EFSA GMO Panel reconfirms that the use of the nptII gene as a selectable marker in GM plants does not pose a risk to human or animal health or the environment

EFSA’s GMO Panel has published a scientific statement confirming earlier safety assessments of GM plants and derived food/feed comprising the nptII gene.  On 2nd March, the European Commission (EC) forwarded information to EFSA from the European Medicines Agency (EMEA) on the therapeutic value of aminoglycoside antibiotics.  The EC asked EFSA to consider this information and any potential consequences for the safety of the nptII gene and for previous opinions on specific GM plants (and derived food and feed) comprising the nptII gene.

According to the EMEA information, aminoglycosides comprise a class of antibiotics that has become increasingly important in the prevention and treatment of serious invasive bacterial infections in humans. This is because bacteria, such as tuberculosis bacteria, are becoming resistant to other classes of antibiotics.  It also said that, although kanamycin and neomycin are used relatively infrequently, the development of similar antibiotics should be taken into account and that aminoglycosides as a group are a class of antibiotics critically important for veterinary medicine.

At its last meeting on 22-23rd March, EFSA’s GMO Panel considered the recent EMEA information and taking this into account looked again at its previous opinion on the use of the nptII gene as a marker gene in genetically modified plants[1].  Following this exercise, the Panel reached consensus on its position and issued a statement on nptII antibiotic resistance marker genes in GM plants which includes the following conclusions all of which are substantiated with additional evidence:

- the GMO Panel agrees with the EMEA that the preservation of the therapeutic potential of the aminoglycoside group of antibiotics is important. The Panel is also of the opinion that the therapeutic effect of these antibiotics will not be compromised by the presence of the nptII gene in GM plants, given the extremely low probability of gene transfer from plants to bacteria.

- The GMO Panel considers it very unlikely that the presence of the nptII gene in GM plants will change the existing widespread prevalence of this antibiotic resistance gene in bacterial sources in the environment.

- the GMO Panel reconfirms its earlier conclusions in its opinion on antibiotic resistant marker genes that the use of the nptII gene as selectable marker in GM plants (and derived food or feed) does not pose a risk to human or animal health or to the environment. The GMO Panel also confirms earlier safety assessments of GM plants (and derived food or feed) comprising the nptII gene.

The EFSA GMO Panel statement has been forwarded to the EC, EU Member States (and Norway and Switzerland) through the EFSA Advisory Forum and to the EMEA.  The EC and Member States will now be able to take into account EFSA’s most recent scientific advice on the nptII gene when considering GMO authorisation issues.

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