News Releases
No.73/05
August 8, 2005
GMOs:
Commission Authorizes the Import of GM Maize MON 863 for
Use in Animal Feed
The European Commission authorized 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 authorization
has been granted to Monsanto for 10 years.
With today’s approval of MON 863, the Commission is applying
the regulatory framework governing the release of GMOs,
one of the strictest in the world. The MON 863 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 authorization covers the import and the use as
animal feed, but not cultivation or food uses. The product
will be covered by the new strict labeling and traceability
rules which came into force in April 2004[3].
When put on the market, it will need to be clearly labeled
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 labeling rules allow farmers,
other users and consumers to choose whether or not to
purchase such products. Individual authorizations are
granted, following appraisal of the GMOs in question on
a case-by-case basis. Requests for authorizations which
do not fulfill all criteria have been and will continue
to be rejected.
Background on MON 863
A request to market a genetically modified maize product
(line MON 863), 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 characterization, 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 MON 863 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 labeling of genetically
modified organisms and the traceability of food and feed
products produced from genetically modified organisms
Further Contact Information
Press and Media Relations
Delegation of the European Commission
2300 M Street, NW
Washington, DC 20037
http://www.eurunion.org/PressRoom
Tel: 202-862-9552
Fax: 202-429-1766
