SCCS - Guidance on the safety assessment of nanomaterials in cosmetics - 2nd revision

SCCS members: U. Bernauer (Rapporteur and Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCHEER member: 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/1655/23
Adopted on: 6 June 2023

Main changes in this revision of the SCCS guidance on the safety assessment of nanomaterials in cosmetics:

● New sections have been introduced (solubility and dissolution rate, solubility in non acqueous media, evidence for the absence of nanoparticles, dispersion, aspect ratio, uptake into blood cells, reproductive toxicity, endocrine disruption),

● The new European Commission recommendation for a definition of nanomaterials published in 2022 has been introduced,

● Key aspects triggering safety concerns over a nanomaterial based on SCCS/1618/2020 have been introduced,

● Other sections and Annex 1 have been updated based on literature that has been published since the last update,

● Section on read-across and grouping has been revised.

● A text explaining when historical/existing data can be used has been included.

This Guidance may be subject to future changes based on the evolution of science in the field of safety assessment of nanomaterials.

Keywords:

SCCS, scientific opinion, nanomaterials, Guidance

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Guidance on the Safety Assessment of Nanomaterials in Cosmetics, 2nd revision, 6 June 2023, SCCS/1655/23.