Applicants can apply for GMO authorisations by submitting a dossier with experimental data and a risk assessment.
Authorisations are valid throughout the EU and may be for:
- Marketing of food and feed and derived products
If the GMO is to be used in food or feed without cultivation: applying for food and feed purposes is enough.
If the GMO is to be used in food or feed with cultivation in the EU: companies need applying both cultivation and food/feed purposes under the same Regulation.
If the GMO is not to be used in food or feed: applying for authorisation for cultivation is enough.
- Regulation (EC) No 1829/2003 on GM food & feed
- Directive 2001/18/EC on deliberate release into the environment
- Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) 1829/2003
- Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
Communication/Proposal adopted by the Commission - 22/04/2015
- Communication from the Commission Reviewing the decision-making process
- Annex to the communication
- Proposal for a Regulation