Agriculture Reference
In-Depth Information
be made between uncertainty and variability.
Uncertainty is linked to knowledge gaps or
lack of data. Variability refers to variation
that exists in reality; for example, individual
variation in food consumption or varying
concentrations of compounds in dif erent
food items. Uncertainty can be reduced
through research, whereas variability cannot
since it is an intrinsic property of a system.
As pre-market risk assessment studies
cannot fully reproduce the diversity of
consumers (human or animals), the
possibility that unpredicted side ef ects may
occur in some individuals - such as those
with certain disease states, those with
particular genetic/physiological character-
istics or those who consume the products at
high levels - remains. In such cases, a post-
market monitoring (PMM) programme can
be used to verify if the outcome of the
pre-market risk assessment is coni rmed in
reality. Most GM plants that have been
evaluated by the EFSA to date did not require
PMM; however, this may change in the
future with the increasing complexity of
new generations of GM plants targeting
signii cant compositional or physiological
changes (see Chapter 7).
import and processing for food and feed or
industrial uses (66%), implying that these
GM plants are not going to be cultivated
within the EU. Some GM plant applications
are intended for deliberate release in the EU
(15%), implying that these GM plants are
going to be cultivated within the EU, if
authorized.
If an applicant wishes to continue to
market an authorized GM plant after the
original 10-year approval decision, the GM
plant must be reassessed by the EFSA prior
to any renewal authorization decision by the
European Commission and EU member
states. At present, the EFSA has received a
total of 23 renewal applications for GM
plants (19%).
Modern biotechnology broadens the
possibilities of genetic changes that can be
introduced into organisms used for the
production of human food and animal feed.
All over the world, many countries have put
in place dif erent regulatory frameworks to
assess the safety of GM plants and derived
products. h e statutory and non-statutory
approaches regulating food and feed derived
from GM plants may dif er across countries,
but the criteria used to assess the safety of
these products is generally consistent from
one country to another. h is is probably
attributable to the concerted ef orts made
by dif erent forums created to develop
internationally agreed approaches and
standards to assess the safety and the impact
of GM food and feed on human and animal
health.
h e
Codex Alimentarius Commission
(CAC), established by the Food and
Agriculture Organization of the United
Nations (FAO) and the World Health
Organization (WHO), now with 180 member
governments, published the 'Principles for
the risk analysis of food derived from
modern biotechnology' (CAC, 2011) and the
'Guideline for the conduct of food safety
assessment
Food and Feed Uses
Currently, several GM plants and derived
products are placed on the EU market, and
an increasingly growing number of
applications are entering the approval
process (EC, 2012). At the time of writing of
this chapter (February 2013), a total of 123
applications for GM plants have been
submitted to the EFSA (EFSA, 2012c) under
one of the two relevant legislations:
Regulation (EC) No 1829/2003 and
Directive 2001/18/EC. h ese applications
cover a diversity of crops (mostly maize,
followed by cotton and soybean) and traits
(mostly herbicide tolerance, insect
resistance, or a combination of the two).
Other traits include: drought tolerance in
maize, altered oleic acid content in soybean,
or reduced amylose content in potato (Fig.
3.1). Most GM plant applications are for
of
food
produced
using
