EU's GMO approval delays represent 'maladministration'EU's GMO approval delays represent 'maladministration'
Delays of more than a year past regulated three-month time period represent "the norm rather than the exception."
February 2, 2016

European Ombudsman Emily O'Reilly decided that between 2012 and 2014, the European Commission repeatedly failed to meet the legally binding three-month deadline for processing applications for the import of genetically modified organisms (GMOs) for food and feed and did not make its decisions within a reasonable time.
“These failures constituted maladministration,” O'Reilly wrote.
Europe's biotechnology industry (EuropaBio), grain traders (COCERAL) and feed manufacturers (FEFAC) welcomed the decision on their complaint. The three groups had jointly filed a complaint with the European Ombudsman on Sept. 12, 2014, after having repeatedly raised their concerns with the European Commission regarding the unduly delayed authorizations for GMOs and the resulting trade disruptions in the past.
The complaint concerns delays at two stages of the authorization process for GMO applications: (1) the stage at which the European Commission is bound by law to submit a draft implementing decision for a vote to the Standing Committee on Plants, Animals, Food & Feed within three months of a positive safety assessment by the European Food Safety Authority (EFSA), and (2) the stage at which the commission adopts the draft implementing decision after the Appeal Committee reaches no qualified majority during a vote.
The ombudsman said there were 20 applications during the two-year time period. Draft decisions took approximately 16 months, on average, per product — well beyond the three months provided. In addition, the commission's delays averaged 3.5 months per product to make decisions following the Appeal Committee's failure to make a decision (compared to an average of one month in the 2011-13 period.
“The delays in question did not occur in one or two isolated instances but were the norm rather than the exception. The commission has put forward no convincing reasons to explain these delays,” the ombudsman said.
EuropaBio said it has repeatedly called on the European Commission to maintain a fully functional and predictable GMO approval system as the use of biotech commodities continues to be substantial in the European Union.
“Being so highly dependent on imports, it is crucial for the EU to avoid asynchronous approvals and risks of trade disruptions. This is why, in addition to normalizing the approval system at commission level, it is important that increasing timelines for risk assessment at the (EFSA) level receive due attention,” EuropaBio said in a statement.
EuropaBio, COCERAL and FEFAC said they are pleased that the commission has started approving EFSA-assessed GMO events for food and feed imports within reasonable time limits again and continue to call for a functioning, evidence-based EU policy on GMOs.
The American Soybean Assn. (ASA) also asked for ongoing work to address delays in the approval timeline as such delays create a barrier to market entry for U.S. soybeans and put the supply of high-quality feed for Europe's livestock industry at risk.
ASA president Richard Wilkins said while the European Commission currently is making progress, it must continue to do so. “While Ombudsman O'Reilly's report is a reaffirmation of what we have known to be true for some time, it is still a good acknowledgement of the work that is ahead with regard to Europe. The process for approving new traits for export must be a transparent, efficient and science-based one," he said.
Wilkins added that the commission "must not shirk its responsibility to provide final authorization of new biotech products after they have traveled through the EU's established reviews and processes. Several new soybean biotech traits now are awaiting final approval by the commission; it needs to provide final authorizations expeditiously and in accord with EU regulations."
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