EU regulatory aspects of resistance risk assessment

摘要

The EPPO Standard PP 1/213(1) on resistance risk analysis is the basis for risk assessment within the authorisation process in Germany. Data for resistance risk analysis have to be provided by the applicant and risk-mitigation strategies prepared if necessary. The extent of data requirements and the intensity of the evaluation process depend mainly on the type of target organism, crop, mode of action of the active substance and the resistance history of the organism in combination with products of similar mode of action as the one being applied for. Because resistance risk is a very complicated issue during the authorisation of plant-0protection products, intensive co-operation between applicants and regulators is essential prior to submission of the dossier, with due consideration of the amount of data necessary and, where reqired, the proposed resistance-management strategy.