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Consultation Notice

Transposition of GM Directive – consultation noticeSeed Label

Changes to the Genetically Modified Organisms Legislation in Scotland



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.

The Changes

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.


Bake saleConclusion

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.


Further information

If you have any comments or require further information on this article, the amending Directive or the implementation of the amending Directive please email the Scottish Government’s GM team.  All comments must be received by 24 January 2017

Email:             GMOLegislationScotland@gov.scot

1 Article 26a concerns measures to avoid the unintended presence of GMOs