BASF Plant Science Takes Amflora Case to EU Court

According to the company between July 2007 and May 2008 Commissioner Stavros Dimas did not adopt the approval for the cultivation of Amflora following the completion of all other procedural steps.

25/07/08 BASF Plant Science filed an action with the European Court of First Instance in Luxembourg against the EU Commission for failure to act. According to the company, the approval process of the cultivation of Amflora, its genetically improved potato, has been unjustifiably delayed by the EU Commission on several occasions. In particular, this includes the period between July 2007 and May 2008 during which Commissioner Stavros Dimas did not adopt the approval for the cultivation of Amflora following the completion of all other procedural steps.

“EU Commissioners have postponed Amflora’s approval despite repeated positive safety assessments by EFSA, the European Food Safety Authority. Although we welcome some positive signs by the Commission and President Barroso, such as their commitment to base decisions regarding genetically modified products purely on science, we are not prepared to accept any further delays,” said Dr. Stefan Marcinowski, Member of the Board of Executive Directors of BASF SE.

“We are filing this case in order to ensure that European farmers and starch producers get access to an innovative product that offers them a potential added value of more than €100 million annually. In addition, we estimate that failure to approve Amflora is depriving BASF Plant Science of peak license income of €20 to 30 million per lost cultivation season,” said Dr. Hans Kast, CEO and President of BASF Plant Science GmbH.

The Amflora approval process was initiated 12 years ago with the request for authorization submitted in August 1996. During the moratorium on genetically modified products between 1998 and 2004, no approvals for genetically modified plants where granted in the EU. BASF Plant Science resubmitted a dossier for cultivation and a dossier for food and feed use in 2003 and 2005, respectively, due to modified EU regulations.

In 2006, EFSA concluded for both dossiers that Amflora is as safe for humans, animals and the environment as any conventional potato. In November 2006, Commissioner Dimas forwarded his proposal for authorization of cultivation of Amflora to the EU Member States.

After two inconclusive votes in the Regulatory Committee in December 2006 and the Council of Agricultural Ministers in July 2007, Commissioner Dimas failed to adhere to the defined approval procedure defined by the EU and to adopt the proposal for cultivation. BASF addressed the issue through an open letter to Commissioner Dimas on April 17, 2008. The dossier for food and feed use was voted upon in the Standing Committee in October 2007 and Council of Agricultural Ministers in February 2008. According to the defined EU approval procedure, the responsible Directorate-General Health and Consumers has been responsible for adopting the proposal since February 2008.

In its “orientation debate” on genetically modified plants on May 7, 2008, the Commission decided to request EFSA to prepare a new consolidated scientific opinion on the use of antibiotic resistance marker genes in genetically modified plants by September 30, 2008. Such a marker gene is also used in Amflora.In a press release following the debate, Commission President Barroso stated that Amflora will be approved “if and when” EFSA confirms the safety of antibiotic resistance marker genes. EFSA responded recently that an opinion can be finalized not earlier than by December 15, 2008.

On May 19, 2008, BASF Plant Science formally requested access to any documents in the possession of the EU Commission in connection with the authorization procedure for Amflora. These documents did not reveal any new scientific evidence regarding the safety of Amflora. One year after the vote in the Agricultural Council, the last formal step prior to adoption of a decision, BASF Plant Science filed an action with the European Court of First Instance against the EU Commission for failure to act.