When deriving health-based guidance values for non-genotoxic substances, the No-Observed-Adverse-Effect Level (NOAEL) has been the dose traditionally used as a reference point in the risk assessment process, although clearly this level is restricted to one of the doses actually tested in the critical study. Recently, an alternative approach based on the BMD procedure has found considerable favour as it uses all of the dose-response data to estimate the dose that causes a low, but measurable, adverse effect. Any uncertainties in the experimental data are taken into account by calculating the lower confidence limit of that estimated dose (BMDL), which is then used as the reference point in the risk assessment process. Following a detailed critique, EFSA’s Scientific Committee has now concluded that the BMD approach is “a scientifically more advanced method” than the NOAEL approach for deriving a reference point, and that it is suitable for assessing the risks of all chemicals in foods (including additives, pesticides and contaminants). While the Committee considered the BMD approach to be of particular value for calculating Margins of Exposure for genotoxic carcinogens and in the dose-response assessment of epidemiological data, it was (thankfully) felt unnecessary to repeat all previous evaluations in which the NOAEL approach had been used.

[Guidance of the Scientific Committee on a request from EFSA on the use of the benchmark dose approach in risk assessment. Adopted on 26 May 2009. The EFSA Journal 2009, 1150, 1. The document can be obtained from the European Food Safety Authority’s website (at {182387}

The above item was taken from the August 2009 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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