GENET archive


3-Food: Commission authorises import of GM-oilseed rape for use in animal feed

                                 PART I
------------------------------- GENET-news -------------------------------

TITLE:  GMOs: Commission authorises import of GM-oilseed rape for use in
        animal feed
SOURCE: European Commission, Press Release IP/05/1077
DATE:   31 Aug 2005

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GMOs: Commission authorises import of GM-oilseed rape for use in animal feed

The European Commission authorised today the placing on the market of the
genetically modified oilseed rape known as GT73 for import and
processing. This decision is valid for 10 years and results from an
application submitted by the company Monsanto. The GT73 oilseed rape,
which is tolerant to the herbicide glyphosate, is already widely used in
North America with no reports of any adverse effects on health or the
environment. The authorisation today, which is backed by science, covers
the specific use for imports of the GM oilseed rape and processing for
use in animal feed or for industrial purposes. The authorisation is
complemented by a Recommendation concerning the measures to be taken by
the consent holder to prevent any damage to health and the environment in
the event of the accidental spillage of GT73. Refined oil derived from
GT73 oilseed rape has already been approved for food use in 1997 in the EU.

The GT73 oilseed rape has been subject to a rigorous pre-market risk
assessment. It has been scientifically assessed by the European Food
Safety Authority as being as safe as any conventional oilseed rape. Clear
labelling provides farmers and consumers with the information they need
to decide whether to buy the product or not. And robust post-marketing
rules will ensure that the product can be traced and monitored when put
on the market.

The GT73 oilseed rape is the third product[1] to be assessed and approved
after the entry into force of Directive 2001/18/EC[2]. Today's
authorisation covers the import and the use as animal feed, but not
cultivation or food uses. The product will be covered by the new strict
labelling and traceability rules which came into force in April 2004[3].
When put on the market, it will need to be clearly labelled as containing
genetically modified oilseed rape. Its post-marketing monitoring will be
assured through a unique identifier assigned to the oilseed rape to
enable its traceability. In addition, the authorisation is complemented
by a Recommendation containing a set of guidelines to Monsanto on how to
deal appropriately with accidental spillage if it should occur.

During the past four years, the EU has put in place a clear, transparent
and stringent system to regulate genetically modified food, feed and
crops. The authorisation procedure under this new system ensures that
only GMOs which are safe for human and animal consumption and for release
into the environment can be placed on the European market. Individual
authorisations are granted following appraisal of the GMOs in question on
a case by case basis. Requests for authorisations which do not fulfil all
criteria have been and will continue to be rejected.

Further information:


(Questions and Answers on the regulation of GMOs in the EU)


In January 2003, Monsanto submitted a request, under Directive 2001/18/
EC, to the competent authorities of the Netherlands for placing
genetically modified oilseed rape GT73 on the market for import,
processing for use in feed, and industrial purposes. The GT73 oilseed
rape is tolerant to the herbicide glyphosate. The product involves a
simple modification and does not contain an antibiotic resistance marker gene.

The Dutch competent authority came to the conclusion that GT73 oilseed
rape is as safe as conventional oilseed rape. The European Food Safety
Authority also appraised the application and focused on the scientific
issues raised by competent authorities from the other Member States. Its
opinion similarly concluded that GT73 oilseed rape was as safe as
conventional oilseed rape.

The Regulatory Committee established under Directive 2001/18/EC did not
give an opinion in June 2004. The Commission therefore submitted a
proposal to the Council.

The proposal was considered by the Environment Council on 20 December
2004. At that meeting neither a qualified majority vote in favour or
against approval was obtained. Consequently, the Commission under the
legal procedure is obliged to adopt the Decision.

The methodology used for the safety assessment of the GT73 oilseed rape
was entirely that of the new regulatory framework, notably Directive
2001/18/EC. The Directive also provides for mandatory measures to be
applied to the product following approval.

This includes post-market monitoring of the continued safety of the
product once it has been placed on the market via use of surveillance
systems. This monitoring is required throughout the period of validity of
the consent. The consent holder is required to submit reports of this
monitoring programme to all Member States and the Commission on an annual

The product will also have to be identifiable every time that it is
placed on the market allowing individuals to choose whether or not to
purchase and use the product. This will be ensured via the labelling and
traceability provisions of the Directive and those of Regulation 1830/
2003. Under this Regulation, business operators must transmit and retain
information about products that contain or are produced from GMOs at each
stage of the placing on the market. Traceability provides the means to
trace products containing or produced from GMOs through the production
and distribution chains. The Regulation also provides for comprehensive
information by its requirement for labelling of GMOs at all stages of the
placing on the market. The label has to indicate "This product contains
genetically modified organisms" or "This product contains genetically
modified oilseed rape ".

