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Expert opinion

Guidance on the safety assessment of nanomaterials in cosmetics

Final Opinion

Details

Publication date
31 October 2019
Author
Scientific Committee on Consumer Safety (SCCS)

Description

SCCS members: U. Bernauer (Rapporteur and Chairperson of the Working Group), L. Bodin, Q. Chaudhry (SCCS Chair), P. Coenraads (SCCS Vice-Chair), M. Dusinska, E. Gaffet, E. Panteri, V. Rogiers (SCCS Vice-Chair), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCHEER members: W.H. de Jong
SCCS external experts: A. Simonnard, N. von Goetz
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1611/19
Adopted on: 30-31 October 2019

Background:

The Guidance is aimed at facilitating the Applicants in preparing safety dossiers, and assisting risk assessors and risk managers in the implementation of the provisions of article 16 of Cosmetics Regulation (EC) No 1223/2009. The Regulation imposes strict conditions and timelines for notification and assessment of cosmetic products containing NMs on the Responsible Persons, as well as on the SCCS. All the essential elements that would be required in an NM safety dossier are covered in this Guidance, i.e. physicochemical characterisation, exposure assessment, toxicological evaluation and risk assessment. As such, this Guidance is complementary to the SCCS general Notes of Guidance for specifically addressing safety aspects of NMs, and therefore must be considered in conjunction with the SCCS Notes of Guidance (SCCS/1602/18 or its most recent revision).

The Guidance will be revised and updated by the SCCS when considered appropriate to take account of any new scientific advancements and the new knowledge and experience in this field.

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, 30-31 October 2019, SCCS/1611/19.

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sccs_o_233.pdf
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