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Annex III Entry 372 04/06/2024

Hydroxyapatite (nano)

Hydroxyapatite

Hydroxyapatite (nano) is listed in Annex III and may only be used under the conditions shown in this record. Maximum concentration in this record: (a) 10 % (b) 0,465 %.

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Restricted substance— Annex III, EU Regulation 1223/2009
Max conc.: (a) 10 % (b) 0,465 %
Entry: 372

Record details

Maximum concentration

(a) 10 % (b) 0,465 %

Product type

Toothpaste Mouthwash

Other restrictions

For (a) and (b): Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
Only nanomaterials having the following characteristics are allowed:
— [composed of] rod-shaped particles of which at least 95,8 % (in particle number) have an aspect ratio less than 3, and the remaining 4,2 % have an aspect ratio not exceeding 4,9;
— the particles are not coated or surface modified

INCI glossary name

Hydroxyapatite (nano)

Chemical name

Hydroxyapatite

Regulatory information

Regulation

(EU) 2024/858

SCCS opinions

Identified ingredients

Key data

CAS
1306-06-5
EC
215-145-7
Annex
III
Entry number
372

Inventory links for Hydroxyapatite (nano)

Inventory Identified ingredient
Ref 34479

HYDROXYAPATITE

CAS: 1306-06-5
EC: 215-145-7

Direct matches are limited for this record, so nearby entries from Annex III are shown as well.

Annex III 379
Shared product type

Silver

CAS: 7440-22-4
EC: 231-131-3
Annex III 371
Nearby record in the same annex

Pinene

CAS: 80-56-8/ 7785-70-8/ 127-91-3/ 18172-67-3
EC: 201-291-9/ 232-087-8/ 204-872-5/ 242-060-2
Annex III 373
Nearby record in the same annex

Genistein

CAS: 446-72-0
EC: 207-174-9
Annex III 374
Nearby record in the same annex

Daidzein

CAS: 486-66-8
EC: 207-635-4
Annex III 369
Nearby record in the same annex

Geranyl Acetate

CAS: 105-87-3
EC: 203-341-5
Annex III 375
Nearby record in the same annex

Kojic Acid

CAS: 501-30-4
EC: 207-922-4

What Annex III means for Hydroxyapatite (nano)

Hydroxyapatite (nano) 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: (a) 10 % (b) 0,465 %
  • Confirm product type compatibility: (a) Toothpaste (b) Mouthwash
  • Document conditions of use in the Product Information File (PIF).

Frequently asked questions

Hydroxyapatite (nano) 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 1306-06-5 is the unique numerical identifier assigned to Hydroxyapatite (nano) 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 (a) 10 % (b) 0,465 % 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 Hydroxyapatite (nano)

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

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