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Annex III Entry 32 14/05/2013

POTASSIUM FLUORIDE

Potassium fluoride

POTASSIUM FLUORIDE is listed in Annex III and may only be used under the conditions shown in this record. Maximum concentration in this record: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %.

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Restricted substance— Annex III, EU Regulation 1223/2009
Max conc.: 0,15 % calculated as F. When mixed with other fluorin…
Entry: 32

Record details

Maximum concentration

0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Product type

Oral products

Warnings

Contains potassium fluoride
For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory:
"Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

INCI glossary name

POTASSIUM FLUORIDE

Chemical name

Potassium fluoride

Regulatory information

Regulation

(EC) 2013/344

SCCS opinions

Identified ingredients

Key data

CAS
7789-23-3
EC
232-151-5
Annex
III
Entry number
32

Inventory links for POTASSIUM FLUORIDE

What Annex III means for POTASSIUM FLUORIDE

POTASSIUM FLUORIDE is a restricted substance under Annex III of EU Cosmetics Regulation 1223/2009. Its use in cosmetics is only permitted under the specific conditions set out in the entry above, including applicable concentration limits, product type restrictions and required warning statements.

When including this substance in a formulation, all conditions — maximum concentration, product scope and warning labels — must be met simultaneously. Compliance with one condition does not override the others.

This record is linked to 2 CosIng inventory ingredients for name and identifier cross-reference. The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Ensure formulation concentration does not exceed: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
  • Confirm product type compatibility: Oral products
  • Include required warning statement on product label.
  • Document conditions of use in the Product Information File (PIF).

Frequently asked questions

POTASSIUM FLUORIDE is listed in Annex III of EU Regulation 1223/2009 as a restricted substance. It may only be used under the conditions specified in the entry, including any maximum concentration, product type limitation and required warning statements shown above.

CAS 7789-23-3 is the unique numerical identifier assigned to POTASSIUM FLUORIDE by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

The maximum concentration of 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % applies to the concentration of the substance in the ready-to-use cosmetic product. When the substance is supplied as part of a blend or mixture, the calculation must account for the contribution of all sources in the formulation. The combined concentration must not exceed the stated limit.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex III record POTASSIUM FLUORIDE

This page summarizes one Annex III record for POTASSIUM FLUORIDE from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex III conditions for POTASSIUM FLUORIDE, but confirm any final regulatory decision against the current official annex wording and source files.

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