Registration of pesticides Evaluation of efficacy dossiers
ContextEuropean Directive 91/414/EEC regulates authorisations for placing pesticides for agricultural use on the market. New active substances are authorised at European level (since 1993) following inclusion in Annex 1 of the Directive. Authorisations for placing products formulated from such active substances on the market, on the other hand, are the responsibility of each Member State. The European Directive establishes the required data for inclusion in each part of the dossier submitted by the applicant, in particular physical and chemical properties, toxicology, ecotoxicology, fate in the environment and effectiveness. The Directive also provides uniform principles establishing common criteria for evaluation of dossiers by Member States so as to guarantee the level of requirements and uniformity of decisions taken. Member States must ensure that authorisations granted do not adversely affect human or animal health or the environment, and also that products are effective against the target pests and selective against crops treated. Prior to 1991, effectiveness and selectivity had to be demonstrated by the results of tests carried out by official institutions in each country (in Belgium, the Pesticide Research Department). Since then these data, which are compiled as a dossier called the “Biological Dossier”, can come from any EU state but have to be evaluated in order to check the relevance of results for local agro-climatic conditions.
ObjectivesTo deliver to the authorities in Belgium a reasoned opinion on the efficacy and selectivity of pesticides that are the subject of a marketing authorisation application. This will include checking the relevance of the pest to the crop to be protected and the compatibility of the proposed use with Good Agricultural Practice.
Description of tasks- Check the conformity of the dossier submitted with the requirements of the European Directive. As well as data on effectiveness as such and phytotoxicity, the dossier should comprise details of the appearance or possible development of resistance, the effects of treatment on yield, plant quality including data on any adverse effects on the organoleptic properties of treated plants, processing methods, following crops, adjacent crops and plants used for propagation. All the aspects mentioned should be covered and data supplied to back up claims. - Ensure comparability of agronomic and climatic conditions at test locations with Belgian conditions. - Assess the quality of tests carried out. Experimentation must be rigorous and must comply as a minimum with the EPPO directives (European and Mediterranean Plant Protection Organization). These are plant protection standards recognized by Europe. Tests may be official or “officially recognized”, that is, carried out by bodies working according to a specific quality system for pesticides for agricultural use laid down by European legislation, known as GEP (Good Experimental Practices). - Analyse results and their compatibility with local agricultural conditions. Products tested must be at least as effective as the recognized reference products. The proposed dose must be the lowest effective dose. Assessments should take account of: • changes in pest distribution or the emergence of new pests, • introduction of new equipment that improves cultural practices and in particular pesticide application, • development of resistance to the pesticides used. Experts attend all the meetings of the Belgian Approval Committee. The European dimension of the legislation also requires participation on the EPPO working groups involved in updating test methods and devising new methods and attending international meetings called to harmonise consideration of dossiers in Member States. The team plays an active part in revising practices (“crop-pest” pairs) for the purposes of harmonising authorisation documents and creating a database to facilitate access to information.
ContributionThere is frequent contact with the various CRA W Departments directly or indirectly involved in plant protection. In particular, experts can call on the assistance of their colleagues in the Pesticide Research Department in charge of fungicide, herbicide or insecticide testing.
PartnersThe experts cooperate closely with the Plant Protection Division of the Animals, Plants and Food General Directorate at Federal Public Service for Public Health, Food Chain Safety and the Environment and with executives at the Regional Development Department. They also liaise in the course of dossier evaluation with companies and organisations seeking pesticide marketing authorisations.
- SPF Public Health