applications are more acceptable than others. For
example, according to the European Federation of
Biotechnology, the use of biotechnology to change
plants was considered more acceptable than using it
to change animals. In addition, around 85% of inter-
viewees said that food obtained with genetic tech-
niques should be clearly labeled. It will be necessary,
therefore, to develop programs to educate the public
about the benefits and problems of biotechnology in
the production and processing of food. Governments
and scientific institutions must be encouraged to
share knowledge on transgenic foods with society,
such that people are well informed about the impact
of biotechnology on the environment, food safety,
sustainability, and global food safety. In addition, as
with any technology, there are limits that will and
must be subjected to law. Countries must be helped
to develop appropriate legislation and to set up
proper regulatory bodies for all aspects of biosafety.
Appropriate regulation is a prerequisite from the
point of view of both the general public and the
food industry.
0040 In the USA, there are three organizations respon-
sible for controlling GM organisms and products.
The Environmental Protection Agency (EPA) and
the United States Department of Agriculture (USDA)
oversee the effects of GM organisms on the environ-
ment and on plant production. The Food and Drug
Administration (FDA) is responsible for overseeing
the safety of food, which is determined by the charac-
teristics of the consumed or processed product rather
than the method by which it was produced. The FDA
policy statement also addresses the labeling of foods
obtained from new plant varieties. It states that label-
ing is only required when a food obtained from a GM
variety differs from that obtained from a conven-
tional counterpart.
0041 Nowadays, in Europe, there is no equivalent over-
all agency for food regulation, although a European
Institute will be in operation in the near future. Until
this time, the European Commission has therefore
proposed harmonizing regulation between member
states. The Council of the European Community
(EC) adopted the Directive 90/220/EC on the deliber-
ate release into the environment of GM organisms.
This directive had two main objectives: to protect
human health and the environment and to provide a
harmonized regulatory framework of GM organisms
with the EC.
0042 In the EC, the safety of GM foods is controlled by
Regulation (EC) No. 258/97 concerning novel foods
and novel food ingredients, and the labeling of GM
foods is regulated by two regulations, with important
differences with American Regulations. First, Com-
mission Regulation (EC) No. 49/2000 establishes that
the foodstuffs shall not be subject to the additional
specific labeling requirements when the material de-
rived from the GM organisms is present in a propor-
tion no higher than 1% of the food ingredients
individually considered or food comprising a single
ingredient, or this presence is adventitious. Second,
Commission Regulation (EC) No. 50/2000 estab-
lishes the labeling of foodstuffs and food ingredients
containing additives and flavorings that have been
genetically modified or have been produced from
GM organisms. In addition, novel foods and GM
foods also have to fulfill the general labeling require-
ments set out in the Directive 2000/13/EC, which
deals with an approximation of the laws of the
Member States relating to the labeling, presentation,
and advertising of foodstuffs.
0043With so many foods traded internationally, there is
a clear need to reach a harmonized approach to label-
ing GM foods if potential trade barriers are to be
eliminated. Therefore, it will be necessary to develop
international safety guidelines.
0044In 1990, Food and Agriculture Organization (FAO)
and the World Health Organization (WHO) took the
first steps towards international harmonization of the
food safety assessment of GM foods. It was recom-
mended that the safety assessment of foods produced
by biotechnology should take into account the mo-
lecular, biological, and chemical characteristics of
these foods. The 1996 FAO/WHO report defined
substantial equivalence as ‘established by a demon-
stration that if the characteristics assessed for the GM
organisms, or the specific food product derived there-
from, are equivalent to the same characteristics of the
conventional food, then it can be assumed that the
new food is as safe as the conventional equivalent.’ In
1999, the FAO/WHO of Codex Alimentarius estab-
lished the Codex Ad Hoc Intergovernmental Task
Force on Foods derived from Biotechnology to elab-
orate norms and guidelines for the foods derived from
biotechnology. The Task Force held its first session in
March 2000, and approved the elaboration of major
texts with a set of broad general principles for risk
analysis and specific guidance on the risk assessment
of foods derived from biotechnology. It will also have
to prepare a list of available analytical methods in-
cluding those for the detection or identification of
these kinds of foods.
0045The Task Force agreed that the labeling was
covered by the Codex Committee on Food Labeling,
and the environmental risk was addressed by other
bodies such as the Cartagena Biosafety Protocol
under the Convention on Biological Diversity, the
International Plant Protection Convention, and the
Commission on Genetic Resources for Food and
Agriculture.
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