Dispositivi di protezione individuale nella valutazione del rischio da antiparassitari: definizione, ruolo, armonizzazione

Summary The authorisation for plant protection products at European level is regulated by directive 91/414/EEC. To this aim the toxicological profile of an active substance is discussed in relation to different contexts, such as human toxicity (operators and consumers), ecotoxicity and environmental fate. As for the operator exposure, the exposure assessment is performed through the use of predictive models or field studies. The models are a collection of field studies, performed in different conditions of use. Through the elaboration according to mathematical algorithms, the introduction of selected parameters leads to estimated exposure outcomes. Estimated exposures are faced to Acceptable Operator Exposure Levels (AOELs) which represent health-based trigger values, derived from the assessment of a complete toxicological dossier. The toxicological end point relevant to human exposure (operator exposed to pesticides) is selected. By the application of an assessment factor (in general 100, accounting for intra- and interspecies differences), the AOEL is established. The European Food Safety Authority (EFSA) is in charge with this activity since 2002.In the predictive models currently used, exposure reduction factors can be applied as a measure to reduce estimated exposures, mimicking the real conditions of use of personal protective equipments. They are derived from field studies and laboratory measurements. The application of such reduction factors is in many cases a key point for the refinement of the estimated exposures below the AOEL, leading to the so called safe MSummaryrtainties characterise this activity: * The models aThe authorisation for plant protection products at European level is regulated by directive 91/414/EEC. * They do not cover all the possible To this aim the toxicological profile of an active substance is discussed in relation to different contexts, such as human toxicity (operators and consumers), ecotoxicity and environmental fate.