EFSA panel reconfirms opinion on nptII plant gene safety
nptII gene as a selectionable marker in GM plants for food or feed
poses no risk to human or animal health or the environment.
The nptII gene (neomycin phosphototransferase II) provides resistance to certain antibiotics, such as the aminoglycosides kanamycin, neomycin and geneticin, in plants.
The panel previously addressed the issue of whether the antibiotic resistance could be transferred from plants to animals in 2004, finding that there is no scientific evidence that such a transfer would occur.
The new assessment was prompted by information provided by the European Medicines Agency (EMEA) on the therapeutic value of such antibiotics.
According to EMEA, aminoglycosides are becoming increasingly important in the prevention and treatment of serious invasive bacterial infections in humans (such as tuberculosis), since such bacteria are becoming resistant to other classes of antibiotics.
But in its earlier assessment the panel had said that aminoglycosides were not commonly used.
It said that both kanamycin and neomycin were rarely used because of their side-effects.
Although EFSA agrees with EMEA on its evaluation of the use of antibiotics, a spokesperson for the authority told FoodNavigator.com that the evaluation is not about how much the antibiotics are used but on whether or not resistance can be transferred from plants to animals.
On the basis of evidence - both previously existing and additional - the panel concluded that the therapeutic potential of the antibiotics will be compromised by the presence of the nptII gene in plants "given the extremely low probability of gene transfer from plants to bacteria".
It considers that it is "very unlikely" that the presence of the nptII gene in plants would change the existing prevalence of the gene in bacterial sources in the environment.
The conclusions of its previous opinion, that the use of the nptII gene as selectable marker in GM plants does not pose a risk to human or animal health or to the environment.
EFSA has forwarded its opinion to the EC and EU member states (plus Norward and Sweden).
These, it says, "will now be able to take into account EFSA's most recnet scientific advice on the nptII gene when considering GMO authorisation issues.
