GMOs: Commission authorises import of GM-oilseed rape for use in animal feed
The European Commission authorised today the placing on the market of the genetically modified oilseed rape known as
GT73 for import and processing. This decision is valid for 10 years and results from an application submitted by the
company Monsanto. The GT73 oilseed rape, which is tolerant to the herbicide glyphosate, is already widely used in North
America 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 oilseed rape and processing for use in animal feed or for
industrial purposes. The authorisation is complemented by a Recommendation concerning the measures to be taken by the
consent holder to prevent any damage to health and the environment in the event of the accidental spillage of GT73.
Refined oil derived from GT73 oilseed rape has already been approved for food use in 1997 in the EU.
The GT73 oilseed rape 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 oilseed rape. 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 GT73 oilseed rape is the third 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 oilseed rape. Its
post-marketing monitoring will be assured through a unique identifier assigned to the oilseed rape to enable its
traceability. In addition, the authorisation is complemented by a Recommendation containing a set of guidelines to
Monsanto on how to deal appropriately with accidental spillage if it should occur.
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.
Further information:
MEMO/05/104
(Questions and Answers on the regulation of GMOs in the EU)
Background:
In January 2003, Monsanto submitted a request, under Directive 2001/18/EC, to the competent authorities of the
Netherlands for placing genetically modified oilseed rape GT73 on the market for import, processing for use in feed, and
industrial purposes. The GT73 oilseed rape is tolerant to the herbicide glyphosate. The product involves a simple
modification and does not contain an antibiotic resistance marker gene.
The Dutch competent authority came to the conclusion that GT73 oilseed rape is as safe as conventional oilseed rape. 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 GT73 oilseed rape was as safe as
conventional oilseed rape.
The Regulatory Committee established under Directive 2001/18/EC did not give an opinion in June 2004. The Commission
therefore submitted a proposal to the Council.
The proposal was considered by the Environment Council on 20 December 2004. At that meeting neither a qualified majority
vote in favour or against approval was obtained. Consequently, the Commission under the legal procedure is obliged to
adopt the Decision.
The methodology used for the safety assessment of the GT73 oilseed rape 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
basis.
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 oilseed rape ".
The Commission Decision will only apply when a validated detection method and appropriate reference material is
available which will allow for the physical detection of the GT73 oilseed rape 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.
In addition, further to the publication in February 2005, of a report by the Japanese Environmental Studies Institute
referring to the accidental presence of oilseed rape genetically modified for tolerance to a herbicide around five of
the six port facilities where sampling had been carried out, the European Commission has considered necessary to take
measures to prevent the same situation arising in the European Union.
Therefore, the authorisation is complemented by a Recommendation containing a set of guidelines to the consent-holder
(in this case Monsanto) on how to deal with accidental spillage if it should occur; and in particular to prevent any
damage to health and the environment in the event of accidental spillage of the oilseed rape GT73 during transportation,
storage, handling in the environment and processing into derived products.