WRITTEN QUESTION E-2223/00

by Béatrice Patrie (PSE) to the Commission

(3 July 2000)

Subject: LMO rules

Living Genetically Modified Organisms (LMOs) are now a scientific reality. Following experiments on mice in 1982, research was carried out on fish in 1994 and some 100 000 transgenic salmon, called AquAdvantage, are now proliferating in Canada. The modifications to their genetic make-up enable them to grow six times as large as their wild counterparts in a tenth of the time. A large number of such experiments are being conducted in North America, as well as in the United Kingdom and China, with a view to producing cheaper fish.

If marketing authorisation is granted, these fish could be available in European supermarkets as early as 2002. This raises serious ethical, social, public health and environmental questions.

Is the Commission aware of the problems relating to this type of research and breeding? Can we expect sales and consumption of this type of product to be authorised?

Does the Commission intend to put forward rules governing research into and marketing of such LMOs, along the same lines as the rules currently being established for GMOs?

Answer given by Mrs Wallström on behalf of the Commission

(26 September 2000)

Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (GMOs)(1) covers release of live genetically modified organisms for both experimental purposes and the placing on the market, which would include releases of genetically engineered salmon. The scope of the Directive does not extend to non-viable GMOs or products that are produced from but do not contain GMOs. As such, the Directive would not cover the import and placing on the market of harvested (dead) salmon or fillets but their use as food would require authorisation under Regulation (EC) No 258/97 of the Parliament and of the Council of 27 January 1997 concerning novel foods and novel foods ingredients(2).

Applications for deliberate releases of GMOs under Directive 90/220/EEC require, as a pre-requisite, a comprehensive assessment of risks to human health and the environment and are considered on a case-by-case basis. For deliberate releases of fish, this would clearly include an assessment relating to the type of environment (waters) in which they are intended to be released. An authorisation is only granted on the basis that there is no reason to believe that the release will have an adverse effect on human health or the environment under the conditions of consent.

To date, there have been no applications under Directive 90/220/EEC for releases of genetically modified salmon for the purpose of placing on the market and no consents for such have been granted. Similarly, the Commission has received no summary notifications from Member States with respect to experimental releases of genetically modified salmon under the Directive.

Directive 90/220/EEC is currently being revised. A common position on the Commission proposal to amend the Directive was adopted on 9 December 1999(3) and introduces a number of new provisions that should allow for a more effective, efficient and transparent regulatory framework for the deliberate release of GMOs into the environment. These new provisions, when adopted and transposed into national laws, will apply to releases of GMOs, for both experimental purposes and the placing on the market, including genetically modified fish.

The application of Council Directive 90/219/EEC of 23 April 1990, on the contained use of genetically modified micro-organisms(5) has been extended by the majority of Member States to cover plants and animals in their resultant national laws. Experimental work with genetically modified salmon has been done under the provisions of Directive 90/219/EEC on the basis that adequate containment measures have been employed to limit contact with the general population or the environment.

Use of genetically modified (GM) salmon as or in food requires authorisation under the Novel Foods Regulation. Under this regulation, GM-food and GM-food ingredient must not present a danger for the consumer, mislead the consumer or differ from conventional foods to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.

As for rules governing relevant research, the Council decision 1999/167/EC of 25 January 1999 adopting a specific programme for research, technological development and demonstration on quality of life and management of living resources (1998 to 2002)(4) stipulates that Modifications of the genetic heritage of animals and animal cloning will be envisaged within this programme only for objectives which are justified on ethical grounds and when carried out under conditions respecting animal welfare and genetic diversity. Participants in EC research projects must conform to national legislation and applicable codes of conduct and seek the approval of the relevant ethics committee prior to the start of the research and technological development (RTD) activities. These rules would apply to genetically modified fish as to any other genetically modified animal.

(1) OJ L 117, 8.5.1990.

(2) OJ L 43, 14.2.1997.

(3) OJ C 64, 6.3.2000.

(4) OJ L 64, 12.3.1999.

(5) OJ L 117, 8.5.1990.