The practice of EU Commission health service SANTE to approve pesticides while important safety data are missing – the so-called ‘confirmatory data procedure’ (CDP) – has been judged a case of official ‘maladministration’.

This is the verdict of the EU Ombudsman, Emily O’Reilly, in a decision published today following a complaint by Pesticides Action Network (PAN) Europe.

The Commission’ s reliance on CDPs “was not compatible” with the provisions of Directive 91/414, she wrote, and “its use of CDPs appeared to constitute maladministration.”

And she makes clear that the Commission must adopt a far more precautionary approach with is pesticide approvals:

“Bearing in mind that any possible error in the Commissionʹs assessment based on insufficient data may cause serious, possibly irreversible harm to human health, the health of animals or to the environment in general … the CDP needs to be applied with particular caution and restraint.”

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.”

Twisting and bending the rules

In 2012 PAN Europe published a report entitled ‘Twisting and bending the rule: In ‘Resubmission’ all efforts are aimed to get pesticides approved‘ which argued that in numerous cases, the Commission had approved active substances for pesticides where the legal requirements are not met.

In particular the report highlighted cases where there was insufficient data to justify excluding risks for human health, animal health, groundwater and the environment.

Under general EU legislation, active ingredients are added to an approved list once industry has submitted a dossier to show that they are safe and effective. Only once an active ingredient is registered can a pesticide product then be registered using that chemical. (Note: this is done by Member States, rather than at the EU level.)

Under the ‘Resubmission’ rule, however, active ingredients can be added which have failed the first round of safety checks. In 2012, there were 87 substances which had been applied for under this ruling, many of which had unknown – but potentially high – risk to people and the environment.

Under the previous pesticide Directive (91/414) O’Reilly considers use of these practices by DG SANTE as “unlawful”.

Meanwhile the new Regulation (1107/2009) should only allow the use of CDP in “exceptional cases” – and she concludes the use was not restricted as it should have been. Possible consequences for human health would be particularly worrying, writes the Ombudsman.

Several other shortcomings in the pesticide decisions were observed by the Ombudsman such as a lack of requirements to protect the environment, a lack of systematic verification of protective measures and even cases of approval when no safe use was demonstrated by Food Authority EFSA.

A potential cover up in the process

In the PAN Europe report, it was demonstrated that the CDP procedure was used as standard practice as 22 out of 25 recent approvals were based on this procedure. The Ombudsman now concludes that these practices were unlawful 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” and states that the priority should be requesting and assessing all required data 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 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”.

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, according to O’Reilly.

She writes that she “could understand the complainant’s impression that the Commission’s review reports and approval decisions are ‘misleading’ and inaccurate” after identifying that the Commission had adopted misleading review reports and decisions through the process of Resubmission.

Commission ordered to change its practices

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, that they have actually implemented the changes.

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.

Vanessa Amaral-Rogers is a freelance journalist writing mainly on environmental themes.

Principal source: Pesticides Action Network Europe.

Also on The Ecologist:

• ‘Disgraceful ‘Honour’ for failing to protect people from poisons‘ by Georgina Downs
• ‘Thank you Greens! Now other parties too must keep us safe from pesticides‘ by Georgina Downs
• ‘UK fights EU attempts to bring in stricter rules on pesticide and crop spraying‘ by Alistair Driver
• ‘Negligent and unlawful: EFSA’s latest guidance on pesticide use and exposure‘ by Georgina Downs