Applications for the placing on the market of the glufosinate-tolerant
genetically modified oilseed rape T45, for food and feed uses, import and
processing and for
renewal of the authorisation of oilseed rape T45 as existing product, both
under Regulation (EC) No 1829/2003 from Bayer CropScience.
This document provides an opinion of the Scientific Panel on
Genetically Modified Organisms (GMO Panel) of the European Food Safety
Authority (EFSA) on genetically modified oilseed rape T45 developed to
provide tolerance to glufosinate-ammonium
herbicides.

In delivering its scientific opinion, the GMO Panel considered the new
application EFSA-GMO-UK-2005-25, additional information provided by the
applicant (Bayer CropScience) and the scientific comments submitted by the
Member States. The scope of application EFSA-GMO-UK-2005-25 is for food and
feed uses, import and processing of oilseed rape T45 and all derived
products, but excluding cultivation of the crop in the EU. Information
provided in the context of the application for renewal of the authorisation
of oilseed rape T45 as existing product, submitted under Regulation (EC) No
1829/2003 (Reference EFSA-GMO-RX-T45), was also taken into account. The
scope of application EFSA-GMO-RX-T45 covers the continued marketing of
existing food additives and feed materials produced from oilseed rape T45.

A single risk assessment for all intended uses of genetically modified
oilseed rape T45 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 oilseed rape T45 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 (EFSA, 2006). 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 newly expressed protein 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 undertaken.

Oilseed rape T45 was transformed by Agrobacterium tumefaciens-mediated
gene transfer technology. Oilseed rape T45 expresses the pat gene leading to
the production of the enzyme phosphinothricin acetyl-transferase (PAT) that
acetylates L-glufosinate-ammonium. The PAT enzyme confers tolerance to
glufosinate-ammonium herbicides (trade names: LibertyŽ, IgniteŽ, FinaleŽ,
BastaŽ).

The molecular characterisation data established that only one copy of
the gene cassette (corresponding to the T-DNA region of plasmid
pHOE4/Ac(II)) is integrated in the oilseed rape genomic DNA. Appropriate
analyses of the integration site including sequence determination of the
inserted DNA and flanking regions and bioinformatic analysis have been
performed. Bioinformatic analysis of junction regions 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 insert and flanking regions of oilseed rape T45 does not raise any
safety concern, and that sufficient evidence for the stability of the
genetic modification was provided.

Analyses carried out on materials from T45 oilseed rape and its non-GM
comparators in a representative range of environments and seasons do not
provide indication of biologically relevant compositional and agronomical
changes. The GMO Panel is of the opinion that the composition of oilseed
rape T45 does not deviate from that of conventional oilseed rape varieties,
except for the introduced trait.

The PAT protein induced no adverse effects in acute dose oral toxicity
studies in rodents. In addition, the PAT protein is rapidly degraded in
simulated gastric fluid and inactivated during heat treatments.

A 42-day feeding study with broilers did not indicate differences in
the nutritional value of T45 oilseed rape versus the non-GM comparator and
confirms the nutritional equivalence of T45 oilseed rape containing diet in
comparison with a conventional diet in broiler chickens.

The applications for oilseed rape T45 concern food and feed uses,
import and processing of oilseed rape T45 and all derived products, but
excluding cultivation of the crop in the EU. There is therefore no
requirement for scientific assessment of possible environmental effects
associated with the cultivation of oilseed rape T45. There are no
indications of increased likelihood of establishment or survival of feral
oilseed rape plants in case of accidental release into the environment of
oilseed rape T45 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 oilseed rape T45 since cultivation is
excluded. The monitoring plan provided by the applicant is in line with the
EFSA Guidance document (EFSA, 2006) and the Opinion of the GMO Panel on
post-market environmental monitoring (EFSA, 2006). However, the GMO Panel
advises that appropriate management systems should be in place to minimise
accidental loss and spillage of transgenic oilseed rape during
transportation, storage, handling in the environment and processing into
derived products.

In conclusion, the GMO Panel considers that the information available
for oilseed rape T45 addresses the scientific comments raised by the Member
States and that the GM oilseed rape T45 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 oilseed
rape T45 is unlikely to have any adverse effect on human or animal health or
on the environment in the context of its intended uses.

The Panel advises that appropriate management systems are in place to
minimize accidental loss and spillage of transgenic oilseed rape during
transportation, storage and handling in the environment and processing into
derived products.


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