WRITTEN QUESTION E-2685/00

by Armando Cossutta (GUE/NGL) to the Commission

(1 September 2000)

Subject: Suspension of the moratorium on GMOs

The precautionary principle laid down by the World Health Organisation is recognised to be valid. Some scientists are warning that GMOs should not be allowed to spread, because their effects on human health are unknown. In the judgment handed down in the case arising from a dispute between ToolsAlpha and Sweden, the Court of Justice ruled that in view of priority objectives such as public health, it was justifiable to adopt provisions restricting the free movement of goods. As matters now stand, there is no measure of certainty as to the nature and extent of legal and economic liability, in particular of manufacturers, for damage caused by GMOs.

In the light of the foregoing:

1. What new scientific data have prompted the Commission decision to suspend the moratorium on authorisation for the entry of genetically modified organisms?

2. What health guarantees is the Commission offering to Union citizens regarding the entry of transgenic cultures to Union territory?

3. Will it assume responsibility for bio-contamination damage resulting from the decision in question, or will it pass on that responsibility to the Member States or indeed the manufacturers?

Answer given by Mrs Wallström on behalf of the Commission

(18 October 2000)

Against a background of public and political concern, Member States are increasingly reluctant to approve new genetically modified organism (GMO) products and the authorisation procedure has subsequently ground to a standstill. This standstill has been referred to as a moratorium although it does not constitute a legal ban on GMOs.

The objective of the Commission, as discussed at its meeting of 12 July 2000, is to re-launch the authorisation procedure under a regulatory framework that guarantees the highest level of protection for public health and the environment and which allows citizens to make an informed choice with respect to the purchase and consumption of GMO products. The authorisation procedure is based upon a comprehensive assessment of risks to human health and the environment and where necessary the opinion of the scientific committees is sought to validate the scientific basis. A notification is only carried forward where the scientific data demonstrates that there is no reason to believe that the GMO will cause adverse effects on human health and the environment.

The approach that the Commission is proposing, following finalisation of the conciliation process for a revision of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(1), will be a first step towards a more constructive and responsible strategy on GMOs, and for biotechnology in general.

The importation and placing on the market of GMOs in the Community requires authorisation under Community legislation. Directive 90/220/EEC covers both experimental releases and the placing on the market of GMOs. Applications for such releases require, as a pre-requisite, a comprehensive assessment of risks to human health and the environment.

The objective of the risk assessment, on a case-by-case basis, is to identify and evaluate potential adverse effects of the GMO, either direct or indirect, immediate or delayed, on human health and the environment which may arise from the deliberate release or placing on the market of a GMO. The risk assessment is conducted with a view to identifying whether there is a requirement for risk management measures and if so, the most appropriate methods to be used.

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.

The question of liability in terms of damage to health or property is addressed under Council Directive 85/374/EEC of 25 July 1985(2), as modified by Directive 1999/34(3), which concerns liability for defective products. This directive imposes strict liability on the producer (or importer) of a defective product, and joint liability in cases where more than one person is liable for the same damage. Producer is defined as the manufacturer of a finished product, the producer of any raw material or the manufacturer of a component part and any person who, by putting his name, trade mark or other distinguishing feature on the product presents himself as its producer.

As a follow-up to the white paper on environmental liability(4), the Commission intends to prepare a framework directive which will deal with environmental liability in a more general way, including any potential damage caused to the environment by GMOs.

(1) OJ L 117, 8.5.1990.

(2) OJ L 210, 7.8.1985.

(3) OJ L 141, 4.6.1999.

(4) COM(2000) 66 final.