title: EU regulatory aspects of resistance risk assessment.
abstract: 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-protection 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 required, the proposed resistance-management strategy.
authors.affiliation: Biological Research Centre for Agriculture and Forestry, Messeweg 11/12, D-38104 Braunschweig, Germany. U.Heimbach@bba.de
authors.forename: Udo
authors.initials: U
authors.lastname: Heimbach
authors.forename: Gregor
authors.initials: G
authors.lastname: Kral
authors.forename: Peter
authors.initials: P
authors.lastname: Niemann
mesh_terms: D000818:Animals; D005075:Biological Evolution; D018556:Crops, Agricultural; D025141:Drug Resistance, Fungal; D005062:European Union; D005658:Fungi / Q000187:drug effects; D005659:Fungicides, Industrial / Q000592:standards; D005858:Germany; D007313:Insecta / Q000187:drug effects; D007305:Insecticide Resistance; D007306:Insecticides / Q000494:pharmacology / Q000592:standards / Q000633:toxicity; D010571:Pest Control / Q000331:legislation & jurisprudence / Q000592:standards*; D010575:Pesticides / Q000494:pharmacology* / Q000592:standards / Q000633:toxicity; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000592:standards*
chemical_list: D005659:Fungicides, Industrial; D007306:Insecticides; D010575:Pesticides