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APPROVAL / FEED: EU authorises GMO rapeseed by legal rubberstamp

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TITLE:  EU authorises GMO rapeseed by legal rubberstamp
SOURCE: Reuters
DATE:   27.03.2007

EU authorises GMO rapeseed by legal rubberstamp

BRUSSELS - The European Union authorised German drugs and chemicals
group Bayer on Monday to market various genetically modified (GMO)
rapeseed types across the bloc for the next 10 years, the EU executive said.

Bayer's application relates to industrial processing, which includes use
in animal feed, for rapeseed types Ms8, Rf3 and hybrids of these two --
all engineered to resist the glufosinate-ammonium herbicide. It does not
involve cultivation.

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 was the case last September, when ministers failed to reach a
consensus agreement under the weighted EU voting system. For many years,
EU countries have not been able to secure the majority needed to vote
through a new GMO approval.

Since the EU's six-year unofficial moratorium on approving new GMO
products was lifted in 2004, the Commission has authorised a string of
GMOs in this way, outraging green groups.

National governments have consistently clashed over biotech policy. They
last agreed on a new GMO approval in 1998.

Green groups had complained about the impending authorisation, citing
risks that GMO rapeseed might sprout up if its seeds were spilled during
transit and then cross with related native, and non-GMO, rapeseed types.

European consumers are well known for their wariness towards GMO foods
but the biotech industry insists its products are safe and no different
to conventional foods. Europe's hostility to GMO foods is unfounded, it says.

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                                 PART II
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TITLE:  GMOs: Three oilseed rapes authorised for import and processing in
        animal feed
SOURCE: European Commission, Belgium
AUTHOR: Midday Express IP/07/416
DATE:   26.03.2007

GMOs: Three oilseed rapes authorised for import and processing in animal feed

The European Commission today authorised the placing on the market of
three oilseed rapes known as Ms8, Rf3 and Ms8xRf3, genetically modified
for tolerance to the herbicide glufosinate-ammonium. This decision is
valid for 10 years and covers the use of the oilseed rapes for imports
and processing into animal feed or for industrial purposes. It includes
measures to be taken by the company who developed the GM oilseed rapes
to prevent any damage to health and the environment in the event of
accidental spillage. Processed oil derived from these GM oilseed rapes
has already been approved for food use in 1999 and 2000 in the EU.

Today's authorisation covers the import and the use of Ms8, Rf3 and
Ms8xRf3 oilseed rapes as animal feed, but not cultivation or food uses.
These genetically modified oilseed rapes are tolerant to the herbicide
glufosinate-ammonium and do not contain an antibiotic resistance marker
gene. They have been subject to a rigorous pre-market risk assessment
and have been scientifically assessed by the Member States, as well as
the European Food Safety Authority, as being as safe as any conventional
oilseed rape.

When put on the market, products containing Ms8, Rf3 or Ms8xRf3 will
need to be clearly labelled as containing genetically modified oilseed
rape. They will be covered by the strict labelling and traceability
rules in force since April 2004. The labelling will provide operators
and consumers with the information they need to decide whether to buy
the product or not.

Robust post-marketing rules will ensure that the product can be traced
and monitored once put on the market, thanks to a unique identifier
assigned to the oilseed rape products. In addition, the authorisation
includes a set of guidelines to Bayer, the company who developed the
oilseed rape, on how to deal appropriately with accidental spillage
should it occur.

During the past six 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 genetically modified organisms (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.

This is the sixth authorising decision[1] to be issued under the
Directive of 2001 on the deliberate release into the environment of GMOs[2].


In January 2003, Bayer submitted a request to the competent authorities
of Belgium for placing genetically modified oilseed rapes Ms8, Rf3 and
Ms8xRf3 on the market. The initial request was for import, processing,
feed use and cultivation, but not food use.

The Belgian authorities came to the conclusion that Ms8, Rf3 and Ms8xRf3
oilseed rapes are as safe as conventional oilseed rapes and should be
placed on the market for import and processing and for use as any other
oilseed rape but not for the requested use of cultivation.

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 Ms8, Rf3
and Ms8xRf3 oilseed rapes were as safe as conventional oilseed rapes.

The Regulatory Committee established under Directive 2001/18 on the
deliberate release into the environment of GMOs did not give an opinion
in December 2005. The Commission therefore submitted a proposal to the

The proposal was considered by the Agriculture and Fisheries Council on
18 September 2006. At that meeting the Council did not reach a qualified
majority either for or against the Commission proposal. Consequently,
under the legal "comitology" procedure, the Commission must adopt the
Decision. The Commission's decision to approve Ms8, Rf3 and Ms8xRf3 is
therefore designed to ensure that this legal framework is correctly and
fully applied by Member States.

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

See also Memo/07/117 on the Regulation of GMOs in the EU

[1] The first product was NK 603 maize, see IP/04/957 of 19 July 2004.
The second product was maize MON 863, see IP/05/1046 of 8 August 2005.
The third product was oilseed rape GT73, see IP/05/1077 of 31 August
2005. The fourth product was maize 1507, see IP/05/1366 of 3 November
2005. The fifth product was maize MON863xMON810, see Commission Decision
2006/47/EC of 16 January 2006.

[2] Directive 2001/18/EC

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