The Commission Decision will only apply when a validated detection method
and appropriate reference material is available which will allow for the
physical detection of the GT73 oilseed rape in products enabling
labelling claims to be verified. Guidance as to sampling and testing to
verify the presence of GMOs in products has also been agreed to by Member
States and this will enable their inspection and control authorities to
operate in a harmonised manner throughout the EU.

In addition, further to the publication in February 2005, of a report by
the Japanese Environmental Studies Institute referring to the accidental
presence of oilseed rape genetically modified for tolerance to a
herbicide around five of the six port facilities where sampling had been
carried out, the European Commission has considered necessary to take
measures to prevent the same situation arising in the European Union.

Therefore, the authorisation is complemented by a Recommendation
containing a set of guidelines to the consent-holder (in this case
Monsanto) on how to deal with accidental spillage if it should occur; and
in particular to prevent any damage to health and the environment in the
event of accidental spillage of the oilseed rape GT73 during
transportation, storage, handling in the environment and processing into
derived products.

[1] First product was NK603 maize, see IP/04/957 the second was MON 863
maize see IP/05/1046.

[2] Directive 2001/18/EC on the deliberate release of genetically
modified organisms into the environment

[3] Regulation (EC) No 1829/2003 on GM food and feed

Regulation (EC) No 1830/2003 concerning the traceability and labelling of
genetically modified organisms and the traceability of food and feed
products produced from genetically modified organisms

                                 PART II
------------------------------- GENET-news -------------------------------

TITLE:  EU Authorises GMO Rapeseed by Legal Rubberstamp
SOURCE: Reuters, by Jeremy Smith
DATE:   1 Sep 2005

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EU Authorises GMO Rapeseed by Legal Rubberstamp

BRUSSELS - The European Union has approved a genetically modified (GMO)
rapeseed made by US biotech giant Monsanto, the fourth new authorisation
after the EU's biotech ban ended last year, the EU executive said on

The rapeseed, known as GT73, is designed to resist the herbicide
glyphosate and allow farmers to manage weeds better. It will be used in
animal feed and industrial processing, but not for growing. The
authorisation is valid for 10 years.

The EU decision is a rubberstamp procedure applied by the European
Commission -- the EU's executive arm. It is permitted under a legal
default process that kicks in when ministers are unable to agree among
themselves after a period of three months.

This GMO rapeseed has been the subject of particular controversy, since
the EU first issued an authorisation by mistake in June but then withdrew
it after a bureaucratic error.

Part of the reason for the hasty withdrawal was that the Commission had
not tightened up wording over liability for inadvertent seed spills
during transportation, storage, general handling and processing of GT73
seeds. It has now included a set of non-binding guidelines for Monsanto
to follow.

"The authorisation is complemented by a recommendation containing a set
of guidelines to Monsanto on how to deal appropriately with accidental
spillage if it should occur," the Commission said in a statement.

Green groups slammed the latest GMO approval, saying it would fail to
hold Monsanto liable for any inadvertent spillage and calling on EU
states to impose national bans on GT73 seeds.

"Although the Commission accepted that seed spills are an area of
concern, it failed to specify measures to safeguard against this,"
environmental group Friends of the Earth said.

"Instead it has included a simple recommendation that ... Monsanto will
be free to disregard," it said in a statement.

There were also two occasions during August that the Commission had been
poised to approved the rapeseed but stopped at the final hurdle due to
internal disagreements.

In early August, the Commission rubberstamped a similar approval for a
Monsanto GMO maize, again for use in animal feed.

Even though the EU has now lifted its six-year unofficial moratorium on
approving new GMO products, national governments have consistently
clashed over biotech policy.

The EU's member states have ended meetings in deadlock 14 times in a row
-- either as ministers or as national experts -- on whether to approve
new GMO products, usually for use in industrial processing or as animal feed.

The last time they agreed on a new GMO approval was in 1998.

                                 PART III
------------------------------- GENET-news -------------------------------

TITLE:  FACTBOX-Chronology of EU moves on GMO crops and foods
SOURCE: Reuters
DATE:   31 Aug 2005

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FACTBOX-Chronology of EU moves on GMO crops and foods

BRUSSELS, Aug 31 (Reuters) - The European Union authorised a genetically
modified rapeseed made by U.S. biotech giant Monsanto on Wednesday, the
fourth new approval after the EU's biotech ban ended last year.

Following is a short history of the European Union's unofficial
moratorium on authorising new genetically modified organisms (GMOs),
which ended in 2004 after its executive body authorised imports of a
biotech maize.

During the ban, the EU did not allow experimental or commercial growth of
new gene crops or imports of new GMO-based food products. In or before
1998, approval was given for 18 biotech plants, including maize,
rapeseed, chicory and soybeans.


