Crop Protection Registration
Registration of EU plant protection products is currently regulated by Directive 91/414/EEC. Each applicant must submit a dossier Annex II for the active substance and Annex III for a plant protection product. The Directive, its amendments and additional guidance documents describe details of the testing requirements and the format of the dossier. Directive 91/414/EEC is under review for updating.
The dossier is submitted to the competent authorities of one EU member state, the rapporteur country. The dossier is checked first for completeness and, when found complete, reviewed in detail. This review can be a complex process with frequent discussions between reviewer and applicant. Once a new active substance has passed the approval procedure it is listed in Annex I of the Directive 91/414/EEC. Only then can the active substance be used in products for sale in the EU.
After a successful Annex I inclusion, each formulated product must be approved and a dossier according to Annex III of the Directive must be submitted.
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