A dossier supporting an application for the authorisation of a plant protection product must contain a number of scientific studies. These must be carried out in accordance with established quality standards and international guidelines.
The following studies must be carried out in accordance with GLP:
- the physical and chemical properties of the active substance;
- the toxicological properties of the active substance and of the plant protection product;
- the residues of the active substance in treated products;
- the ecotoxicological properties of the active substance and of the plant protection product;
- the behaviour and the spreading of the active substance and metabolites in the environment.
However, studies carried out for the efficacy dossier must be in accordance with GEP (Good Experimental Practice). The requirements in this regard are laid down in the Ministerial Decree of 7 April 1995 and are based on Regulation 1107/2009 and standard PP 1/181 of the EPPO (European and Mediterranean Plant Protection Organisation).
In short, the GEP standards require that the institution which carries out the tests:
- meets the specific requirements in the area of personnel policy, equipment which is used during the tests, facilities, traceability, etc.
- works in accordance with the standards PP1 from the EPPO;
- provides specific procedures for actions for which no EPPO standards exist. This concerns, among others, procedures for receiving trial products and the calibration and maintenance of equipment;
- provides specific procedures to verify whether all steps in the testing are GEP compliant.
Any natural or legal person which is not an official institution and wishes to carry out trials in Belgian territory must have a Belgian GEP approval. This approval is issued by the Minister for Agriculture, on the recommendation of the Authorisation Committee, and following an examination of the application dossier and an audit of the applicant.