GMOs: the current legal framework and the latest proposals for change
In European Food Law there is nothing more controversial than the issue of Genetically Modified Organisms (GMOs). Member States are divided in the Council, one half of the EU legislator. Thus clear decision making in the Council is not easy. The other legislator, the European Parliament, seems to be strongly against their use. The Commission, or the EU executive and the competent authority for the authorisation of new GMOs, is caught in the middle trying to devise legislation to respect the fact that EU food law is based on Science and the EU’s scientific advisor, the European Food Safety Authority (EFSA), considers that many GMOs are scientifically safe to use.
What are GMOs and what is the EU approach on GMOs
Food and feed generally originate from plants and animals selected, grown and bred by humans over thousands of years. Over time, those plants and animals with the most desirable traits were chosen for breeding and planting as next generations of food and feed. This was, for example, the case for plants with an increased resistance to environmental pressures such as diseases, or with an increased yield. These desirable traits appeared through naturally occurring variations in the genetic make-up of those plants and animals. In recent times, it has become possible to modify the genetic make-up of living cells and organisms using techniques of modern biotechnology called gene technology. The genetic material is modified artificially to give the organism a new property (e.g. a plant’s resistance to a disease, insect or drought, a plant’s tolerance to an herbicide, improving a food’s quality or nutritional value, increased crop productivity). Such organisms are called ‘genetically modified organisms’ (GMOs). Food and feed which contain or consist of such GMOs, or are produced from GMOs, are called ‘genetically modified (GM) food or feed’.
The approach chosen in the EU as regards GMOs is a precautionary approach imposing a pre-market authorisation for any GMO to be placed on the market and a post-market environmental monitoring to ensure that non authorised GMOs are not present on the market. In order to provide consumers with information and freedom of choice, traceability and labelling obligations are imposed for the use of any authorised GMO.
Regulation (EC) No 1829/2003
The European Union has in place a comprehensive legal framework for the authorisation, traceability and labelling of GM food and feed.
Regulation (EC) No 1829/2003 on GM food and feed 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. The Regulation has put in place an authorisation procedure, the aim of which is to ensure that the placing on the market of the products concerned will not pose a risk to human and animal health or the environment.
Applications to request the authorisation are submitted first to the competent authority of a Member State. The application must clearly define the scope of the application, contain studies and data demonstrating the safety of the product, indicate which parts are confidential and must include a monitoring plan, a labelling proposal and a detection method. The application and any supplementary information supplied by the applicant must be made available for a scientific risk assessment covering risk to both the environment and human and animal health.
The scientific risk assessment is at the centre of the procedure: every authorisation for placing on the market of a product has to be duly justified and the main ground on which such a justification can rely is scientific assessment. The law gives responsibility for this scientific risk assessment to EFSA. Where the application is made for cultivation of GMOs, a first risk assessment is made by the scientific bodies of the Member States. This is then endorsed, or not, by the other Members States working though EFSA. The EFSA’s opinion is made available to the public and a public consultation is open for a period of one month.
Where the results of the risk assessment show that the product does not pose a risk to health or to the environment under the proposed conditions of placing on the market and use, the Commission – within three months of receiving the opinion of EFSA – submits to the Member States, represented in the Standing Committee, a draft decision to authorise the marketing and or use of the GMO. Under this procedure, Member States vote under the ‘qualified majority’ defined in the Treaty.
In the Standing Committee, if Member States vote ‘Yes’, the Commission adopts the draft decision. If they vote ‘No’, or if the result of the vote is ‘No opinion’ (no qualified majority either in favour or against is expressed), the Commission may submit the draft decision to another body representing the Member States at a higher level: the Appeal Committee.
In the Appeal Committee, the Member States vote a second time on the draft decision tabled by the Commission. If the Member States vote ‘Yes’, the Commission adopts the draft decision. If they vote ‘No’, the Commission cannot adopt the draft decision. If the result of the vote is ‘No opinion’, the Commission is required by the GMO legal framework and by the Charter of Fundamental Rights to adopt a decision on the application so, in practice, has little choice but to give the authorisation.
Examining this procedure might be considered a bit too much for readers of Across the EUniverse. However, it is important to look at this process. Member States have competence to decide. But the Member States have never been able to reach clear positions. This, in effect, has delegated decision making power to the Commission. And for many GMOs it is the Commission which has taken the decision to authorise its use.
Once a GMO has been authorised by the EU authorisation procedure, based on a thorough scientific evaluation of risk and a political management of that risk, the story should end there. But it doesn’t. Because Member States still have the capacity to ban the use of the authorised GMOs on their territory and some Member States have continually done so, often in breach of the EU rules.
It is this problem that the latest changes to law seek to address. First, there is the change on cultivation already adopted into law. Second, there is the proposed change in relation to the use of GMOs.
Opt-out measures by Member States for the GMOs cultivation: Directive (EU) 2015/412
The newly adopted Directive (EU) 2015/412 gives Member States more flexibility to decide on the cultivation of GMOs under certain conditions, at two distinct points in time. First, during the authorisation procedure: a Member State can ask to amend the geographical scope of the application to ensure that its territory will not be covered by the EU authorisation. Second, after a GMO has been authorised: a Member State may prohibit or restrict the cultivation of the crop based on grounds related amongst others to environmental or agricultural policy objectives, or other compelling grounds such as town and country-planning, land use, socio-economic impacts, co-existence and public policy.
Before the adoption of this Directive, Member States could provisionally prohibit or restrict the use of a GMO on their territory only if they had new evidence that the organism concerned constitutes a risk to human health or the environment or in the case of an emergency. No Member State which had adopted a so-called ‘safeguard clause’ had ever been in a position to put forward new evidence. As EU food law is based on science, only a scientific justification could be used. This set the bar very high. Particularly as the EU’s own scientific advisor, EFSA, had found that the GMO in question was scientifically safe.
