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3-Food: European Commission authorises import of GM-maize for usein animal feed

                                  PART I
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TITLE:  GMOs: Commission authorises import of GM-maize for use in animal
SOURCE: European Commission, Belgium
DATE:   19 Jul 2004

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

Reference: IP/04/957

Date: 19/07/2004



Brussels, 19 July 2004

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

The European Commission authorised today the placing on the market of the
genetically modified maize known as NK603 for import and processing. This
decision is valid for 10 years and results from an application submitted
by the company Monsanto. Imports of the maize, whether in bulk shipments,
bags or other containers, will have to be labelled as containing
genetically modified maize. The NK603 maize is already widely used in
other parts of the world 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 maize and processing for
use in animal feed or for industrial purposes. A separate decision in
terms of authorisation of the NK603 maize for use in food will be taken
in the coming months.

Margot Wallström, Commissioner for the Environment, said: "The NK603
maize 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 maize. Its safety is, therefore, not in
question, and neither is the question of user or consumer choice. 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 NK603 maize is the first product to be assessed and approved after
the entry into force of Directive 2001/18/EC[1]. It will be covered by
the new strict labelling and traceability rules which came into force in
April[2]. When put on the market, it will need be clearly labelled as
containing genetically modified maize. Its post-marketing monitoring will
be assured through a unique identifier assigned to the maize to enable
its traceability. Today's authorisation covers the import and the use as
animal feed, but not cultivation or food uses.

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.

Today's decision grants approval for the use of NK603 maize in animal
feed. However, imports for this use can only commence once the equivalent
approval has also been granted for food use. A separate decision under
the Novel Foods Regulation is currently being considered by the
Agriculture Council. A decision is expected in the coming months.

See annex for lists of approved and pending GM products.
[please go to web page to see annexes]
Further information: MEMO/04/102 (Questions and Answers on the regulation
of GMOs in the EU)

Note to the editors:

In January 2001, Monsanto submitted a request, under Directive 2001/18/
EC, to the competent authorities of Spain for placing genetically
modified maize line NK603 on the market for import and processing for use
in feed and for industrial purposes. The NK603 maize is tolerant to the
herbicide glyphosate. The product involves a simple modification and does
not contain an antibiotic resistance marker gene.

The Spanish competent authority came to the conclusion that NK603 maize
is as safe as conventional maize. The European Food Safety Authority also
appraised the application and focused on the limited number of scientific
issues raised by competent authorities from the other Member States. Its
opinion similarly concluded that NK603 maize was as safe as conventional

The Regulatory Committee established under Directive 2001/18/EC did not
give an opinion. The Commission therefore submitted a proposal to the
Council on 29 March 2004. The Council was required to act within 3 months.

The proposal was considered by the Environment Council on 28 June 2004.
At that meeting, which included Ministers from the new Member States,
neither a qualified majority vote in favour or against approval was
obtained. This deemed that the Council did not act within the requisite
time limit and consequently, the Commission under the legal procedure is
obliged to adopt the Decision.

The methodology used for the safety assessment of the NK603 maize 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 maize".

A validated detection method and appropriate reference material is
available and will allow for the physical detection of the NK603 maize 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.

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

TITLE:  Monsanto's Biotech Cleared by EU for Animal Feed Use
SOURCE: Bloomberg, USA, by Jonathan Stearns
DATE:   19 Jul 2004

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Monsanto's Biotech Cleared by EU for Animal Feed Use

July 19 (Bloomberg) -- Monsanto Co. won European Commission approval for
one of its gene-modified corn varieties to be used in animal feed as part
of European Union efforts to ease biotech- food restrictions and a trans-
Atlantic trade dispute.

The decision by the EU's executive arm is the bloc's first endorsement of
a Monsanto biotech product in six years. The commission is trying to
speed up EU approvals of genetically modified foods, including several
developed by St. Louis, Missouri-based Monsanto, the biggest producer in
a global biotech crop market with sales of as much as $4.75 billion last year.

"We welcome the decision," said Daniel Rahier, director for industrial
affairs at Monsanto in Brussels. "It's an encouraging step." A split
among the EU's 25 nations in June gave the commission the power to decide
on the product, known as NK603.

The commission in May allowed the import from the U.S. and elsewhere of a
gene-altered corn type made by Switzerland's Syngenta AG, the world's
largest maker of crop chemicals. It was the region's first biotech food
approval since 1998 and also followed a split among EU countries. More
than 30 applications are still pending.

Monsanto shares were unchanged at $36.58 in New York Stock Exchange
composite trading at 4:16 p.m. They have risen 67 percent in the past year.

'Pretty Big Win'

"It's a pretty big win," said Michael Judd, an analyst at Greenwich
Consultants in New Jersey who has a "hold" rating on Monsanto shares.
"Time will tell how big the volumes are."

The commission said it plans in a separate decision "in the autumn" to
permit the sale of foods made from NK603. It got this authority earlier
today from the EU's national farm ministers, who were divided over
allowing the corn to be used in foods including biscuits and ingredients
such as starch and oil.

EU approval to use NK603 in animal feed is conditioned on the EU
approving it for human food, Monsanto spokesman Lee Quarles said.
Monsanto calls the corn "Roundup Ready" because it is genetically altered
to resist the company's Roundup herbicide.

Greenpeace, which has lobbied against biotech foods, said the commission
was ignoring consumer demands.

"Most consumers do not want genetically modified organisms and member
states have not agreed to approve them," Eric Gall, a Greenpeace adviser
in Brussels, said in a statement. "The commission is defying democracy by
pushing through these approvals to satisfy the biotech lobby and its U.S.

