Brussels, Belgium
December 1, 2008
The GMO Panel of the
European Food Safety
Authority (EFSA) has today published the positive scientific
safety assessment of stacked maize product 59122xNK603 for
import, food and feed use, concluding it to be as safe as
conventional maize. We anticipate that based on this safety
assessment, Member States will soon have the opportunity to
approve this product under the EU’s regulatory framework.
The stacked maize product incorporating traits 59122 maize and
NK603 maize has already been approved in seven countries around
the world to date. Furthermore, both individual traits have
already been approved for import, food and feed use in the EU –
59122 in October 2007 and NK603 in March 2005. Additionally, the
stacked 59122xNK603 maize combination was developed using
traditional plant breeding techniques and thus contains no new
genetic modifications – further reason why the EU should approve
this product without undue delay. The 59122 maize contains no
antibiotic resistance marker gene and the Bt protein expressed
in 59122 maize has a long history of safe use by organic
farmers.
“The Commission now needs to ensure that the EU’s regulatory
system allows European livestock producers and others who depend
on grain imports equal access to safe, innovative products that
are improving the sustainability and competitiveness of
producers in the rest of the world,” said Gyula Kovács, Director
of Pioneer European Operations, Pioneer Hi-Bred, a DuPont
business.
59122 maize is genetically modified with the Bt trait to provide
maize plants with environmentally-friendly protection against
destructive insect attacks. 59122 maize reduces the need to
spray maize crops with insecticide and, because it produces more
grain on the same land area, it improves farm productivity and
profitability – sustainable agriculture in practice. NK603 maize
confers tolerance to glyphosate, the active compound in a
herbicide commonly used for many years by farmers around the
world.
“59122xNK603 maize has been proven safe,” Kovács said. “It is an
important tool of sustainable agriculture, and its approval
represents a test of Europe’s commitment to increasing
competitiveness. 59122xNK603 maize should be given a fair and
equitable opportunity to compete with other products already
approved in the EU, and we trust that a draft decision for
approving 59122xNK603 maize will be submitted by the Commission
to Member States for a vote by early-February, 2009.”
Pioneer Hi-Bred, a
DuPont business, is the world’s leading source of customized
solutions for farmers, livestock producers and grain and oilseed
processors. With headquarters in Des Moines, Iowa, Pioneer
provides access to advanced plant genetics in nearly 70
countries.
DuPont
is a science-based products and services company. Founded in
1802, DuPont puts science to work by creating sustainable
solutions essential to a better, safer, healthier life for
people everywhere. Operating in more than 70 countries, DuPont
offers a wide range of innovative products and services for
markets including agriculture and food; building and
construction; communications; and transportation.
xThe EFSA Opinion on 59122/NK603 maize for import, food and
feed use:
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902200229.htm
Summary
Following a request from Pioneer Hi-Bred International
within the framework of Regulation (EC) No 1829/2003 on
genetically modified food and feed (EC, 2003) for food and
feed uses, import and processing, the Panel on Genetically
Modified Organisms was asked to deliver a scientific opinion
on the authorisation of the insect-resistant, glyphosate-
and glufosinate-tolerant genetically modified 59122 x NK603
maize (Unique Identifier DAS-59122-7xMONØØ6Ø3-6).
In delivering its scientific opinion, the GMO Panel
considered the new application EFSA-GMO-UK-2005-20,
additional information provided by the applicant (Pioneer
Hi-Bred International) and the scientific comments submitted
by the Member States. Further information from applications
for placing the parental events 59122 and NK603 on the
market under EU regulatory procedures was taken into account
where appropriate. The scope of application
EFSA-GMO-UK-2005-20 is for food and feed uses, import and
processing of genetically modified 59122 x NK603 maize and
all derived products, but excluding cultivation in the EU.
The GMO Panel assessed 59122 x NK603 maize with reference to
the intended uses and the appropriate principles described
in the Guidance Document of the Scientific Panel on
Genetically Modified Organisms for the risk assessment of
genetically modified plants and derived food and feed and
the Guidance Document of the Scientific Panel on Genetically
Modified Organisms for the risk assessment of genetically
modified plants containing stacked transformation events.
The scientific assessment included molecular
characterization of the inserted DNA and expression of the
new proteins. A comparative analysis of agronomic traits and
composition was undertaken and the safety of the newly
expressed proteins and the whole food/feed was evaluated
with respect to potential toxicity, allergenicity and
nutritional quality. An assessment of environmental impacts
and the post-market environmental monitoring plan were also
undertaken.
