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Exposure-based waiving under REACH

: Vermeire, T.; Bovenkamp, M. von de; Bruin, Y.B. de; Delmaar, C.; Engelen, J. van; Escher, S.; Marquart, H.; Meijster, T.


Regulatory toxicology and pharmacology 58 (2010), No.3, pp.408-420
ISSN: 0273-2300
Journal Article
Fraunhofer ITEM ()
exposure-based waiving; integrated testing strategy; exposure models; uncertainty; REACH; consumer; worker; environment

Within the REACH framework, but also within OECD, there is understanding that for reasons of animal welfare, costs and logistics, it is important to limit the number of tests to be conducted. previous termExposure-based waivingnext term (EBW) is a potentially important element in testing strategies. This publication describes criteria for previous termexposure-based waivingnext term as foreseen in the REACH regulation and gives more detail to the REACH requirements for previous termexposure-based waivingnext term The principle behind any EBW is that there are situations when human or environmental previous termexposuresnext term are so low or infrequent that there is a very low probability that the acquisition of additional effect information may lead to an improvement in the ability to manage risk. EBW therefore is risk-previous termbasednext term and needs thorough knowledge on previous termexposurenext term as well as on effects criteria. Both elements are discussed: previous termexposurenext term models are analysed and the uncertainty in their predictions discussed as well as no-effect criteria such as the threshold of toxicological concern. Examples of EBW are provided for environmental, consumer and worker previous term REACH only allows EBW in a limited number of cases with constraints on tonnage levels, types of tests to be waived and the need for a thorough ES and previous termexposurenext term assessment throughout the life cycle of a chemical and for all human previous termexposurenext term routes and environmental pathways. EBW will only be considered a real option by industry if a cost-benefit analysis shows an advantage, which may heavily depend on the weighing factor one applies for the non-use of experimental animals.