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Study questions EU pesticide approval process

PAN Europe investigated the revised risk assessment reports for seven pesticides

19.09.2014 |




ENDS Europe DAILY (18/09/14)

The approval process for pesticides is deeply flawed due to poor guidance from the responsible EU agency, an NGO has claimed.

PAN Europe investigated the revised risk assessment reports for seven pesticides. It found that member states have been disqualifying research for “administrative reasons” and claimed that “tens of thousands” of independent studies on toxicity are “effectively thrown in the trash”.

PAN says this is contrary to EU law, under which sound science must be the basis of any decision-making. “They’re not breaking the law, but it’s certainly not in the spirit of the [2009 pesticides] regulation,” said a spokesman.

Under this regulation, all scientific peer-reviewed literature, including independent studies, should be taken into consideration by the European Commission and member states when approving pesticides. Previously, decisions were based on industry-sponsored studies.

But PAN Europe found that 434 independent studies showing adverse effects of seven chemicals up for re-approval not deemed “relevant” by the industrial applicant and this was not questioned by member states.

The group blames a 2011 guidance document produced by the European Food Safety Authority (EFSA). PAN says this document suggests the Klimisch score be used to assess data, a method which prioritises industry studies adhering to OECD test protocols, including Good Laboratory Practice.

Many independent studies reject these protocols because they are deemed “outdated” and “restrictive of [researchers’] freedom to investigate”.
“This means that far more scientifically advanced studies are bureaucratically dismissed,” PAN concluded.

But EFSA defended its guidance, which it said does not prevent independent studies, such as those from universities, being considered.

“The guidance stresses that study reliability must be judged solely on the basis of the accuracy and the reproducibility of the facts reported. Furthermore, it says that Good Laboratory Practice standards should not be considered as a guarantee of reliability,” an EFSA spokesman told ENDS.

He added that the guidance does not require the use of the Klimisch ranking.
“The Klimisch ranking is referred to as one of several options for classification in the guidance, which also indicates that those schemes should be used with caution,” he added.

Pesticide industry association ECPA said it would welcome more studies financed by third parties being taken into account during the risk assessment process. But it rebuffed PAN's report.

“It’s not up to one anti-pesticide group to choose which science they think is more reliable than what has been accepted by everyone else. If they have their own data, the legislation already allows for them to submit it as part of the process,” a spokesman said.

Follow Up:
PAN Europe press release and study, EFSA guidance. See also recent statement from EU health commissioner Tonio Borg.


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