Types of Feeding Studies for Nutritional and Safety Assessment of Feeds from GM Plants - Animal Nutrition with Transgenic Plants - page 66

been published (Clark and Ipharraguerre et
al ., 2001; Flachowsky and Aulrich, 2001;
Aumaitre et al ., 2002; Flachowsky et al .,
2005a, 2007; CAST, 2006; Spiekers et al .,
2009) and are described in more detail in
Chapter 6. Furthermore, the ILSI (2003)
and EFSA (2006, 2008, 2011a) documents
also summarize the present state of
knowledge in the feeding of GM plant-
derived feed of the i rst generation to target
animals. In the ILSI document (ILSI, 2003),
protocols for evaluating feedstuf s from GM
plants with input traits in poultry for meat
and egg production, pigs, lactating dairy
cows and growing and i nishing ruminants
are given.
h e necessity of animal feeding studies
with feed from i rst-generation GM plants,
or of substantial equivalent plants, is often
questioned concerning their sensitivity and
scientii c output. According to various
guidance documents (EFSA, 2006, 2008,
2011a), such studies are not needed urgently
for nutritional assessment and are not
required for safety assessment. No animal
feeding studies are required if the dif erences
in compositional analyses between isogenic
and transgenic plants are small or negligible
(i rst-generation GM plants; see Chapter 4).
h e scientii c yield of such studies is
considered as negligible by some authors
(EFSA, 2008, 2011a).
On the other hand, feeding experiments
with target animals with i rst-generation
GM plants may contribute towards showing
the public the nutritional equivalence and
safety of the feed, and therefore they could
improve the public's acceptance of GM feed.
Furthermore, recommendations for optimal
amounts of feed from GM plants in target
animal feeding may be deduced.
Another point is the so-called wastage of
animals (the '3Rs'; Russell and Burch,
1959). Under the present regulations, only
animals fed with non-permitted GM feed
cannot be used in the food chain. h is
means that if a GM feed with its isogenic
counterpart and four commercial varieties
are tested in a feeding study, more than
80% of target animals can be used for
human nutrition. h erefore, ei ciency
feeding studies with i rst-generation GM

plants could be useful in some cases (see
Tables 5.3 and 5.4).
More details on conducting animal feed-
ing studies to evaluate GM crops modii ed
for input traits (i rst-generation GM crops)
are described in detail by ILSI (2003), the
EFSA (2011a) and in Chapter 6.

5.5.3 Effi ciency studies including transfer
of nutrients with GM plants with output
traits (second generation)

More and other feeding studies are necessary
for the nutritional assessment of food/feed
from second-generation GM plants (so-
called plants with substantial changes in
composition, plants with output traits, or
plants with improved nutritional quality or
so-called 'biofortii ed' plants; see Chapters 7
and 12). h e principle of substantial
equivalence as used for the safety and
nutritional assessment of feed from i rst-
generation GM plants does not have adequate
relevance for feed with substantial changes
in composition (ILSI, 2004, 2007; EFSA,
2008; Llorente et al ., 2011). ILSI (2004)
mentioned various examples of modii cations
by biotechnology and distinguished in the
following groups (see also Chapters 7 and
12):
 Proteins and amino acids.
 Carbohydrates.
 Fibre and lignins.
 Oils/lipids/fatty acids.
 Vitamins and minerals.
 Nutraceuticals.
 Anti-nutrients.
 Allergens and substances causing food/
feed intolerance.
 Toxins.
Specii c studies are necessary to demonstrate
the ef ects of genetic modii cation on the
nutritional value of feeds. Experimental
designs for such studies with second-
generation GM crops are described in detail
by the EFSA (2008, 2011a), Flachowsky and
Böhme (2005) and ILSI (2007). King (2002)
described a three-step process for evaluating
plant biofortii cation in human nutrition
(see also Chapter 7). Flachowsky and Böhme