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GMO authorisation
The EU’s GMO authorisation policy is based on the principle that genetically modified organisms cannot be placed on the market without a prior application supported by experimental data and a risk assessment. Authorisations are valid across the entire EU, which means the system is designed as a Union-wide approval regime rather than a set of separate national authorisations.
The framework distinguishes between different intended uses. A GMO may be authorised for cultivation, for the marketing of food and feed and derived products, or for both. If a GMO is intended for food or feed use without cultivation, an application for food and feed purposes is sufficient. If it is intended for food or feed use with cultivation in the EU, companies must apply for both cultivation and food/feed purposes under the same regulatory framework. If it is not intended for food or feed use, then an authorisation for cultivation alone is enough.
The legal basis of this policy rests mainly on Regulation (EC) No 1829/2003 on genetically modified food and feed and Directive 2001/18/EC on the deliberate release of GMOs into the environment. For applications concerning GM food and feed, the Commission also points to Implementing Regulation (EU) No 503/2013, which sets specific rules on the submission of authorisation dossiers.
The policy also leaves room for national restrictions in one specific area: cultivation. Under Directive (EU) 2015/412, Member States may restrict or prohibit the cultivation of GMOs in their territory, even within the broader EU authorisation system. This means the EU model combines a common approval framework with a degree of national discretion on cultivation.
Overall, the EU approach to GMO authorisation is meant to ensure that approvals are based on a structured scientific dossier, linked to the intended use of the GMO, and managed under a harmonised legal framework that applies across the Union.
The framework distinguishes between different intended uses. A GMO may be authorised for cultivation, for the marketing of food and feed and derived products, or for both. If a GMO is intended for food or feed use without cultivation, an application for food and feed purposes is sufficient. If it is intended for food or feed use with cultivation in the EU, companies must apply for both cultivation and food/feed purposes under the same regulatory framework. If it is not intended for food or feed use, then an authorisation for cultivation alone is enough.
The legal basis of this policy rests mainly on Regulation (EC) No 1829/2003 on genetically modified food and feed and Directive 2001/18/EC on the deliberate release of GMOs into the environment. For applications concerning GM food and feed, the Commission also points to Implementing Regulation (EU) No 503/2013, which sets specific rules on the submission of authorisation dossiers.
The policy also leaves room for national restrictions in one specific area: cultivation. Under Directive (EU) 2015/412, Member States may restrict or prohibit the cultivation of GMOs in their territory, even within the broader EU authorisation system. This means the EU model combines a common approval framework with a degree of national discretion on cultivation.
Overall, the EU approach to GMO authorisation is meant to ensure that approvals are based on a structured scientific dossier, linked to the intended use of the GMO, and managed under a harmonised legal framework that applies across the Union.
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