DG SANTE ordered to prove in future that they have reformed their practices

The practice of EU Commission health service SANTE of approving pesticides while important safety data are missing, the so-called "confirmatory data procedure" (CDP), is a case of maladministration, according to the EU Ombudsman Emily O’Reilly in a decision published today.

Under the previous pesticide Directive (91/414) she considers the use of these practices by DG SANTE as unlawful and under the new Regulation (1107/2009), which allows use of CDP only in exceptional cases, she concludes the use was not restricted as it should have been. Possible consequences for human health could be “particularly worrying”, writes the Ombudsman.

Several other shortcomings in the pesticide decisions were observed by the Ombudsman, such as a lack of requirement to protect the environment, a lack of systematic verification of protective measures, and even cases of approval where “critical areas of concern” were identified by the food safety authority EFSA. The solution proposed by the Ombudsman includes changes of practice by DG SANTE: she orders SANTE to prove in a report, to be published in two years time, that they have actually implemented the needed changes.

The complaint that led to the Ombudsman’s report was brought by Pesticide Action Network Europe. PAN Europe comments that the confirmatory data procedure (CDP) “was an invention of DG SANTE when industry was reluctant to present the obligatory safety data for their pesticides”.

Through the CDP, pesticides could be approved with serious data gaps and with high risks, allowing industry to submit additional information in the future. A report published by PAN Europe in 2012 called "Resubmission" found that the CDP procedure was used as standard procedure by SANCO and that people and the environment were being placed at risk.

The Ombudsman now concludes that these practices were unlawful in the past and currently not restricted as legally required. She concludes that the Commission ”may be too lenient in its practices and might not be taking sufficient account of the precautionary principle" and states that all required data should be assessed before a decision is taken.

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, “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".
 
Pesticide Action Network says, “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".

Hans Muilerman, PAN Europe's chemicals coordinator, commented, “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.”