Editorial note

Directive 2001/18 is a so-called ‘horizontal’ Directive and aims to regulate, in accordance with the precautionary principle and to protect human health and the environment, the carrying out of deliberate release into the environment of genetically modified organisms (GMOs) for any purpose other than placing on the market within the Community and the placing on the market of genetically modified organisms as or in products within the Community (Article 1). Specific exemptions to the application of the Directive are found in Article 3. All appropriate measures shall be taken by Member States to avoid adverse effects on human health and the environment which might arise from the deliberate release or placing on the market of GMOs. GMOs can only be released or placed on the market according to the provisions of the Directive (Article 4).

Part B of the Directive regulates the deliberate release of GMOs for any purpose other than for placing on the market (Articles 5–11). Before undertaking deliberate release, any person must submit a notification to the competent authority of the Member State within whose territory the release is to take place. The notification should include, inter alia, a full risk assessment. The competent authority is to respond to the notifier within ninety days and either consent to or deny the proposed release (Article 6). In specific circumstances, a differentiated procedure for the release of certain GMOs is provided (Article 7). In case of modifications, unintended changes or the emergence of new information, the notifier must immediately take measures to protect human health and the environment and notify the competent authority (Article 8).