This week, Scotland's rural affairs secretary, Richard Lochhead, announced that he is to request that the country be excluded from the scope of EU consents for the cultivation of new genetically modified organisms (GMOs). In this update, we take a look at the new EU legislation governing that request. As a result of that legislation, EU member states now have additional power to decide to what extent they are prepared to permit GMOs to be grown in their territories. This makes public perception of GMOs and the state of local scientific knowledge more important and may result in an increase in limitations on the growing of genetically modified crops in Europe.
What are GMOs?
GMOs encompass plants, animals and all other organisms in which the genetic material has been modified (for example, by the introduction of a useful gene that is foreign to the host species). However, when people talk about GMOs they are generally referring to GM crops, which are by far the most prevalent form of GMO in the EU.
Controversy abounds in relation to the release of GMOs, particularly regarding the safety of GM foods for human consumption and the threat that GM crops are (rightly or wrongly) perceived to present to indigenous and unmodified species.
What has changed?
It has become clear over the course of the past two decades that a number of countries in Europe are reluctant to concede control of the release of GMOs in their territories to the EU. Following a lengthy consultation process, this is now reflected more fully in the recent legislative changes at the EU level.
On 11 March 2015, the EU Directive 2015/412 (the new Directive), which amends Directive 2001/18/EC (the release Directive), was implemented to allow EU member states to restrict or prohibit the cultivation of GMOs in their own country.
What restrictions and protections can be applied under old law?
There is a 'safeguard clause' included in the release Directive (in Article 23), which allows member states to restrict or prohibit the sale and use of GMOs in certain circumstances where those GMOs have received written consent for release into the EU. The safeguard is only available where a member state has detailed reasons for considering that the relevant GMOs constitute a risk to human health or the environment, on the basis of evidence made available after consent for release has been granted. Member states have no other control over such release.
Despite the high threshold for restriction or prohibition, the safeguard clause has been invoked by a number of member states on nine separate occasions (all of which occurred in the late 1990s or in 2000 under Directive 90/220/EEC, which was replaced by the release Directive). In each case, it was found that there was no new evidence to justify revoking permission for the relevant GMO.
What’s new under the new Directive?
The new Directive operates to insert additional provisions into the release Directive. The release Directive will remain in force and a risk assessment will still be performed at an EU level to determine whether or not a GMO is safe for release into the EU.
However, the EU has acknowledged that decisions as to cultivation within individual member states raise complicated regional issues that are best dealt with at a national level. The EU has therefore introduced a new provision allowing member states to demand that the scope of consents for the cultivation of new GMOs in the EU be restricted so their territories, or parts of them, are excluded.
Any demand should be made prior to issue of the EU’s written authorisation for release for cultivation and is subject to the consent of the applicant for authorisation. There are saving provisions in case a demand is not raised before the EU authorisation is given, or if the applicant for authorisation refuses to limit the scope of its application to exclude the relevant territory, but these are more limited in scope.
The provisions of the new Directive are not intended to conflict with the EU risk assessment. As such, where EU authorisation has already been granted or the applicant for a new authorisation refuses to limit the scope of its application, member states will only be able to restrict or prohibit GMO cultivation for environmental reasons that are distinct and complementary to those addressed in the risk assessment.
Article 1(2) of the new Directive (inserting a new Article 26b into the release Directive) lists the following relevant factors that may be taken into account:
environmental policy objectives;
town and country planning;
avoidance of GMO presence in other products;
agricultural policy objectives; and
public policy (although this last factor cannot be the only ground relied on).
In addition, restrictions must comply with EU law and be reasoned, proportionate and non-discriminatory.
What does this mean for the future?
Member states now have until 3 October 2015 to apply for their territories, or areas within them, to be excluded from the scope of authorisations granted prior to 2 April 2015. If the authorisation holder refuses to limit the scope of the authorisation, member states will have to show that the restriction demanded is compliant with the requirements of the new Article 26b of the release Directive.
For all authorisations granted on or after 2 April 2015, the provisions of the release Directive as amended by the new Directive will apply.
At present, the Defra website reveals that no GM crops are being grown commercially in the UK, so the availability of extra restrictions is not going to bring about immediate changes. However, it would be worth watching out for applications for exclusion from certain areas of the EU, particularly from those countries that have been most vehemently opposed to the cultivation of GMOs (notably Austria and France, which have invoked the safeguard procedure thrice and twice respectively). For new applicants, there will be additional challenges in overcoming any opposition at the application stage and afterwards.