
