APRIL 1998 - EU's last approvals of new GMO food products.

OCTOBER 1998 - EU authorises two biotech carnation varieties (to improve
vase life and modify flower colour), the last live GMO plants to win EU
approval. The United States sees this as the point where the EU shuts its
doors to new GMOs - at this time, 18 GMOs are allowed for commercial
release in the EU.

JUNE 1999 - France and Greece lead calls for de facto moratorium on new
GMO approval at meeting of EU environment ministers and win backing from
Italy, Denmark and Luxembourg.

They are later joined by Belgium and Austria, forming a minority of EU
states that can block any vote on a new approval.

JANUARY 2000 - European Commission adopts regulation that additives and
flavourings have to be labelled if DNA or protein of GMO origin is
present in the final product.

JUNE 2000 - French Environment Minister Dominique Voynet insists on the
need for a liability scheme for biotech products.

JULY 2000 - EU environment ministers say they will support the moratorium
at least until proposals are presented for labelling and tracing GMO
content in biotech products.

JULY 2001 - European Commission presents labelling and traceability proposals.

OCTOBER 2002 - Updated "deliberate release" directive enters into force,
regulating the release of live GMOs into the environment. This repeals
previous legislation dating from 1991.

The updated directive sets down a step-by-step approvals process for GMOs
or products containing GMOs, and tightens controls on traceability and

MAY 2003 - United States announces its intention to file a complaint
against the EU's unofficial ban on GMOs at the World Trade Organisation.

JULY 2003 - EU adopts strict rules on labelling and tracing all GMO food
and feed which apply in all member states from mid-April 2004. The
labelling threshold for GMO content in non-GMO food is set at 0.9 percent.

JULY 2003 - European Commission issues guidelines on how to grow and
separate GMO crops in Europe's fields to minimise the spread of GMOs to
organic and conventional crop cultivation.

AUGUST 2003 - United States, Canada and Argentina challenge the EU over
its de facto moratorium on GMOs at the WTO, arguing that the ban is
illegal and without any scientific foundation.

SEPTEMBER 2003 - European Commission rejects a request by the regional
government of Upper Austria to ban the cultivation of GMO crops and
create a GMO-free zone.

OCTOBER 2003 - European Commission delays debate on its proposed seed
purity rules setting GMO content in conventional and organic seeds after
EU states demand stricter safety checks.

The proposed thresholds range from 0.3 to 0.7 percent.

NOVEMBER 2003 - Government of Upper Austria says it will challenge
Commission's ruling on its proposed GMO-free zone at the Court of First
Instance - the EU's second highest court.

NOVEMBER 2003 - EU food safety committee fails to agree on proposal to
authorise imports of Bt-11 sweet maize, a GMO food whose seeds are made
by Swiss agrochemicals giant Syngenta.

JANUARY 2004 - European Commission passes Bt-11 maize to EU ministers,
who have three months to consider the issue and reach a final decision.

FEBRUARY 2004 - EU environment experts fail to agree to allow imports of
NK603 maize, made by U.S. biotech giant Monsanto, for use in animal feed.
The matter passes to EU ministers who have three months to decide.

APRIL 2004 - EU's updated laws on GMO traceability and labelling in food
and feed come fully into effect.

APRIL 2004 - EU ministers lose last chance to approve or reject
application to authorise Bt-11, debate ends in deadlock. Application
passes to Commission for a rubberstamp approval, effectively ending EU
moratorium on new GMO foods.

APRIL 2004 - EU food safety experts fail to agree to allow imports of
NK603 maize for its use in processed products for human consumption.
Issue again passes to EU ministers with a three-month discussion period.

MAY 2004 - Draft Commission proposal setting GMO content in conventional
and organic seeds is leaked by green groups. The proposed thresholds
range from 0.3 to 0.5 percent.

MAY 2004 - European Commission ends de facto ban by authorising imports
of Bt-11 maize for sale on supermarket shelves as canned sweetcorn.

OCTOBER 2004 - European Commission authorises second new GMO product,
Monsanto's NK603 maize, via default legal rubberstamp.

MARCH 2005 - European Food Safety Authority (EFSA) says 1507 maize, made
jointly by Pioneer Hi-Bred, a subsidiary of DuPont and Dow AgroSciences,
is safe to grow.

MAY 2005 - EU food safety authority says Syngenta's Bt-11 maize is safe
to grow, its second assessment of a "live" GMO.

JUNE 2005 - EU environment ministers uphold eight national bans on GMO
maize and rapeseed types, rejecting draft orders from the European
Commission that were directed at Austria, France, Germany, Greece and
Luxembourg. JULY 2005 - EFSA issues first assessment of hybrid GMO
strains for use in food and animal feed -- three Monsanto maize types --
saying they are no different than the equivalent conventional maize hybrids.

