Deliberate Release into the Environment
Despite its name, Directive 2001/18/EC on the deliberate release into the environment of GMOs is really concerned with two partly distinct activities: the introduction of GMOs into the environment and their placing on the market. However, as noted in the preamble, living organisms, whether released into the environment in large or small amounts for experimental purposes or put on the market as commercial products, may reproduce and cross national frontiers.[1] [2] Hence there is reason to regulate both activities at EU level.
Based as it is on an article corresponding to the current Article 114 TFEU, Directive 2001/18/EC aims, in accordance with the precautionary principle, to approximate the laws, regulations, and administrative provisions of the Member States and to protect human health and the environment both when carrying out the deliberate release into the environment of GMOs for any other purposes than placing on the market within the EU and when placing on the market GMOs as or in products within the EU (Art 1).
By ‘GMO’ is understood 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 and/or natural recombination. As ‘organism’ counts any biological entity capable of replication or of transferring genetic material. Annex I A, Part 1 contains a non-exhaustive list of techniques through which genetic modification occurs, whereas Part 2 of the same Annex lists techniques not considered to result in genetic modification. The techniques of genetic modification listed in Annex I B, including mutagenesis, are exempted from the scope of the Directive, as is the carriage of GMOs by rail, road, inland waterway, sea, or air. (Arts 2 and 3.)
Directive 2001/18/EC deals with the two main activities to which it applies in different parts: Part B sets out the procedure for deliberate release of GMOs for any other purpose than for placing on the market; Part C contains specific rules on the placing on the market of GMOs as or in products. These are complemented by Part A containing general provisions and Part D with final provisions. As will be further discussed presently, the procedure for placing GMOs on the market allocates decision-making power largely at the EU level, whereas the one for deliberate releases is more of an information procedure which leaves the authority to decide on the release with the Member State within whose territory the release is to take place.
As ‘deliberate release’ counts any intentional introduction into the environment 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 term ‘placing on the market’ covers, with a few exceptions/2 the making available of GMOs to third parties, whether in return for payment or free of charge. (Art 2.)
General obligations applicable to the measures of both Parts B and C are set out in Article 4 of Part A. The first of these is that Member States must, in accordance with the precautionary principle, 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. To that end, anyone intending to submit a notification under Part B or Part C must first carry out an environmental risk assessment. Potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from GMOs to other organisms, must be accurately assessed on a case-by-case basis in accordance with Annex II.
Inspections and other control measures must be organised as appropriate, and in the event of a release of GMOs or placing on the market for which no authorisation was given, the Member State concerned must ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission, and other Member States. (Art 4.)
- [1] Preambular para 4.
- [2] Exceptions apply inter alia to the making available of GMOs to be used exclusively for deliberatereleases complying with the requirements laid down in Part B of the Directive and to GMOs used exclusively for activities where appropriate stringent containment measures are used to limit their contactwith and to provide a high level of safety for the general population and the environment. Art 2.
