Scientific Opinion on a request from the European Commission related to the prolongation of prohibition of the placing on the market of genetically modified oilseed rape events Ms8, Rf3 and Ms8 x Rf3 for import, processing and feed uses in Austria

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Article
EFSA Journal 2012;10(9):2878 [33 pp.].
doi
10.2903/j.efsa.2012.2878
EFSA Panel on Genetically Modified Organisms (GMO)
Panel Members
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Pagona Lagiou, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe.
Acknowledgement

The Panel wishes to thank the members of the Environment Standing Working Group on GMO applications, as well as the EFSA staff member Yann Devos for the preparatory work on this Scientific Opinion, and the EFSA staff members Yann Devos and Sylvie Mestdagh for the support provided to the development of this EFSA scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2012-00714
Adopted
6 September 2012
Published
11 September 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (191.7 KB)191.7 KB
Abstract

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape events Ms8, Rf3 and Ms8 x Rf3 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape Ms8, Rf3 and Ms8 x Rf3. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import and processing of oilseed rape Ms8, Rf3 and Ms8 x Rf3 for feed uses in the EU pose a significant and imminent risk to the environment. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape Ms8, Rf3 and Ms8 x Rf3.

Summary

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape events Ms8, Rf3 and Ms8 x Rf3 for import, processing and feed uses in Austria according to Article 23 of Directive 2001/18/EC.

The EFSA GMO Panel assessed whether the documentation submitted by Austria comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape Ms8, Rf3 and Ms8 x Rf3. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature.

During its evaluation of the supporting documentation, the EFSA GMO Panel observed that the scientific rationale provided by Austria to justify the prolongation of its safeguard clause measure includes data derived from cultivation. The authorised uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3 exclude cultivation, and cover import and processing for food and feed uses only. The EFSA GMO Panel considered the data compiled by Austria and other data on gene flow, persistence and invasiveness derived from cultivation. These data were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. However, the EFSA GMO Panel notes that data on gene flow, persistence and invasiveness derived from cultivation represent worst-case conditions that do not reflect those associated with the levels of environmental exposure related to the import, distribution and processing of oilseed rape Ms8, Rf3 and Ms8 x Rf3.

The EFSA GMO Panel also noted that some publications referred to by Austria were already part of the dataset submitted by Austria to support its 2008 safeguard clause measure. These publications were addressed previously by the EFSA GMO Panel in its 2009 Scientific Opinion on the safeguard clause measure invoked by Austria on oilseed rape Ms8, Rf3 and Ms8 x Rf3.

The EFSA GMO Panel could not identify new scientific evidence in the documentation provided by Austria and in the scientific literature that indicated that the import and processing of oilseed rape Ms8, Rf3 and Ms8 x Rf3 for feed uses in the EU pose a significant and imminent risk to the environment.

In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria, and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape Ms8, Rf3 and Ms8 x Rf3.

Keywords
GMO, oilseed rape (Brassica napus), Ms8 x Rf3, Austria, safeguard clause measure, environment, Directive 2001/18/EC
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Number of Pages
33