EUROPEAN COMMISSION Brussels, 22.4.2015 COM(2015) 176 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Reviewing the decision-making process on genetically modified organisms (GMOs)



1.INTRODUCTION The European Commission was appointed on the basis of the set of Political Guidelines it presented to the European Parliament. In these Guidelines, the Commission made a commitment to review the current legislation on the authorisation of genetically modified organisms (GMOs). This Communication reports on the results of the Commission’s review of the decision-making process for authorising GMOs and sets out the rationale that has led to the legislative proposal adopted by the Commission. The decision-making process in the field of GMOs is governed by both a specific legal framework and common institutional rules. This Communication summarises the context of such decisions, discusses the way the authorisation process has worked in practice, and describes changes introduced recently. It explains the conclusion reached by the Commission and the considerations taken into account in drawing this conclusion: the exceptional circumstances specific to GMOs which underlie the commitment in the Political Guidelines, in particular the democratic and legal issues. 2.THE DECISION-MAKING PROCESS IN THE FIELD OF GMOs 2.1.The legal framework The European Union has a comprehensive legal framework in place for the authorisation, traceability and labelling of GMOs. Regulation (EC) No 1829/2003 on genetically modified food and feed (“the 2003 Regulation”) covers food, food ingredients, and feed containing, consisting of or produced from GMOs. It also covers GMOs for other uses such as cultivation, if they are to be used as source material for the production of food and feed. All above, as covered by the 2003 Regulation, are hereafter referred to as “GM food and feed”. The other piece of legislation in this area is Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (“the 2001 Directive”). This covers GMOs for uses other than food and feed (notably for cultivation). Both legislative acts set out authorisation procedures the aim of which is to ensure that the placing on the market of the products concerned will not pose a risk to human or animal health or to the environment. In view of this, a scientific risk assessment is at the centre of the procedure: every authorisation for placing a product on the market must be duly justified, and the main ground on which such a justification can rely is scientific assessment. The legislation gives responsibility for scientific risk assessments to the European Food Safety Authority (EFSA), in cooperation with the Member States’ scientific bodies. From a legal point of view, decisions to authorise GMOs take the form of implementing acts adopted by the Commission. Whilst the Commission therefore plays a decisive role in the authorisation process, Member States are also very much involved. Member States' involvement at the authorisation stage Member States are involved at two stages: they vote on draft decisions tabled by the Commission in the Standing Committee, and, if no decision can be reached at that level, they then vote in the Appeal Committee. As in all other committees set up under EU legislation, Member States vote in these committees under the rule of the qualified majority, as defined in the Treaty. Where there is no qualified majority in favour of or against the draft decision in the Appeal Committee, the result is “no opinion”. Final adoption by the Commission The rules governing this procedure (Regulation (EU) No 182/2011) provide that where “no opinion” is issued by the Appeal Committee, “the Commission may adopt the draft implementing act . This wording implies that the Commission can exercise a certain amount of discretion. In the case of decisions relating to GMOs, however, the 2003 Regulation and the 2001 Directive significantly reduce its margin for manoeuvre. The system of prior authorisation, interpreted in the light of Article 41 of the Charter of Fundamental Rights and the case-law of the Court of Justice, requires the Commission to adopt a decision (authorising or prohibiting placing the product on the EU market) within a reasonable period of time. This means that where the legislation prohibits the placing of a product (in this case, a GMO) on the market unless it is authorised, it is not possible for the authorising body (in this case, the Commission) to simply abstain for an unlimited period of time from taking any decision (be it authorising or prohibiting the product) assuming that a valid request for authorisation had been submitted. Where a vote results in “no opinion”, the Commission cannot therefore simply abstain from taking a decision. Possible emergency measures at EU or Member State level The 2003 Regulation contains provisions allowing the Commission or Member States to adopt emergency measures to prevent the placing on the market or use of an authorised GMO. Recourse can only be made to such measures if there is scientific evidence demonstrating that the product is likely to pose a serious risk to health or to the environment.

