EFSA replies to European Commission questions related to GMO safeguard clauses

April 13, 2006

Brussels, 12 Apr 2006

The European Commission asked EFSA to provide a scientific reply to questions relating to five genetically modified organisms (GMOs) subject to safeguard clauses invoked by certain Member States to restrict or prohibit their use at national level. EFSA's Panel on genetically modified organisms (GMO Panel) concluded that on the basis of current knowledge and within the scope of the specific questions asked by the European Commission, there is no reason to believe that the continued placing on the market of the five GMOs is likely to cause any adverse effects for human and animal health or the environment.

EFSA's GMO Panel noted that all five of the GMOs concerned (i.e. Bt176, T25, MON810 maize and Ms1xRf1 and Topas 19/2 oilseed rape) have been evaluated for their impact on human health and the environment by the previous Scientific Committees of the European Commission or in the case of one of the GMOs (MS1xRf1 oilseed rape) by a Member State[1]. It also said that, with the exception of MS1 x Rf1, all had recently been evaluated by EFSA's GMO Panel, in the context of questions related to safeguard clauses invoked by some Member States to provisionally restrict the marketing of these GMOs. In replying to the European Commission, EFSA's Panel took into account all new scientific data which became available since these GMOs were last evaluated, including at that time the arguments of member states applying a safe guard clause. Based on this, the panel answered the specific questions raised by the European Commission in relation to the following:

- the current safety implications to human health and the environment of antibiotic resistance genes as marker genes in Bt176 and T25 maize varieties;

- the consequences of accidental spillage of Topas 19/2, Ms1xRf1 and GT 73 oilseed rape;

- confirmation of the safety of MON 810 maize, with particular emphasis on the environmental safety aspects of the introduced Cry1Ab protein.

On the basis of current scientific knowledge and within the scope of the specific questions raised by the European Commission, the GMO Panel concluded that the continued placing on the market of the five GMOs currently subject to safeguard clauses is not likely to cause any adverse effects for human and animal health or the environment in the context of their authorised uses.

The Panel also noted that in line with the EU regulatory framework for GMOs, a new risk assessment would have to be carried out over the coming years should the applicants wish to continue to market these in the EU.

Full text of the opinion

The following opinions relative to safeguard clauses have been adopted by EFSA's GMO Panel:

Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safeguard clause invoked by Hungary according to Article 23 of Directive 2001/18/EC,

Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Austrian invoke of Article 23 of Directive 2001/18/EC.

Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Greek invoke of Article 23 of Directive 2001/18/EC.

European Food Safety Authority -- EFSA
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