Opinion of the Scientific Panel on genetically modified organisms [GMO] related to the safeguard clause invoked by Hungary according to Article 23 of Directive 2001/18/EC
Hans Christer Andersson, Detlef Bartsch, Hans-Joerg Buhk, Howard Davies, Marc De
Loose, Michael Gasson, Niels Hendriksen, John Heritage, Sirpa Kärenlampi, Ilona
Kryspin-Sørensen, Harry Kuiper, Marco Nuti, Fergal O’Gara, Pere Puigdomenech, George
Sakellaris, Joachim Schiemann, Willem Seinen, Angela Sessitsch, Jeremy Sweet, Jan
Dirk van Elsas and Jean-Michel Wal.
Acknowledgment
The GMO Panel wishes to thank Achim Gathmann for his contribution to the draft
opinion.
No abstract available
On 20 January 2005, Hungary invoked Article 23 of Directive 2001/18/EC (safeguard clause) to provisionally prohibit the cultivation of the authorised genetically modified maize line MON 810 on its territory. On 27 January 2005, the Commission received from Hungary a detailed list of reasons with documents supporting Hungary’s measures.
As a consequence, the European Commission requested in a letter dated 8 April 2005, a scientific opinion from the European Food Safety Authority (EFSA) as to whether the statement and documents submitted by the Hungarian authorities are in accordance with Article 23 of Directive 2001/18/EC. Further EFSA was requested to consider whether new information affects the environmental risk assessment in the light of existing information and on the basis of new scientific knowledge.
Following investigation of the evidence presented in the Hungarian submission, EFSA’s Scientific Panel on Genetically Modified Organisms (GMO Panel) concludes there is no new information affecting scientific evidence, in terms of risk to human health and the environment, that would invalidate the risk assessment of genetically modified maize line MON 810 established under Directive 90/220/EEC (repealed by Directive 2001/18/EC from 17 October 2002) and that would justify a prohibition to cultivation of these genetically modified crops in Hungary. The GMO Panel strongly recommends that in order to facilitate a thorough assessment of the identified risk, Member States should support any claims to invoke the safeguard clause by supplying an appropriate risk assessment accompanied by the supporting new scientific data of a quality which can be subjected to detailed scientific scrutiny.
GMOs, maize, health, environment, Directive 2001/18/EC. Zea mays, MON 810, Hungary, safeguard clause, human
