The European Commission has asked the Scientific Committee to assess the safety of the fragrance ingredient Citral concerning the skin sensitisation endpoint. On the 16th of February 2022, this mandate has been accepted by the SCCS and the Committee has 9 months to deliver its opinion.
Background
Citral (CAS No. 5392-40-5, EC No. 226-394-6) with the chemical name ‘3,7-Dimethyl-2,6- octadienal’ is a mixture of neral and geranial, which are monoterpene aldehydes. It is widely used as both a fragrance and flavour ingredient in food, beverages and various cosmetic and household products due to its distinct, acceptable, and lemon-like pleasant odour. Citral is also a common constituent of many essential oils, such as lemongrass and Litsea cubeba oils.
Citral has been subject to a safety evaluation by SCCP in 2008 (SCCP/1153/08) using the QRA methodology and by the SCCS in 2012 (SCCS/1459/11) in the context of the opinion on Fragrance Allergens. Citral is currently regulated as a fragrance ingredient in cosmetic products in entry 70 of Annex III to the Cosmetics Regulation. In particular, the presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)g of the Cosmetics Regulation when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
Questions to be addressed by SCCS
In light of the information provided, the Commission requests the SCCS to assess whether the derived safe use levels for Citral by application of the QRA2 based on the induction of skin sensitisation is adequate to protect consumers (SCCS/1589/17).
Therefore, SCCS needs to investigate the following:
- In light of the data provided and taking under consideration the derived upper safe levels using QRA2 methodology for the sensitization 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?
- 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?