Member States are to have the final say on GMO cultivation from 2015 but is the compromise “messy”? Many commentators say it is.

On 12 June 2014 the European Council voted to allow Member States to choose whether to embrace or to ban GMO cultivation within their territories. This was proposed in 2010 but stalled when Member States failed to reach agreement.

The European Commission sees the end to this deadlock as a significant achievement. It believes that a two-stage opt out procedure (see below) established under the agreement will give Member States much called-for flexibility and legal certainty. But parties on both sides of the debate have been quick to criticise, branding the agreement a “messy compromise” that pleases no-one and opens the door to legal challenges and trade disputes.

The GMO Cultivation Market

The global biotech seed market is estimated to be worth around US$21 billion and is expected to reach US$42 billion in 2020.   The UK Department for Environment Food & Rural Affairs (Defra) estimates that more than 12% of the world’s current arable land is used for cultivating GM crops. The picture, however, is not uniform. In the EU only one GMO (GM maize MON 810) is commercially cultivated and by only a few Member States (with Spain accounting for over 90%).

Current Legislative Regime

Directive 2001/18/EC on the environmental release of GMOs and Regulation 1829/2003/EC on GM food and feed, require that a GMO can only be put on the EU market following a detailed procedure including national evaluation agencies, a scientific risk assessment by the European Food Standards Agency (EFSA) and at the agreement of the European Commission together with representatives of Member States.

Under this current legislative regime, if a Member State wishes to restrict or ban cultivation of an authorised GMO in its territory it has to rely on so-called “safeguard clauses” which are limited to circumstances where scientific evidence shows that the GMO poses a new serious risk to human or animal health or to the environment. Some Member States have implemented national bans but complaints have arisen about this (including as to the legality of the bans) from pro-GMO countries and industry.

Proposed Changes

Unhappy with the uneasy status quo, in 2009 13 Member States called on the European Commission to propose legislation which would introduce greater flexibility for Member States in choosing whether to accept, restrict or prohibit GMO cultivation in their territory. In 2010 the European Commission adopted a proposal which would technically amend Directive 2001/18/EC and allow Member States to take into account wider national circumstances. However Member States were unable to reach agreement on the draft text. Despite a generally positive first reading by the European Parliament the initiative stalled.

Having reignited momentum, the European Council reached this political agreement which the Commission describes as a “balanced compromise text” giving greater autonomy to Member States whilst not impacting the existing stringent authorisation procedure.

A New Two-Stage Procedure

The European Council says that a material feature of the agreement is that it provides Member States which wish to restrict or prohibit cultivation of a GMO in their territory, two stages at which to raise such objection in the GMO authorisation procedure:

  • Stage 1 – making a restriction of scope request at the pre-authorisation stage: before a GMO is approved by the EU, a Member State will be able to ask the applicant company, via the European Commission, to specify in its application that the GMO cannot be cultivated in part or all of its territory. Importantly this can be done “without justification”. The applicant company will be at liberty agree, disagree or do nothing, but if the applicant company does not make a timely response, this is to be taken as tacit agreement to the restriction. 
     
  • Stage 2 – opting out post-authorisation: after approval by the EU of the GMO for cultivation in the EU, Member States may consider an opt out provision (i.e. restrict or ban cultivation of the GMO in any part or all of its territory). The basis for opt out must be justified but the agreement is to provide a wide-ranging (and non-exhaustive) list of possible grounds of justification, including notably environmental and socioeconomic reasoning, and public policy issues; a significant move away from purely science-based risk reasoning. It is conceivable that such opt outs may give rise to disputes.

The agreement additionally ensures the right of a Member State to reconsider and change its views within the 10 year GMO authorisation period if new circumstances arise.

A Workable Solution or Unhappy Compromise?

Traditionally most of the EU has been GMO–sceptic or cautious. Seven Member States have bans on GMO cultivation. This agreement by 26 Member States (two abstained) is therefore seen as positive by the European Commission, but there remains some division in opinion. Some argue that differential standards between Member States may disrupt free trade and that cross-border contamination may occur. There is concern that disputes will arise, leading to legal challenges, or that these disputes will be played out in world trade forums.

Next Steps

After formal adoption by the European Council, talks will be opened with the newly elected European Parliament in early Autumn 2014. The European Commission hopes that final adoption of the agreed text, as an amendment to Directive 2001/18/EC, will take place in 2015.