Agriculture Reference
In-Depth Information
Allergenicity assessment of the whole
GM plant
When the plant receiving the new gene(s) is
known to be allergenic, its allergenicity is
compared with that of the appropriate
non-GM comparator(s), taking into account
natural variation. For this comparison, the
approach to follow depends on the available
information on the allergenicity of the
recipient plant. Possible proposed approaches
are: the use of analytical methodologies in
conjunction with human sera; the inclusion
of allergens among the endpoints tested
in the compositional analysis; and immuno-
logical testing with sera collected from
animals sensitized experimentally (EFSA,
2011a).
h e conclusion of the allergenicity assess-
ment provides information on: (i) the
likelihood of the newly expressed protein(s)
to be allergenic; and (ii) the likelihood of the
GM plant to be more allergenic than the
non-GM comparator.
lactation cycle for dairy cows and the laying
cycle for hens or quails (see Chapter 5).
Growth studies with aquatic species, such as
carp, are preferable for feedstuf intended
only for aquaculture.
h e experimental design and statistical
analysis of feeding studies depends on the
choice of animal species, the type of plant
trait(s) studied and the magnitude of the
expected ef ect. Endpoint measurements
vary according to the target species used in
the study and should include data on animal
health and welfare, animal losses, feed
intake, body weight and animal performance
(see Chapter 5).
h e nutritional assessment addresses not
only the nutritional relevance in the total
diet for the consumers/animals of the newly
expressed protein(s) (the intended ef ect of
the genetic modii cation) but also the
nutritional relevance of other possible new
constituents, and the changes in the levels
of endogenous constituents in the GM plant
and derived food and feed (the potential
unintended ef ects of the genetic modii -
cation).
h e conclusion of the nutritional assess-
ment of food and feed derived from GM
plants provides information on: (i) the
nutritional proi le of the GM plant and
derived products as compared to the
non-GM comparator; and (ii) the altered
nutrient levels in the GM-derived products
that impact the anticipated intake and
nutritional properties of the food and feed
(EFSA, 2011a).
Food and feed derived from GM plants
intended to be placed on the EU market
should not be nutritionally disadvantageous
to humans and animals. If the outcome of the
comparative compositional assessment does
not indicate a relevant dif erence between
the GM plant and its non-GM comparator(s),
except for the introduced trait(s), nutritional
equivalence can be inferred and no further
nutritional studies are needed (see also
Chapter 4). If this cannot be demonstrated,
animal feeding studies are necessary. For
example, in the case of GM plants having an
altered content of nutrients, animal studies
with model or target species (e.g. poultry,
pigs, ruminants, i sh, etc.) are performed in
order to determine the bioavailability of
individual nutrients and their impact on
animal performance and feed safety (see
Chapters 5-8).
Properly designed animal feeding studies
should span the growing or the i nishing
period to slaughter for chickens, pigs and
cattle and should cover the major part of the
Environmental risk assessment (ERA) is an
integral part of the safety assessment of GM
plants and derived products. Although the
ERA is always carried out for each GM plant
application submitted to the EFSA, the
amount of data requirement increases if the
GM crop is expected to be cultivated in the
EU (EFSA, 2010a).
h e ERA is based on the
biological and ecological characteristics of
the plant, the nature of the introduced
trait(s), the receiving environment in which
the plant will be introduced and the scale
