SCCS Opinion on Citral (CAS No. 5392-40-5, EC No. 226-394-6) sensitisation endpoint

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven (Rapporteur)
SCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro , W. Uter, 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/1666/24
Adopted on: 27 March 2024

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the derived upper safe levels using QRA2 methodology for the sensitisation endpoint, does the SCCS consider Citral safe when used as a fragrance ingredient in cosmetic products up to the maximum concentrations provided in the dossier submission?

The SCCS has noted some aspects of the QRA2 methodology that still need clarification and possible refinement. While some questions remain, the SCCS is of the opinion that the assessment based on QRA2 methodology has indicated that Citral can be considered safe in relation to the induction of sensitisation at the concentrations proposed for use in cosmetic products.

(2) Does the SCCS have any further scientific concerns with regard to the use of QRA2 to derive safe upper levels for Citral or for fragrance allergens in general?

Whilst the proposed QRA2 methodology is an improvement to QRA1 methodology, the SCCS recommendation is specific for the sensitisation potential of Citral at the proposed use concentrations. More case studies are needed to further confirm the applicability of this approach to other fragrances and other cosmetic ingredients. Until then, the SCCS will consider the suitability (for a population not already sensitised) of this methodology for other fragrances and other cosmetic ingredients on a case-by-case basis.

Keywords:

SCCS, scientific opinion, fragrance, Citral, Regulation 1223/2009, CAS No. 5392-40 -5, EC No. 226-394-6)

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Citral (CAS No. 5392-40-5, EC No. 226-394-6) - sensitisation endpoint, preliminary version of 27 March 2024, SCCS/1666/24.