title: Towards a harmonized approach for risk assessment of genotoxic carcinogens in the European Union.
abstract: The EU Scientific Committees have considered in the past the use of matematical models for human cancer risk estimation not adequately supported by the available scientific knowledge. Therefore, the advice given to risk managers was to reduce the exposure as far as possible, following the as low as reasonably achievable (ALARA) principle. However, ALARA does not allow to set priorities for risk management, as it does not take into consideration carcinogenic potency and level of human exposure. For this reason the European Food Safety Authority (EFSA) has identified as a priority task the development of a transparent, scientically justifiable and harmonized approach for risk assessment of genotoxic carcinogens. This approach, proposed at the end of 2005, is based on the definition of the (MOE), i.e. the relationship between a given point of the dose reponse curve in the animal and human exposure. As point of comparison EFSA recommends the BMDL10, i.e. the lower limit of the confidence interval of the Benchmark Dose associated with an incidence of 10% of induced tumors. Based on current scientific knowkedge, EFSA concluded that a MOE of 10000 or greater is associated with a low risk and low priority for risk management actions. The approach proposed does not replace the ALARA. It should find application on food contaminants, process by-product, and other substances unintentionally present in food. On the other hand, it is not intended to provide a tool for the definition of tolerable intake levels for genotoxic carcinogens deliberately added to food.
authors.affiliation: Dipartimento di Ambiente e Connessa Prevenzione Primaria, Istituto Superiore di Sanità, Rome, Italy. crebelli@iss.it
authors.forename: Riccardo
authors.initials: R
authors.lastname: Crebelli
mesh_terms: D002273:Carcinogens / Q000633:toxicity*; D005062:European Union; D006801:Humans; D009153:Mutagens / Q000633:toxicity*; D009369:Neoplasms / Q000139:chemically induced* / Q000453:epidemiology; D018570:Risk Assessment / Q000592:standards
chemical_list: D002273:Carcinogens; D009153:Mutagens