2.2.The reality of decision-making for the authorisation of GMOs Since the entry into force of Regulation (EC) 1829/2003, Member States have never obtained a qualified majority in favour of or against a draft Commission decision authorising GMOs, whether for cultivation or for GM food and feed. The result has always been “no opinion”. This has consistently been the case at all stages of the procedure (both in the Standing Committee and in the Appeal Committee, under the current rules, and in the Council in the past) (see Tables 1 to 3 and Graph 1 of the Annex). GMOs for cultivation The cultivation of GMOs in the EU is limited. Since 1990, only three GMOs have been authorised for cultivation, and only one product (MON810 maize) is currently authorised. It is cultivated in five Member States and the areas on which it is grown represent only 1.5% of the total area of land devoted to maize production in the EU. The low number of authorisations for cultivation granted to date, as well as the safeguard clauses adopted by a number of Member States to prevent the use of GMOs authorised by EU legislation, both illustrate the position of many Member States on this issue. The resistance to GMOs in cultivation has increased in recent years, with many Member States opposing the authorisation of maize 1507 in the Council in February 2014 (see Table 1 of the Annex). GM food and feed The number of GM food products available for purchase is small (even though the joint authorisation with feed means that a larger number are authorised). Evidence from opinion surveys confirms the general impression that EU citizens are opposed to GM food. Many food retailers have chosen not to place GM food on shelves. This may be as a result of the labelling requirements for GM food, and also the availability of non-GM alternatives. Some consumers want to be sure that there are no GMOs involved at any stage of the production of the food they buy. A number of livestock producers, traders and retailers, in various Member States, have therefore tried to make their avoidance of GMOs a selling point. This has led to the use of labels such as “fed with GM-free feed” or organic. In contrast to the situation observed for GM food, there is a substantial market in the EU for GM feed. This is particularly true for compound feed, a mixture of feed materials for farm animals used for its high energy and high protein content. Most of the feed used in the EU is imported (over 60% of the EU’s plant protein needs being met with imports in 2013 – essentially soybean and soya meal), and imports come mainly from countries where cultivation is dominated by GMOs – 90% of imports originate from countries where around 90% of the land used for soybeans is planted with GM soybean. The main reasons for the widespread use of GM soymeal appear to be availability, price and competitiveness. The fact that GM feed is widely used has not, however, affected voting patterns. Votes on GM food and feed continue to systematically lead to “no opinion” (see Tables 2 and 3 and Graph 1 of the Annex). While voting positions have broadly stabilised over time, there is typically more Member States supporting the draft decision than opposing to it. Whilst Member States have been keen to introduce safeguards clauses to prevent the use of GMOs for cultivation, they have not been widely used for GM food and feed (with only one Member State currently having measures in place, relating to three products). Nevertheless, the number of Member States voting against the authorisation of GM food and feed shows that Member States do not feel that the process allows them to fully address their individual concerns. Conclusion on the decision-making process It has become “the norm” for decision on GMO authorisations that the dossier is returned to the Commission for the final decision, making decisions in this area very much the exception to the usual functioning of the EU comitology procedure as a whole. The issues raised by Member States who have opposed authorisations are most often not based on scientific considerations, but reflect national concerns which do not only relate to issues associated with the safety of GMOs for health or the environment. Whilst the current legislation allows the Commission to take into consideration “other legitimate factors”, in addition to the risk assessment carried out by EFSA, it has not been in a position to justify an EU-wide ban on products considered safe by EFSA on the grounds of these factors. This implies de facto that the Commission is systematically put in a situation where it has to take a decision on authorisations without support of Member States in relevant committees. This situation is specific to the granting of GMOs authorisations. 3.THE RECENT REFORM OF THE RULES FOR GMOs AUTHORISED FOR CULTIVATION In 2010, the Commission submitted a proposal to amend the GMO legislation to extend the grounds on which Member States could restrict or prohibit the cultivation of EU authorised GMOs on their territory ("opt-outs"). In the explanatory memorandum of the proposal, the Commission explained that “national, regional or local levels of decision-making are considered to be the most appropriate frameworks to address the particularities linked to GMO cultivation”. The proposed amendment has now been adopted into EU law as Directive (EU) 2015/412 ("The 2015 Directive"). It enables Member States to restrict or prohibit GMO cultivation on their territory (or part of it) provided that such measures are justified on the basis of compelling reasons other than the risk to human or animal health and the environment that is, criteria other than those assessed by EFSA in its risk assessment. This is a major development, as it allows Member States to take into account their national context, where there might be legitimate grounds for restricting or prohibiting GMO cultivation, other than those related to risks to health and the environment. Member States can therefore take account of considerations beyond those covered by the EU system of authorisation, which is focussed on scientific assessment and operates within the limits imposed by EU law. The provision applies to both future authorisations and to GMO that have already been authorised at EU level. The 2015 Directive therefore gives Member States more flexibility to decide whether or not they wish to cultivate GMOs on their territory, whilst still maintaining the system of EU authorisation based on risk assessment. The Directive thus addresses one of the main concerns voiced over years in relation to the authorisation procedure, and is fully in line with the approach set out in the Political Guidelines presented by the Commission to the European Parliament. The 2015 Directive only applies, however, to GMOs for cultivation and not to GM food and feed, which represent the majority of the authorisations granted in the EU. 4.THE COMMISSION PROPOSAL