Literature review – under Regulation (EC) No. 1107/2009

Literature review

Reviews of scientific peer-reviewed open literature are required to fulfil the data requirements for the market authorisation of plant protection products (PPP) in the European Union, since the implementation of Regulation (EC) No 1107/2009.

Article 8(5) of the Regulation demands the submission of "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 and published within the last ten years before the date of submission". The review process of compiling and evaluating available literature should be conducted with "methodological rigour and transparency" – following pre-defined steps that are specified in an EFSA guidance document on the submission of scientific peer-reviewed open literature for the approval of pesticide active substances (EFSA Journal 2011;9(2):2092).


ecotox consult • Dr. Michael Meller • ecotoxicological consulting service...

...supports you with systematic reviews of peer-reviewed open literature for the registration of plant protection products – in compliance with EU legislation and EFSA guidance.

Steps of the literature review process according to EFSA guidance (EFSA Journal 2011;9(2):2092) including the development of a search strategy (Steps 1-2), the study selection process according to relevance criteria (Step 3) the reliability assessment (Step 4) as well as the summarisation and interpretation of results (Steps 5-8)

We apply a systematic method for literature reviews which was developed in close compliance with the EFSA guidance document. Our approach follows structured working procedures for each of the required steps to ensure reproducible results.

Prior to literature search the review question and criteria for study selection are defined in a Literature Review Protocol. Then appropriate data sources are selected and a specifically targeted search strategy is developed. Search results are subject to a selection process based on scientifically sound relevance criteria adapted to the respective review question. In a following step remaining literature which was considered relevant is evaluated for reliability. Approved quality criteria for non-standard test data are applied, e.g. according to Klimisch et al. (1997). Summaries are provided for all relevant and reliable publications and relevant information is extracted, analysed and prepared for accurate reporting.

ecotox consult supports you with the compilation of a literature review report that includes the results as well as the completely transparent documentation of the review process complying with regulatory requirements. Furthermore, ecotox consult can assist you in interpreting results obtained from literature review and integrating these results in lower or higher-tier risk assessment strategies using scientifically sound approaches (e.g. probabilistic risk assessment approaches such as species sensitivity distributions).

ecotox consult is specialised in ecotoxicology and environmental risk assessment. We are highly experienced with literature research and evaluation for both generic data required in context of current research topics and specific data for the environmental risk assessment of chemicals. We have implemented the EFSA guidance for systematic literature research in our approach and have applied it successfully. Various literature review objectives in ecotoxicological and environmental sciences can be approached this way in order to precisely derive literature data, e.g. for the environmental risk assessment of plant protection products, pharmaceutical products for human and veterinary use, industry chemicals, biocidal products, as well as for current research topics.

If requested, we are ready to develop a customised strategy for your review objectives and/or specific regulatory requirements. For further questions and information, please feel free to contact us.

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