Does EU legislation allow the use of the Benchmark Dose (BMD) approach for risk assessment?
| Autor: | A.S. Bulder, M.J. Zeilmaker, J.G.M. Bessems, W.C. Mennes, Esther Brandon, Wout Slob, Gerrit Wolterink, C.M. Mahieu, A.G. Rietveld, S.E.C.G. ten Voorde, J.G.M. van Engelen, M.E.J. Pronk, B.M. van de Ven |
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| Rok vydání: | 2013 |
| Předmět: |
No-observed-adverse-effect level
Legislation Context (language use) Cosmetics Toxicology Risk Assessment Government regulation Benchmark (surveying) Economics media_common.cataloged_instance Animals Operations management European Union European union Pesticides media_common No-Observed-Adverse-Effect Level Actuarial science Dose-Response Relationship Drug Veterinary Drugs General Medicine Hazard Government Regulation Food Additives Risk assessment Disinfectants |
| Zdroj: | Regulatory toxicology and pharmacology : RTP. 67(2) |
| ISSN: | 1096-0295 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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