Plantebeskyttelsesmiddelforordningen artikel 7
English language version pr. 2026-10-28 tier 2 Forordning (EF) nr. 1107/2009, konsolideret tekst pr. 16.06.2026, CELEX 02009R1107-20260616
stk. 1 An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State (the ‘rapporteur Member State’), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation. The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it.
stk. 2 Assessment of an application may be performed by a number of Member States together under a co-rapporteur system.
stk. 3 When submitting the application, the applicant may submit a request, pursuant to Article 63, to treat certain information, including certain parts of the dossier, as confidential and shall physically separate that information. Member States shall assess the confidentiality requests. After consultation with the Authority, the rapporteur Member States shall decide what information is to be treated as confidential, in accordance with Article 63. The Authority, following consultations with the Member States, shall lay down practical arrangements to ensure the consistency of those assessments.
stk. 4 When submitting the application the applicant shall at the same time join a complete list of tests and studies submitted pursuant to Article 8(2) and a list of any claims for data protection pursuant to Article 59.
stk. 5 When assessing the application the rapporteur Member State may at any time consult the Authority.