MON 810, a variety of genetically modified insect resistant maize authorised under EU GM legislation for cultivation and for particular food uses (including food use for maize flour, gluten, starch, glucose and oil, but as highlighted by recent events, not pollen) is yet again being discussed at EU level with the Monsanto Group, the original applicant of the authorisation, closely following the developments.
Court Rulings
In September of this year the substance was the subject of not one but two ECJ rulings.
The first concerning honey owned by German beekeepers which was unintentionally contaminated by pollen from field trials of MON 810 in which the Court ruled that the honey did not fall under the existing EU authorisation and thus prevented the beekeepers bringing the action from selling their honey on the EU market. This strict approach evidence by the Court made it clear that honey containing the GM pollen would require its own separate EU authorisation. [see our previous EU Reg Bulletin].
The second ECJ ruling came two days later in a case where the French government had unilaterally instituted a ban on the cultivation of MON 810 in France. The Court found the ban to be procedurally incorrect and thus invalid. [see our previous EU Reg Bulletin].
Assessment
The latest developments consist of the European Commission requesting the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to provide a scientific opinion concerning the substance. Specifically, the Commission has asked the EFSA GMO Panel to assess the monitoring report for the 2009 cultivation season of maize variety provided by Monsanto Europe S.A, a report the company is required to produce annually. Last month EFSA published its findings.
EFSA’s Findings
The EFSA GMO Panel found that the presence of pollen from MON 810 in honey or when consumed directly as food is unlikely to raise specific safety concerns given it did not identify adverse effects on the environment, human and animal health due to maize cultivation during the 2009 growing season based on the data submitted by Monsanto in its 2009 report.
However, the panel did find a number of shortcomings in the methodology applied by Monsanto in its post-market environmental monitoring of the substance. As a result, the EFSA opinion lays down a number of specific recommendations for the improvement of the strategy, methodology and reporting to applied by Monsanto going forward.
For example it suggested additional information be collected by the farmer questionnaires, part of ongoing initiatives to educate farmers about the importance of implementing insect resistance management measures; and notes that standardised interviews should be carried out by independent parties.
Impact
As for the future of the substance, the European Commission has already stated it is working towards expanding the approval of MON 810 maize so that it includes the use of pollen in food. The recent EFSA scientific opinion will inevitably help rather then hinder the Commission in the accomplishment of that objective.