Won't Eat It

More than 60 percent of EU citizens probably wouldn't eat foods with
genetic modifications even if the goods were cheaper or had less fat,
according to an EU survey of about 1,000 people in each country of the
then 15-nation bloc published last year.

"In terms of market potential, today's approval of the corn's use in
animal feed is more important" than the food request, Monsanto's Rahier said.

The U.S., Argentina and Canada, the world's three largest growers of
gene-modified seeds, have complained to the World Trade Organization
about the EU's restrictions. The curbs affect products ranging from grain
to tomatoes whose genetic material has been altered to add beneficial
traits such as resistance to weed-killing chemicals, limiting the number
on the EU market to 34 until the Syngenta and Monsanto corn approvals.

Some EU nations say the products pose threats to the environment and
human health, while the commission says scientific backing and stricter
EU food labeling rules justify approvals. The European Food Safety
Authority last year endorsed NK603.

Rigorous Assessment

"NK603 has been subject to a rigorous pre-market risk assessment," EU
Environment Commissioner Margot Wallstroem said in a statement in
Brussels. "Its safety is not in question."

Argentina, Australia, Bulgaria, Canada, Colombia, Japan, Mexico, the
Philippines, Russia, South Africa, South Korea, Taiwan and the U.S. have
also approved the product, according to Rahier.

The EU approval of this corn type for animal feed is for 10 years. It
won't necessarily reopen U.S. corn exports to the EU because the product
is generally mixed with other gene-altered corn varieties that have yet
to win European endorsement. U.S. corn exports to the EU have
traditionally gone to Spain and Portugal.

U.S. corn exports to the EU fell to 59,182 metric tons, valued at 82
million euros ($102 million), in 2002 from 1.75 million tons, or 324
million euros, in 1997, according to the U.S. Foreign Agricultural
Service in Brussels. The U.S. share of EU corn imports dropped to 2.1
percent from 64 percent.

Expanded Planting

By opening new markets to U.S. farmers, Monsanto will increase planting
of Roundup Ready corn to 20 million acres next year from 16.1 million in
2004, Kerry Preete, Monsanto vice president of U.S. crop production, said
in a statement. That ultimately could reach 50 million acres, Preete said.

Another Monsanto application on NK603 covers cultivation. No EU decision
is yet scheduled on this or any of the more than 10 total biotech
requests involving plantings, which are more controversial than imports
because of concerns about contamination of conventional and organic crops.

The commission won't seek fast-track approval of plantings as part of its
efforts to accelerate biotech food approvals, the commission's Wallstroem
said in June.

All nations in the EU have a say over biotech decisions because the
bloc's barrier-free trade rules mean a product sold in one member country
can be sold in the others. Commission proposals go to EU ministers if
they don't win majority support on a committee of national regulators.
Failure by national ministers to decide hands the power back to the

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

TITLE:  US dismay as EU fails to agree GM - again
SOURCE: EUPolitix, by Bruno Waterfield
DATE:   19 Jul 2004

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US dismay as EU fails to agree GM - again

A decision by Europe's agriculture ministers not to allow imports of
genetically modified maize raises the spectre of a continued EU freeze on
biotech, warn US officials.

The EU's 25 national governments failed to back a Brussels proposal to
open Europe's door to imports of Monsanto's NK603 maize as a 'novel food'.

The US biotech company is seeking EU authorisation for NK603 as a food
product; the maize has been modified to tolerate a Monsanto herbicide.

A Luxembourg meeting of environment ministers, under an EU labelling of
GM products procedure, on June 28 also failed to give the green light to
the maize.

The latest failure to authorise a GM product has not impressed Washington.

US officials have told that the decision raises a "serious"
question mark over an EU commitment to end a five-year moratorium on
biotech crops.

"This demonstrates that the EU still lacks a functioning, objective, and
predictable approval process that considers applications for agricultural
products of modern biotechnology without undue delay," Stan Cohen, senior
agricultural attache, at the US Mission to the EU, told this website.

"This is particularly true when so many applications that have already
received positive scientific evaluations continue to await approval."

 "This situation raises serious questions about whether or when the EU's
moratorium on biotech products will, in fact, come to an end."

 With no clear 'yes' from governments, the buck has now been passed back
to the European Commission - and Europe's executive is expected to give
NK603 the go-ahead in September.

Brussels is getting frustrated with a failure of nerve by national
governments to authorise biotech products that are unpopular with public
opinion, leaving the commission holding a hot political potato.

Commissioners point to scientific evidence giving NK603 a clean bill of
health and the possibility of international litigation if EU governments
continue to block GM.

Highlighting the issue, and also on Monday, the EU executive cleared
NK603 "for use in animal feed or for industrial purposes".

EU environment chief Margot Wallstrom stressed that authorisation
followed rigorous procedures.

"The maize 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 maize," she said.

"Its safety is, therefore, not in question, and neither is the question
of user or consumer choice. Clear labelling provides farmers and
consumers with the information they need to decide whether to buy the
product or not."

 Green campaigners believe the situation indicates the failure of the
EU's GM regulatory structures, revived in April after a five year freeze
on the new technology.

"This pattern of decision-making by default is starting to expose the
lack of credibility of EU authorisation procedures," said Greenpeace
spokesman Eric Gall.

 "Most consumers do not want GMOs and member states have not agreed to
approve them, the commission is defying democracy by pushing through
these approvals to satisfy the biotech lobby and its US backers."


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