News Release
|
Pascal Lamy
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Margot Wallström
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David Byrne
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No.
36/03
May 13, 2003
EUROPEAN COMMISSION REGRETS US DECISION TO FILE
WTO CASE ON GMOs AS MISGUIDED AND UNNECESSARY
The
US announced today its request for WTO consultations on the EU’s authorization
system for genetically
modified organisms (GMOs). The European Commission regrets this move as legally
unwarranted, economically unfounded and politically unhelpful.
EU
Trade Commissioner
Pascal Lamy said:
"The EU’s regulatory system for GMO’s authorization is in line with WTO
rules: it is clear, transparent and non-discriminatory. There is therefore no
issue that the WTO needs to examine. The US
claim that there is a so-called “moratorium” but the fact is that the EU has authorized
GM varieties in the past and is currently processing applications. So what is
the real US motive in bringing a case?"
David Byrne,
EU Commissioner for Health
and Consumer Protection stated: "We have been working hard in
Europe to complete our regulatory system in line
with the latest scientific and international developments. The finalization process
is imminent. This is essential to restore consumer confidence in GMOs in
Europe.”
Mr. Byrne recalled that it is the lack of consumer demand for GM-products that
accounts for the low sales of GMOs in the EU market. “Unless consumers see
that the authorization process is up to date and takes into account all legitimate
concerns, consumers will continue to remain skeptical of GM products."
EU Commissioner for the Environment
Margot
Wallström added: "This US move is unhelpful. It can only make
an already difficult debate in Europe more difficult. But, in the meantime, the
Commission strongly believes that we in Europe should move ahead with completing
our legislation on traceability and labeling and on food and feed currently before
the European Parliament. We should not be deflected or distracted from pursuing
the right policy for the EU."
The
EU stance on GMOs is in line with WTO rules
The EU wants to address the challenges posed by modern technologies of genetic
modification. Its regulatory system provides a reliable framework for GMOs in
the EU, meeting demands for human and animal health and the environment in the
EU. Under the EU system, the prospective effects of GMOs on human, animal and
plant health and the environment have to be scientifically assessed before being
approved for marketing. Under the EU system, companies intending to market GMOs
in the EU must first submit an application to a member state including a full
environmental risk assessment. The assessment is sent to the European Commission,
which circulates it to all other member states. In case of objections, the European
Commission seeks an opinion from the Scientific
Committee (and the European Food Safety
Authority in the future) and makes then a decision. A total of 18 GMOs have
already been authorized in the EU.
Reference
is often made to a so-called “moratorium” in the EU on approval of new GM varieties.
This relates to the fact that since October 1998, no new GMOs have been authorized
for release into the environment due to the fact that the EU’s regulatory regime
was incomplete to address the challenges posed by modern technology of genetic
modification. This new regulatory framework was adopted in March 2001 and entered
into force in October 2002.
The
entry into force of these improved rules on approval procedures has enabled biotech
companies to submit revised applications for approval of their innovative products.
Recently two cottonseed oils for food use have been placed on the market in the
EU following authorization. A number of new applications for marketing of GMOs
are at an advanced stage of examination and may therefore be granted over the
next few months in line with EU legislation.
The
EU is also finalizing the adoption of rules on labeling
and traceability, which aim at responding to citizens’ demands for more and better
information on GMOs, and the need to facilitate the freedom of choice between
new and more traditional agricultural products. Therefore, the EU system is and
will be science-based, not driven by economic considerations.
It
must be recalled that the US has so far
opposed the Cartagena
Protocol on Biosafety, which has been signed by over 100 countries and is
intended to ensure through agreed international rules that countries, exporters
and importers have the necessary information to make informed choices about GMOs.
The
case for appropriate approval mechanisms and marketing regulations has been reinforced
by the problems experienced in the US.
The “Starlink” case is a clear example of the need for appropriate rules for authorization
and traceability of GMOs. In 2000, GM corn not approved for human consumption
was found to have entered the US
food supply chain in large amounts. More than 300 product brands had to be recalled
from supermarkets by US authorities. In a study of February 2002, the American
National Academy of Sciences concluded that there are a number of inadequacies
in the way GM plants are regulated in the US.
The
development argument ignores legitimate concerns of developing countries
A
number of developing
countries, including a large number African countries suffering a shortage
of food, have requested that main donors of food aid avoid providing GMO food.
