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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 %.

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

Chemical identity and properties

PubChem 2D chemical structure for CAS 1306-06-5
CAS 1306-06-5PubChem CID 14781

Hydroxylapatite (Ca5(OH)(PO4)3)

Hydroxylapatite is a mineral with formula of Ca5(PO4)3OH. The corresponding IMA (International Mineralogical Association) number is IMA2010 s.p.. The IMA symbol is Hap. RRUFF Project

IUPAC name
pentacalcium;hydroxide;triphosphate
Molecular formula
Ca5HO13P3
Molecular weight
502.3 g/mol
Exact mass
501.675955 Da
Topological polar surface area
260.0 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
13
Covalent units
9
Defined stereocentres
0

Also known as

DurapatiteCalcium hydroxyapatiteRadiesseMoniteWin 40350Apatite, hydroxyCalcium hydroxylapatiteSupertite 10
16 more reported names
Calcium phosphate hydroxideCalcium orthophosphate, basicPentacalcium monohydroxyorthophosphateInterpore200Interpore500215-145-7235-330-6Interpore 200Interpore 500Hydroxyapatite, CalciumOssein Hydroxyapatite CompoundOssopan 200Ossopan 800RefChem:56158HYDROXYAPATITEHydroxylapatite
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match14781

Attributed physical-property, hazard, environmental and use annotations.

  • Note: This chemical does not meet GHS hazard criteria for 97.8% (362 of 370) of all reports. Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: Not Classified; Reported as not meeting GHS hazard criteria by 362 of 370 companies (only 2.2% companies provided GHS information). For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 370 reports by companies from 5 notifications to the ECHA C&L Inventory.; Reported as not meeting GHS hazard criteria per 362 of 370 reports by companies.; There are 3 notifications provided by 8 of 370 reports by companies with hazard statement code(s).; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
  • Note: This chemical does not meet GHS hazard criteria for 94% (188 of 200) of all reports. Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: Not Classified; Reported as not meeting GHS hazard criteria by 188 of 200 companies (only 6% companies provided GHS information). For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 200 reports by companies from 6 notifications to the ECHA C&L Inventory.; Reported as not meeting GHS hazard criteria per 188 of 200 reports by companies.; There are 3 notifications provided by 12 of 200 reports by companies with hazard statement code(s).; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)

Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record

Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.

Additional source coverage and match status
SourceResultChecked
NIH PubChem PUG-ViewExact match2026-08-31

A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Maximum concentration

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

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

Key data

Annex
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.

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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