Submission of scientific peer-reviewed open literature for the approval of pesticide active substances

EFSA have recently issued a Guidance Document on how to identify and select “scientific peer-reviewed open literature” and how to report it in a dossier, as required by Regulation (EC) No 1107/2009, concerning placing of plant protection products on the market.

This Guidance is intended for:

• Applicants submitting dossiers on active substances of plant protection products under Regulation (EC) No 1107/2009;
• EU Member States’ competent authorities evaluating the dossiers and preparing the draft assessment reports; and
• the European Food Safety Authority (EFSA), responsible for drawing conclusions on the dossiers.

The 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).

Potentially the application of this Guidance increases the workload for both applicants and the Member States, particularly for active substance renewals. 

JSC experts will be pleased to advise on how this Guidance may affect the preparation of active substance dossiers.  We can also conduct the necessary literature searches and provide assessments of the studies.  Please contact us on +44 (0)1423 520245, enquiries@jsci.co.uk