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Post-authorisation
The EU’s post-authorisation policy for GMOs is based on the principle that approval does not end regulatory oversight. GMOs are authorised only if they are considered safe for human and animal health and for the environment, but once authorised they remain subject to a set of follow-up activities carried out by different actors within the EU system.
A first element is the use of detection methods. Applications for the authorisation of genetically modified food or feed must include methods for the detection, identification and quantification of the GMO, so that authorities can verify its presence in products and along the supply chain.
A second pillar is the system of official controls by EU countries. Under the GMO framework, together with Regulation (EC) No 882/2004 and Regulation (EU) 2017/625, Member States are responsible for carrying out controls to ensure that GMO rules are being applied in practice.
The policy also requires monitoring plans and reports, which are part of the post-authorisation obligations linked to GMO applications. In addition, the EU has established harmonised methods of sampling and analysis for official controls and applies the concept of technical zero for detection in certain control contexts. Together, these tools are meant to ensure continued oversight after a GMO has entered the market.
Overall, the EU approach to post-authorisation is designed to ensure that GMO approval is followed by ongoing verification, control and monitoring, rather than being treated as a one-off decision.
A first element is the use of detection methods. Applications for the authorisation of genetically modified food or feed must include methods for the detection, identification and quantification of the GMO, so that authorities can verify its presence in products and along the supply chain.
A second pillar is the system of official controls by EU countries. Under the GMO framework, together with Regulation (EC) No 882/2004 and Regulation (EU) 2017/625, Member States are responsible for carrying out controls to ensure that GMO rules are being applied in practice.
The policy also requires monitoring plans and reports, which are part of the post-authorisation obligations linked to GMO applications. In addition, the EU has established harmonised methods of sampling and analysis for official controls and applies the concept of technical zero for detection in certain control contexts. Together, these tools are meant to ensure continued oversight after a GMO has entered the market.
Overall, the EU approach to post-authorisation is designed to ensure that GMO approval is followed by ongoing verification, control and monitoring, rather than being treated as a one-off decision.
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