Hydroxyapatite (nano)

SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle (Rapporteur), M. Stepnik, S. Wijnhoven
SCHEER member: W.H. de Jong
SCCS external expert: N. von Goetz
Contact: SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1624/20
Adopted on: 30-31 March 2021

Conclusion of the opinion:

(1) In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterial Hydroxyapatite safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported in the attached list, taking into account reasonably foreseeable exposure conditions?

Having considered the data provided, and other relevant information available in scientific literature, the SCCS cannot conclude on the safety of the hydroxyapatite composed of rod–shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications given in this Opinion. This is because the available data/information is not sufficient to exclude concerns over the genotoxic potential of HAP-nano.

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

Although the particle shape in the HAP-nano considered in this Opinion is reported as rod-shaped, the SCCS is aware that, depending on the manufacturing process, needle-shaped HAP nanoparticles may also be produced. The available information indicates that HAP-nano in needle-shaped form is of concern in relation to potential toxicity. Therefore, needle-shaped HAP-nano should not be used in cosmetic products.

As detailed in Annex I, the SCCS has concluded that there is a basis for concern that the use of HAP-nano in cosmetic products can pose a risk to the consumer. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.

Keywords:

SCCS, scientific opinion, Hydroxyapatite (nano), CAS No 1306-06-5, EC No. 215-145-20, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Hydroxyapatite (nano), preliminary version of 27-28 October 2020, final version of 30-31 March 2021, SCCS/1624/2020.