Revision Directive 98/81/EC

Directive 98/81/EC: Historical background
(Last revised: June 15, 2009 )

Biotechnology involves the use of modern genetic engineering, which affect many different products and processes. The Community's regulatory framework for biotechnology was designed, in the late 1980's, in order to provide the necessary legislation to ensure adequate protection of health and the environment, while at the same time creating the internal market for biotechnological products.

The Community's regulatory framework is composed of both "horizontal" (contained use of genetically modified micro-organisms, deliberate release into the environment of genetically modified organisms, and the protection of workers from risks related to exposure to biological agents at work) and product legislation (medicinal products, additives used in animal nutrition, plant protection products, novel foods, seeds). Legislation on intellectual property protection also forms part of this framework.

Directive 90/219/EEC on the contained use of genetically modified micro-organisms was proposed and adopted in April 1990 together with Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. The basis for Directive 90/219/EEC was the scientific knowledge of the early 1980's and the limited practical experience of that time with genetically modified micro-organisms specially in industrial applications. The Community adopted legislation aiming at a broadly preventative approach as regards the use of modern biotechnology.

Within a short time of Directive 90/219/EEC entering into force, it was recognised by many within the EU that it was being rapidly overtaken by developments in gene technology and that the administrative procedures and notification requirements were not appropriately related to the risk of the contained uses. Furthemore, as a result of the extensive use of the techniques of genetic modification in many research laboratories and industrial facilities, there has been scientific evidence pointing to the safety of many types of contained use activities involving genetically modified micro-organisms provided they are carried out by applying the principles of good microbiological practices and good occupational safety and hygiene.
Last but not least, the Commission's White Paper on Growth, Competitiveness and Employment, published in 1993, concluded that the Community should be open to reviewing its biotechnology regulatory framework, in order that the full potential of modern biotechnology for jobs, investment and growth could be realized.

Following this commitment, the Commission, in consultation with national Competent Authorities for implementation of the Directive, undertook such a review in 1993. Its objective was to ensure that the safety requirements and administrative procedures are appropriate to the risks for human health and the environment and reflect acquired experience, advances in scientific knowledge and established international practices. It also took account of the existing regulatory frameworks on modern biotechnology used by its main competitors, in particular the United States.

Discussions led to the publication by the Commission in December 1995 of a proposal for revision of the Directive. After hard negotiations, Member States reached in December 1996 unanimous political agreement on a modified version of the original Commission proposal.

According to the Treaty, that proposal had to go through several procedural steps:

Directive 98/81/EC amending Directive 90/219/EEC was finally adopted by the Council on the 26th of October 1998.

In 2009, the European legislation on contained use has been recasted in the interests of clarity (due to the various amendments that were made and to the need to introduce new elements concerning the committee procedures). Directive 2009/41/EC repealing Directive 90/219/EEC has been published on the 21st of May 2009.