DG SANTE ordered to prove in a future report they changed their practices.
The practice of EU Commission health service SANTE to approve pesticides while important safety data are missing, the so-called "confirmatory data procedure" (CDP), is a case of maladministration according to the EU Ombudsman in a decision published today (pnt 8 of the decision). Under the previous pesticide Directive (91/414) she considers use of these practices by DG SANTE as unlawful (pnt 27) and under the new Regulation (1107/2009) that allows use of CDP only in exceptional cases she concludes the use was not restricted as it should (pnt 11). Possible consequences for human health would be particularly worrying, writes the Ombudsman (pnt 27). Several other shortcomings in the pesticide decisions were observed by the Ombudsman such as a lack of requirements to protect the environment (pnt 44), a lack of systematic verification of protective measures (pnt 50) and even cases of approval when no safe use was demonstrated by Food Authority EFSA (pnt 28). The solution proposed by the Ombudsman includes a change of practices by DG SANTE; the Ombudsman orders SANTE to prove in a report, to be published in two years time, they have actually implemented the changes (pnt 71).
The confirmatory data procedure (CDP) was an invention of DG SANCO when industry was reluctant to present the obligatory safety data for their pesticides. With this CDP pesticides could be approved with serious data gaps and with high risks, allowing industry to submit additional information only in future (pnt 27). In a report published by PAN Europe in 2012, PAN report Resubmission, it was demonstrated that the CDP procedure was used as standard procedure by SANCO and people and the environment put at (unknown but potential serious) health risks. The Ombudsman now concludes that these practices are unlawful in the past and currently not restricted as legally required. She concludes that "Commission may be too lenient in its practices and might not be taken sufficiently account of the precautionary principle" (page 3) and states that all required data should be present before a decision is taken (pnt 11).
Even when Food Authority EFSA calculated high risks based on the available scientific evidence, DG SANTE in several cases approved the pesticide. The Ombudsman writes that it is "difficult to understand how the Commission could legitimately decide .......that these substances have no harmful effect or no unacceptable influence on the environment" and that a "satisfactory explanation has not been provided by Commission" (pnt 28). Many of these high risks concern the environment, such as birds.
In their reports and decisions DG SANTE tries to hide the (high) risks and data gaps observed by EFSA and claims that the pesticides are safe. The EU Ombudsman writes that the " Ombudsman could understand the complainant's impression that the Commission's review reports and approval decisions are "misleading" and inaccurate" (pnt 30).
Hans Muilerman, PAN Europe's chemicals coordinator, comments that it is clear that DG SANTE and the member states let the interests of industry and farmers prevail over the interests of the public in allowing harmful pesticides on the market with data gaps and high risks. This structural violation of the rules implies that the pesticides currently on the market are not safe.