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: 29 July 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 that the 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. However, the SCCS has identified some aspects of the QRA2 methodology that still need clarification and therefore, some refinement is needed before a firm conclusion on the safety of Citral could be drawn.

(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?

Whereas the SCCS considers that the proposed QRA2 methodology is an improvement to QRA1 methodology, more case studies are needed to further confirm the applicability of this approach to fragrances and other cosmetic ingredients. Until then, the SCCS will consider the suitability (for a population not already sensitised) of this methodology for 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, final version of 29 July 2024, SCCS/1666/24.