EU Authorisation

EU Authorisation section

In this section you can read about the EU regulations governing the field trials, commercial growing and food safety of GMOs. This is governed at the European level and by international agreements.

In this section, you can also find information about GeneWatch's work to ensure that decisions about whether to allow markeing or testing of GMOs is governed by the Precautionary Principle. In particular, GeneWatch is following the decision making process of the European Food Safety Authority (EFSA) which plays a key role in the European assessment system. More information about this work can be found under the EFSA topic heading.


In 1990 the European Union passed the first Directive (90/220/EEC) explicitly covering the deliberate release of GMOs. This Directive made it necessary to carry out a environmental risk assessment of the GMO and gain official authorisation prior to any field trial, commercial planting or importation into the EU.

In 1997 the first food safety regulations were passed (Regulation EU 258/97) in the EU and in 1998 the first food labelling regulations came into effect.

Also 1998, the EU Council of Ministers bought about a de-facto moratorium on all applications for import and commercial growing of GM crops and food in Europe. Member States had a number of concerns and wanted;

  • the risk assessment process to be stronger and able to take into account the wider effects of altered agricultural practices on the environment;
  • their to be a fuller traceability and labelling system;
  • a liability regime should something go wrong.

In 2001 the EU agreed new regulations covering the Environmental risk assessment of field trials and commercial growing and in 2003 agreed rules covering the authorisation, traceability and labelling of GM foods and animal feeds. This process has resulted in a more centralised process of authorisation that is mainly handled by the European Food Safety Authority.

By 2004 the EU member states were still failing to authorise the commercial planting or importation of GM crops. There was growing realisation that some kind of co-existence legislation was needed to prevent the contamination of non-GM seed by GM seed. This problem has not yet been resolved.

In May 2003 the USA, Argentina and Canada made a formal complaint to the WTO about the de-facto moratorium on GM crops and food in the EU. By May 2004 the EU Commission giving into pressure from the US, started to override the EU Council of Ministers and authorised the first GMO (Bt11 maize) in Europe since 1998.

In 2010, new proposals were made by the European Commission, to try to speed up approvals of GMOs whilst devolving decisions on cultivation to member states (the "opt out" proposal). The European Commission's proposals to speed up the authorisation of GM crops have been attacked by member states and its legal opinion on its own plans suggested they may not be compatible with international trade rules.

The "opt out" proposal for GM crop cultivation was revived in 2014 by UK Environment Secretary Owen Paterson, who worked with the industry to develop a version which could fast-track RoundUp Ready GM crops into England and some other countries (especially Spain). This proposal was later amended by the European Parliament's Environment Committee and a compromise "opt out" proposal was adopted in 2015 following further discussion with parliament and member states.

According to documents leaked by Wikileaks, the US has also lobbied Spain to adopt a pro-GM position in Brussels (see the El Pais report [in Spanish]) and proposed retaliation against EU countries opposed to GM crops.


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