Use of science in EU risk assessment

Risk assessment of pesticides is based almost entirely on tests performed by the chemical industry. Regulators develop data requirements and standard tests; the industry is obliged to do these tests and deliver them to regulators for evaluation.

For many years already PAN-Europe and others have been arguing for considering open literature in decision-making, the research done by independent scientists at universities and institutes, published in journals and peer-reviewed. Published peer-reviewed research, in general, is of a higher quality and reliability than industry tests. Open literature is discussed in public meetings and is many times repeated by other scientists to build on the results of their colleagues. Peer-review results in an evaluation of high-level experts in the same fields and leads to a rejection of publication in many cases to filter out low-quality studies. Industry tests lack most of the time publication, peer-review, open discussion and repeating.

In the adoption of pesticide regulation, 1107/2009 one of the main elements of progress was the inclusion of a provision saying “scientific peer-reviewed open literature” needs to be taken into account. EFSA got the role of making a guideline on how to do this. So far everything is okay.

However, the EFSA guideline mentioned as one of the "methods" to find reliable literature, the "Klimisch ranking", a publication of three BASF-employees saying that industry-sponsored GLP studies are the most reliable studies and raking academic literature at a lower level. At the time the provision took effect, PAN Europe took a sample of 9 pesticide approval dossiers to find out if independent literature was taken into account (see the report "Missed and Dismissed"). It turned out that from the about 434 studies identified by PAN Europe where serious harm of pesticides was observed, only 23% (99) were found by industry and next 0% (none!) seen as reliable (and also approved by the Rapporteur member state). In the end, no independent study was used for risk assessment.

The compliance with the approval procedures, especially with Article 8 (5) regarding adding the scientific peer-reviewed open literature to the approval dossier remains a big concern as is shown in this document.

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Pesticide Action Network Europe (PAN Europe) gratefully acknowledges the financial support from the European Union, European Commission, DG Environment, LIFE programme. Sole responsibility for this publication lies with the authors and the funders are not responsible for any use that may be made of the information contained herein.