title: Reflections on the implications of thresholds of mutagenic activity for the labelling of chemicals by the European Union.
abstract: During the course of the safety evaluation and regulatory control of chemicals it is important to distinguish between "potential hazard" and "actual risk" of exposure to toxins. In the case of DNA reactive chemicals, it has been prudent to assume that hazard is expressed as risk at low exposure concentrations. However, analysis of the dose-response relationships of both DNA reactive and non-DNA reactive genotoxins (e.g., aneugens) indicate that there are exposure concentrations below which protective mechanisms such as DNA repair activity and the presence of multiple targets may lead to the prediction of no risk until threshold concentrations are achieved. Current European Union management procedures for mutagenic chemicals are based predominantly upon hazard assessment rather than assessment of actual risk under likely exposure scenarios. As our knowledge of protective mechanisms increases, the time is now appropriate to undertake a re-evaluation of European Union criteria and to base the clarification mutagenic chemical more firmly upon the basis of actual risks to the human population and to the environment.
authors.affiliation: Centre for Genetic and Molecular Toxicology, School of Biological Sciences, University of Wales Swansea, Singleton Park, Swansea, UK. jmp@swansea.ac.uk
authors.forename: J M
authors.initials: JM
authors.lastname: Parry
mesh_terms: D004305:Dose-Response Relationship, Drug; D005062:European Union; D006801:Humans; D009153:Mutagens / Q000145:classification / Q000633:toxicity; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000592:standards; D014116:Toxicology / Q000331:legislation & jurisprudence
chemical_list: D009153:Mutagens