EUROPEAN
COMMISSION
Environment fact sheet:
genetically
modified
organisms
• Genetic modification of micro-organisms,
plants and animals has existed since the
1970s.
• Genetically modified (GM) crops grow on a
quarter of the land under cultivation worldwide and some GM products or GM organisms (GMOs) have already been marketed in
the European Union.
• However, genetic modification raises widespread public concern in terms of health and
environmental protection.
• United Nations conventions address these
concerns. The World Trade Organisation
(WTO) deals with trade in GM products. The
European Union (EU) is both party to the
UN conventions (e.g. on biosafety) and a key
actor in the WTO.
• The European Union’s GMO legislation is
the strictest in the world. The EU has been
legislating on GMOs since the early 1990s
and has recently modernised its legislation.
GM crops — a quarter
of all land cultivated
in the world
Worldwide, about 672 million
acres of land are under cultivation, of which 25 % or 167.2
million acres — an area greater
than twice the size of the United
Kingdom — consisted of GM
crops in 2003. Since 1996, the
United States has consistently
planted more GM crops than any
other country, with 105.7 million
acres supporting GM crops in
2003. Argentina is the next largest producer, with 34.4 million
acres, followed by Canada with
10.9 million acres, Brazil with
8.4 million acres, China with 6.9
million acres, and South Africa
with 1.0 million acres in 2003.
Together, these six countries grew
99 % of the global GM crop area.
Australia, Mexico, Romania, Bulgaria, Spain, Germany, Uruguay,
Indonesia, the Philippines, India,
Columbia, and Honduras planted
significant acreage in GM crops
in 2003.
The number of farmers planting
GM crops has also increased over
the past three years. In 2000,
3.5 million farmers planted GM
crops. That number has nearly
doubled, to an estimated total
of 7 million farmers planting GM
crops in 2003. More than 85 %
of the farmers who planted GM
crops in 2003 were resource
poor, including Chinese and
South African Bt cotton growers.
Fact 1: Biotechnology and life sciences are
important for the future of mankind
There are currently over 6.4 billion people living on the planet, a figure which
is increasing by 77 million each year. By 2050, the United Nations estimates
that total world population will be over 9.3 billion. The bulk of this population
growth will occur in the economically developing world, where today over 1.2
billion people, mainly women and children, are living in extreme poverty.
Life sciences and biotechnology can help produce agronomically enhanced
crops which have the potential to play a major role both:
• feeding the world’s growing population and preventing diseases; and
• improving the environment and promoting sustainable agricultural practices throughout the world, as enhanced crops require less chemical pesticides, fertilisers and drugs.
Advances in biotechnology can also result in major healthcare benefits,
allowing for the production of cheaper, safer drugs in large quantities. Personalised and preventive medicines based on genetic predisposition, targeted screening, and innovative drug treatments are among the possibilities on
offer.
Fact 2: Genetic modification has
existed since the 1970s
Genetic modification — also known as ‘genetic engineering’ or ‘recombinant
DNA technology’ — is a method to introduce novel characteristics to microorganisms, plants and animals. It allows selected individual genes to be
transferred from one organism into another, and also between non-related
species.
The European Union defines genetically modified organisms (GMOs) as organisms in which genetic material (DNA) has been altered in a way that does
not occur naturally by mating or natural recombination.
The most common types of GMOs are genetically modified crop plant species and include genetically modified maize, soybean, oilseed rape and cotton
varieties. Such varieties have, in the main, been genetically modified to provide resistance to certain insect pests and tolerance to specific herbicides.
Some fruits have been genetically modified to delay ripening. Some fish
(e.g. salmon) have been genetically modified to become more resistant to
cold. Genetically modified micro-organisms, which are living microscopic
entities, are used in the production of numerous vitamins, flavourings and
additives.
Fact 3: Genetic modification raises
widespread public concern
Over time, genetic modification has raised widespread public concern about
the possible impact on human health and the environment. For example,
people ask whether crops engineered to resist pesticides and herbicides might
not increase reliance on those chemicals and damage environments, pass the
new tolerances on to weeds, and ultimately diminish biological diversity?
In June 1992, the UN conference on environment and development (the
‘Earth Summit’), held in Rio de Janeiro, Brazil, introduced the precautionary
principle in its declaration: ‘Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be used for postponing costeffective measures to prevent environmental degradation’.
Also in 1992, the UN signed a Convention on Biological Diversity which
states as its objectives ‘the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits
arising out of the utilisation of genetic resources’. An outcome of this conven-
tion was the Cartagena Protocol on Biosafety in transboundary movement, transit,
handling and use of all living modified organisms, which entered into force on
11 September 2003. This protocol recognises the specificity of trade in biotechnology and the right to treat GMOs in a cautious way.
Fact 4: Genetic modification
is also a trade issue
Biotechnology is also addressed by the World Trade Organisation (WTO),
which sets global rules of trade between nations.
