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EFSA: Case studies for the application of the Guidance of EFSA on Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009

Description: Das Projekt "EFSA: Case studies for the application of the Guidance of EFSA on Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009" wird vom Umweltbundesamt gefördert und von Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES) durchgeführt. In 2011, EFSA issued Guidance (European Food Safety Authority; Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011; 9(2):2092 (49 pages)) addressed to applicants and Member States to identify and select scientific peer-reviewed open literature and how to report it in a dossier, as required by Article 8(5) of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market. However, until now, there is only limited experience on use of this Guidance. In the current project, the Guidance should be applied to the search and analysis of peer-reviewed scientific literature on selected dossier sections (toxicology, residues, ecotoxicology and environmental fate) of three active substances (AIR2 substances: Metalaxyl-M, Thifensulfuron-methyl, Metsulfuron- methyl), their relevant metabolites and PPPs on the European market. The case studies are meant to provide an independent benchmark of the scientific literature presented in the dossiers of the active substances and will allow identifying areas of improvement in the Guidance. Based on the output of the project, EFSA should gain better understanding of the resource needs associated to the preparation and evaluation of the scientific peer-reviewed open literature required by the Regulation (EC) No 1107/2009 and gain feedback on the applicability of Guidance as well as recommendations for its improvement.

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SupportProgram

Origin: /Bund/UBA/UFORDAT

Tags: Schädlingsbekämpfungsmittel ? Pflanzenschutzmittel ? Pestizid ? Rückstandsanalyse ? Stoffwechselprodukt ? Pflanzenschutzmittelanwendung ? Fallstudie ? Lebensmittelsicherheit ? Toxikologie ? Wirkstoff ? Zulassung ? Stoff ? Peer-Review ? Benchmarking ? Ernährungssicherheit ? Ressource ? EG-Lebensmittel-Rahmenverordnung ? EINREICHEN ? LITERATUR ? UNTER ?

License: cc-by-nc-nd/4.0

Language: Deutsch

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Time ranges: 2012-10-01 - 2013-10-29

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