
On November 17, 2025, the European Chemicals Agency (ECHA) launched a consultation on 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 of European Cosmetics Regulation 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.
Identification
Index number
• 009-004-00-7
Chemical name
• sodium fluoride
EC number
• 231-667-8
CAS number
• 7681-49-4
Classification
Hazard class and Category code(s)
• Repr. 1B
• Acute Tox. 3
• Acute Tox. 3
• Skin Irrit. 2
• Eye Irrit. 2
• ED HH 1
Hazard statement code(s)
• H360F - May damage fertility.
• H331 - Toxic if inhaled.
• H301 - Toxic if swallowed.
• H315 - Causes skin irritation.
• H319 - Causes serious eye irritation.
• EUH380 - May cause endocrine disruption in humans.
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