Brussels, Belgium
March 26, 2007
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].
Background
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
Council.
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
Questions and Answers on the Regulation of GMOs in the European
Union |
