Re-registration of plant protection products in Europe

摘要

With the implementation of Council Directive 91/414/EEC, a two stage regulatory system was introduced for the evaluation and authorisation of both active substances and plant protection products. Active substances are assessed for acceptability at theCommunity level, while the safety and efficacy of products and uses are evaluated at the Member State level at re-registration. Until recently the main focus has been on the effort needed to take decisions on inclusion or non-inclusion on Annex I of theDirective, but consideration also needs to be given to the amount of work now falling to the Member States after Annex I inclusion. For the older active substances being considered under the review programme, only a limited number of uses are being considered as the basis for Annex I inclusion. This means that the consideration of the safety and efficacy of all the remaining uses being supported is being put back to the Member States at re-registration, with substantial workloads envisaged and plenty of scope for duplication of effort. An expert group has been commissioned to look at the possibilities for harmonisation of deadlines and procedures post-Annex I inclusion, to facilitate the sharing of the workloads envisaged. This will also involve looking at the possibilities for increasing the uptake of mutual recognition as a route for approval.