The European Commission has just asked the SCCS to assess the safety of Citral (fragrance ingredient) with regard to its sensitising potential. The Scientific Committee accepted this mandate on 16 February 2022 by written procedure and has nine months to deliver its Opinion.
Background on Quantitative Risk Assessment (QRA)
Skin allergies may arise from exposure to certain chemicals and may lead to Allergic Contact Dermatitis (ACD). This adverse health effect, especially from fragrance ingredients is a common and relevant problem from exposure to cosmetic and other household products. Therefore, it is a topic of high interest for consumers, industry and Regulatory Authorities.
A model for dermal sensitisation quantitative risk assessment (QRA) was developed and implemented by the International Fragrance Association (IFRA). The methodology relied on thresholds (no effect or low effect levels) established in healthy human volunteers and/or in animal experiments. A set of safety factors were applied to derive “acceptable exposure level”.
The QRA methodology was evaluated by the Scientific Committee on Consumer Products (SCCP) in 2008 (SCCP/1153/08) stating that there was no confidence that the levels of skin sensitisers identified by QRA are safe for the consumer. However, the committee added that models like the QRA approach may, after refinement and validation, be applicable in the future for risk assessment of new substances. In 2012, the SCCS reiterated this position in the context of the Opinion on Fragrance Allergens (SCCS/1459/11).
Following the SCCS Opinion of 2012, the International Dialogue for the …
