Agriculture Reference
In-Depth Information
EFSA required the use of non-GM lines with
comparable genetic background (near-
isogeneic lines in the case of sexually
propagated crops and isogenic lines in the
case of vegetatively propagated crops) as
comparators in the evaluation of GM plant
applications. h ese non-GM comparators,
dei ned as conventional counterparts, are
derived from the breeding scheme used to
produce the GM plant. In 2011, although
the conventional counterpart remains the
non-GM comparator of choice for the
assessment of GM plants in the EU, the
EFSA developed the 'Guidance on the
selection of comparators for the risk
assessment of genetically modii ed plants
and derived food and feed' (EFSA, 2011b) to
address the new challenges imposed by the
increasing complexity of breeding schemes
that did not always allow the production of a
conventional counterpart but for which a
i t-for-purpose alternative comparator could
be identii ed.
Nevertheless, there will be cases where
no suitable comparator exists. For instance,
when the food and feed derived from a GM
plant is not closely related to a food and feed
with a history of safe use, or when a specii c
trait or a specii c set of traits are introduced
with the intention of signii cantly changing
the composition or the physiology of the
plant (see Chapters 5-7). In all these cases, a
comparative risk assessment cannot be
performed and a comprehensive safety and
nutritional assessment of the GM plant and
derived products needs to be carried out.
include, in general terms, the analysis of
proximates, key macro- and micronutrients,
anti-nutritional compounds, natural toxins
and allergens, as well as other plant
metabolites relevant for the specii c plant
species. h e vitamins and minerals selected
for analysis should be those present at levels
which are nutritionally signii cant and/or
those with a nutritionally signii cant con-
tribution to the diet at the levels at which
the plant or its derived products are
consumed.
Depending on the intended ef ect(s) of
the genetic modii cation, on the nutritional
value and on the intended use of the GM
plant, additional compositional analyses on
specii c compounds may be required. For
example, in the case of oil-rich GM plants, a
fatty acid proi le for the main saturated
monounsaturated and polyunsaturated
fatty acids should be included. Whereas, in
the case of GM plants intended to be used as
an important protein source, an amino acid
proi le on individual amino acids and main
non-protein amino acids should be included.
h e analysis of specii c metabolites may also
be relevant in case the genetic modii cation
alters metabolic pathways af ecting the
physiology of the plant.
Depending on the outcome of the
compositional analysis, and in particular
whenever relevant changes between the
GM plant and its non-GM comparator
are identii ed, further toxicological and
nutritional assessments are required.
Agronomic and phenotypic characteristics
h e safety of the agronomic and phenotypic
characteristics of the GM plant is also
assessed following the comparative approach.
A variety of endpoints are analysed,
including: yield, l owering time, day degrees
to maturity, duration of pollen viability,
sensitivity to biotic and abiotic stress, etc.
Where specii c agronomic characteristics
are the objective of the intended
modii cation (e.g. a genetic modii cation
conferring drought tolerance), additional
studies under relevant selected conditions
are required (e.g. in the case of drought
tolerance, the performance of the GM plant
Compositional analyses
h e comparative compositional analysis is
usually performed on the raw agricultural
commodity, as this represents the main
point of entry of the material into the food
and feed chain (see also Chapter 4).
Additional analysis of processed products is
conducted where appropriate, on a case-by-
case basis. h e compositional analysis is
carried out on an appropriate range of
compounds selected in accordance with the
OECD consensus documents on com-
positional considerations for new plant
varieties (OECD, 2012b). h ese compounds