May 8, 2008

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European Commission

Back to EFSA: Decision on cultivation approval delayed

The European Commission has once again delayed a decision on cultivation approval for two genetically modified maize lines and the Amflora potato. The European Food Safety Authority (EFSA) is to look again at the safety of these GM plants. By contrast, the Commission intends to follow a quick, pragmatic approach for introducing thresholds for GM plants not yet approved in the EU.

The European Commission had included an “orientation debate” on issues relating to the approval of GMO products in the EU on the agenda of its meeting in Brussels on Wednesday. But no concrete decisions to alter the existing approval process were taken. Recently, France and Germany had spoken out in favour of depoliticising approval decisions and placing them on a more scientific footing.

EU Environment Commissioner Stavros Dimas is resisting cultivation approvals for the two Bt maize lines Bt11 and 1507 and for the Amflora potato. Now EFSA is to reassess their safety.

When it comes to genetic engineering, the EU member states are at odds with one another politically. During votes in the Council of Ministers, the different camps block each other, so that all approval decisions concerning GMO products have so far failed to achieve the qualified majority of member states prescribed by the European treaties. To prevent such political blockades leading to an inability to act at EU level, in such cases, the European Commission has a duty to bring about a decision. Community genetic engineering law stipulates that the European Commission should generally follow the scientific opinion of EFSA, the expert authority responsible.

Until now, the European Commission has approved all applications for GMO products where EFSA has concluded that they are as safe as comparable conventional products. Now, however, the political conflict surrounding plant genetic engineering is blocking the European Commission itself. The situation has been triggered by the pending decisions on three GM plants intended for cultivation in the EU: the two Bt maize varieties 1507 and Bt11 and a GM potato with modified starch composition developed by BASF (Amflora).

EFSA classified all three GM plants as harmless to the environment, humans and animals back in 2005 following detailed examination. The EU Environment Commissioner Stavros Dimas has been postponing a decision for a long time. Unlike his expert scientific authority, he referred to security issues that had not been clarified. He claimed that there were “serious indications” that both Bt maize lines could harm other animal species. In the case of the Amflora potato, Dimas’s concerns focus on an antibiotic-resistance marker used in its development.

However, Dimas failed to find support for his proposal to refuse the approvals from a majority of the 27-strong Commission. By way of compromise, the Commission agreed to ask EFSA to investigate certain safety aspects of the three GM plants again. This will delay the decision by a further few months. “The Commission will approve the pending applications if EFSA confirms the products’ safety,” a Commission spokesman told the press. At the same time he affirmed the Commission’s confidence in the work of EFSA. The last time GM plants were approved for cultivation in the EU was in 1998.

Applications for other GMO products were also referred to EFSA for reassessment. The products involved are three hybrids of various GM maize lines (MON863xMON810, MON863xMON603, MON863xMON810xNK603) which contain an antibiotic-resistance marker, and LL62 rice.

Technical solution: Threshold for GM plants not authorised in the EU

By contrast, the Commission is aiming for a pragmatic “technical solution” in another area that is also politically very contentious – thresholds for the presence of GM plants that are not authorised in the EU. Since there is currently a zero tolerance policy in the EU for these plants, agricultural raw materials cannot be imported if they are found to contain traces of unauthorised GM plants. In the past, even minimal GMO traces on or below the limit of detection have led to whole shipments being rejected. In view of the increasing shortage of animal feed and protein in Europe, the EU intends to set a threshold for unauthorised GMOs by the summer at the latest.

The Commission also instructed Austria to lift its national import ban on food and feed produced from the two GM maize lines MON810 and T25, since the safety concerns put forward had no scientific basis. However, the national cultivation bans on the GM maize lines continue to stand.