The European Union has implemented the obligations under the Cartagena Protocol on biosafety through:

1) directive 2001/18/EC (consolidate text 2021) on the deliberate release into the environment of GMOs that establishes a common methodology among EU Member States to:

  • carry out risk assessment on the basis of common and relevant scientific arguments to identify the possible negative effects of GMOs on the environment and human and animal health;
  • apply management strategies for all possible risks arising from the deliberate release into the environment for experimental or commercial purpouses of GMOs;
  • regulate monitoring activities after the deliberate release into the environment for experimental or commercial purposes of GMOs, indicating the methods for carrying out them and the rules for traceability;
  • define a mechanism that modifies, suspends or interrupts the deliberate release into the environment of a GMO if new information regarding the risk of emission becomes available.
  • promote public information and consultation.

Directive (EU) 2015/412 has amended directive 2001/18/E as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory.

2) regulation (EC) n. 1946/2003, on transboundary movements of GMOs, contains specific provisions on the export of GMOs from the European Union to third Countries, provisions not included in directive 2001/18/EC.

3) regulation (EC) n. 1829/2003 on genetically modified food and feed regulates the placing on the market of products intended for human or animal nutrition that contain or consist of GMOs or are obtained from GMOs. The European Food Safety Authority (EFSA), established by regulation (EC) no. 178/2002, produces scientific opinions on the safety of GM food and feed.

4) regulation (EC) n. 1830/2003 concerning the traceability and labeling of GMOs and the traceability of food and feed products produced from GMOs.