Agriculture Reference
In-Depth Information
h e hazard identii cation and char-
acterization, as performed in the EU,
includes the molecular characterization of
the GM plant, its food and feed safety
evaluation and its environmental impacts.
h ese three components, together with the
exposure assessment, allow characterizing
the risk associated to any given GM plant
and its derived products by addressing the
following aspects:
1.
Characteristics of the donor organisms
and recipient plant.
2.
Genetic modii cation and its functional
consequences.
3.
Agronomic and phenotypic character-
istics of the GM plant.
4.
Compositional characteristics of GM
plants and derived products.
5.
Potential toxicity and allergenicity of
gene products (proteins, metabolites) of the
whole GM plant and its derived products.
6.
Anticipated intake and potential for
nutritional impact.
7.
Inl uence of processing and storage on
the characteristics of the derived products.
8.
Environmental impact of the GM plant.
inserted nucleic acid sequence(s), the
genomic location where the sequence(s) is/
are inserted (insertion site(s)), the possible
genomic alteration(s) due to the insertion of
the sequence(s) and the expression and
stability of the inserted sequence(s).
The comparative approach
As described above, the foundation of the
food and feed safety evaluation is the
comparative assessment which identii es
dif erences in compositional, agronomic and
phenotypic characteristics between the GM
plant and derived products with respect to
its non-GM comparator, taking into account
the natural variation of the measured
characteristics.
h e EFSA 'Guidance for risk assessment
of food and feed from genetically modii ed
plants' (EFSA 2011a) provides detailed
guidance on how to perform such com-
parative assessment. In particular, the
EFSA's approach requires the simultaneous
application of two complementary statistical
tests: the test of dif erence and the test of
equivalence (EFSA, 2010b). h e test of
dif erence is used to verify whether the GM
plant, apart from the introduced trait(s), is
dif erent from its non-GM comparator. h e
test of equivalence is used to verify whether
the agronomic, phenotypic and com-
positional characteristics of the GM plant
fall within the range of natural variation,
estimated from a set of non-GM reference
varieties with a history of safe use included
in the i eld trial. h e combination of these
two statistical tests allows the objective
quantii cation of the degree of similarity
between the GM plant and its non-GM
comparator, taking into account natural
variability.
h e test materials (grain, forage, etc.)
necessary to perform the comparative
assessment (see Chapter 4) must be obtained
from appropriately designed i eld trials in
which the GM plant is grown together with
its non-GM comparator and selected
non-GM reference varieties. Until 2011, the
h e i rst step of the risk assessment of GM
plants and derived products is the
comprehensive molecular characterization
of the GM plant in question. h e objective of
this characterization is to gather information
on the structure and expression of the
insert(s) and on the stability of the intended
trait(s) to characterize the intended changes
and to identify any potential unintended
change. If present, these unintended
changes, linked to the interruption of endo-
genous genes or to the possible production
of new toxins or allergens, are further
investigated in the relevant complementary
part(s) of the risk assessment process.
h e information required to perform the
molecular characterization concerns both
the genetic modii cation itself and the actual
GM plant resulting from the transformation.
h is information focuses on the trans-
formation method, the characteristics of the
