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Tuesday, April 9, 2024Regulation

Citral: preliminary Opinion of the SCCS

Citral : Opinion préliminaire du CSSC

Following the mandate given by the European Commission, the SCCS has assessed the safety of Citral (a fragrance ingredient) with regard to its sensitising potential. The Scientific Committee has just published its preliminary Opinion. It is open to comments until 2 June 2024.

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Background

Citral (CAS No.5392-40-5, EC No.226-394-6) is a mixture of neral and geranial, widely used as a fragrance ingredient various cosmetic products.
It 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.
It is currently regulated in entry 70 of Annex III to the Cosmetics Regulation: the presence of the substance must be indicated in the list of ingredients when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
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.

For an exhaustive background information, see the article
Citral: Request for an Opinion to SCCS, CosmeticOBS, 21 February 2022

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 …

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