Efficacy evaluation of plant protection products at EU level: Data requirements and evaluation principles

Plant protection products (pppsub(s)) have been evaluated and authorised in the European Union (EU), in accordance with a harmonised regulatory system (Dir. 91/414/EEC), since 1993. Efficacy evaluation is an integral part of the EU regulatory system of registration of pppsub(s) (Dir. 91/414/EEC) and is the main subject of this review paper. The efficacy data requirements and evaluation principles are analyzed and discussed along with an outline presentation of the evaluation systems of the EU. The trials needed for the efficacy evaluation of plant protection products (pppsub(s)) across EU have to be conducted according to the principles of Good Experimental Practice by officially recognized testing facilities and in line with the methods specified by the Standards of the European and Mediterranean Plant Protection Organization. For registration purposes, the efficacy parameters which should be considered in the experimentation and evaluation of a ppp, according to EU criteria, are effectiveness (direct efficacy), resistance risk and the absence of undesirable effects on: a) plants or plant products (phytotoxicity, yield, quality), b) succeeding and adjacent crops, c) plants or plant products used for propagation, and d) beneficial arthropods. Efficacy and other desirable effects from the use of pppsub(s) have to be weighed against their potential phytotoxicity and/or other undesirable effects during the evaluation process. The evaluation of efficacy data of pppsub(s), provided by the notifiers in the Biological Assessment Dossier, and the decision taken on authorization are performed across Member States on the basis of the 'Uniform Principles' of the EU. Experience gained in implementing the provisions of Dir. 91/414/EEC has demonstrated that a number of changes are required. The main changes to this system, which are in progress, and also other systems on efficacy evaluation of pppsub(s) outside EU are discussed.