SCCS Issued Final Opinion on the Safety of Hydroxyapatite (nano)

On March 23, 2023, the European Union Scientific Committee on Consumer Safety (SCCS) issued the final opinion on the safety of hydroxyapatite (nano) in cosmetics (SCCS/1648/22). The preliminary comments on hydroxyapatite (nano) were released on January 4, 2023.

The final conclusion is as follows:

1. 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:

- 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.

2. Does the SCCS have any further scientific concerns with regard to the use of hydroxyapatite (nano) in oral cosmetic products?

This Opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles. Although the use of hydroxyapatite (nano) is indicated also for breath spray, no data were provided to allow assessment of consumer safety from inhalation exposure. Therefore, this Opinion is not applicable to sprayable products that might lead to exposure of the Consumer’s lungs to nanoparticles by inhalation.

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SCCS/1648/22：https://health.ec.europa.eu/system/files/2023-03/sccs_o_269.pdf