17th September 2014
Legal obligation to base pesticide approval decisions on science dismantled by EU regulators and industry
For 7 pesticides proposed by industry for re-approval, PAN Europe identified 434 studies with adverse effects in independent literature. Only 23% (99) of these studies were found by industry in the review they were legally obliged to do and even 0% of these studies were qualified relevant by the industrial applicant for EU decision-taking. EU member states, the Rapporteurs for regulating pesticides, approved these reviews and the dismissal of independent science, while EU Commission was not acting at all.
Dismissing studies showing harmful health effects also means that food safety standards could be set at a too high level and EU citizens put at harm. For instance, while EU considers the lowest harmful level for the herbicide 2,4-D to be at a 62,5 mg/kg dose in animal studies sponsored by industry, independent literature shows effects at 3,3 and 2,5 mg/kg dose level in two different animal studies, 20 times lower.
PAN-Europe took this sample of 7 active substances of pesticides to test the new EU obligation of Regulation 1107/2009 to take scientific peer-reviewed literature into account for the approval process of pesticides. Up to now all EU pesticide decisions are solely based on industry-sponsored studies with unknown bias while the millions of academic studies are disregarded. Politicians in 2008 agreed this had to change and obliged industrial applicants to do a review of the literature and include independent research in every new application for approval.
The first bad sign for the implementation of the new rule was the guidance document made by Food Authority EFSA in 2011 putting OECD-protocol studies at a high level of reliability and non-protocol studies at a lower level. This so-called "Klimisch-ranking" -a proposal of three BASF-employees- will almost automatically dismiss the hundreds of thousands of relevant studies performed at universities and research institutes because fixed protocols are rarely used by them. Billions and billions of research money are therefore spend by society to learn about science and adverse health effects, but are disregarded and dismissed in Brussels decision-making procedures.
PAN Europe comments: "Again regulators show their stubborn behavior and dismantle democratically agreed legal obligations and keep on ignoring academic science. EU citizens are put at risk now dangerous health effects are disregarded. PAN Europe feels the EFSA guidance should be revised and all studies considered for their quality and not for administrative reasons like having a certain protocol".
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Further information and contacts:
PAN Report: Missed & Dismissed - Pesticide Regulators Ignore The Legal Obligation To Use Independent Science For Deriving Safe Exposure Levels
For further information please contact:
Hans Muilerman, Tel: +316 55807255 firstname.lastname@example.org