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?

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

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

Answer given by Mrs Wallström 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 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 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'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'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.