Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2) - Submission I

WG on Methodologies
SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
External experts: A. Simonnard, N. von Goetz, W. Uter
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/1589/17
Adopted on: 30 July 2018

Conclusion of the opinion:

In light of the methodology provided, does the SCCS consider QRA2 adequate to establish a concentration at which induction of sensitisation by a fragrance ingredient unlikely to occur?

The "QRA2 final report" together with the supplementary information received shows that a lot of progress has been achieved since the initial publication of the QRA. However, it is not yet possible to use the QRA2 to establish a concentration at which induction of sensitisation of fragrance is unlikely to occur. Several aspects of the methodology are not clear and the scientific rationale behind the methodology needs to be better described. These aspects have been highlighted in this Opinion.

Does the SCCS have any further scientific comments with regard to the use of QRA2 methodology to determine, in particular regarding applicability, development and improvements?

A number of additional considerations and refinements have been incorporated to the proposed methodology. However, explanation of certain methodological approaches and assumptions, as well as a description of uncertainties is lacking, the provision of which would enhance understanding of the methodology. These aspects have been highlighted in the SCCS comments under each section with the aim to provide pointers for improvement. If shaped up properly, this could be a useful methodology not only for risk assessment of fragrance allergens, but potentially also for other cosmetic ingredients.

Keywords:

SCCS, scientific opinion, Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2), Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2), preliminary version of 24-25 October 2017, final version of 30 July 2018, SCCS/1589/17.