Explanatory Memorandum to COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests - Main contents
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| dossier | COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to ... |
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| source | COM(2013)758  |
| date | 06-11-2013 |
In accordance with the procedure under Article 14 of Directive 2001/18/EC, the competent authority of Spain prepared an assessment report, which concluded that there is no scientific evidence to indicate that the placing on the market of the Zea mays L. line 1507 poses any risk to human and animal health or the environment for the requested uses.
The assessment report was submitted in August 2003 to the Commission and the competent authorities of the other Member States, some of which raised and maintained objections to the placing on the market of the product.
The opinion of EFSA, adopted on 19 January 2005, concluded that Zea mays L. line 1507 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed use.
The Commission convened a technical meeting with national competent authorities on 19 June 2006, to address the remaining objections of Member States in view of the EFSA opinion and subsequently requested EFSA to complement its opinion on 1507 maize by providing more specific information concerning the lepidopteran species referred to in the EFSA opinion of 19 January 2005. EFSA was also asked to recommend whether more precise risk management measures, notably monitoring plans, should be implemented. EFSA adopted the annex complementing its opinion on non-target organisms on 7 November 2006 (published 21 November 2006). After the publication of the above annex, the Commission requested EFSA on 24 July 2008 to review eleven scientific studies, published after the adoption of the EFSA opinion of 19 January 2005, as well as any other relevant study, and to confirm its risk assessment of 1507 maize.
On 29 October 2008 EFSA adopted its opinion which concluded that these publications do not provide new information that would change previous risk assessments conducted on 1507 maize. Having also considered other recent scientific publications, EFSA reaffirmed its previous conclusions on the environmental safety of 1507 maize.
Against this background, a draft Commission Decision to place the product on the market, in accordance with Article 18 of Directive 2001/18/EC, was presented to the Regulatory Committee for vote on 25 February 2009. The Committee delivered no opinion: 6 Member States (91 votes) voted in favour, 12 Member States (127 votes) voted against, 7 Member States (95 votes) abstained and 2 Member States (32 votes) were not represented.
Following a request of the Commission on 14 June 2010 to consider whether new scientific elements might require a revision of the conclusions of its scientific opinion adopted on 19 January 2005, EFSA adopted on 19 October 2011 a Scientific Opinion updating the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize 1507 for cultivation. The EFSA GMO Panel concludes that, subject to appropriate management measures, maize 1507 cultivation is unlikely to raise safety concerns for the environment. In addition, on 18 October 2012, EFSA adopted a Scientific Opinion supplementing the 2011 opinion and providing with additional evidence and further clarifications.
Following a further request of the Commission on 20 June 2012 for a consolidated opinion, EFSA adopted on 18 October 2012 a Scientific Opinion updating the risk assessment conclusions and risk management recommendations on the genetically modified insect resistant maize 1507. The GMO EFSA Panel did not identify new scientific publications reporting new information that would invalidate its previous conclusions on the safety of maize 1507.
On 26 September 2013, the General Court of the European Union delivered its Judgement on the case T-164/10, Pioneer Hi-Bred International v. European Commission, and declared that 'the European Commission has failed to fulfil its obligations under Article 18 of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC by failing to submit to the Council a proposal relating to the measures to be taken pursuant to Article 5 i of Council Decision of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission'.
Consequently, pursuant to Article 30(2) of Directive 2001/18/EC and Article 5 of Council Decision 1999/468/EC, the Commission is required to submit to the Council a proposal relating to the measures to be taken, the Council having three months in which to act by a qualified majority, and inform the Parliament.