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.