Education and Science, EU – Baltic States, Law and Regulations, Legislation, Markets and Companies

Health and Food Safety Commissioner Vytenis Andriukaitis underlined that delivering on one of the important commitments taken by this Commission needed to review the legislation on the decision-making process on GMOs. The Commission has listened to the citizens’ concerns reflected in the positions expressed by the national governments. Once adopted, the proposal (being fully in line with the principle of subsidiarity), would grant the EU states a greater say as regards the use of EU- authorised GMOs in food and feed on their respective territories.  

Commission’s review derives from the Political Guidelines presented to the European 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.

More flexible approach towards use of GMOs

The proposal adopted by the Commission sends a strong signal to citizens that Europe takes into account their concerns, which may vary from one country to another. The new approach aims to achieve the right balance between maintaining an EU authorisation system and the freedom for the states to decide on the use of GMOs on their territory. Since it is crucial that a single risk management system is maintained – as this ensures the same level of protection throughout the EU – the current authorisation system, based on science and the labeling rules ensuring consumer choice, will not be amended. What will change is that once a GMO is authorised for use as food or feed in Europe, the states will have the possibility to decide on whether to opt out from allowing that particular GMO to be used in their food chain.

Member states will have to justify that their opt-out measures comply with EU law, which includes the principles of the Internal Market, and EU's international obligations of which the EU's WTO obligations are an integral part. Member states’ opt-outs shall be based on legitimate reasons other than those assessed at EU level, i.e. risk to human or animal health or the environment.

This proposal mirrors and complements the rights already given to the EU states in respect of GMOs for cultivation by Directive (EU) 2015/412 that entered into force in early April 2015, based on a recent agreement between the European Parliament and the Council. As a result, the EU would have a consistent set of rules for GM authorisations for cultivation and for food and feed, allowing the states’ individual concerns to be taken into account in both of these areas.

See: http://europa.eu/rapid/press-release_IP-15-4777_en.htm

GMOs package

The new Commission’s package on GMOs is adopted on 22 April 2015 and comprises the following documents: a Commission Communication reviewing the decision-making process on genetically modified organisms; and a proposal for a Regulation allowing the states to restrict or prohibit the use of GMOs for food or feed in their territory.

The decision-making process: roles of the Commission and of the states in the EU’s procedure of authorisation

The EU legal framework on GMOs provides that GMO or genetically modified food and feed cannot be placed on the market before it has been granted an authorisation in accordance with that legal framework (see the Directive 2001/18/EC and Regulation (EC) No 1829/2003).

To this end, a scientific assessment is performed by the European Food Safety Authority (EFSA), in cooperation with the scientific bodies of the EU member states.

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/use, the Commission submits to the Member States, represented in the Standing Committee, a draft implementing decision of authorisation, in accordance with the procedure set out in Regulation (EC) No 182/2011 (comitology procedure).

Under this procedure, the states vote under the “qualified majority” defined in the Treaty. 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.

In the Standing Committee, if the 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 the Standing and Appeal Committee, which is another body representing the EU states at a higher level.

In the Appeal Committee, the 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 authorization.

Member States’ authorizations

Since the entry into force of the EU legal framework on genetically modified food and feed, the results of the votes in Standing and Appeal Committees have systematically been “no opinion”, whether the authorisation was for cultivation or GM food and feed. The final decision on authorisations is therefore always left to the Commission at the very end of the procedure. This situation of repeated “no opinion” results is unique compared to the thousands of implementing decisions adopted via comitology every year, where the Member States generally support the Commission’s draft decision in the Standing Committee stage.

As regards genetically modified food and feed, the voting patterns show that there are generally more EU states supporting the draft decision than opposing it. The reasons invoked by the states to justify their abstentions or negative votes are sometimes scientific in nature, but in majority of the cases are based on other considerations, reflecting the societal debate in their country.

Currently, the legal framework on genetically modified food and feed does not allow Member States to express all of their individual concerns, in what is an area of high public interest.

GMOs in the food and feed chain

Presently, there are 58 genetically modified food and feed authorised in the EU (see the link to the GMO register). The number of GM food products actually available on shelves in the member states is limited. This may be the result of the labelling requirements for GM food and the availability of non-GM alternatives.

