Genetically Modified Organism

Genetically Modified Organisms in Europe

The application of GMO technology is strictly regulated and the European Union (EU) has established an extensive legal framework on GMOs since the early 1990s. The entire body of EU GMO legislation was amended between 2000 and 2003. In 2008, the European Commission undertook to review the EU GM legislation and this review is still on-going.

One issue that the Commission was keen to resolve was the lack of consensus among EU Member States regarding approval of GMO applications for commercial cultivation. For many years, Member States have failed to reach a qualified majority either for or against GMO cultivation applications, and the Commission has been required to make the decision. Member States who vote against such applications often do so for political or socio-economic reasons.

By the time a GMO has reached the stage of a vote by Member States it has already been through a comprehensive scientific risk assessment. The European Food Safety Authority (EFSA) will have provided a scientific opinion that the GMO is as safe as its non-GM counterpart in terms of human health, animal health and the environment. Member States’ own advisory committees, like the UK’s Advisory Committee on Releases to the Environment, have the opportunity to comment on EFSA’s opinion. In the absence of any evidence of risk to health or the environment, the Commission is left with little option but to accept the scientific opinion provided.

This has resulted in a protracted approval process for GMO applications in the EU, especially those for commercial cultivation. This in turn has led to a lot of criticism from countries, such as the US and Canada (where genetically modified (GM) crops are widely cultivated), and the biotechnology companies who submit the applications for approval. In the case of the latter, some companies have stopped designing GMOs for the European market because they see the EU authorisation process as dysfunctional and with prohibitive costs.

In 2010, the Commission proposed changes to the GMO regulations that would give Member States more powers when deciding whether or not to grow EU approved GM crops. After several years’ negotiations between the Commission, European Parliament and European Council of Ministers, an agreement was reached as regards the possibility for Member States to restrict or ban the cultivation of GMOs in all or part of their territory.

Ad hoc Working Party on Genetically Modified Organisms (GMO)

The Working Party on Genetically Modified Organisms (GMO) deals with the legislation and regulation of cultivation and marketing of genetically modified organisms.

More details about Ad hoc Working Party on Genetically Modified Organisms (GMO)

Directive 2001/18/EC and Regulation 1946/2003/EC

Note: in the UK, there is a concordat on the implementation of Directive 2001/18/EC and Regulation 1946/2003/EC (Agreement between the Department of the Environment in Northern Ireland, the National Assembly for Wales, the Scottish Executive and the UK Government).

The European Union made amendments to the GMO regulations by way of EU Directive 2015/412 (the amending Directive), which came into force in April 2015. The provisions in the amending Directive refer to applications for commercial cultivation of GM crops and are discretionary. Transitional provisions in the amending Directive allowed Member States and regions to restrict or ban (opt out) of growing one GM maize variety that was already approved in the EU and others that were pending EU approval. Scotland, along with around two thirds of EU countries, used these transitional provisions by the 3 October 2015 deadline.

However, in order for Member States or regions to implement the provisions in the amending Directive for future GM crop cultivation applications, it is necessary to transpose the provisions in the amending Directive into domestic legislation.

Details of the changes

The amending Directive sets out two ways in which Member States and regions can opt out of growing an EU approved GM crop. The first, and simplest way (Stage 1), allows Member States to demand that the geographical scope of an EU consent for commercial cultivation of a GM crop is adjusted to exclude the whole or part of its territory. The demand must be submitted to the Commission after EFSA has issued its opinion on the application, but before the EU issues a consent. Provided the applicant does not object within the specified period, the Commission will accept the Member State’s demand and adjust the consent accordingly.

The second approach (Stage 2) applies if a Member State wishes to opt out of growing EU approved GM crops in the following circumstances:

  • the applicant has objected to the Member State or region’s Stage 1 demand for an adjustment to the geographic scope of a consent;
  • the Member State has missed the deadline for applying for a Stage 1 opt out; or
  • the Member State wishes to opt out of a group of GM crops, grouped by crop type (e.g. maize, soya, oil seed rape) or GM trait (e.g. herbicide tolerance, insect resistance).

With Stage 2, the Member State or region has to make a case to the Commission on grounds other than those used in the scientific risk assessment. A list of possible grounds is set out in the amending Directive. These are:

  • environmental policy objectives;
  • town and country planning;
  • land use;
  • socio-economic impacts;
  • avoidance of GMO presence in other products without prejudice to Article 26a1;
  • agricultural policy objectives;
  • public policy.

Implementation of Directive 2001/18/EC and Regulation 1946/2003/EC</h3
The Member States are responsible for the administration and coordination of the regulatory frameworks established under:

  • Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms; and
  • Regulation (EC) No.1946/2003 on transboundary movements of genetically modified organisms.

Directive 2001/18/EC sets out a harmonised and generic EU framework for the regulation of deliberate releases into the environment of genetically modified organisms (GMOs). The Directive entered into force in October 2002. Regulation (EC) No. 1946/2003 introduces, for the first time, requirements relating to exports of genetically modified (GM) products from the Community, to international transboundary movements of Genetically Modified Organisms, and to information exchange with the Biosafety Clearing House established under the Cartagena Protocol on Biosafety. It completes EU implementation of the Protocol, which the UK ratified on 19 November 2003.


Expert scientific advice

The Directive requires that decisions taken by competent authorities on applications to release GMOs on their territories are based on sound scientific evidence. For the purposes of the Concordat the term ” expert scientific advice” will be taken to mean the best available expert scientific advice on risks posed by a GMO (or GMOs) to human health or the environment in accordance with the requirements of Directive 2001/18/EC.

1 thought on “Genetically Modified Organism”

  1. Although transposition of the powers in the amending Directive is discretionary, the Scottish Government supports the general principle of Member States having more national discretion in relation to EU decisions. It is also considered best practice to transpose EU regulations into Scottish law. Transposing the amending Directive will give Scotland the option to continue to opt out of EU approved GM crops, if this were required or wished for in future.

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