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European biotechnology legislation

The first EU regulations regarding potential problems arising from the use of biotechnology came into force in the early 1990's, approximately 20 years after the discovery of DNA restriction enzymes (Choen & Boyer, 1973) that represents the beginning of the modern biotechnology. The origin of the first important EU Directive (90/220/EEC) can be traced back to 1988, the same year that the “Human Genome Project” began. It resulted from a large number of relevant EEC acts (Regulations, Directives, Decisions and Opinions) on the environmental release of genetically modified microorganisms. It defines a genetically modified organism (GMO) as 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. The Directive was ratified in 1993 in Italy by Legislative Decree No. 92 (in Italian), but has since been repealed by EU Directive 2001/18/CE “on the deliberate release into the environment of genetically modified organisms”, which aims to:

1. assure that EU Members States take decisions on GMO environmental releases on the basis of common and relevant arguments;
2. improve the management of all possible risks (direct, indirect, immediate, or delayed) to the environment and the human health;
3. regulate the post-release monitoring of the GM products on the market, and indicate common criteria concerning the formal procedures to carry it out, as well as rules regarding traceability;
4. promote information-sharing and consultation with the public regarding GMO experimental releases.

The latter Directive 2001/18/CE defines the area of GMO application with respect to issues arising from deliberate releases into the environment, including the limitation of any initial authorisation for the control of products containing GMOs to a maximum of ten years. Prior to any authorisation for release, Article 6 of the Directive obliges a notification to be submitted to the Competent Authority of the State where the environmental release of the GMO is to be carried out. The notification consists of a technical report containing all the information concerning the GMO (potential environmental risks, management plans, waste treatment procedures, and a plan of action in case of emergency) and a summary report of the impact assessment as detailed in Annex II. This Annex describes the general principles and methodology for undertaking an environmental risk assessment, on a case by case basis, to evaluate potentially negative effects arising from the release of a GMO, with specific regard to the organism released and the release environment. A new element for Directive 2001/18/EC is the obligation of the ratifier to present a monitoring plan, as reported in Annex VII, with the aim to identify the long term effect of the interaction between the GMO and both non-GMOs and the environment.

This Directive was brought into Italian law with Decree No. 224 of 8 July 2003. Subsequent regulation has come into force following 2001/18EC, specifically concerning genetically modified food and feed (Reg. 1829/2003/EC), and GMO traceability and labelling ( Reg. 1830/2003/EC).

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