Brussels, Belgium
April 1, 2005
The European Commission has
written to the US authorities and to the biotechnology company
Syngenta requesting
clarification of the situation regarding the unauthorised
genetically modified maize Bt10. According to the information
received to date from the US authorities and from Syngenta, the
developer of Bt10, up to 10 kg of Bt10 seed may have been
exported inadvertently as Bt11 for research purposes to Spain
and France. The resulting materials have all been destroyed. In
addition, the Commission is informed that an estimated 1000
metric tonnes of Bt10 food and feed products may have entered
the EU through the Bt11 export channels since 2001, the date
from which the inadvertent release of Bt10 started. At a meeting
yesterday with representatives of Syngenta, officials of the
European Commission were informed that Bt10 included the gene
conferring resistance to the antibiotic ampicillin.
EU Health and Consumer Protection
Commissoner Markos Kyprianou said: "The European Commission
deplores the fact that a GMO which has not been authorised
through the EU’s comprehensive legislative framework for GMOs,
nor by any other country, has been imported into the EU, and we
are writing to the US authorities asking them to guarantee, by
taking the appropriate measures, that present and future exports
of maize to the EU do not contain GMOs which are not authorised
for the EU market, including Bt10. This case again shows the
importance of the European Unions’s comprehensive framework for
traceability and labelling of GMOs."
EU Environment Commissioner
Stavros Dimas said: “In order to avoid any adverse effect on
human and animal health or the environment of such an accidental
release, the Commission has asked Member States to carry out
appropriate control measures to stop Bt10 entering their
territory. Member States should also notify the state of play
regarding past or current national experimental releases of
Bt11, and implement any necessary monitoring and surveillance
measures in the surrounding areas where these releases took
place.”
The Commission was first
informed by the US Mission to the European Union on 22 March
about an inadvertent release in the US of a non authorised
genetically modified maize line called Bt10. The Commission
informed the Member States without delay via the Rapid Alert
System for food and feed. Moreover, the Commission has asked the
US Administration for the full safety information about Bt10 at
its disposal without delay, including the full risk assessments
upon which it is based as well as for an urgent audit and an
official view as to the quantities exported, including the
channels they may have taken in the EU.
The Commission has also asked
Syngenta, the developer of the Bt10 crop, to release the full
information about the molecular characterisation of Bt10 and its
distinction from Bt11, as well as the specific detection method
and adequate reference materials to trace Bt10. The Commission
has also asked Syngenta to confirm that all Bt10 plantings and
seed stock in the USA have been destroyed or isolated for
further destruction. Syngenta has committed to provide this
information next week.
The US government has given
reassurance that no food, feed or environmental concerns are
associated with the inadvertent release of this non authorised
genetically modified crop, based on the fact that the Bt protein
in Bt10 is similar to the one in Bt11, which is fully authorised
in the US and which the EU has authorised for use in food and
feed.
However, the US authorities did
not inform the Commission that Bt10 contains, contrary to Bt11,
the gene conferring resistance against the antibiotic
ampicillin. It was only on the 31 of March that this information
was given officially to the Commission by Syngenta. According to
the advice of the European Food Safety Authority, the ampicillin
resistance gene should not be present in crops grown
commercially. However, according to Syngenta, this gene is
inactive in Bt10. |