GENET archive


3-Food: European Commission authorises the import of GM maize MON 863 for use in animal feed

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

TITLE:  Commission authorises the import of GM maize MON 863 for use in
        animal feed
SOURCE: European Commission, Press Release IP/05/1046
DATE:   8 Aug 2005

------------------- archive: -------------------

GMOs: Commission authorises the import of GM maize MON 863 for use in
animal feed

The European Commission authorised today the placing on the market of the
genetically modified maize MON 863 for import and processing as animal
feed. The decision does not cover uses as human food or cultivation. The
maize has been modified by Monsanto to make it resistant to the corn
rootworm. This authorisation has been granted to Monsanto for 10 years.

With today's approval of MON863, the Commission is applying the
regulatory framework governing the release of GMOs, one of the strictest
in the world. The MON863 maize has been subject to a rigorous pre-market
risk assessment, and has been deemed as safe as any conventional maize by
the European Food Safety Authority. Robust post-marketing rules will
ensure that the product can be traced and monitored when put on the market.

MON863 is the second 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
maize. Its post-marketing monitoring will be assured through a unique
identifier assigned to the maize to enable its traceability.

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. Under this new system, only GMOs which are safe for human and
animal consumption and for release into the environment can be placed
onto the European market. Clear labelling rules allow farmers, other
users and consumers to choose whether or not to purchase such products.
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.

Background on MON 863

A request to market a genetically modified maize product (line MON863),
with resistance to corn rootworm, was submitted by Monsanto to the
competent authority of Germany for assessment. The requested uses of the
product included import, processing and feed use but not use in food or
for cultivation.

The German competent authority concluded that there was no scientific
evidence that indicated any risk for human health or the environment for
the requested uses. However, other Member States raised and maintained
objections in terms of molecular characterisation, allergenicity,
toxicity, an inadequate monitoring plan, accidental spillage, presence of
an antibiotic resistance marker gene and detectability. The European Food
Safety Authority (EFSA) was consulted and delivered its opinion on 16
April 2004 concluding that the MON863 maize was as safe as conventional
maize and unlikely to produce adverse effects.

Consequently, a draft Commission Decision to place the product on the
market was presented to the Regulatory Committee for vote on 20 September
2004. However, on 17 September 2004, the German competent authority
submitted to the Commission and to the Member States, a re-evaluation of
a rat-feeding study included in the original application.

Many Member States expressed concerns in terms of reaching a formal
position in the Regulatory Committee meeting, pending an examination of
this re-evaluation and consequently, no formal vote took place at this
time. Following the meeting, EFSA was requested to evaluate the impact of
the conclusions of the re-evaluated rat study on the original risk
assessment concluded that it did not put into question its initial
opinion on this product.

The Regulatory Committee was re-convened on 29 November 2004. The
Committee, acting by qualified majority, did not deliver an opinion. The
Commission consequently submitted a draft Proposal to the Council. On 24
June, the Environment Council failed to reach a position on the proposal.
As foreseen under EU legislation, the Commission is therefore required to
adopt a final decision.

Further information on the regulation on GMOs in the European Union can
be found at: MEMO/05/104

[1] First product was NK603 maize, see IP/04/957 of 19 July 2004

[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 -------------------------------

SOURCE: Friends of the Earth Europe
DATE:   8 Aug 2005

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Brussels August 8 2005 - The European Commission today approved the
import of a controversial genetically modified (GM) maize, MON863 for use
as animal feed [1]. Friends of the Earth has condemned the decision,
which once again ignores Member States' concerns over safety.

Monsanto's animal feed application failed to get support at the June 24th
EU Environment Council when the majority of Member States abstained or
voted against it [2]. As a qualified majority was not reached, the final
decision reverted to the European Commission.

MON863 maize has been genetically modified to resist certain insects by
producing a toxin in the plant. It has caused controversy due to food and
feed safety concerns, the fact that the European Food Safety Authority
(EFSA) disregarded these concerns, and Monsanto's refusal to publish
documents that are crucial to assessing the application. These include:

- Food safety studies: the results of a feeding study of the GM maize on
rats showed significantly different levels of white blood cells, kidney
weights and kidney structure, as well as lower albumin/globulin rate in
the rats fed the GM maize.

- Scientists' criticism of the maize: a number of scientists from
different Member States, including the French Commission for Genetic
Engineering (CGB), were therefore concerned and severely criticized to maize.

- EFSA's disregard of member state scientists: the European Food Safety
Authority (EFSA) rejected all concerns raised by Member States when
reviewing the application, and delivered a positive opinion

- Monsanto's refusal to publish key documents: Monsanto refused to
publish the initial rat study, having requested when it filed the
application, that crucial documents including the rat study be classified
as confidential.

- German court rules against Monsanto: in June 2005, the German
government won a court ruling against Monsanto and the documents where
made public

- The documents released in June seem to confirm that there is cause for
serious safety concern.

Helen Holder, GMO campaign coordinator for Friends of the Earth said:
"Once again, the Commission has ignored serious concerns raised by Member
States over the safety of GMOs. The Commission has authorized this maize
despite attempts by Monsanto to hush up the food safety results. Member
States have another chance to block this maize at the September
Agriculture Council: they must use the opportunity to protect their
citizens, stand up to the Commission, and reject it once and for all."

Helen Holder, GMO campaign coordinator, mobile: +32 4 74 857 638


[1] This is a decision on animal feed: EU Ministers will vote on the food
application for the same maize this coming September. Under EU
legislation, no import, including that of animal feed, is allowed until
the food application has been authorized. In this case, no imports will
be able to start unless the MON863 food application is authorized. EU
Ministers are scheduled to vote on this in September 2005.

Environment Council 24 June 2005
In favour: DE, EE, FR, NL, FI, SE, UK
Against: DK, EL, IT, CY, LV, LT, LU, HU, MT, AT, PL, PT, SI, SK
Abstention: BE, CZ, ES, IE,

[3] European Commission press release:


European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
In den Steinäckern 13
D - 38116 Braunschweig

P: +49-531-5168746
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