Agriculture Reference
In-Depth Information
3.4 EFSA Guidance for Risk
Assessment of Food and Feed from
GM Plants
agronomic, phenotypic and compositional
characteristics of a GM plant with those of
its non-GM comparator(s), grown under the
same conditions. h e relevance of the
observed intended and unintended changes
to human and animal health is then assessed
by investigating the toxicological, allergen-
icity and nutritional properties of the GM
crop. A detailed description on how this
assessment is done in the EU is available in
the EFSA guidance document (EFSA, 2011a).
h e risk assessment includes four steps:
hazard identii cation, hazard character-
ization, exposure assessment and risk
characterization. According to Codex
Alimentarius (CAC, 2007a), hazard identii -
cation is the identii cation of biological,
chemical and physical agents capable of
causing adverse health ef ects and which
may be present in a particular food and feed
or group of foods and feeds. h is i rst step
focuses on the identii cation of relevant
dif erences between the GM plant and its
non-GM comparator, taking into account
natural variation. Codex Alimentarius (CAC,
2007a) dei nes hazard characterization as
the qualitative and/or quantitative evalu-
ation of the nature of the adverse ef ects
associated with biological, chemical and
physical agents, which may be present in
food and feed. A dose-response assessment
should be performed whenever data are
obtainable. h e exposure assessment aims to
estimate quantitatively the likelihood of
exposure of humans and animals to the food
and feed derived from GM plants. In general,
an exposure assessment characterizes the
nature and size of the populations exposed
to the food and feed derived from GM plants,
together with the magnitude, the frequency
and the duration of such exposure. It is
necessary that every signii cant source of
exposure is identii ed. Finally, the risk
characterization is the qualitative and/or
quantitative estimation of the probability of
occurrence and severity of known or
potential adverse health ef ects in a given
population based on hazard identii cation,
hazard characterization and exposure
assessment (CAC, 2007a). A proper risk
characterization should also identify and
possibly quantify any uncertainty.
h e European legal framework for GMO risk
assessment requires the evaluation of any
possible ef ect on human and animal health
and on the environment that the release or
the placing on the market of any given GMO
may have. To do so, the EFSA has published
two guidance documents: one focuses on
food and feed safety - 'Guidance for risk
assessment of food and feed from genetically
modii ed plants' (EFSA, 2011a); the other
focuses on environmental risk assessment
(ERA) - 'Guidance on the environmental
risk assessment of genetically modii ed
plants' (EFSA, 2010a). Given the scope of
this topic, this chapter will focus primarily
on the food and feed safety of GM products.
We do, however, provide in Section 3.4.6 a
short summary of the ERA approach
adopted by the EFSA.
h e current food and feed risk assessment
strategy for GM plants and derived products
(EFSA, 2011a) seeks to deploy methods and
approaches to compare GM plants and
derived products with their appropriate
non-GM comparators. h e underlying
assumption of this comparative approach is
that traditionally cultivated non-GM crops
have gained a history of safe use for
consumers and/or domesticated animals.
h ese traditionally cultivated crops can thus
serve as comparators when assessing the
safety of GM plants and derived products.
h e introduction of gene(s) in a plant by
genetic modii cation has the objective to
introduce, in the recipient plant, novel
characteristics of interest. h ese char-
acteristics are the so-called 'intended ef ects'
or 'introduced traits' that fuli l the original
objectives of the genetic modii cation. At
the same time, the insertion of genes may
result also in other, additional ef ects in the
recipient plant, going beyond the intended
ef ect(s) of the genetic modii cation: the
so-called 'unintended ef ects'. Unintended
ef ect(s) are potentially linked to genetic
rearrangements or metabolic perturbations
af ecting dif erent pathways (see Chapter 2).
Both intended and unintended dif-
ferences are identii ed by comparing the
 
 
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