In his Political Guidelines, Commission President Jean-Paul Juncker announced a review of the legislation applicable to the authorisation of genetically modified organisms (GMOs). On 22 April 2015, the Commission presented a package including a proposal for a regulation allowing Member States to restrict or prohibit the use of GMOs for food or feed purposes in their territory.

The current EU legal framework on GMOs provides that no genetically modified food and feed can be placed on the market before it has been granted an authorisation. To this end, a scientific assessment is performed by the European Food Safety Authority (EFSA), in cooperation with the scientific bodies of the Member States. If the assessment shows that the product does not pose a risk to health or to the environment, the Commission submits to the Member States a draft implementing decision of authorisation.

Over the last years, Member States' votes in standing and appeal committees on genetically modified food and feed have systematically been 'no opinion' outcomes (no qualified majority either in favour or against). As a consequence, the final decision on authorisation is always left to the Commission, which is required by the GMO legal framework to adopt a decision, and in practice, has little choice but to grant the authorisation.

The Commission's proposal intends to adapt the GMO legal framework 'to allow for a better expression of national views on the use of GMOs'. The authorisation process would not be changed, but the Member States would be given decisional power regarding the use of GMOs after they have been authorised at EU-level (opt-out measures). The proposal was modelled on another EU law, Directive 2015/412/EU, which allows Member States to ban the cultivation of GMOs on their territory (see ARRIVALS).

The European Economic and Social Committee (EESC) had reservations about the real possibility of implementing the rules in the single market and about certain legal aspects. It advised the Commission to withdraw the proposal and to draw up an improved one.

Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) adopted its draft report on 13 October 2015, requesting the Plenary to reject the Commission proposal. The European Parliament (EP) rejected the Commission proposal in its Plenary on 28 October 2015 (by 619 votes to 58, with 13 abstentions).

In the view of the Parliament, the main reasons for the rejection of the proposal are the following:

• It could lead to the reintroduction of border controls between pro and anti-GMO countries: whereas cultivation necessarily takes place on a Member State’s territory, GMO trade crosses borders, which means that a national 'sales and use' ban could be difficult or impossible to enforce without reintroducing border checks on imports. Thus, it could fragment the internal market and harm the competitiveness of the EU agricultural sector.
• It would prove unworkable: the ENVI committee had expressed concern about the lack of any impact assessment and evaluation of the potential consequences, or of other available options. Furthermore, the proposal contains no definition of the term 'use'. According to the rapporteur (Giovanni La Via, S&D, Italy), it fails to ensure the necessary legal certainty and adequate tools for Member States wishing to ban the use of GM food and feed.
• It would be incompatible with World Trade Organization (WTO) rules.

The Parliament called on the Commission to table a new proposal.

During the EP plenary session in October 2015, the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission would not withdraw the legislative proposal. In its 2016 work programme, the Commission listed the proposal among the priority pending proposals for that year.

The Council has discussed the proposal, but has yet to take a position on it. An exchange of views was held in the Agriculture and Fisheries Council on 13 July 2015. Most of the ministers questioned the proposed opt-out option and considered that it would not offer a practicable and legally sound solution. They pointed out that the word 'use'  is not sufficiently defined and could lead to different interpretations. Many delegations highlighted that the new process could weaken the single market and contravene the international commitments of the EU. A number of ministers regretted that an impact assessment had not been prepared to evaluate the consequences.

Responding to Member States' concerns about the compliance of the proposal with internal market and WTO rules, the Council requested its Legal Service to provide an opinion on these issues. In its opinion of 21 December 2015, the Council Legal Service expressed the opinion that the Commission proposal could not be based on Article 114 TFEU. It also expressed serious doubts about the compatibility with internal market and WTO rules of any restricting or prohibiting measures that Member States could adopt.

As a follow-up to the discussions held in the Council, the European Commission published a staff working document on 8 March 2016 on genetically modified commodities in the EU, providing data regarding the EU market for genetically modified (GM) food and feed.

The Council working party of agricultural attachés discussed the proposal on 3 November 2015 and again on 20 May 2016.

According to the decision by the EP Conference of Presidents in October 2019, the file is on the list of files that Parliament should request the Commission to withdraw. 

• EP Legislative Observatory, Procedure file of Regulation on Possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory, 2015/0093(COD)
• European Commission, Communication reviewing the decision-making process on genetically modified organisms (GMOs), COM(2015) 176
• European Commission, Proposal for a Regulation allowing Member States to restrict or prohibit the use of GMOs for food or feed purposes in their territory, COM(2015)0177
• European Commission, Work Programme 2016, COM(2015) 610
• European Economic and Social Committee, Opinion on the Proposal for a regulation amending Regulation (EC) No 1829/2003 as regards the possibility for Member States to restrict or prohibit the use of genetically modified food and feed on their territory, 2016/C 013/30
• Directive 2015/412/EU 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
• Council, Outcome of the Agriculture and Fisheries Council meeting of 13 July 2015
• European Commission, Staff Working Document on Genetically modified commodities in the EU, SWD(2016) 61

Further reading:

• European Parliament, EPRS, Imports of GM food and feed: right of Member States to opt out (third edition), Briefing, EU Legislation in Progress, October 2015

Author: Ivana Katsarova, Members' Research Service, legislative-train@europarl.europa.eu