Opinion of the Scientific Panel on
Genetically Modified Organisms on
applications (references EFSA-GMO-UK-2005-19
and EFSA-GMO-RX-GA21) for the placing on the
market of glyphosate-tolerant genetically
modified maize GA21, for food and feed uses,
import and processing and for renewal of the
authorisation of maize GA21 as existing
product, both under Regulation (EC) No
1829/2003 from Syngenta Seeds S.A.S. on
behalf of Syngenta Crop Protection AG [1]
Question
number: EFSA-Q-2005-226 and
EFSA-Q-2007-147
Adopted on
13/09/2007
Published on 02/10/2007
Published on 02/10/2007
Summary
(source:
http://www.efsa.europa.eu/EFSA/Scientific_Opinion/gmo_ej541_GA21Maize_summary_en,0.pdf)
This
document provides the opinion of the
Scientific Panel on Genetically Modified
Organisms (GMO Panel) of the European
Food Safety Authority (EFSA) on
herbicide-tolerant genetically modified
maize GA21 (Unique Identifier
MON-ØØØ21-9) developed to provide
tolerance to glyphosate by expressing a
modified version of the EPSPS protein.
In
delivering its opinion the GMO Panel
considered the new application
EFSA-GMO-UK-2005-19, additional
information provided by the applicant
(Syngenta Seeds on behalf of Syngenta
Crop Protection AG) and the scientific
comments submitted by the Member States.
The scope of application
EFSA-GMO-UK-2005-19 is for food and feed
uses, import and processing of maize
GA21 and all derived products, excluding
cultivation. Information provided in the
context of the application for renewal
of the authorisation of maize GA21 as
existing product, submitted under
Regulation (EC) No 1829/2003 (Reference
EFSA-GMO-RX-GA21), was also taken into
account. The scope of application
EFSA-GMO-RX-GA21 covers the continued
marketing of existing food additives,
feed materials and feed additives
produced from maize GA21.
A single
risk assessment for all intended uses of
maize GA21 has been performed by the GMO
Panel and one single scientific opinion
for both applications submitted under
Regulation (EC) No 1829/2003 is issued.
The GMO Panel assessed maize GA21 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. The scientific assessment included
molecular characterization of the
inserted DNA and expression of the new
protein. A comparative analysis of
agronomic traits and composition was
undertaken and the safety of the new
protein and the whole food/feed was
evaluated with respect to nutritional
quality, potential toxicity and
allergenicity. An assessment of
environmental impacts and the
post-market environmental monitoring
plan were undertaken.
Maize GA21
was transformed by particle bombardment
of maize cells and expresses a modified
EPSPS (5-enol
pyruvylshikimate-3-phosphate synthase)
protein. The molecular characterisation
data established that maize GA21
contains a single insert having four
intact and two truncated fragments of
the introduced DNA. Appropriate analyses
of the integration site including
flanking sequences and bioinformatic
analysis have been performed.
Bioinformatic analysis of the insert and
junction regions demonstrated the
absence of any ORF potentially coding
for known toxic or allergenic
proteins.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
insert and flanking regions of maize
GA21 does not raise safety concerns, and
that sufficient evidence for the
stability of the insert structure was
provided.
Based on
the results of compositional analysis of
samples from a representative range of
environments and seasons, the GMO Panel
concludes that forage and kernels of
maize GA21 are compositionally
equivalent to those of conventional
maize, except for the presence of the
mEPSPS protein. In addition, field
trials did not show changes in
phenotypic characteristics and agronomic
performance except for the introduced
trait.
The mEPSPS
protein did not induce adverse effects
in a study on acute oral toxicity in
mice. There were no adverse effects in a
subchronic (90-day) feeding study with
rats fed diets including kernels from
maize GA21. A feeding study on broiler
chickens provided evidence of
nutritional equivalence of maize GA21 to
conventional maize. In addition the
overall allergenicity of the whole plant
is not changed. The GMO Panel is of the
opinion that maize GA21 is as safe as
conventional maize. Maize GA21 and
derived products are unlikely to have
any adverse effect on human and animal
health in the context of the intended
uses.
The
applications for maize GA21 concern food
and feed uses, import and processing of
maize GA21 and all derived products.
There is therefore no requirement for
scientific assessment of possible
environmental effects associated with
the cultivation of maize GA21. There are
no indications of increased likelihood
of establishment or survival of feral
maize plants in case of accidental
release into the environment of GA21
seeds during transportation and
processing. The scope of the post-market
environmental monitoring plan provided
by the applicant is in line with the
intended uses of maize GA21.
In
conclusion, the GMO Panel considers that
the information available for maize GA21
addresses the scientific comments raised
by the Member States and that maize GA21
is as safe as its non genetically
modified counterparts with respect to
potential effects on human and animal
health or the environment. Therefore the
GMO Panel concludes that maize GA21 is
unlikely to have any adverse effect on
human and animal health or on the
environment in the context of its
intended uses.
Opinion
http://www.efsa.europa.eu/EFSA/Scientific_Opinion/gmo_op_ej541_GA21Maize_en,0.pdf
[1] For
citation purposes: Opinion of the
Scientific Panel on Genetically Modified
Organisms on applications (references
EFSA-GMO-UK-2005-19 and
EFSA-GMO-RX-GA21) for the placing on the
market of glyphosate-tolerant
genetically modified maize GA21, for
food and feed uses, import and
processing and for renewal of the
authorisation of maize GA21 as existing
product, both under Regulation (EC) No
1829/2003 from Syngenta Seeds S.A.S. on
behalf of Syngenta Crop Protection AG,
The EFSA Journal (2007) 541, 1-25.