The European Commission finds it unacceptable that such legitimate concerns are
used by the US against the EU policy on
GMOs. The European Commission believes that it is the legitimate right of developing
countries’ governments to fix their own level of protection and to make the decision
they deem appropriate to prevent unintentional dissemination of GM seeds.
Food
aid to starving populations should be about meeting the urgent humanitarian needs
of those who are in need. It should not be about trying to advance the case for
GM food abroad (while staying away from the international consensus such as the
Cartagena Protocol) or planting GM crops for export or indeed finding outlets
for domestic surplus, which is a regrettable aspect of the US food aid policy.
The
European Commission policy is to source food aid for emergency situations as much
as possible in the region, thus contributing to the development of local markets,
providing additional incentives for producers and ensuring that products distributed
closely match local consumption habits.
GM
crops of interest to developing countries, such as drought tolerant, acid soil
tolerant crops are still in laboratories. Commercially available GM crops are
largely dominated by herbicide tolerant crops (75%) and insect resistant crops
(17%). However, the use of herbicides on small farmers in poor countries is very
limited while insecticides are generally used on commercial crops such as cotton
but not on staple crops.
Some
key figures related to commodities market
The
US is by far the main maize producer in
the world and exports ~20% of its production. However, emerging countries such
as Argentina
and China have started to compete with the US maize export.
Production trade flow of maize 1997-2001 average
(in million tons)
|
Countries
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Production
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Net imports
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Net exports
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Domestic consumption
|
|
World
|
591
|
|
|
|
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USA
|
241
|
|
47.1
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189.9
|
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China
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118
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5.6
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116.9
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EU
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37.3
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2.1
|
|
38.9
|
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Argentina
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16.1
|
|
10.7
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5.4
|
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Mexico
|
18.3
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4.9
|
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23.3
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(Source: US Department of Agriculture, Economic
Research Service)
The
rejection of GM maize by a growing number of importing countries creates a serious
threat to US maize export. In the US, ~35% of the maize is GM maize but only 1-2%
of the production is segregated. Therefore, ~98% of the US maize may contain GM
maize varieties, many of which have not been approved in other countries. Since
the US refuses to implement measures to segregate and control the spread of different
GM maize varieties, its exports are affected.
Main source of maize imports in the EU 1995-2002 (in tons)
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Origin
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Argentina
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US
|
|
1995
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528 028
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3 325 082
|
|
1996
|
584 453
|
2 045 317
|
|
1997
|
918 790
|
1 708 445
|
|
1998
|
1 433 829
|
237 567
|
|
1999
|
2 031 431
|
30 359
|
|
2000
|
2 238 814
|
52 635
|
|
2001
|
1 357 138
|
32 018
|
|
2002
|
1 347 595
|
25 934
|
Since
1997, imports of US
maize in the EU have largely been replaced with Argentine maize, as some GM maize
varieties cultivated in the US are not authorized for cultivation in the EU. On
the other hand, Argentine GM maize producers grow and export approved GM maize
varieties and now have a competitive advantage against US producers.
Origin of soybean imports in the EU 1995-2002 (in
tons)
|
Origin
|
USA
|
Argentina
|
Brazil
|
|
1995
|
9 811 570
|
2 081 522
|
3 073 057
|
|
1996
|
8 571 884
|
1 288 060
|
3 121 094
|
|
1997
|
7 843 877
|
350 494
|
4 637 269
|
|
1998
|
6 691 269
|
1
064 751
|
5 439 613
|
|
1999
|
6 471 928
|
960
502
|
6 105 756
|
|
2000
|
6 908 250
|
381
482
|
6 372 400
|
|
2001
|
6 474 057
|
670
486
|
9 729 136
|
|
2002
|
5 518 096
|
1
163 840
|
8 933 295
|
In
the US, soybean growers cultivate only the GM soybean authorized in the EU. Therefore,
they do not have problems of access to the EU market. The decrease of the share
of US soybeans reflects, therefore, a lost of competitiveness of US soybeans on
the international markets.
Background
WTO consultation and dispute settlement procedures
The
first step in a WTO
dispute settlement is a request for consultation from the complaining member.
