European Food Safety Authority (EFSA)
Opinion adopted on 29 March 2006 (Question No EFSA-Q-2005-294)

Summary

During the late 1990s and in 2000, a number of Member States invoked Article 16 of Directive 90/220/EEC, the so-called 'safeguard clause'. This safeguard clause provides that, where a Member State has justifiable reasons to consider that a genetically modified organism (GMO) which has received consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that GMO on its territory. Genetically Modified (GM) Bt176 maize (Zea mays L.), T25 maize and MON810 maize were authorised under Directive 90/220/EEC for all uses including cultivation and covering any progeny derived from crosses with any traditionally bred maize. Ms1 and Rf1 oilseed rape (Brassica napus L. ssp. oleifera) lines were authorised under Directive 90/220/EEC for production of seeds of all hybrids derived from crosses of these two lines (Ms1xRf1) and from crosses with any traditionally bred oilseed rape, but not extended to the use for human food or animal feed, without prejudice to any future assessment. Topas 19/2 oilseed rape was authorised under Directive 90/220/EEC for handling in the environment during import and before and during storage and processing. Subsequently these GM plants were subjected to the safeguard clause by certain Member States. Following the advice of the former Scientific Committees, the European Commission submitted draft decisions in 2004, requesting that the Member States concerned should lift their national safeguard measures. However, the draft decisions were not supported by a majority of Member States and the European Council suggested that the European Commission should assess further whether the national measures were justified.

Hence, the European Commission consulted the European Food Safety Authority (EFSA) and requested a scientific opinion under Article 29(1) and in accordance with Article 22(5)c of Regulation (EC) No 178/2002. The GMO Panel addressed the specific questions raised by the Commission with regard to Bt176, T25, MON810 maize and Ms1xRf1 and Topas 19/2 oilseed rapeon the basis of generally available scientific data and earlier assessments by the GMO Panel, but stated that it was not in a position to comment on the quality of the earlier applications or their compliance with the current legislation.

The GMO Panel concludes that the likelihood of adverse effects due to the presence of the antibiotic resistance marker genes (ARMGs) in Bt176 and T25 maize is extremely low. This is further supported by the fact that no gene transfer from Bt176 maize to culturable bacteria has been detected under field conditions, and that T25 maize contains only a partial bla<SUB>TEM-1</SUB>gene, which is, therefore, non-functional. Supported by the assessment of several applications on hybrids containing MON810 maize, the GMO Panel affirms its conclusions with respect to the potential impact of Cry1Ab toxin on biodiversity, that MON810 maize is unlikely to have adverse effects on human and animal health or the environment.

Concerning Ms1xRf1 and Topas 19/2 oilseed rape, the GMO Panel affirms that, in the unlikely scenario of establishment and spread of herbicide tolerant oilseed rape, a selective advantage would only occur in the case of treatments with the complementary herbicides. Therefore, having recommended the setting-up of appropriate management systems to minimize accidental loss and spillage of GM oilseed rape during transportation, storage, handling in the environment and processing into derived products,the GMO Panel considers that it is unlikely that there will be adverse effects for human and animal health or the environment as a consequence of accidental spillage of Topas 19/2 and Ms1xRf1 and subsequent establishment of GM oilseed rape plants.

In conclusion, the GMO Panel is of the opinion that, with respect to the specific questions raised by the European Commission and on the basis of current scientific knowledge, there is no reason to believe that the continued placing on the market of Bt176, T25 and MON810 maize, and Ms1xRf1 and Topas 19/2 oilseed rape is likely to cause any adverse effects for human and animal health or the environment under the conditions of their respective consents.

Opinion in PDF format:
http://www.efsa.eu.int/science/gmo/gmo_opinions/1439/gmo-op-ej338-safeguard-clauses_en1.pdf