Brussels, 6 November 2013
Questions and Answers on EU's policies on cultivation and imports of GMOs
What is the current procedure for authorising the cultivation of GMOs?
Genetically Modified Organisms (GMOs) are authorised at EU level on a case-by-case basis following an application by a company. Applications for cultivation of GMOs can be submitted under Regulation (EC) N° 1829/2003 on Genetically Modified (GM) food and feed or under the Directive for the deliberate release of GMOs into the environment (Directive 2001/18/EC). In both cases, the Member States play a significant role, carrying out the initial risk assessment of the GMO for cultivation.
For more information on the authorisation procedures:
Are any GMOs already cultivated in the EU?
Yes. There is one GM maize –MON 810– that is commercially cultivated in the EU. This product's genetic modification aims to protect the crop against a harmful pest – the European corn borer. It was authorised in 1998.
In 2012, MON 810 was cultivated mainly in Spain (116,306 hectares), Portugal (9,278 hectares), Czech Republic (3,052 hectares), Romania (217 hectares) and Slovakia (189 hectares)1. It represents 1,35% of the 9,5 million hectares of maize cultivated in the EU, and 0,23% of the 55,1 million hectares of genetically modified maize cultivated worldwide2.
In 2010, a GM starch potato, known as "Amflora" potato, was authorised for cultivation and industrial processing in the EU. It is no longer cultivated in the EU since 2011.
Have Member States already prohibited GMO cultivation?
Yes. Eight Member States (Austria, Bulgaria, Greece, Germany, Hungary, Italy, Luxembourg and Poland) adopted safeguard measures and prohibited the cultivation of the GM maize MON810 on their territories. France also had a cultivation ban in place until August 2013, when it was annulled by the French Conseil d'Etat. Moreover, Austria, Greece, Hungary, Luxembourg and Poland have notified to the Commission the prohibition of the cultivation of the "Amflora" potato. All safeguard clauses submitted to EFSA have been declared scientifically unfounded.
Why is the Commission sending today a draft decision of authorisation for the Pioneer 1507 maize to the Council?
In 2001, the company Pioneer lodged an application for the authorisation of the maize 1507 (confer resistance to specific harmful moth larvae for maize such as the European corn borer) for cultivation under Directive 2001/18/EC on the deliberate release of GMOs into the environment. In 2007, Pioneer initiated a first action for failure to act before the General Court of the European Union against the Commission for not having presented a decision of authorisation of that maize for vote to the Regulatory Committee. This action was closed by the Court following the proposal by the Commission, in February 2009, of a draft decision of authorisation to the Regulatory Committee, though which failed to deliver an opinion. In 2010, Pioneer launched a second action for failure to act (case T-164/10) against the Commission for not having, following that absence of opinion by the Regulatory Committee, referred the to the Council a proposal for an authorisation decision, in line with the comitology procedure applicable at the time (Council Decision 1999/468/EC).
On 26 September 2013, the General Court issued a judgment in relation to case T-164/10 by which it declared that the Commission failed to act under Directive 2001/18/EC by not submitting to the Council a proposal under Article 5(4) of the Council Decision 1999/468/EC.
In accordance with Article 266 TFUE, the Commission is therefore taking the necessary measures to comply with the ruling and put an end to the failure to act, and is submitting a draft decision of authorisation for the maize 1507 to the Council. To ensure a high level of protection of health and the environment, the draft decision of authorisation has been slightly amended in order to include recommendations made by EFSA in 2011 and 2012.
Does it mean that the European Commission is in favour of the cultivation of Pioneer 1507?
The Commission does not express an opinion in favour or against a particular GMO. The Commission is obliged as guardian of the Treaties to apply the existing legislation. It will be recalled that Directive 2001/18/EC which is the basic act for this authorisation was adopted by the Council and the Parliament in 2001 to reinforce the framework for authorisation of GMOs for cultivation. It will also be recalled that at the request of a number of Member States, the Commission proposed in July 2010 an amendment to the said legislation to allow MS freedom to restrict or prohibit the cultivation of GMOs on their territory.
Where are we on the legislative proposal tabled by the Commission in July 2010 to amend the legislation on cultivation of GMOs? (see MEMO/10/325 of 13 July 2010)
In response to a long standing request from several Member States, the Commission published in July 2010 a proposal for a Regulation revising Directive 2001/18/EC to provide legal basis to Member States in order to decide on GMO cultivation on grounds other than those based on a scientific assessment of health and environmental risks performed at European level. Thanks to this amendment Member States will be able to restrict or prohibit GMO cultivation in part or all of their territory without recourse to safeguard clauses which up to now have not been backed by EFSA.
The European Parliament adopted a first reading opinion on the proposal in July 2011. In Council, despite efforts of consecutive Presidencies, and most particularly of the Danish one in 2012, no agreement could be reached yet due to the blocking position of a minority of Member States. The Commission has never stopped making significant efforts to address the concerns of these blocking Member States while gaining the support of the large majority of Member States in favour of the proposal.
Why does the Commission expect the Member States to move forward on this legislative proposal on cultivation?
The Commission considers that the problems that triggered the legislative proposal on cultivation in 2010 remain unsettled and insistent, as illustrated today with the submission to the Council of a draft decision of authorisation for the maize 1507 following the ruling of the General Court of the European Union on the case T-164/10.
Having also in mind the constructive elements arising from the European Parliament's first reading opinion, and the persistent calls from the majority of supporting Member States to be allowed to ban or restrict GMO cultivation on their territory along the approach set in the Cultivation proposal, the Commission believes it is critical and foreseeable to instigate a new political momentum so that significant progresses on the file with the Council and the Parliament are reached in the coming months.
What are the GM plants that are authorised in the EU for feed and/or food uses?
Besides cultivation, the placing on the EU market of GMOs and the use of their derived products in the food and feed chain is subject to an EU authorisation, conditioned by the demonstration of absence of risk for human and animal health and for the environment following a thorough assessment by the European Food Safety Authority.
As of today, the list of 49 authorised GMOs for food and feed use includes 27 maizes, 8 cottons, 7 soybeans, 3 oilseed rapes, 1 sugar beet, 1 potato, 2 microorganisms.
The list of authorised GM plants and the precise scope of their authorisation is available in the EU register of GM food and feed, which can be found here: http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
For more information please see:
Source: Annual monitoring report on the cultivation of MON 810 in 2012 in the EU submitted by Monsanto. http://ec.europa.eu/food/plant/gmo/reports_studies/report_2012_mon_810_en.htm