Environmental Law

21/12/2015

The EU Regulation of Genetically Modified Organisms in 2015: at the Crossroad of History

The EU authorization of genetically modified organisms (GMOs) is the most strange and controversial area in the whole EU law system: the scientists are seriously distrusted by the general public, the authorization procedure is ‘unreasonably’ paralyzed or delayed, and the authorized GM products are banned by Member States without legitimate reason. But this is not the case in any other field of innovative technology or environmental law, and cannot be explained simply by precautionary principle or political pressure. This conundrum has puzzled the EU policy makers and lawyers for many years, and 2015 is a crucial year of fundamental reform. With the introduction of the opt-out clause, Member States now have freedom to ban GMOs without recourse to scientific evidence. Such a move may also cause negative effects concerning the EU internal market law and its obligations under the WTO law. We are now standing at the crossroad of history.

GMO is defined as “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.^[1] The commercial application of GM technology in the agricultural sector can introduce many desirable traits into one single crop, thus has huge economic, health and environmental benefits. At the same time, people are also concerned about its potential environmental and health risks, as well as some ethical and socio-economic issues. Under the current EU law, both GM crops and foods/feeds must go through the authorization procedure before marketing. This involves two stages of decision-making: a scientific assessment about their safety and a political vote about their overall acceptability. However, in the past voting, because Member States were deeply divided in their opinions, there were hardly any qualified majority reached in the authorization procedure. In the end, it is always the Commission makes the decisions, which are based on the scientific reports of the European Food Safety Authority (EFSA) and usually grant the authorizations. This fact (purely science-based decisions, at least on the surface) triggers many Member States’ objections and the Council’s reactions. As a result, the authorization of GM food/feed is seriously delayed, and the authorization of GM crops is totally paralyzed, which are in violation of the EU law. But the Commission could not do anything about it because the Member States’ ‘illegal’ actions were backed by the Council.^[2]

After many years’ tough negotiations and some small legal revisions, in March 2015 a fundamental legal reform called ‘opt-out clause’ was agreed by all Member States and enacted by the Commission.^[3] According to this new legislation, on the issue of GMO cultivation, Member States pro- and anti-GMO are finally unleashed from the political disputes and formally part with each other. For anti-GMO countries, they can now ban GM crops even after authorization without any need of scientific evidence. This can be done either by a blanket withdrawal from all the future authorizations (without need of giving any reason) before 3 October 2015, or (after that date) by quoting some ‘compelling’ socio-economic reasons listed in the legislation in individual case. As a result, 17 out of the 28 Member States have totally opted out on all their territories in this way,^[4] while 3 kingdoms of the UK (Scotland, Wales and Northern Ireland, leaving only England to be willing to cultivate GMO) and the French-speaking Wallonia region of Belgium also declared to be GMO-free.^[5] For pro-GMO countries, it is expected that the paralysis in the GMO authorization can be unblocked so that more GM crops can be authorized and cultivated.

However, this move also brings about legal uncertainties and new challenges. First, it is hard to say the opt-out clause is conform to the EU internal market law. It is rather to say that it is an exception to the principle of free movement of goods based upon all Member States’ political endorsement.^[6] Some Member States and MEPs also would like to opt out for GM food/feed, but such requests were firmly rejected by the European Parliament’s Environmental Committee on the grounds of protecting the EU internal market. This shows that the EU policy makers are very aware that the political exception to the internal market rule cannot be too wide. Second, the opt-out clause is also against the EU’s obligations under the WTO law, especially after the famous US-EU Biotech case in 2006. There is no way to defend in this respect, people just hope the EU will not be sued by the Unites States (and other GMO-producing countries) for two practical reasons: (1) more GM crops will be cultivated in pro-GMO countries, which will hopefully make up for their losses; (2) the import of GM crops is relatively a small part of business (compared to GM products). Third, whether the principle of proportionality is applicable in the scenario of GMOs is also a big issue. It is uncertain at this moment whether Member States’ blanket ban of GM crops (without even giving reasons) would be challenged in the EU courts. Last, the increased cultivation in pro-GMO countries and the total ban in anti-GMO states will expose the sensitive issue of cross-border coordination and the potential liability arising out of GMO ‘contamination’.

In sum, the whole EU GMO regulatory framework stands at the crossroad of history and is facing new possibilities and challenges. Instead of one unified procedure, now the EU regulation of GMOs is running on double trajectories. In the coming few years we will witness how this new approach addresses the needs and pressures from inside and outside EU.

[1] Article 2(2), Directive 2001/18/EC.

[2] It is illegal because these Member States do not have scientific evidence to support a prohibition or restriction to the free movement of an authorized goods in the EU internal market.

[3] Directive (EU) 2015/412.

[4] These Member States include: Austria, Bulgaria, Croatia, Cyprus, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland and Slovennia.

[5] Reuters.com by Barbara Lewis, ‘Majority of EU Nations Seek Opt-Out from Growing GM Crops’, 2015.10.04, available online at: http://www.reuters.com/article/2015/10/04/us-eu-gmo-opt-out-idUSKCN0RY0M320151004#xu0BYp9saiqghPUK.97 (last visited on 2015.11.08).

[6] The Commission indicates that the legal basis of opt-out clause could be Article 2 TFEU, which is a new provision introduced by the Lisbon Treaty. The third sentence of Article 2 (2) TFEU reads: “the Member States shall again exercise their competence to the extent that the Union has decided to cease exercising its competence”.