Hydroxyapatite (nano)

SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska (Rapporteur), E. Gaffet, E. Panteri, M. Stepnik, S. Wijnhoven
SCHEER external experts: W.H. de Jong
SCCS external experts: N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1648/22
Adopted on: 21-22 March 2023

Conclusion of the opinion:

(1) In view of the above, and taking into account the scientific data provided, does the SCCS consider hydroxyapatite (nano) safe when used in oral cosmetic products according to the maximum concentrations and specifications as reported in the submission, taking into account reasonably foreseeable exposure 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:
- 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.

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.

Keywords:

SCCS, scientific opinion, Hydroxyapatite, HAP, nano, CAS/EC No.: 1306-06-5/215-145-7, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Hydroxyapatite (nano), preliminary version 4 January 2023, final version 21-22 March 2023, SCCS/1648/22.