How to apply for authorisation?
Under Directive 2001/18/EC, a notification for the deliberate release of a GMO into the environment must be submitted to a national competent authority, who approves or refuses the deliberate release of the GMO.
Notifications are submitted to the competent authority of an EU Member State through an electronic submission platform. This electronic submission platform allows notifiers to submit notifications online and to follow-up their notifications from the submission until the outcome.
Commission Notice 2021/C 80/01 provides guidance both to business operators that intend to submit notifications under Part C of the Directive and to the competent authorities of the Member States that receive such notifications. The Commission Notice focuses on the changes introduced in the approval procedure by Regulation (EU) 2019/1381 (Transparency Regulation).
The competent authority of the notified EU Member State prepares an assessment report and sends it to the Commission and the other EU Member States for comments. The Commission requests the opinion of the European Food Safety Authority (EFSA) if at least one EU Member State or the Commission raises an objection as regards the risks, or where the assessment report indicates that the GMO should not be placed on the market.
For each notification submitted, the Commission publishes a summary of the notification and the EU Member State competent authority's assessment report favourable to the placing on the market of the GMO, and convenes a public consultation.
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
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.