The situation is different when it comes to the GM feed sector. There is a substantial market for GM feed in the EU: more than 60% of the EU’s needs in vegetable proteins for cattle are met through imports of soya and soymeal from third countries where GMO cultivation is widespread.

Amending the Regulation on genetically modified food and feed

The Commission’s Communication outlines the different elements which need to be considered in that context and confirms the need to adapt the GMO legal framework to allow for a better expression of national governments’ views on the use of GMOs.

In March 2015, the Council and the Parliament agreed on an amendment of the GMO legal framework to allow the states to restrict or prohibit the cultivation of authorised GMOs (Directive 2015/412/EU). The Communication concludes on the need to extend this solution to genetically modified food and feed.

Thus a proposal is made to the European Parliament and the Council to amend Regulation (EC) No 1829/2003; while the authorisation process will not be amended, the states will be given decisional power regarding the use of genetically modified food or feed on their territory.

Main elements of the legislative proposal

The Commission proposes to amend the Regulation on genetically modified food and feed, to allow the EU states to adopt national decisions restricting or prohibiting the use in food or feed of GMOs, after they have been authorised at EU level (so-called opt-out measures).

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 the European Food Safety Authority (EFSA).

The EU proposal should not alter the uniform level of safety ensured by the EU-wide assessment. In addition, in case new evidence that the product could pose a severe risk to health or to the environment are identified, the EU legal framework already contains provisions allowing the states to ban a genetically modified food and feed pending an EU review of the situation.

These measures would have to be communicated to the Commission and to the states before adoption, and the Commission and the states would have 90 days to comment.

Where genetically modified food and feed was already used at the time a member state adopts an opt-out measure, the proposal foresees that operators should be provided a reasonable period of time to exhaust the stocks of this product. Furthermore, the measures should not target products in which an adventitious presence of EU-authorised GMOs below the labeling threshold set out in the legislation is found.

Opt-out measures: compatibility with the internal market and WTO obligations

The measures adopted by the EU states need to be compatible with the internal market. Article 34 TFEU prohibits measures of equivalent effects to quantitative restrictions to the free movement of goods.

Thus the states in using the proposal will 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 will need to be compatible with the principles of proportionality and non-discrimination between national and non-national products.

More generally, the EU states' measures will have to be consistent with the EU law and the EU's international obligations, of which the EU's WTO obligations are an integral part.

GMOs proposal: scientific assessment

The proposed amendment to the Regulation on genetically modified food and feed does not impact on the risk assessment carried out on GMOs prior to their authorisation, nor does it affect the level of safety which is fixed for all the EU states in the decision of authorisation, and which takes dues account of the precautionary principle.

Member states are allowed to adopt opt-out measures once the GMO is authorised at EU level and these measures cannot be justified by reasons which conflict with the risk assessment carried out by EFSA, but need to be based on different considerations.

Indeed, the legal framework currently foresees procedures for cases where it appears that a product presents a severe risk which was not addressed during the authorisation procedure. In such a context, the Commission and the states are already granted the possibility to adopt emergency measures which may lead, if appropriate, to the prohibition of the product on the territory of a EU state, or part of it, or on the whole EU.

It should be stressed that a Commission implementing Regulation was adopted in 2013 to reinforce and improve the risk assessment and risk management process for GMOs for food and feed use, in particular by clarifying the scientific data requirements for submitting a GMO application.

See: Commission Implementing Regulation (EC) No 503/2013 on applications for authorisation of genetically modified food and feed.

GMO for cultivation excluded

GMOs for cultivation are excluded from the scope of the proposal because that they are already covered by Directive (EU) 2015/412, which was recently adopted by the European Parliament and the Council.

That Directive is based on the same principles as the current proposal: it offers the possibility for the EU states wishing to restrict or prohibit GMO cultivation on their territory without affecting the EU risk assessment.

Perspectives

This legislative proposal will be sent to the European Parliament and the Council as well as to the Economic and Social Committee and the Committee of the Regions, which will consider it in the context of the ordinary legislative procedure.

More information on the following websites:

= Press release MEMO/15/4779 “General Q&A on GMOs fact sheet”;

=Main reference: European Commission, Fact sheet memo/15/4779 “Review of the decision-making process on GMOs in the EU”, Brussels, 22 April 2015; in:

 http://europa.eu/rapid/press-release_MEMO-15-4779_en.htm