The defendant has 10 days to reply to the request and shall enter into consultation
within a period of no more than 30 days (unless otherwise agreed by the 2 parties).
The consultation should aim at finding a positive solution to the issue at stake.
If
the consultations fail to settle the dispute within 60 days after the date of
receipt of the consultation request, the complaining party may request that the
Dispute Settlement Body (DSB) establish a Panel. (However, the complaining party
may request a panel during the 60 day period if the 2 parties consider that the
consultations have failed to settle the dispute.)
Once
the panelists are nominated, the complaining party has normally between 3 and
6 weeks to file its first written submission and the party complained against
another 2-3 weeks to respond. Two oral hearings and a second written submission
follow. On average a panel procedure lasts 12 months. This can be followed by
an appeal that should not last longer than 90 days. In a case such as the one
at stake here, the necessity of hearing scientific experts may prolong the timetable.
Timetable (with the shortest possible deadlines
taken into consideration):
Filing of request by US Mid-May
Consultation 60 days Mid-July
Request for establishment of Panels Immediate
Establishment of Panel +/-45 days End of August
Appointment of Panelists 20 days End of September
US first written submission 3 weeks Mid-October
EC first written submission 2 weeks Early November
For
more information go to:
http://trade-info.cec.eu.int/europa/index_en.php
http://europa.eu.int/comm/food/fs/gmo/gmo_index_en.html
http://europa.eu.int/comm/environment/biotechnology/index_en.htm
ANNEX:
A. Current EU legislation in the EU on GMOs
Community legislation on
GMOs has been in place since the early 1990s, and throughout the decade this regulatory
framework has been further extended and refined. The EU introduced specific legislation
designed to protect its citizens' health and the environment while simultaneously
creating a unified market for biotechnology.
1. GMOs for deliberate release in the environment
Directive
2001/18/EC sets out the rules governing the release of GMOs into the environment.
It entered into force in October 2002. It puts in place a step-by-step approval
process, based on a case-by-case assessment of the risks to human health and the
environment before any GMO or product consisting of or containing GMOs, such as
maize, tomatoes or microorganisms, can be released into the environment or placed
on the market.
Under Directive 2001/18/EC,
a company intending to market a GMO must first submit an application to the competent
national authority of the member state where the product is to be first placed
on the market. The application must include a full environmental risk assessment.
If the national authority gives a favorable opinion on the placing on the market
of the GMO concerned, this member state informs the other member states via the
Commission. If there are no objections, the competent authority that carried out
the original evaluation grants the consent for the placing on the market of the
product. The product may then be placed on the market throughout the European
Union in conformity with any conditions required in that consent.
If objections are raised
and maintained, a decision has to be made at Community level. The Commission first
asks for the opinion of its Scientific Committees, composed of independent scientists,
highly qualified in the fields associated with medicine, nutrition, toxicology,
biology, chemistry or other similar disciplines. If the scientific opinion is
favorable, the Commission then proposes a draft Decision to the Regulatory
Committee composed of representatives of member states for opinion. If the
Regulatory Committee gives a favorable opinion, the Commission adopts the Decision.
If not, the draft Decision
is submitted to the Council of Ministers
for adoption by qualified majority or rejection. If the Council does not act within
3 months, the Commission can adopt the decision.
During the notification
process, the public is also informed and has access to the publicly available
data on the Internet: http://gmoinfo.jrc.it/.
Three complete dossiers
have been submitted to the Commission (GM maize NK 603, GM oil seed rape GT 73,
GM maize NK 603 x MON 810—all from Monsanto). The 3 applications are for import
and processing only (not for cultivation).
2. GM foods
Regulation
(EC) 258/97 on Novel
Foods and Novel Food Ingredients sets out rules for authorization and labeling
of novel foods including food products containing, consisting or produced from
GMOs.
The first step of an authorization
procedure is an assessment of an application to market a GM food product by the
member state where the food is to be first placed on the market. In case of a
favorable opinion, this member state informs the other member states via the Commission.
If there are no objections against the application, this member state can authorize
the product for marketing in the entire EU.
If there are objections
by other member states, a decision at Community level is required. The Commission
consults the Scientific Committees on matters relating to public health and adopts
a decision after receiving a favorable opinion from the Regulatory Committee composed
of member state representatives.
