Does EU legislation allow the use of the Benchmark dose (BMD) approach for risk assessment?

•EFSA scientific opinion states Benchmark dose (BMD) approach is preferred.•EU regulatory frameworks for chemicals were scanned for obstacles.•EU legislation for chemicals safety does not preclude use of BMD approach. Hazard characterisation is largely based on an approach of (statistically) compari...

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Bibliographic Details
Published in:Regulatory toxicology and pharmacology 2013-11, Vol.67 (2), p.182-188
Main Authors: Brandon, E.F.A., Bulder, A.S., van Engelen, J.G.M., Mahieu, C.M., Mennes, W.C., Pronk, M.E.J., Rietveld, A.G., van de Ven, B.M., ten Voorde, S.E.C.G., Wolterink, G., Slob, W., Zeilmaker, M.J., Bessems, J.G.M.
Format: Article
Language:English
Subjects:
Animals
BMD
Cosmetics - toxicity
Disinfectants - toxicity
Dose-Response Relationship, Drug
European Union
Food Additives - toxicity
Government Regulation
Guidance
No-Observed-Adverse-Effect Level
NOAEL
Pesticides - toxicity
Regulation
Risk Assessment - legislation & jurisprudence
Veterinary Drugs - toxicity
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Summary:•EFSA scientific opinion states Benchmark dose (BMD) approach is preferred.•EU regulatory frameworks for chemicals were scanned for obstacles.•EU legislation for chemicals safety does not preclude use of BMD approach. Hazard characterisation is largely based on an approach of (statistically) comparing dose groups with the controls in order to derive points of departure such as no-observed-adverse-effect levels (NOAELs) or lowest-observed-adverse-effect levels (LOAELs). This approach suggests the absence of any relevant effect at the NOAEL. The NOAEL approach has been debated for decades. A recent Scientific Opinion by the European Food Safety Authority (EFSA) concluded that the Benchmark Dose (BMD) approach should be preferred over the NOAEL approach for deriving human (health-based) limit or guidance values. Nonetheless, the BMD approach is used infrequently within European regulatory frameworks. The reason for this may lie in legislation or guidelines requiring the use of the NOAEL approach. In this context, various EU regulatory frameworks were examined on such demands. Interestingly, no single legislation was identified containing statutory requirements in conflict with the use of the BMD approach.
ISSN:0273-2300
1096-0295
DOI:10.1016/j.yrtph.2013.07.005