Special issue 40th ISEO: Toxicological challenges for essential oils in REACH

Abstract

Regulation on the registration, evaluation, authorization and restriction of chemicals (REACH) requires that substances produced or imported at ≥ 1 tonne/year in the European Community (EC) are submitted for registration following a phased-in timetable according to tonnage until 2018. Toxicological and ecotoxicological information is required for submission, along with a risk assessment that considers consumer, occupational and environmental exposures. These requirements apply to natural aromatic extracts (mainly essential oils, but also concretes, resinoids, absolutes, etc.), termed 'natural complex substances' (NCSs), in REACH, and present a unique set of challenges, not only due to the cost and administrative burden for essential oils producers and importers, but also in the approach used for the toxicological evaluation of these oils. Identification of representative specifications for the conduct of studies and natural variability of product composition is an important and complex area to resolve, even before studies can begin. Adaptation of toxicological test methods to essential oils and the interpretation of results and use in risk assessment present perhaps the greatest challenge. Alternative test and evaluation strategies for essential oils, based on a components approach, offer the potential for strategic testing in achieving REACH compliance. Different approaches may apply, dependent on whether the NCS, which belongs to the category of substances called UVCB in REACH, is a 'simple' well-defined substance, e.g. sweet orange peel oil, or one that is complex in nature and is not usually fully characterized, e.g. vetiver oil. Industry has already started work through REACH consortia and industry association activities, yet further refinement in the assessment approach and experience in dossier submission and acceptance with the European Chemicals Agency (ECHA) remains a real challenge for essential oils producers and importers. Copyright © 2009 John Wiley & Sons, Ltd.