As a derogation from the
full authorization procedure, the Novel Foods Regulation provides for a simplified
procedure for foods derived from GMOs but no longer containing GMOs, which are
"substantially equivalent" to existing foods with respect to composition,
nutritional value, metabolism, intended use and the level of undesirable substances.
In such cases, the companies only have to notify the Commission when placing a
product on the market together with either scientific justification that the product
is substantially equivalent or an opinion to the same effect, delivered by the
competent authorities of a member state.
Under the Novel Food Regulation,
there are 2 applications at an advanced stage of the approval process (1 for Monsanto
GA 21 maize, and 1 for Syngenta Bt 11 sweet maize) that are almost ready for a
decision. The European Commission is working with both companies with a view to
clarifying a number of pending issues.
Last December, the Commission
informed member states that cottonseed oil from two Monsanto GM cottonseeds have
been placed on the market under the simplified procedure of the Novel Food Regulation.
(The Regulation provides that, when substantial equivalence is established, applicants
have only to notify the Commission of the placing of the product on the market.)
The 2 cottonseed oils are not distinguishable from their conventional counterparts.
Another
new application under Novel Food (for Monsanto GM Maize NK 603) is currently being
examined by the EU.
B. EU Rules on traceability and labeling
The EU recognizes the consumers’
right for information and labeling as a tool to make an informed choice. Since
1997 labeling to indicate the presence of GMOs as such or in a product is mandatory.
From 17 October 2002 onwards Directive 2001/18/EC foresees that member states
shall take all necessary measures to ensure a labeling of GMOs as or in products
at all stages of the placing on the market.
The Novel Foods Regulation
provides for the mandatory labeling of foods and food ingredients which contain
or consist of a GMO without prejudice to the other labeling requirements of Community
law. The labeling requirements for foods produced from GMOs but no longer containing
GMOs are based on the concept of equivalence.
Council
Regulation (EC) 1139/98 (consolidated
version) lays down provisions for the labeling of foods and food ingredients
derived from one maize and one soya variety based on the presence of DNA or protein
resulting from genetic modification. This criterion serves as a model providing
the rules applicable to labeling of all foods and food ingredients derived from
GMO.
In January 2000, the Commission
adopted Regulation
(EC) 50/2000 ensuring that also additives and flavorings have to be labeled
if DNA or protein of GMO origin is present in the final product.
The Commission has recently
adopted two
common positions (1) on GM food and feed and (2) on traceability and labeling
of GMOs. These common positions are in the process of being examined by the European
Parliament and the Council and expected to be adopted by the end of the year.
Indeed, second readings are planned for July.
C. International regulatory framework for GMOs
All international agreements
such as the WTO Sanitary and Phytosanitary Measures (SPS) Agreement, the WTO Technical
Barriers to Trade (TBT) Agreement and the Cartagena Protocol on Biosafety to the
Convention on Biological Diversity recognize the right to their members to take
the measures at the levels they consider appropriate, for example to protect human
or animal health or the environment.
The Cartagena Protocol to
the Biodiversity Convention regulates the transboundary movements of GMOs. It
has been signed by 102 countries including the European Union. The US is not a
party to the Biodiversity Convention and therefore has not signed the Biosafety
Protocol. The Protocol will come into force after ratification by 50 countries
(41 countries have ratified it, as of the end of January 2003, including the European
Community). It will be legally binding for the countries that ratify it and countries
that have signed it are expected, under international law, to act in good faith
and not to take measures which could contradict its objectives.
The Protocol establishes
an Advanced Informed Agreement (AIA) procedure for ensuring that countries are
provided with the information necessary to make informed decisions before agreeing
to the import into their territory of GMOs intended for deliberate release into
the environment (this includes all vegetative parts that are meant for planting
such as seeds). However, the AIA procedure does not apply to GMOs which are for
human consumption (food), for animal feeds or for processing. For these, relevant
information has to be provided to the Parties through the Biosafety Clearing House
(a mechanism set up by the Protocol to facilitate the exchange of information
on GMOs, including national regulation pertaining to them, and to assist countries
in the implementation of the Protocol). Moreover, these commodities, when exported,
must be accompanied by documentation specifying that they “may contain” GMOs and
that they are not intended for intentional introduction into the environment.
The Parties shall decide on the detailed requirements for this purpose, including
specification of the identity of the GMOs and any unique identification.
