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Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009

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Abstract

This Guidance of EFSA provides instructions on how 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. The EFSA Guidance is intended for: (1) applicants submitting dossiers on active substances of plant protection products under Regulation (EC) No 1107/2009; (2) EU Member States’ competent authorities evaluating the dossiers and preparing the draft assessment reports; and (3) the European Food Safety Authority (EFSA), responsible for drawing conclusions on the dossiers. This EFSA Guidance provides a definition of scientific peer-reviewed open literature and instructions on how to minimise bias in the identification, selection and inclusion of peer-reviewed open literature in dossiers, according to the principles of systematic review (i.e. methodological rigour, transparency, reproducibility). The EFSA Guidance is compatible with existing OECD Guidance documents for the preparation of active substances dossiers.

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