New EFSA Opinion: BASF now calls for approval of the Amflora potato

(11 June 2009) The European Food Safety Authority (EFSA) has published a new opinion on antibiotic resistance marker genes in genetically modified plants. Based thereon, BASF has called for the EU Commission to approve Amflora, the genetically modified potato developed by the company.

For years, the EU has debated approval of the Amflora potato, which displays an altered starch composition. In May 2008, the EU Commission postponed its pending decision, since not all aspects of the antibiotic resistance marker gene (nptII) used in the potato had been clarified. EFSA received the mandate to deliver a new "consolidated safety assessment". As a change to previous conditions, not only the GMO Panel of experts was called into play, but also the Biological Hazards Panel (BIOHAZ).

The joint scientific opinion of both panels concluded that "adverse effects on human health and the environment" as a result of the use of the marker genes in genetically modified plants "are unlikely based on the current state of knowledge". No transfer of the marker gene from GM plants to bacteria has been seen to date, either under natural conditions or in the lab. Only if such a "horizontal gene transfer" were actually to occur would the antibiotic resistance be transferred from the GM plant to the pathogen.

EFSA's opinion specifically addresses two antibiotic resistance markers, nptII (resistance to Kanamycin) and aaDA (resistance to Streptomycin). Both antibiotics are of  "clinical importance" in human and veterinary medicine. Of course, there is "worldwide concern" when an increasing number of infectious disease pathogens spread that are resistant to these antibiotics, but the marker genes from GM plants have not contributed to this development, said EFSA.

Two members of the BIOHAZ Panel expressed minority opinions. The EFSA consequently addressed these opinions in order to determine if further scientific evaluations were necessary. The chairs of both panels declared that these minority opinions were extensively considered in the preparation of the joint scientific assessment and that no additional work was needed.

Immediately following publication of the EFSA opinion, BASF called on the EU Commission to grant approval for the use of the Amflora potato in the EU. "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. He reiterated the EU Commission's statement from May 2008 that it would grant approval for Amflora as soon as EFSA confirmed the safety of the product.

See also on GMO-Compass:

• Overview: Genetically modified potatoes
• GMO database: Amflora potato (EH92-527-1)

Further information:

• EFSA evaluates antibiotic resistance marker genes in GM plants
• EFSA reconfirms the safety of Amflora, BASF’s genetically modified potato (BASF press release, 11.06.2009)