Literature Review Report in support of a plant protection product active substance regulatory submission

Client

A global company 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 and impurities, dealing with side-effects on human health, the environment and non-target species, published within ten years of the date of dossier submission.

Project goals

The aim of the project was to identify information published in the last ten years that was considered to be relevant to a toxicological assessment of the Plant Protection Product active substance, and also considered to be reliable. From those publications, bibra would summarise the key primary data considered likely to have an impact on the current regulatory data package for the active substance. The opinion of the European Food Safety Authority (EFSA), as published in its review report on the active substance, would be taken into account, with particular reference to the critical endpoint values.

Approach and outcome

Bibra scientists determined a suitable string of search terms pertinent to the substance of interest and any possible metabolites and impurities identified as relevant. These were used to carry out comprehensive searches in a wide range of online databases with the aim of identifying published literature on the active substance and related materials, in order to determine potential toxicological effects on the health of consumers/workers, on the environment and on non-target species. Following EFSA guidance on best practice for the identification and selection of relevant literature, the search results were screened and filtered. Clear documentation on studies not considered relevant to the risk assessment of the active substance and/or not reliable was provided in tabulated form, justifying their exclusion. The same table was also used to document the relevance and reliability of the included publications. Studies considered both relevant to the current regulatory package and reliable were summarised using templates designed to capture the critical information, including a Klimisch evaluation for reliability. The summaries were grouped by toxicological endpoint and collated into the Literature Review Report.

Bibra successfully carried out comprehensive searches for data on the active substance, its metabolites and impurities. The searching, filtering and selection processes were clearly documented, detailing the search terms, the sources and the inclusion and exclusion criteria. Summaries of relevant and reliable data were provided in the form of a Literature Review Report (LRR) in a format suitable for regulatory submission.