Moderate Cosmetic Ingredient SCCS/CIR Reviewed

Hydroxyapatite

Also known as: Apatite hydroxide (Ca10(PO4)6(OH)2), Calcium hydroxyapatite, Hydroxypol, EINECS No.: 215-145-7, Hydroxylapatite (+8 more)

INCI: HYDROXYAPATITE

Hydroxyapatite (CAS 1306-06-5) is a cosmetic cosmetic ingredient functioning as Abrasive; oral care active; whitening; bulking agent; structuring agent;. EU Regulation 1223/2009 status: restricted, max Non-nano conventional hydroxyapatite permitted in cosmetics (e.g., oral care). Nano-form prohibited in cosmetics effective February 2025 per Commission Regulation (EU) 2024/858; 5 safety opinions reviewed (sccs). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 1306-06-5 →

Auto-generated CPSR Part A draft with source citations
CAS Number
1306-06-5
View industrial chemical safety profile →
Function
Abrasive; oral care active; whitening; bulking agent; structuring agent; nano-form was investigated as skin delivery carrier
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
215-145-7
ChEBI: CHEBI:747153 UNII: 91D9GV0Z28 Wikidata: Q18211477

Regulatory Status

EU EU Status restricted
EU Max Conc. Non-nano conventional hydroxyapatite permitted in cosmetics (e.g., oral care). Nano-form prohibited in cosmetics effective February 2025 per Commission Regulation (EU) 2024/858
US US Status permitted
US Notes FDA permits hydroxyapatite in oral care cosmetics (e.g., toothpaste); nano-hydroxyapatite oral care products subject to case-by-case FDA review; no general prohibition on nano-HA in the US for cosmetic use as of 2026

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Hydroxyapatite.

Calculate MoS for your specific formulation with the MoS Calculator.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

sccs SCCS/1677/25 26 June 2025
Verdict: safe
Max Concentration: 29.5% in oral care

osure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mut

sccs SCCS/1677/25 26 June 2025
Verdict: safe
Max Concentration: 10% in oral care

osure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mut

sccs SCCS/1677/25 26 June 2025
Verdict: safe
Max Concentration: 0.465% in oral care

osure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mut

sccs SCCS/1648/22 22 March 2023
Verdict: safe
Max Concentration: 10% in oral care

posure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash. This safety evaluation only applies to the hydroxyapatite (nano) with the following characteristics: - compo

sccs SCCS/1648/22 22 March 2023
Verdict: safe
Max Concentration: 0.465% in oral care

posure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash. This safety evaluation only applies to the hydroxyapatite (nano) with the following characteristics: - compo

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE
SVHC Candidate
No

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

Additional Jurisdictional Restrictions (1)
Jurisdiction Status Max % Product Type
UK restricted - -

Additional Ingredient Properties

1 property record from structured ingredient metadata.

mineral_clay
{"cas_number": "1306-06-5", "ingredient_class": "calcium_compound", "chemical_formula": "Ca10(PO4)6(OH)2", "mineral_origin": "synthetic", "particle_size_range_um": "0.02-5", "surface_area_m2_per_g": "50-200", "crystal_structure": "hexagonal", "color_appearance": "white", "opacity": "opaque", "refractive_index": "1.65", "oil_absorption_g_per_100g": "40-80", "water_absorption_capacity": "30-60%", "s…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Abrasive Filler Softener and conditioner

Expert Verdict

Expert safety assessment and concern-level summary for Hydroxyapatite.

Regulatory Flags

eu-nano-prohibited-2025 sccs-insufficient-safety-evidence annex-ii-prohibited-nano non-nano-still-permitted oral-care-traditional-use us-eu-divergence compliance-critical eu-2024-858

Known Synonyms

Apatite hydroxide (Ca10(PO4)6(OH)2) Calcium hydroxyapatite Hydroxypol EINECS No.: 215-145-7 Hydroxylapatite Cellyard-AX Coralina HAP 200 Boneceram P-G 1 Bone ject Captal 60-1 HAP 100 (mineral) Micro-SHAp IHM 100P000 Calcium hydroxyphosphate

Chemical Function

Abrasive Softener and conditioner Filler

Regulatory Lists

Canada; consumer_product; Substances in Products - Canada (4/2014)

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
DURAPATITE
ChEMBL ID
CHEMBL2218916
Max Phase
2
Adverse Event Associations
1
View full pharmaceutical profile →

Frequently Asked Questions

Is Hydroxyapatite safe in cosmetics?

Hydroxyapatite has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. This ingredient has been reviewed by sccs.

Is Hydroxyapatite allowed in the EU?

Hydroxyapatite EU regulatory status: restricted. Maximum allowed concentration: Non-nano conventional hydroxyapatite permitted in cosmetics (e.g., oral care). Nano-form prohibited in cosmetics effective February 2025 per Commission Regulation (EU) 2024/858. This is based on EU Regulation 1223/2009 and its amendments.

What does Hydroxyapatite do in cosmetics?

Hydroxyapatite functions as: Abrasive; oral care active; whitening; bulking agent; structuring agent; nano-form was investigated as skin delivery carrier. It is classified as a cosmetic ingredient in our database. CAS number: 1306-06-5.

Is Hydroxyapatite used outside cosmetics?

Hydroxyapatite also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Compliance Tools

Check Hydroxyapatite compliance across multiple jurisdictions:

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Substance Compliance
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MoS Calculator
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