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Monday, June 16, 2025ECHA

Proposal of CLH classification for Sodium Fluoride

Proposition de classification CLH pour le Sodium fluoride

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.

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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 …

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