Annex III Entry 30 14/05/2013

Calcium fluoride

Calcium 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%.

Restricted substance— Annex III, EU Regulation 1223/2009
Max conc.: 0.15% calculated as F. When mixed with other fluorine …
Entry: 30

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

Warnings

Contains calcium 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."

Chemical name

Calcium fluoride

Regulatory information

Key data

Annex
Entry number
30

Inventory links for Calcium fluoride

What Annex III means for Calcium fluoride

Calcium 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

Calcium 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 7789-75-5 is the unique numerical identifier assigned to Calcium 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.

Source note for Annex III record Calcium fluoride

This page summarizes one Annex III record for Calcium 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 Calcium fluoride, but confirm any final regulatory decision against the current official annex wording and source files.

Tools & next steps

Check your formula

Paste a full INCI list to detect Calcium fluoride and other flagged EU annex records in one pass.

INCI Checker

Compare entries

Compare Calcium fluoride side by side with another annex record to review differences in restrictions, concentrations and annex placement.

Compare

Browse the annex

See all records in Annex III and compare regulatory conditions across substances in this annex.

Open Annex III