GMO authorisations for cultivation

GMO authorisations for cultivation

The process for authorisation of cultivation of GMOs in the EU takes place under Directive 2001/18/EC or Regulation (EC) 1829/2003 (if the scope covers also food and feed).

How to apply for authorisation?

Under Directive 2001/18/EC, an application for authorisation of a GMO for cultivation must be submitted to a national competent authority. The summary of the notification has to be forwarded to the Commission which makes it available for public consultation.

The lead country prepares an assessment report within 90 days and sends it to the Commission which forwards it to the EU countries for comments. The Commission requests a European Food Safety Agency (EFSA) risk assessment if at least one EU country proposes one or more reasonable objections based on the assessment report.

More on EFSA's risk assessment here.

According to Directive 2001/18/EC:

  • Initial authorisations can be granted for up to 10 years (renewable)

  • GMOs must be monitored once placed on the market

  • Public consultation is compulsory

  • Labelling is required to guarantee consumers an informed choice

  • Information on GMOs must be recorded in a register

Final decision

Within three months of receiving the competent authority assessment report, the Commission proposes to EU countries to grant or refuse the authorisation.

Authorisations are valid for a maximum of 10 years (renewable).

National representatives approve the Commission’s proposal by qualified majority in the Regulatory Committee under Directive 2001/18/EC.

If the Committee does not approve or reject the proposal by a qualified majority, the Commission may summon an Appeal Committee.

If the Appeal Committee fails to reach an opinion by a qualified majority, the Commission has to take the final decision.

The procedure under Regulation (EC) 1829/2003 is described here.

Restricting or banning GMO cultivation

Under the new Directive (EU) 2015/412 EU countries have 2 possibilities to restrict or prohibit GMO cultivation on their territory:

  • During the authorisation procedure, an EU country may ask to amend the geographical scope of the application to exclude part of or all its territory. The applicant has 30 days to adjust or confirm the scope of its application. Member States are allowed to ask for their territory to be reintegrated into the geographical scope of the authorisation after the GMO authorisation has been granted.

  • After a GMO has been authorised for cultivation in the EU, an EU country may adopt national opt out measures restricting or prohibiting the cultivation of a GM crop, by invoking compelling grounds such as environmental or agricultural policy objectives, town and country-planning, land use, coexistence, socio-economic impacts, or public policy.

EU countries can use the new Directive’s provisions immediately, meaning that they can launch the procedure to adopt national opt out measures to ban/restrict cultivation of already authorised GMOs; or, during a 6 month transitional period (e.g. until 1 October 2015), they can request to be excluded from the geographical scope of the GMO applications that have already received an EFSA opinion or are already authorised.

EU countries' demands for restriction of the geographical scope of a GMO application or authorisation can be found here.

EU countries will still be able to adopt safeguard clauses to address new risks on health or the environment that may be identified after a GMO is authorised.

This new Directive imposes to EU countries cultivating GMOs to put in place coexistence measures at their borders with non-cultivating EU countries.

The national measures adopted can be found here.