SCCS OPINION ON Hydroxyapatite (nano) - SCCS/1624/20 - Final Opinion

U. Bernauer (1) , L. Bodin (2, 1) , Q. Chaudhry (1) , P.J. Coenraads (1) , M. Dusinska (1) , E. Gaffet (3, 1) , E. Panteri (1) , C. Rousselle (4, 1) , M. Stepnik (1) , S. Wijnhoven (1) , W.H. De Jong (1) , N. Von Goetz (1)

1 SCCS - Scientific Committee for Consumer Safety (SCCS)
2 CEA - Commissariat à l'énergie atomique et aux énergies alternatives
3 IJL - Institut Jean Lamour
4 ANSES - Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail

The SCCS concludes the following: (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.

Mots clés: consumer protection; cosmetic product; health risk; nanotechnology; regulation (EU); scientific report; toxic substance

Domaines: Science des matériaux [cond-mat.mtrl-sci]

U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, et al.. SCCS OPINION ON Hydroxyapatite (nano) - SCCS/1624/20 - Final Opinion. SCCS/1624/20, European Commission - Directorate-General for Health and Food Safety. 2021, pp.62. ⟨hal-03759688⟩