EU SCCS Concludes Hydroxyapatite (nano) Is Safe at Higher Levels for Oral Use

In April 2025, EU Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion on hydroxyapatite (CAS No. 1306-06-5) in nano form, following the industry's fourth submission of a safety assessment dossier for the ingredient. After reviewing public comments received, SCCS issued its final opinion on July 1, 2025.¹

Hydroxyapatite is listed in CosIng with reported functions such as abrasive, bulking agent, oral care agent, and skin-conditioning agent. It was previously assessed by SCCS in 2015, 2021, and 2023. In view of the 2023 opinion, EU introduced Commission Regulation (EU) 2024/858, restricting the use of hydroxyapatite (nano) in oral care products. During the regulation's development, stakeholders submitted additional data supporting the safe use of this ingredient at higher concentrations, prompting SCCS to conduct a new safety review.

Based on new evidence, SCCS concludes in its final opinion that hydroxyapatite (nano) can be safely used in oral care products at concentrations higher than those set by Commission Regulation (EU) 2024/858. A side-by-side comparison of the SCCS's final conclusions and the current regulatory limits is shown below, with updates in the latest opinion highlighted in red.

Ingredient

Current Limits under Commission Regulation (EU) 2024/858

SCCS Final Opinion (July 2025)

Hydroxyapatite (nano)

CAS No.: 1306-06-5

a. Hydroxyapatite (nano) is safe for use at the following maximum concentrations:

Toothpaste: 10%
Mouthwash: 0.465%

b. The specified concentrations apply only to hydroxyapatite (nano) characterized by these properties:

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.

a. Hydroxyapatite (nano) is safe for use at the following maximum concentrations:

Toothpaste: 29.5%
Mouthwash: 10%

b. The specified concentrations apply only to hydroxyapatite (nano) characterized by these properties:

Composed of rod-shaped particles of which at least 87% (in particle number) have an aspect ratio of 3 or less, and the remaining 13% have an aspect ratio not exceeding 9;
The particles are not coated or surface modified;
The particles have a maximum length of 122 ± 43 nm.

EU SCCS Concludes Hydroxyapatite (nano) Is Safe at Higher Levels for Oral Use

Further Reading