The authorisation of pesticides is a two-step procedure. First, the active substance is evaluated on a European level and possibly included in Annex I of Directive 91/414 (soon Regulation 1107/2009). The second step is evaluation on a national level of the pesticide formulation. The way pesticide formulations need to be evaluated in national authorisations of pesticides is described in Annex VI of Directive 91/414, the so-called Uniform Principles.
Commission and Member States have been working to make the provisions more concrete and agree on a different methodology to assess effects like groundwater pollution and effects on organisms. Though the Uniform principles have “cut-off” criteria, applicants are allowed to use a “higher tier” risk assessment in case the “cut-off’ criterion is not met. The industry has been very active in proposing these higher tier assessments and even many times took the lead in developing guidelines (HARAP, CLASSIC).
For several of these methods, it can be questioned if they are in line with the original Directive and are protecting the environment adequately. For instance, an “innovation” was to allow in higher tier eradication of specific organisms if the organisms “recovers” in a given time, ie. re-entered from another area. This was not considered an “unacceptable effect” according to Art.4 of the Directive.
Uniform principles also need urgent revision and inclusion of the new elements of Regulation 1107/2009. Commission will only start revising Uniform Principles in 2011 and the deadline of June 14, 2011will certainly not be met. Every delay will mean pesticides evaluated according to old rules and old methodology.