Guidance of the Scientific Committee on Use of the benchmark dose approach in risk assessment

Abstract

SUMMARY Considering the need for transparent and scientifically justifiable approaches to be used when risks are assessed by the Scientific Committee and the Scientific Panels of EFSA, the Scientific Committee was requested by EFSA to assess the existing information on the utility of the benchmark dose (BMD) approach, as an alternative to the traditionally used NOAEL approach, and to make recommendations on whether EFSA should use the BMD approach and under which circumstances this use would be appropriate. The Scientific Committee was also asked to provide some guidance on how to use the BMD approach for analysing dose-response data from experimental studies, and to look at the possible application of this approach to data from observational epidemiological studies. Finally, the Scientific Committee was asked to advise on whether the selection of appropriate uncertainty factors are needed when using the BMD approach for deriving the Reference Point.