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

Deadline: 6 September 2010

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This draft EFSA Guidance provides instructions on how to identify and select “scientific peer-reviewed open literature” as required by Article 8(5) of Regulation (EC) No 1107/2009[1] on the placing of plant protection products on the market and how to report it in a dossier.

For the development of this draft EFSA Guidance, the Assessment Methodology Unit (AMU) of EFSA, in collaboration with the Unit on Pesticide Risk Assessment Peer Review (PRAPeR), has established a working group of EFSA external members and scientific officers. An advanced draft of the Guidance was submitted to the EFSA Panel on Plant Protection Products and their Residues and the Pesticide Steering Committee and their feedback was considered by the working group members to produce the currently available version of the Guidance.

The draft Guidance would benefit from a broad range of comments, which may support its clarity, completeness and soundness. This public consultation therefore aims to gather the widest range of views to finalise the Guidance and provide the most up-to-date and comprehensive scientific advice to the users of the Guidance.

Interested parties are invited to submit written comments by 6 September 2010 at 12.00.

A submission will not be considered if it:

• is submitted after the deadline set out in the call;
• is presented in any form other than what is provided in the instructions and template;
• does not relate to the contents of the document;
• contains information on individual cases;
• contains complaints against institutions, personal accusations, irrelevant or offensive statements or material;
• is related to policy or risk management aspects, which is out of the scope of EFSA's activity.

EFSA will assess all relevant comments from interested parties which are submitted in line with the above criteria. The comments will be evaluated by the experts of the working group and taken into consideration where these will enhance the scientific quality or understanding of the Guidance. EFSA will publish the relevant comments received, as well as a short report on the outcome of the consultation. 

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