title: Does EU legislation allow the use of the Benchmark Dose (BMD) approach for risk assessment?
abstract: 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.
authors.affiliation: Centre for Nutrition, Prevention and Health Services, National Institute for Public Health and the Environment (RIVM), The Netherlands; Centre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), The Netherlands. Electronic address: esther.brandon@rivm.nl.
authors.forename: E F A
authors.initials: EF
authors.lastname: Brandon
authors.forename: A S
authors.initials: AS
authors.lastname: Bulder
authors.forename: J G M
authors.initials: JG
authors.lastname: van Engelen
authors.forename: C M
authors.initials: CM
authors.lastname: Mahieu
authors.forename: W C
authors.initials: WC
authors.lastname: Mennes
authors.forename: M E J
authors.initials: ME
authors.lastname: Pronk
authors.forename: A G
authors.initials: AG
authors.lastname: Rietveld
authors.forename: B M
authors.initials: BM
authors.lastname: van de Ven
authors.forename: S E C G
authors.initials: SE
authors.lastname: Ten Voorde
authors.forename: G
authors.initials: G
authors.lastname: Wolterink
authors.forename: W
authors.initials: W
authors.lastname: Slob
authors.forename: M J
authors.initials: MJ
authors.lastname: Zeilmaker
authors.forename: J G M
authors.initials: JG
authors.lastname: Bessems
mesh_terms: D000818:Animals; D003358:Cosmetics / Q000633:toxicity; D004202:Disinfectants / Q000633:toxicity; D004305:Dose-Response Relationship, Drug; D005062:European Union; D005503:Food Additives / Q000633:toxicity; D033161:Government Regulation; D019055:No-Observed-Adverse-Effect Level; D010575:Pesticides / Q000633:toxicity; D018570:Risk Assessment / Q000331:legislation & jurisprudence; D019155:Veterinary Drugs / Q000633:toxicity
chemical_list: D003358:Cosmetics; D004202:Disinfectants; D005503:Food Additives; D010575:Pesticides; D019155:Veterinary Drugs
keywords: ADI; AEL; AOEL; ARfD; BMD; BMDL; Benchmark dose; Benchmark dose lower confidence bound; DG SANCO; DNEL; EFSA; EFSA CONTAM; EFSA scientific panel on contaminants in the food chain; EU; EU Scientific Committee on Consumer Safety; EU directorate general for health and consumer affairs; European Food Safety Authority; Guidance; IPCS; International Programme on Chemical Safety; JECFA; Joint FAO/WHO Expert Committee on Food Additives; LO(A)EL; MRL; NO(A)EL; NOAEL; POD; Regulation; SCCS; acceptable daily intake; acceptable operator exposure level; acute reference dose; adverse effect level; derived no effect level; lowest-observed-(adverse)-effect level; maximum residue level; no-observed-(adverse)-effect level; point of departure