The US is the largest agricultural
commodity exporter but also the largest GM crops producer. In 2002, the US grew
more than 35 million hectares out of the 58 million hectares of GM crops cultivated
worldwide. The US opposes the biosafety protocol because the enforcement of the
protocol will interfere with the main US agriculture commodity exports, i.e.,
maize and soybeans. However, if the US were to follow the Biosafety Protocol,
it would have to specify that food aid might contain GMOs if that was the case,
for example.
Several countries have
adopted a case-by-case authorization process for GMOs but authorizations are not
always synchronous with US approvals. Others, such as Sri Lanka, which have not
yet adopted a regulatory framework, have banned the import of GMOs. Even China,
which has one of the largest biotech industries, is now taking a cautious approach
with the authorization of GM food.
Because US traders refuse to segregate, the US maize and soybean face difficulties
on the international market because of the possible presence in shipments of GMOs
that are not authorized in the importing countries. In addition, due to consumers’
concerns over the safety of GMOs, the food and feed industry is increasingly looking
for supply of non-GM maize and non-GM soybean. For those reasons, the
US has a
vested interest in an international deregulation of GMOs trade and in a non-labeling
policy of GM food and feed.
The EU has developed a comprehensive
regulatory framework for GMOs and for GM food and feed including traceability
and labeling provisions. Many countries are now looking at the EU policy to develop
their own policy. The US fears that several countries will adopt a similar approach
as the EU to regulate GMOs and GM food and feed products.
D. GMOs and food aid
A
number of developing countries, especially in Africa,
face a humanitarian crisis as a result of adverse weather conditions.
The
US has committed to supply 499,000 tons of maize grain as food aid between September
2002 and March 2003. In the US, 35% of the maize is produced from GMOs. However,
only 1 to 2% of the harvest is segregated (due to the cost of segregation, such
maize is more expensive than non-segregated maize). Therefore, US
maize is likely to contain GMOs.
Some African
countries in the region have initially refused to take the maize for a combination
of reasons, namely human health concerns, environmental consideration, the risk
of spread of transgenes into their own maize production and the repercussion such
a spread could have on regional and international trade and Intellectual Property
Rights concerns.
Following the Zambian ban
on GMOs, the US sponsored a study trip for Zambian scientists in the US and in
a number of European capitals. The Zambian scientists have met the European Commission
services and have been provided with copies of all scientific assessments from
the EU scientific committees (all opinions are favorable).
In their report, the Zambian
scientists still argued against the introduction of GM maize in Southern Africa.
The Zambian government has confirmed its decision to ban GM maize in the light
of the report of the Zambian scientists.
Other countries (Zimbabwe,
Mozambique, Malawi) eventually accepted US maize provided that it is milled, which
is a process preventing the release of GMOs into the environment. (Their initial
ban relates to environmental concerns.) But the US
has refused to fund the milling.
The
US is blaming the EU for the African refusal of the US
maize. However, the Commission has repeatedly said that there is no reason to
believe that GM food is inherently unsafe to human health. However, developing
country governments have the legitimate right to fix their level of protection
and to make the decision they deem appropriate to safeguard their territory from
unintentional dissemination of GM crops.
With respect to food aid,
the Commission policy is to source food for emergency situations as much as possible
in the region as this contributes to the development of local markets, provides
additional incentives for producers and ensures that products distribute closely
match local consumption habits. The US policy is to provide food aid in kind and
use surplus production.
For practical reasons and
to respect the choice of beneficiary countries, the Commission has requested the
World Food Program to purchase only conventional (non-GM) maize for distribution
as food aid. This avoids food aid being rejected, the cost of milling (in the
case of Zimbabwe, Malawi and Mozambique) and difficulties during the transit of
countries like Mozambique that have taken action against the transit of GMOs in
their territory.
Food
aid is being distributed. In Zambia, the
Commission has allocated EUR 20 Million to the WFP for regional purchase of maize.
By mid January 174,000 tons out of the 277,000 committed by the EU has been purchased—99%
has been procured in the region (70% South Africa, 23% Malawi, 7% Tanzania and
less than 1% in the EU).
|
Press Contacts:
|
Willy Hélin
202-862-9530
|
Wilfried Schneider
202-862-9523
|
