Parma, Italy
April 13, 2007
The European Food Safety
Authority’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.
The GMO Panel statement is available on the EFSA website at:
http://www.efsa.europa.eu/en/science/gmo/statements0/npt2.html |
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