Comparative assessment of plant protection products: how many cases will regulatory authorities have to answer?

BACKGROUND: The substitution principle has been included in the EU pesticides legislation as a new element. Comparative assessments will have to be conducted for all uses of plant protection products (PPPs) that contain active substances with certain hazardous properties, the so-called candidates for substitution (CFS). This study investigated the resulting workload in terms of the number of cases for comparative assessments that regulatory authorities may have to face. The analysis was carried out for Germany as an example. MAIN TEXT: In Germany, the requirement for comparative assessments may affect up to 25% of all PPPs and around 50% of all uses of PPPs. In absolute terms, these are around 350 candidate products with 1,850 different uses. Alternative products without CFS may be available for around 40% of these uses. On average, a candidate product is authorised for around 18 different uses. For 11 of these uses, no alternatives are authorised. For the remaining seven uses, slightly more than seven alternatives are available on average. Multiplication of these factors gives an indicative figure of around 18,500 possible pairwise comparisons of candidate products with alternative products for every common use. CONCLUSIONS: The high number of expectable cases poses a formidable challenge for the efficient conduct of the new task of comparative assessments by competent Member States authorities. To this end, new data handling systems, assessment procedures, and decision rules need to be established.