EFSA reconfirms the safety of Amflora, BASF’s genetically modified potato

• EFSA, the European Food Safety Authority, reiterates earlier assessments that Amflora is safe for humans, animals and the environment
• Assessment allows EU Commission to adhere to its statement and approve Amflora
• European farmers and starch producers are ready to cultivate innovative starch potatoes

Limburgerhof, Germany – June 11, 2009 – EFSA, the European Food Safety Authority, today published its scientific assessment of a gene that is present in Amflora, as well as in other genetically modified products. In the past, EFSA has repeatedly assessed the use of this gene with the scientific name ‘npt2’ and today again concluded that the gene is safe for humans, animals and the environment and that no further scientific work is needed. The mandate to carry out an additional safety assessment on the npt2 gene was given by the EU Commission in May 2008.

“Today’s assessment gives the entire EU Commission the final scientific clarity to approve Amflora,” said Dr. Stefan Marcinowski, Member of the Board of Executive Directors of BASF SE. “I am pleased, since the EU Commission stated in May 2008 that it will approve Amflora “if and when“ EFSA has confirmed the safety of the product.”

In its current scientific opinion, EFSA concluded that “no new scientific evidence has become available that would prompt the Panel to change its previous opinions“ on the use of the npt2 marker gene. These previous opinions stated that the use of the npt2 gene does not pose a risk to human or animal health or to the environment. “Two minority opinions were expressed and extensively considered during the preparation of the joint opinion and no further clarification or scientific work were needed at this time,” according to EFSA’s website.

The documents are available on the Internet.

The idea of developing Amflora originated in the European starch industry. The aim was to improve industrial starch potatoes. Potatoes produce two types of starch – amylose and amylopectin. For many applications, such as in the paper, textile and adhesives industries, amylopectin is preferred. With plant biotechnology, BASF found a solution to avoid the production of the unwanted starch component amylose. With its pure amylopectin starch, higher quality starch can be extracted from Amflora. The industry benefits, since paper produced with high-quality Amflora starch has a higher gloss, and concrete and adhesives can be processed for a longer period of time. Industrial processes can thus be optimized, which results in savings in raw material such as water, additives and energy.

Europe’s farmers and the starch industry have estimated that the product and processing benefits as well as the savings in raw materials and energy use can be translated into a potential added value of €100-200 million per year. In addition, BASF expects peak income from licenses in the range of €20-30 million per year.

The Amflora approval process to date:

• The Amflora approval process was initiated more than 12 years ago with the request for authorization submitted in August 1996. The scope of the application included cultivation, industrial use and feed.
• During the so-called moratorium on genetically modified products between 1998 and 2004, no approvals for genetically modified plants were 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, the EU Commission published two EFSA assessments that for both dossiers concluded that Amflora is safe for humans, animals and the environment.
• In November 2006, EU-Commissioner Dimas forwarded his proposal for authorization of cultivation of Amflora to the Regulatory Committee consisting of representatives from all 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 approval procedure defined by EU legislation and did not adopt the proposal for cultivation.
• On September 21, 2007, EU-Commissioner Dimas answered questions by Green MEP Breyer (WRITTEN QUESTION P-4070/07 by Hiltrud Breyer (Verts/ALE) to the EU Commission that Amflora is safe.
• The dossier for food and feed use was voted upon in the Standing Committee – consisting of members from all EU Member States – in October 2007 and Council of Agricultural Ministers in February 2008. According to the defined EU approval procedure, the EU Commission “shall adopt“ the proposal after no conclusive opinion (no “qualified majority”) has been reached neither in the votes in the Standing Committee nor in the Council of Agricultural Ministers.
• BASF expressed its dissatisfaction with EU-Commissioner Dimas’ handling of the approval process in an open letter to EU-Commissioner Dimas on April 17, 2008.
• In its “orientation debate“ on genetically modified organisms on May 7, 2008, the EU 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, EU-Commission President Barroso stated that the EU Commission will adopt the pending decision “if and when“ EFSA confirms the safety of Amflora.
• 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 obtained by BASF Plant Science did not reveal any new scientific evidence regarding the safety of Amflora.
• On July 24, 2008, one year after the vote in the Council of Agricultural Ministers (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.
• EFSA in autumn 2008 informed that its opinion on antibiotic resistance marker genes would not be finalized until December 15, 2008.
• However, on December 10, 2008, the EU Commission granted EFSA a second extension for its opinion to March 31, 2009.
• Today, on June 11, 2009, EFSA published its final, positive opinion on the use of antibiotic resistance marker genes in genetically modified plants.

About the npt2 marker gene

The gene assessed by EFSA is a so-called npt2 marker gene and is used in plant biotechnology laboratories during the very first stage of development. Genes responsible for desired plant traits are coupled with a marker, for instance a gene conferring resistance to an antibiotic. When the antibiotic is applied on to the plant cells, only successfully modified cells can recover to plants carrying the desired traits.

About BASF Plant Science

BASF – the Chemical Company – consolidated its plant biotechnology activities in BASF Plant Science in 1998. Today, about 700 employees are working to optimize crops for more efficient agriculture, renewable raw materials and healthier nutrition. Projects include yield increase in staple crops, higher content of Omega-3s in oil crops for preventing cardiovascular diseases, and potatoes with optimized starch composition for industrial use.

To find out more about BASF Plant Science, please visit www.basf.com/plantscience.

About BASF

BASF is the world’s leading chemical company: The Chemical Company. Its portfolio ranges from chemicals, plastics and performance products to agricultural products, fine chemicals and oil and gas. As a reliable partner BASF helps its customers in virtually all industries to be more successful. With its high-value products and intelligent solutions, BASF plays an important role in finding answers to global challenges such as climate protection, energy efficiency, nutrition and mobility. BASF posted sales of more than €62 billion in 2008 and had approximately 97,000 employees as of the end of the year. Further information on BASF is available on the Internet at www.basf.com.

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