AUGUST 2005 - European Commission authorises imports of Monsanto's
insect-resistant MON 863 maize for processing into animal feed, its third
rubberstamp approval of a new GMO product since the end of the de facto
moratorium. AUGUST 2005 - European Commission rubberstamps approval for
imports of Monsanto's herbicide-resistant GT73 rapeseed, also for
processing into animal feed.

                                 PART IV
------------------------------- GENET-news -------------------------------

TITLE:  EC approval for Monsanto oilseed rape poses threat to environment
        and democracy
SOURCE: Greenpeace European Unit, Belgium
DATE:   31 Aug 2005

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EC approval for Monsanto oilseed rape poses threat to environment and

Brussels, 31 August 2005 - The European Commission gave its green light
today to imports of a genetically engineered (GE) oilseed rape produced
by US biotech company Monsanto. Only six out of 25 EU member states had
supported the proposal (1). Greenpeace is calling for the decision to be
revoked and for EU authorisation procedures on GE crops to be overhauled.

"Approval for this controversial rapeseed against the will of the member
states says everything about the undemocratic way the Commission is
trying to force GMOs on the European public," said Greenpeace
International Campaigner Geert Ritsema. "Allowing imports of this
Monsanto rapeseed into Europe poses a substantial risk to the environment."

The Monsanto GT73 oilseed rape is to be imported as whole kernels and
then milled for use in animal feed and human food products, a hugely
risky process, as the seeds cannot be completely contained during
transportation. Pollen from rapeseed is reported to travel for several
kilometres. Cross-contamination of wild rapeseed and its GE counterpart
was reported in the UK in July. In Japan, authorities investigating GE
imports found modified rapeseed had contaminated wide areas around the
harbours and the mills. Of 10 harbours investigated, eight were
contaminated. Transport routes as far as 30 kilometres from the port were

There is growing concern among experts that GE rapeseed should never be
cultivated in Europe because of the danger of pollination and
dissemination. The European Environment Agency has classified oilseed
rape as a 'high risk crop for contamination' (2). And biotech company
Bayer withdrew its EU application to grow GE rapeseed after EU member
states raised concerns.

Even the EU Commission has acknowledged the risks of uncontrolled
spillage and unanticipated adverse effects of the GE rapeseed. In light
of this, it is recommending extra measures against spillage and reporting
systems for effects. Greenpeace believes these voluntary measures are
totally insufficient.

"If the EU Commission admits that modified rapeseed is likely to escape
into the environment, it should be using that evidence to reject market
approval of GE seeds. The alternative - seeking voluntary agreements for
control and monitoring systems - is unworkable," said Ritsema. "The
decision should be revoked immediately, and the standards of EU risk
assessment and the EU authorisation procedure reorganised."

Another concern is the health effects that have been observed in animal
feed trials using Monsanto's GT73. The company's studies showed
potentially adverse effects on rats, notably a significant raise in liver
weight. However, the company withheld the original data of these studies
from the public (3).

Greenpeace is an independent, campaigning organisation, which uses non-
violent, creative confrontation to expose global environmental problems,
and to force the solutions, which are essential to a green and peaceful

For more information
Geert Ritsema, Greenpeace International GM campaigner, (m) +31-6 46 19 73 28
Katharine Mill, Greenpeace European Unit Media Officer (m) +32 496 156 229

Notes to editors

(1) In the EU Council of Environment Ministers on December 2004, six
member states voted in favour of the GE rapeseed (GT73), SK, SE, FR, PT,
FI, NL (78 votes), 13 voted against IT, GR, DK, PO, MT, BE, HU, LT, LV,
CY, AT, EE, LU (135 votes), and the rest abstained - IE, SI, ES, DE, CZ,
UK (108 votes).

(2) Genetically modified organisms (GMOs): The significance of gene flow
through pollen transfer

(3) Greenpeace wrote several letters to national authorities to get hold
of the data. After the organisation won a court case allowing it access
to Monsanto's confidential data of feeding trials with GE maize in June
2005, it was expected that the data on the feeding trials with GT73 would
be made public; but so far the documents have not been published.
Contrary to EU law German officials explicitly refuse access to the data.
Greenpeace is awaiting a reaction from the government of the Netherlands,
where Monsanto originally filed the data.

This is the fourth time the EU Commission has allowed the import of GE
crops after a five years moratorium that ended in 2003. The other crops
are herbicide resistant maize (NK603), sweet maize containing
insecticidal toxin (Bt11) and maize meant for animal feed (MON863).


European NGO Network on Genetic Engineering

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