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.

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.