Regulatory Status
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Safety Data
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Expert Verdict
Potassium fluoride is restricted in EU cosmetics (Annex III) to maximum 0.15% total fluorine content and classified as an OTC drug active ingredient in the US when used in oral care products; mandatory labeling and safety warnings required, especially for children's formulations.
Regulatory Flags
Frequently Asked Questions
Is Potassium Fluoride safe in cosmetics?
Potassium fluoride is restricted in EU cosmetics (Annex III) to maximum 0.15% total fluorine content and classified as an OTC drug active ingredient in the US when used in oral care products; mandatory labeling and safety warnings required, especially for children's formulations. The EU classifies Potassium Fluoride as "restricted". Safety rating: MODERATE.
Is Potassium Fluoride allowed in the EU?
Potassium Fluoride EU regulatory status: restricted. Maximum allowed concentration: 0.15%. This is based on EU Regulation 1223/2009 and its amendments.
What does Potassium Fluoride do in cosmetics?
Potassium Fluoride functions as: Oral care (anticaries agent). It is classified as a cosmetic ingredient in our database. CAS number: 7789-23-3.
What is the Margin of Safety for Potassium Fluoride?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
Compliance Tools
Check Potassium Fluoride compliance across multiple jurisdictions:
Related Ingredients
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