Regulation (EC) No 1829/2003 lays down rules on how genetically modified organisms (GMOs) are authorised and supervised, and on how genetically modified food and animal feed is labelled within the European Union. This regulation aims to ensure a high level of protection for human and animal health and the environment, while also ensuring the free movement of safe and wholesome food and feed within the internal market.

The regulation requires that all genetically modified food and feed undergo a rigorous safety assessment through a community procedure before being placed on the market. This assessment is conducted to ensure that the GMOs do not pose a risk to human or animal health or the environment. The European Food Safety Authority (EFSA) plays a key role in this process by providing scientific opinions on the safety of GMOs.

Key provisions of the regulation include:

• Authorisation Procedure: GMOs and genetically modified food and feed must be authorised before they can be marketed in the EU. The authorisation process involves an application submitted to the European Commission, which includes detailed information on the GMO, its intended use, and scientific evidence of its safety. EFSA evaluates the application and provides a scientific opinion, which is then considered by the Standing Committee on Plants, Animals, Food and Feed.
• Labelling Requirements: Genetically modified food and feed must be clearly labelled to inform consumers and users about the presence of GMOs. This ensures transparency and allows consumers to make informed choices.
• Monitoring and Supervision: Once authorised, GMOs and genetically modified food and feed are subject to ongoing monitoring and supervision to ensure continued compliance with safety standards. This includes post-market monitoring to detect any potential adverse effects.

The regulation also provides for the traceability of GMOs throughout the food and feed chain, ensuring that they can be tracked from production to final consumption.

Related content:

• Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 amending Commission Regulations (EC) No 641/2004 (the application for the authorisation of new genetically modified food and feed, notification of existing products and adventitious or technically unavoidable presence of genetically modified mate-rial which has benefited from a favourable risk evaluation) and (EC) No 1981/2006 (as regards the Community reference laboratory for genetically modified organisms).

• Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory