Literature searching, selecting and summarising in support of PPP active regulatory submission

Client

A number of global companies in the market of active ingredients for crop protection products.

Background

The approval or re-registration of pesticide active substances (Plant Protection Products) under Regulation (EC) No 1107/2009 Article 8(5) requires applicants to submit dossiers containing scientific peer-reviewed open literature on the active substance and its relevant metabolites dealing with side-effects on health, the environment and non-target species, published within the last ten years before the date of dossier submission.

Project goals

To identify information considered relevant and reliable to an assessment of the Plant Protection Product active ingredient published in the last ten years and summarise those data that may impact the current regulatory data package.

Approach

Bibra scientists carried out comprehensive searches using online resources to identify literature on the active and any relevant metabolites dealing with the side-effects on health (toxicology), the environment and non-target species. Following EFSA guidance on best practice for the identification and selection of relevant literature, results were screened and clear documentation on studies not considered relevant and/or reliable to the risk assessment of the active was provided. Data considered relevant and reliable to the current regulatory package were summarised.

Project outcome

Bibra successfully carried out comprehensive searches for data on the active ingredient and relevant metabolites. The search and selection process were clearly documented and summaries of relevant and reliable data were provided in the form of a Literature Review Report (LRR) for regulatory submission.

Project leader

Philip Copestake

Emma Russell

 

Environmental hazard and risk assessment

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