A structured approach to Exposure Based Waiving of human health endpoints under REACH developed in the OSIRIS project
article
Within the REACH framework, but alsowithin 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. Exposure-based waiving
(EBW) is a potentially important element in testing strategies. This publication describes criteria for exposure-
based waiving as foreseen in the REACH regulation and gives more detail to the REACH requirements
for exposure-based waiving The principle behind anyEBWis that there are situations when human or environmental
exposures 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-based and needs thorough knowledge on exposure as well as on effects criteria. Both elements are discussed:
exposure 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 exposure. 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 exposure assessment
throughout the life cycle of a chemical and for all human exposure 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.
costs and logistics, it is important to limit the number of tests to be conducted. Exposure-based waiving
(EBW) is a potentially important element in testing strategies. This publication describes criteria for exposure-
based waiving as foreseen in the REACH regulation and gives more detail to the REACH requirements
for exposure-based waiving The principle behind anyEBWis that there are situations when human or environmental
exposures 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-based and needs thorough knowledge on exposure as well as on effects criteria. Both elements are discussed:
exposure 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 exposure. 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 exposure assessment
throughout the life cycle of a chemical and for all human exposure 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.
Topics
TNO Identifier
461966
Source
Regulatory Toxicology and Pharmacology, 62(2), pp. 231-240.
Pages
231-240
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