WRITTEN QUESTION E-2685/00 by Armando Cossutta (GUE/NGL) to the Commission. Suspension of the moratorium on GMOs.
Date: 2000-09-01
Institutions: European Parliament, Provisional data
Subjects: environmental law, environmental liability, environmental protection, genetically modified organism, import restriction

C 113 E/150

Official Journal of the European Communities

EN

18.4.2001

There are no Community Directives in existence that are intended to harmonise compensation for

1.
members of the public having suffered damage of this type.

This is a factor covered neither by Community law nor by the Commission(cid:146)s powers, but by national

2.
and local powers.

The Honourable Member is invited to refer to the answers given by the Commission to Written

3.
Questions E/578/98 (1) from the Honourable Member and 2274/00 from Mr Tajani (2).

(1) OJ C 386, 17.12.1998.
(2) OJ C 103 E, 3.4.2001, p. 104.

(2001/C 113 E/156)

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 Wallstr(cid:246)m 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.

18.4.2001

EN

Official Journal of the European Communities

C 113 E/151

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
(cid:145)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(cid:146).

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.

(2001/C 113 E/157)

WRITTEN QUESTION E-2686/00

by Armando Cossutta (GUE/NGL) to the Commission

(1 September 2000)

Subject: Transposition of Directive 98/44/EC

Two Member States,
Italy and the Netherlands, have brought an action before the Court of Justice
concerning Directive 98/44/EC (1). Moreover, the opinion delivered by the French National Bioethics
Committee on 8 June 2000 expresses grave reservations about the substance of the Directive, among
other things because the legislative text fails to make a proper distinction between invention and discovery.

1.
Does the Commission not consider that it would be useful to await the Court ruling on the appeal by
Italy and the Netherlands before instituting infringement proceedings against Member States which are not
transposing the Directive into their national law?

Does it not believe that it should accept the opinion of the French National Bioethics Committee and

2.
therefore revise the wording of the Directive without delay?

(1) OJ L 213, 30.7.1998, p. 13.