Parma Italy
December 1, 2008
Source:
European Food Safety
Authority (EFSA)
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
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