Three agreements were adopted by the WTO:
• on sanitary and phytosanitary measures (SPS), which requires that a government wishing to regulate a GMO must justify the regulation with a risk
assessment based on scientific evidence that the organism is a threat (but
lack of reliable and long-term data is precisely what has raised concerns
about GMOs);
• on technical barriers to trade (TBT), which requires that product regulations
use the least-trade-restrictive means to accomplish their goals, and that
they conform to international standards;
• on trade-related aspects of intellectual property rights (TRIPS), which enhances the commercial rights of patented GMO products, potentially conflicting with biodiversity and food security concerns.
Fact 5: The European Union has the strictest
legislation in the world
The European Union has been legislating on GMOs since the early 1990s, to
achieve a high degree of protection of its citizens’ health and the environment
while simultaneously creating a unified market for biotechnology. It is party
to the Cartagena Protocol on Biosafety. It is also one of the key players in the
WTO, where the European Commission negotiates on behalf of the Union’s
25 Member States.
In the light of scientific developments and social concerns, the EU has
created a new legal framework which entered into force in April 2004. It is
the strictest GMO legislation in the world as it seeks to ensure that GMOs and
GM products authorised in the EU do not in any way hamper human health
and the environment. It covers the issues listed below.
1. Deliberate release of GMOs into the environment (experimental releases, cultivation, import, transformation of GMOs into industrial products) — The EU
lays down authorisation procedures for deliberate release of GMOs and for
placing them on the market. It establishes a common methodology for risk
assessment and a safety mechanism. It also introduces mandatory public
consultation and GMO labelling. It contains a ‘safeguard clause’, which
provides that where a Member State has justifiable reasons to consider
that a GMO, which has received written consent for placing on the market,
constitutes a risk to human health or to the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory
(Directive 2001/18/EC).
2. Placing on the market of GMO food and feed products — A regulation on food
containing GMOs provides for a stricter regulatory environment. It will also
be applied to feed containing GMOs, and will provide a more appropriate
response to the concerns of economic operators and consumers. The new
regulation is also concerned with environmental protection, setting out
measures to be taken in the event of environmental problems (Regulation
(EC) No 1829/2003).
3. Traceability and labelling of GMOs and traceability of food and feed products
— A regulation stipulates that traceability will be required throughout the
food chain. This measure has two main objectives: first, to inform con-
Authorising GMOs in
the EU — the toughest
procedure in the world
EU legislation on GMOs provides
for specific authorisation procedures. Only GMOs that have
been positively assessed through
these procedures can be placed
on the market in the European
Union. GMOs which have not
been through these authorisation
procedures are strictly forbidden.
For example, under Directive
2001/18/EC on the deliberate
release of GMOs into the environment, a company intending to
market a GMO must first obtain
a written authorisation through a
procedure involving the competent authorities of all 25 Member States, the Commission and
the European Food Safety Authority. The public can give its
comments via the Internet at
http://gmoinfo.jrc.it/. As of 27
July 2005, one GMO product has
been authorised under this directive and 18 other products had
been authorised, between 1992
and 1998, under the former directive (90/220/EEC).
Twenty-eight genetically modified food and feed products have
also been entered into the public
‘Community register of GM food
and feed’. The ‘Community register of GM food and feed’ provides
product information such as the
name of the authorisation holder,
the exact scope of the authorisation, links to relevant risks assessments and the date of entry
on the EU market.
The challenge now is to implement this new legislative framework which
provides for very rigorous authorisation procedures (see box on page 3). Discussions are still taking place on practical management measures such as
coexistence between crops and labelling thresholds for GMOs in conventional
seeds.
For more information
European Commission website on biotechnology
http://europa.eu.int/comm/environment/biotechnology/index_en.htm
Questions and answers on the regulation of GMOs in the European
Union (MEMO/05/104)
http://europa.eu.int/rapid/pressReleasesAction.do?reference=MEMO/
05/104&format=HTML&aged=1&language=EN&guiLanguage=en
August 2005
© European Commission 2005. Reproduction is authorised provided the source is acknowledged.
Photos: Digital Vision, Getty Images
KH-15-04-005-EN-C
sumers through the compulsory labelling of this type of product and, second, to create a ‘safety net’ based on the traceability of these products at
all stages of production and placing on the market. This ‘safety net’ will
facilitate the monitoring and checking of the nutritional claims made on
labels, the targeted surveillance of the potential effects on human health
or the environment and the withdrawal of products if an unforeseen risk to
human health or the environment is identified (Regulation (EC) No 1830/
2003).
4. Transboundary movements of GMOs beyond the EU — EU law sets up a common system for notifying and exchanging information on transboundary
movements of GMOs to third countries. The ultimate goal is to ensure that
movements of GMOs that may have adverse effects on the sustainable use
of biological diversity and on human health take due account of the environment and human health (Regulation (EC) No 1946/2003).
5. Contained use of genetically modified microorganisms (GMMs) for research or
industrial uses — Research and industrial work activities involving GMMs
such as genetically modified viruses or bacteria, under conditions of containment (i.e. in a closed environment in which contact with the population and the environment is avoided, including work in laboratories) are
also regulated.
6. Coexistence between transgenic crops and traditional or organic crops — The
Commission has issued guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified
crops with conventional and organic farming (Recommendation 2003/556/
EC). In June 2005, the Commission created a network for the exchange
and coordination of information concerning such coexistence, made up of
experts appointed by the EU Member States.