Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

In the light of the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when: (a) carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community; (b) placing on the market genetically modified organisms as or in products within the Community. With a view to precisely defining the application scope of the present provisions, article 2 lays down several definitions. In particular, "genetically modified organism" (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination. Moreover, "deliberate release" means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment. The Directive shall not apply neither to organisms obtained through the techniques of genetic modification listed in Annex I B nor to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air.
The Directive consists of four Parts. In addition, 8 Annexes are attached. Part A lays down general provisions, regarding inter alia the obligations of Member States, which shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. Part B regards the deliberate release of GMOs for purposes other than marketing; Part C deals with the placing on the market of GMOs as or in products. In both cases, prior explicit consent is required. Such consent shall be given only upon previous environmental risk assessment. Annex II lays down the principles to be followed for the environmental risk assessment. Article 22 sets forth the free circulation principle: Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive. Nevertheless, article 23 contains a safeguard clause on the basis of which where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory. Article 21 lays down provisions governing labelling. Articles 24 and 31 concern access of public to information and exchange of information and reporting between Member States and the Commission, respectively.