Agriculture Reference
In-Depth Information
unintended ef ect might occur, for example,
in a scenario in which an intrinsic gene of
the host plant has been disrupted by the
insertion of 'foreign DNA' by the genetic
modii cation process into this gene, while a
number of other mechanisms can also be
envisaged (e.g. disruption of regulatory
sequences). Second, comparison of the
compositional data may also help to assess
the possible nutritional impact should the
observed changes in composition af ect the
nutritional value to an extent that reaches
beyond the natural background variability
within that specii c crop.
herbicide to which the plant has been
rendered tolerant (besides plants not treated
with this herbicide but in the same way as
the conventional counterpart) may be
considered in some cases.
With regard to the i eld trial design, the
Codex Alimentarius guideline states that the
choice for the number and locations of the
i eld trial sites, as well as the number of
seasons, should represent the range of
environmental conditions that the com-
mercialized crop will be exposed to. Each
location should be replicated, which means
that it should contain multiple blocks, each
with plots for the various test, counterpart
and reference crops and their treatments
(Codex Alimentarius, 2008).
As noted above, the extensive comparative
analysis that is usually carried out in the
frame of the pre-market safety assessment
of GM crops comprises a range of agro-
nomic, phenotypic characteristics of the
plant that, besides the intended ef ects of
the genetic modii cation, help to identify
potential unintended ef ects. In this
section, we will focus on the compositional
part of this analysis, as well as the design of
the i eld trials used to produce samples for
analysis and the interpretation of the
outcomes.
h e European Food Safety Authority's
(EFSA) guidance for GM plants (EFSA,
2011) is further considered here besides the
Code Alimentarius guideline because it
expands on this guideline by providing more
details and elaborating on methodologies.
For example, the EFSA guidance notes that
preferably the analysis is to be carried out
on the raw agricultural commodity, as
this will be the main source material entering
the food and feed production chains.
When appropriate, additional compositional
analysis of the derived and processed food
and feed products can be considered. h is
may be the case when processing or
preserving steps that are typically used
during production alter the properties of the
GM end product as compared to the
conventional counterpart (EFSA, 2011).
With regard to the parameters to be
measured during the compositional analysis,
the Codex Alimentarius guideline recom-
mends that the 'key components' are
analysed in the GM crop and in its counter-
part (i.e. the control crop). It further explains
that these key components include key
nutrients and anti-nutrients that have a
substantial impact on the overall diet and
that are typical of the crop and the crop-
derived feeds/foods (Codex Alimentarius,
2008). h e EFSA guidance further explains
For the purpose of the comparative
compositional analysis, i eld trials are
typically carried out in multiple locations
during which the GM crop and its counter-
part are grown together in the same localities
and under the same conditions, as recom-
mended by the Codex Alimentarius guideline
(Codex Alimentarius, 2008). h is will help to
rule out all kinds of confounding environ-
mental factors that might occur when the
crops to be compared are grown in separate
places and to ensure that the dif erences
observed can be ascribed to the genetic
modii cation. In the case of herbicide-
tolerant GM crops, the Codex Alimentarius
guideline indicates that an additional group
of GM plants treated with the target
