WRITTEN QUESTION E-2767/97 by Mihail Papayannakis (GUE/NGL) to the Commission (1 September 1997)

Subject: Protection of consumers from genetically manipulated products

Given the discoveries made in recent years as a result of scientific research in the field of genetic engineering and future prospects in this area and in view of the fact that genetic engineering is to a large extent already part of our everyday life, although no reliable methods have yet been developed to assess scientifically the medium and long-term impact of the irreversible release into the atmosphere of genetically manipulated organisms, can the Commission provide the following information:

1. Has a more comprehensive assessment and evaluation been made of the social, economic, ecological, public, health, ethical and legal aspects of new developments in the field of genetic engineering?

2. Are steps being taken to develop a comprehensive policy and measures to protect the consumer in legal, moral and public health terms?

3. Has the Commission, while fully respecting the basic principle of freedom of scientific research, made full use of its powers to monitor research in this area, seeking to establish a common policy in all Member States?

4. Have measures been taken in response to the European Parliament's proposal for the setting up of a European Union Ethics Committee to evaluate the ethical aspects and applications of genetic engineering and monitor developments in this area?

Answer given by Mr Santer on behalf of the Commission (3 November 1997)

The Commission attaches great importance to modern biotechnology for its economic potential and its contribution to human health and the improvement of the environment. Given the rapid progress of genetic engineering technologies, the Commission recognizes the importance of keeping Community policies and regulation up-to-date to facilitate the development of these technologies while assuring a high level of protection.

1. A growing body of assessments and evaluations of different aspects of biotechnology is available. The Commission has, under successive Community framework programmes for research and technological development, supported research into areas such as safety (including for the environment), socio-economic aspects, and ethical and legal aspects. The Commission has proposed to strengthen such research under the fifth framework programme ((COM(97) 142. )).

2. Protection of the consumer is a constant concern in development of the Community's regulatory framework. Community rules impose high safety standards on the use of these technologies, in particular in granting approvals for the release into the environment and placing on the market of genetically modified produce. Community frameworks for labelling, as adopted, under discussion or under preparation by the Commission, and the broader on-going information activities of the Commission intend to provide transparency for consumers on the use of these technologies and their implications. Council Regulation (EC) No 258/97 on novel foods and food ingredients ((OJ L 43, 14.2.1997. )) sets out a framework for labelling of foodstuffs which also takes into account needs for labelling related to particular health problems for certain sectors of the population or ethical reasons. In addition, the Commission has decided to develop a general labelling approach applicable to all products entering the food chain. This approach will be based upon strict science and will include mandatory labelling to indicate the presence of material originating from genetically modified organisms (GMOs). It will be implemented both through existing legislation and new legislation to be introduced as necessary.

3. Under successive framework programmes for Community research and technological development (RTD), the Commission has imposed strict ethical guidelines for research carried out with Community support. All research has to comply with the relevant Community and national legislation. In addition, research into the ethical, legal and social aspects of the life sciences has been supported at the European level. The ethical dimension will be enhanced in the fifth RTD framework programme. Ethical considerations are also integrated into legislative actions, e.g. the Commission's proposal for a directive on the legal protection of biotechnological inventions ((Amended proposal for a Parliament and Council directive on the legal protection of biotechnological inventions, COM(97) 446 final. )).

4. The Commission created in 1992 the independent group of advisers on the ethical implications of biotechnology which has presented a series of opinions on different issues, either upon request of the Commission or on its own initiative. The Commission has asked the group to give an opinion on the proposal for the fifth RTD framework programme. The group has actively promoted an open dialogue on ethical issues with all interested parties which has been welcomed by the Commission. In the light of the positive experience gained with this approach to ethical advice, the Commission intends to adapt the terms of reference of the group when the current mandate expires at the end of 1997. In doing so, the Commission will take into consideration the suggestions made by the Parliament.