The new Directive allows Member States to base a refusal to allow cultivation on grounds other than science. These grounds include: environmental policy objectives; town and country planning; land use; socioeconomic impacts; avoidance of GMO presence in other products; agricultural policy objectives; public policy.
The Directive has been adopted by both EU legislators; the Council and the Parliament, and had been proposed by the Commission. Thus both the EU legislators and the executive agree on its content. However, it can be asked whether this Directive is in line with EU policy as set out in established EU law. In particular, is it in line with the Treaty rules on the free movement of goods within the EU, or the objectives of the Common Agricultural Policy as set out in Article 39 of TFEU. Finally, can this Directive be in line with the objectives of EU food law as set out in the General Food Law Regulation from 2002 which states that all food law must be based on science.
In any event, on the basis of this Directive, by the deadline of 3 October 2015, nineteen EU Member States – including Italy – took advantage from the new expanded and non scientific safeguard clause and notified to the Commission the request to prohibit in their own territory the cultivation of all the genetically modified organism which are authorised in the European Union.
The Commission’s latest proposal on GMOs: more freedom for Member States to decide.
On 22 April 2015 the Commission presented the outcome of its review of the decision-making process for the authorisation of Genetically Modified Organisms as food and feed. This review derives from the Political Guidelines presented to the EU Parliament in July 2014, on the basis of which this Commission was elected. The review confirms the need for changes that reflect public views and allow national governments to have a greater say on the use of EU-authorised GMOs for animal (feed) or human (food) consumption.
As a result of this review, the Commission proposes to amend the legislation to confer upon Member States more freedom to restrict, or prohibit the use of EU-authorised GMOs in food or feed on their territory without affecting the EU risk assessment.
The outcome of the Commission’s review on the GMO’s decision-making process comprises two documents: a communication and a proposal for a Regulation allowing Member States to restrict or prohibit the use of GMOs for food or feed purposes in their territory (GMOs for cultivation are excluded from the scope of the proposal because that they are already covered by Directive (EU) 2015/412).
The Communication highlights the need to extend the principles set forth in Directive (EU) 2015/412 to the use – not only the cultivation – of GM food and feed. To this end, the proposal was made to the EU Parliament and to the Council to amend Regulation (EC) No 1829/2003. While the authorisation process will not be amended, Member States will be given decisional power regarding the use of GM food or feed on their territory.
The Commission suggests that the proposal should mirror the Directive on cultivation: it would offer – under certain conditions – the possibility to Member States to restrict or prohibit the use of GMOs on their territory after these products have been authorised at EU level.
According to the Commission’s proposal, Member States would have to justify that their opt-out measures are compatible with EU law and the principles of proportionality and non-discrimination between national and non-national products. However, they are not allowed to use justifications which conflict with the assessment of risks to human and animal health and the environment carried out by EFSA.
So the Commission’s latest proposal in relation to use has all the difficulties of the previous Directive in relation to cultivation.
The first step: the vote of the EU Parliament’s Environment Committee
On 13 October 2015 European Parliament’s Environment Committee (ENVI) opposed the Commission’s proposal. ENVI Members are concerned that the proposal might prove unworkable and lead to the reintroduction of border controls between pro and anti-GMO countries.
ENVI chair Giovanni La Via said: ‘A clear majority in the committee does not want to jeopardize the internal market. For us, the existing legislation should remain in place, and member states should shoulder their responsibilities and take a decision together at EU level, instead of introducing national bans’.
‘This proposal conflicts with the principles of “better regulation” and transparency which the new European Commission has taken on board. After we spent so many years getting rid of internal barriers, this proposal could fragment the internal market and lead to a return to border inspections, which we all worked hard to get rid of at the time’, he added.
The recommendation was approved by 47 votes to 3, with 5 abstentions. It will be put to a plenary vote at the 26-29 October plenary session in Strasbourg.
The GMO saga continues.
Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, OJ L 268, 18.10.2003, p.1.
 Articles 7 and 19 of Regulation (EC) No 1829/2003 provide that the Commission may, in addition to EFSA’s opinion, take into account ‘other legitimate factors relevant to the matter under consideration’.
 The new qualified majority introduced by the Lisbon Treaty corresponds to at least 55% of the Member States, comprising at least 15 of them, and representing at least 65% of the European population. A blocking minority may be formed comprising at least four Member States.
 Charter of Fundamental Rights of the European Union, OJ C 326, 26.10.2012, p.391.
 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, OJ L 68, 13.3.2015, p. 1.
 Treaty on the Functioning of the European Union, OJ C 326, 26.10.2012, p. 47.
 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002, p. 1.
 See Draft Report on the Proposal for a Regulation amending Regulation (EC) No 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory, COM(2015)0177 – C8-0107/2015 – 2015/0093(COD)), 25.6.2015.
 Better regulation is about designing EU policies and laws so that they achieve their objectives at minimum cost. It ensures that policy is prepared, implemented and reviewed in an open, transparent manner, informed by the best available evidence and backed up by involving stakeholders. See ‘Where is EU Law going? Towards a New Commission Strategy for better regulation’ by Giovanni Moschetta and ‘Will the better regulation for better results works?’ by Bernard O’Connor, both having being published in Across the EUniverse Number 3.
 Article 34 of TFEU reads as follows: ‘Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States.’ That is why the Member States which made use of this proposal should need to justify the measures taken based on grounds in accordance with Article 36 TFEU and the notion of overriding reasons of public interest, as developed by the case-law of the Court of Justice. In addition, the measures envisaged should need to be compatible with the principles of proportionality and non-discrimination between national and non-national products.