Moderate Cosmetic Ingredient SCCS/CIR Reviewed

Hydroxyapatite

INCI: HYDROXYAPATITE

CAS Number
1306-06-5
Function
Abrasive; oral care active; whitening; bulking agent; structuring agent; nano-form was investigated as skin delivery carrier
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ 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
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

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

Expert Verdict

Calcium phosphate mineral naturally present in bone and tooth enamel with long-established safe use in oral care; however, nano-form is prohibited in EU cosmetics effective February 2025 under Commission Regulation (EU) 2024/858 due to insufficient safety evidence, requiring immediate compliance action for EU-marketed products.

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Concern Level: High

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

Frequently Asked Questions

Is Hydroxyapatite safe in cosmetics?

Calcium phosphate mineral naturally present in bone and tooth enamel with long-established safe use in oral care; however, nano-form is prohibited in EU cosmetics effective February 2025 under Commission Regulation (EU) 2024/858 due to insufficient safety evidence, requiring immediate compliance action for EU-marketed products. The EU classifies Hydroxyapatite as "restricted". Safety rating: MODERATE. 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.

What is the Margin of Safety for Hydroxyapatite?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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