Maize 59122 was developed to express CRY34Ab1 and CRY35Ab1
proteins rendering maize 59122 resistant to certain
coleopteran pests and the PAT
(phosphinothricin-N-acetyltransferase) protein which was
used as a selectable marker and confers tolerance to
glufosinate.
Maize 59122 was authorised under Regulation (EC) No
1829/2003 with Commission Decision 2007/702/EC. Maize NK603
was developed to be tolerant to glyphosate by the
introduction of the gene coding for
5-enolpyruvylshikimate-3-phosphate synthase from
Agrobacterium sp. strain CP4 (CP4 EPSPS and CP4 EPSPS
L214P). Maize NK603 has received an opinion in favour of its
authorisation and was authorised under Directive 2001/18/EC
by Commission Decision 2004/643/EC. The use of food and food
ingredients from NK603 maize was authorised under Regulation
(EC) No 258/97 by Commission Decision 2005/448/EC.
59122 x NK603 maize was produced by crosses between maize
inbred lines containing 59122 and NK603 events to combine
resistance to certain coleopteran species trait in 59122 and
the tolerance to glyphosate in NK603.
The molecular characterisation data established the
molecular equivalence and identical copy number of the two
inserts present in maize 59122 x NK603 to each single insert
present in maize 59122 and maize NK603. Appropriate analyses
of the integration sites including the flanking regions in
maize 59122 x NK603 and updated bioinformatics analysis of
the single events have been performed. Bioinformatics
analysis of junction regions in the single events
demonstrated the absence of any potential new ORFs coding
for known toxins or allergens. The expression of the genes
introduced by genetic modification has been sufficiently
analysed and the stability of the genetic modification has
been demonstrated over several generations. The GMO Panel is
of the opinion that the molecular characterisation of the
DNA inserts and flanking regions of maize 59122 x NK603 does
not raise any safety concern, and that sufficient evidence
for the stability of the genetic modification was provided.
Based on the results of comparative analysis it was
concluded that 59122 x NK603 maize is compositionally and
agronomically equivalent to its non-GM counterpart and
conventional maize, except for the presence of CRY34Ab1,
CRY35Ab1, CP4 EPSPS, CP4 EPSPS L214P and PAT proteins in
59122 x NK603 maize. Based on the assessment of data
available, including the additional information provided by
the applicant in response to the Panel request, for 59122 x
NK603 maize, for the single events and for appropriate
non-GM controls, the GMO Panel does not see a reason to
assume that crossing of NK603 maize and 59122 maize results
in an interaction of the newly expressed proteins which
causes compositional or agronomic changes. The GMO Panel
concluded that the maize 59122 x NK603 is as safe as its
non-GM counterpart and that the overall allergenicity of the
whole plant is not changed.
A higher stack of 59122 x NK603 maize, 59122 x 1507 x NK603
maize has been studied in a nutritional feeding study with
broilers and showed its nutritional equivalence with
conventional maize lines. The Panel concluded that this
study provides additional evidence that the nutritional
properties of maize 59122 x NK603 would be no different from
those of the conventional maize.
The application EFSA-GMO-UK-2005-20 concerns food and feed
uses, import and processing, but excluding cultivation in
the EU. There are no indications of increased likelihood of
establishment or survival of feral maize plants in case of
accidental release into the environment of 59122 x NK603
seeds during transportation and processing for food and feed
uses. Taking into account the scope of the application, both
the rare occurrence of sporadic feral plants and the low
levels of exposure through other routes indicate that the
risk to target and non-target organisms is negligible. The
scope of the monitoring plan provided by the applicant is in
line with the intended uses of maize 59122 x NK603 since the
environmental risk assessment did not cover cultivation and
identified no potential adverse environmental effects.
Furthermore the GMO Panel agrees with the reporting
intervals proposed by the applicant in the general
surveillance plan.
In conclusion, the Panel considers that the information
available for 59122 x NK603 maize addresses the scientific
comments raised by the Member States and that it is as safe
as its non genetically modified counterpart with respect to
potential effects on human and animal health or the
environment. Therefore the GMO Panel concludes that 59122 x
NK603 is unlikely to have any adverse effect on human or
animal health or on the environment in the context of its
intended uses.
[1] For citation purposes: Scientific Opinion of the
Panel on Genetically Modified Organisms on a request from
Pioneer Hi-Bred International on the authorisation for the
placing on the market of the insect-resistant and
herbicide-tolerant genetically modified maize 59122 x NK603,
for food and feed uses, and import and processing under
Regulation (EC) No 1829/2003. The EFSA Journal (2008) 874,
1-34
Opinion
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902200229.htm
|
|
