Opinion on application reference EFSA-GMO-RX-Bt11 for renewal of the authorisation of existing products produced from insect-resistant genetically modified maize Bt11, under Regulation (EC) No 1829/2003 from Syngenta [1]
Question number: EFSA-Q-2007-146Summary
This
document provides the opinion of the
Scientific Panel on Genetically Modified
Organisms (GMO Panel) of the European Food
Safety Authority (EFSA) on an application
submitted under Regulation (EC) No 1829/2003
(reference EFSA-GMO-RX-Bt11) for renewal of
the authorisation of existing products
derived from genetically modified maize
Bt11.
The scope of this application covers the
continued marketing of existing food and
food ingredients containing, consisting of
or produced from maize Bt11, food additives
produced from maize Bt11, feed containing,
consisting of or produced from maize Bt11
(feed materials and feed additives) to be
used as any other maize grain but not for
cultivation, and other products containing
or consisting of maize Bt11 with the
exception of cultivation which were lawfully
placed on the market in the Community before
the date of entry into force of Regulation
(EC) No 1829/2003. After the date of entry
into force of Regulation (EC) No 1829/2003
these products were notified to the European
Commission according to Articles 8 and 20 of
that Regulation and included in the
Community Register of genetically modified
food and feed[2].
Maize Bt11 was developed to provide
protection against specific lepidopteran
pests. The maize also contains a gene
providing tolerance to the herbicide
glufosinate ammonium.
The EFSA GMO Panel has previously issued a
scientific opinion related to notification
C/F/96/05.10 for the placing on the market
of insect-resistant genetically modified
maize Bt11, for cultivation, feed and
industrial processing under Directive
2001/18/EC (EFSA, 2005). In this opinion the
Panel concluded that maize Bt11 is unlikely
to have an adverse effect on human and
animal health or the environment in the
context of its proposed uses.
In delivering its present opinion, the GMO
Panel considered information provided in the
renewal application (reference
EFSA-GMO-RX-Bt11) as well as additional
information submitted by the applicant on
request of the Panel. In accordance with the
Guidance Document for renewal of
authorisations of existing GMO products
(EFSA, 2006a), the Panel has taken into
account the new information, experience and
data, which have become available during the
authorisation period.
New information was provided in this renewal
application with regards to 1) a review of
peer-reviewed scientific data on Bt11 maize;
2) a report on areas and quantity of
production, importation, use in Europe of
Bt11 maize and information on known and
estimated human and animal exposure; 3) an
updated molecular characterisation,
including sequence data for the flanking
regions; 4) an updated information on the
levels of expression of the specific
proteins and metabolites resulting from the
genetic modification and on the composition
of the GMO; 5) an updated information on
allergenicity and toxicology; and 6) a
post-market environmental monitoring plan.
The updated
molecular and bioinformatic analyses
provided for the maize Bt11 event do not
indicate any safety concerns and the GMO
Panel maintains its previous opinion on the
safety of this event.
New information from an updated literature
review and from additional studies performed
by the applicant does not prompt the Panel
to change its previous opinion that maize
Bt11 is as safe and as nutritious as its
non-GM counterparts.
The
application for renewal of authorisation of
existing products derived from maize Bt11
excludes cultivation of the crop in the EU.
There is therefore no requirement for
scientific assessment of possible
environmental effects associated with the
cultivation of maize Bt11. The scope of the
post-market environmental monitoring plan
provided by the applicant is in line with
the intended uses of maize Bt11 since
cultivation is excluded and is in line with
the EFSA Guidance Document (EFSA, 2006b) and
the Opinion of the GMO Panel on post-market
environmental monitoring (EFSA, 2006c).
The GMO Panel concludes that the new
information provided by the applicant and
the review of the literature that has been
published since the previous scientific
opinion of the GMO Panel does not require
changes of the previous scientific opinion
on maize Bt11 and addresses the scientific
comments raised by the Member States.
Therefore, the Panel reiterates the previous
conclusion that genetically modified maize
Bt11 is unlikely to have an adverse effect
on human and animal health or the
environment in the context of its proposed
uses. This also applies to the products
which are the subject of the present
application.
[1] For citation purposes: Scientific
opinion of the Scientific Panel on
Genetically Modified Organisms on an
application (Reference EFSA-GMO-RX-Bt11) for
renewal of the authorisation of existing
products produced from insect-resistant
genetically modified maize Bt11, under
Regulation (EC) No 1829/2003 from Syngenta.
The EFSA Journal (2009) 977, 1-13
[2]
Community register of
genetically modified food and feed