WRITTEN QUESTION E-1498/00 by Hiltrud Breyer (Verts/ALE) to the Commission. Animal tests on genetically modified crops.
Date: 2000-05-12
Institutions: European Parliament, Provisional data
Subjects: animal experimentation, animal nutrition, approximation of laws, crop production, food safety, genetically modified organism, protection of animals, public health

18.4.2001

EN

Official Journal of the European Communities

C 113 E/19

All foods and food ingredients that consist of or contain genetically modified organisms, as well as
5.
foodstuffs derived from them which no longer contain genetically modified organisms, are subject to the
novel food regulation unless they have been on the market in the Community to a significant degree
before it entered into force. This regulation allows the placing on the market of a novel food only after
authorisation has been granted.

If an application is made, a decision concerning the marketing of such fish will be taken in the light

6.
of the relevant legislation, in particular the novel food regulation.

(1) OJ L 43, 14.2.1997.

(2001/C 113 E/017)

WRITTEN QUESTION E-1498/00

by Hiltrud Breyer (Verts/ALE) to the Commission

(12 May 2000)

Subject: Animal tests on genetically modified crops

Undertakings placing genetically modified seed or genetically modified plants or products thereof on the
market have to demonstrate that they are not harmful. One probable way of doing this is to carry out
animal feeding tests. These experiments are also carried out in the course of basic research.

On the one hand it has not been established how far their results may be read across to human beings,
and on the other it is likely that such tests may cause pain, suffering and injury to the animals. One such
test has been reported in the United Kingdom in which rats were fed genetically modified potatoes. The
rats suffered damage to their brains, spleens, stomach walls, kidneys and immune systems (dpa report of
8.3.1999).

1.

How many animal feeding tests have been carried out in the European Union since 1995?

2.

On what animal species were these tests carried out?

3.

How many animals were used in total (broken down by species)?

4. What genetically modified crops, seeds or derived products were fed to what species?

5. What were the results of the animal tests?

6. What conclusions were drawn from these tests?

Is the Commission aware of cases other than the UK case mentioned above in which animals suffered

7.
substantial pain, suffering and injury?

8.

Are there EU and national laws requiring such animal feeding tests?

(a)

If so, what laws?

(b)

If not, are there plans for any such laws?

C 113 E/20

Official Journal of the European Communities

EN

18.4.2001

9. Were the experiments carried out by commercial undertakings, public research establishments or
private research establishments?

Answer given by Mrs Wallstr(cid:246)m on behalf of the Commission

(7 September 2000)

The placing on the market of genetically modified organisms (GMOs) is governed by the provisions of
Part C of Directive 90/220/EEC on the deliberate release into the environment of genetically modified
organisms (1). The scope of the Directive includes the placing on the market of GMOs for use in animal
feeds but since the introduction of Regulation (EC) No 258/97 of the Parliament and of the Council of
27 January 1997 concerning novel foods and novel food ingredients (2), no longer covers use of GMOs in
food.

Applications for releases under Directive 90/220/EEC require, as a pre-requisite, a comprehensive assess-
ment 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 on human health and the
environment that may arise from the placing on the market of a GMO. Directive 90/220/EEC does not
specify that animal feeding studies are required as part of the risk assessment. However, applications for
authorisation of a GMO to include use in foods or animal feeds are likely to contain or refer to such
studies to demonstrate an absence of risk to human or animal health.

To date, eight authorisations for genetically modified crops have been granted under Directive 90/220/EEC
to include use in animal feeds. Two of these authorisations were granted prior to the introduction of the
Novel Foods Regulation and also include use in food. The eight authorisations cover one soybean, four
maize lines and three oilseed rape lines and applications for authorisation included or referred to animal
feeding studies as part of the risk assessment.

The relevant scientific committees are requested to appraise notifications and give opinions where
objections to the application are raised by Member States. The scientific committee on plants has produced
a guidance document (3) to facilitate notifiers in the preparation of GMO plant dossiers for appraisal by the
Committee. The document addresses both food and feed safety aspects and suggests that it is desirable that
feeding studies with GM plants or by-products derived from GM sources should be performed, where
possible, in the target animal. It also states that where data is extrapolated to humans, studies using the rat
and one other laboratory species should be included as part of the application.

Directive 86/609/EEC provides for the approximation of regulations and administrative provisions of the
Member States regarding the protection of animals used for experimental and other scientific purposes (4).
However, the provisions of this Directive do not dictate the type of tests to be carried out in Member
States or require Member States to report on such experiments in the detail required as a means to answer
the Honourable Member(cid:146)s questions 1, 2, 3 and 8.

One research project involved the use of small mammals to assess the safety of a transgenic tomato line
and was supported under the AIR (Agro-Industrial Research Programme) 1990-1994 contract No AIR3-
CT94-2311. No adverse mammalian health effects were found. A description of this project is sent direct,
for information, to the Honourable Member and to the Secretariat general of the Parliament. The research
contractor was RIKILT-DLO of the Netherlands. A report of the demonstration programme on food safety
evaluation from the ministry of Economic Affairs of the Netherlands is also sent direct to the Honourable
Member and to the Parliament(cid:146)s secretariat.

(1) OJ L 117, 8.5.1990.
(2) OJ L 43, 14.2.1997.
(3) Reference SCP/GMO/103-Final: 18 January 1999.
(4) OJ L 358, 23.12.1986.