Bruxelles, le 13 juillet 2000
Brussels, 13 July 2000
Commission takes initiative to restore confidence in GMO approval process
The European Commission decided yesterday to propose to Member States a strategy to regain public trust in the approval procedure for Genetically Modified Organisms (GMOs). The objective is to resume the authorisation process for GMOs in the near future whilst addressing public concerns on GMOs as well as problems of legal uncertainty for stakeholders. The Commission wants to give a clear response to political and legal concerns over GMOs which favours consumer choice and legal certainty. The Commission calls upon the Member States to play their part in paving the way for a clearer and more comprehensive GMO strategy in Europe in the future and promoting an open public debate. The Commission proposes to apply the key provisions on the revised directive on the release of GMOs in the environment to all new GMO approvals after agreement on its content has been reached between the Council and the European Parliament. The conciliation procedure is due to start on the 19 September. Further measures on labelling and traceability of GMOs will be put forward in the autumn.
The Commission's strategy aims to enable the relaunch of authorisations of GMO products on the basis of a reinforced framework for approvals. It entails the following:
- Anticipating the key provisions (labelling, traceability, monitoring etc) of the revised Directive 90/220 before they are transposed in all Member States. The new requirements will be incorporated into the individual authorisations of GMO products granted on the basis of the existing Directive 90/220. The notifying companies will need to put forward voluntarily commitments in line with the new requirements as part of their applications for authorisation. Such commitments would become legally binding when the authorisation is granted. Authorisations would be time-limited and control of approved products reinforced.
- A comprehensive set of labelling provisions which would cover GMOs and GMO products to be submitted by the Commission by autumn 2000
- An initiative on a traceability system for GMOs to be submitted by the Commission by autumn 2000
- Acceleration of work on related issues. This includes environmental liability, the monitoring and study of possible long-term effects on biodiversity; further research; as well as taking into account international developments (i.e. Biosafety Protocol)
The Commission firmly believes that it is crucial to all stakeholders to assume their responsibilities and adopt a comprehensive perspective on the issue of GMO authorisations.
Commenting on the Commission's debate, Environment Commissioner Margot Wallström stated:
"The Commission in its discussion acknowledged that there is a need for political leadership to take forward the debate on GMOs in the EU. We are ready to take up that challenge, together with Member States. The approach proposed by the Commission is a first step towards a more constructive and responsible strategy on GMOs." She added: "Our role is first and foremost to provide a framework for the authorisation and control of GMOs, which is reliable and safe for consumers and the environment. We need to re-establish confidence in our approval systems. Citizens must be allowed to chose for themselves whether they want products containing GMOs or not."
David Byrne, Commissioner for Health and Consumer Protection said: "The objective of the Commission is to promote a balanced approach to biotechnology and GMOs in particular. The public needs to be assured of the highest protection of public health, and of the environment, including the protection of biodiversity. At the same time they need to be able to make an informed choice with regard to GMO products. I want to emphasise that our approval system is strictly science-based. Consumers should be assured and informed that we are paying attention to all questions they have raised."
With this approach, the Commission wishes to signal to Member States, other Community institutions, trading partners and civil society that it is necessary to respond to public concern with concrete action. Not to act does not constitute a solution, but would leave the EU unprepared and lagging behind in the handling of GMOs.
The new approach should make it possible for Member States to act on a different and stronger basis in the Regulatory Committee (consisting of representatives of the Member States (considering products for approval under Article 21 of Directive 90/220) as well as in the Council, while restoring the confidence of consumers and trading partners.
The Commission also believes it is important to establish the conditions necessary for the development of a sector that will play a crucial role in the future economy and competitiveness of European industry.
In its debate, the Commission stressed the importance of maintaining the dialogue with all stakeholders and interested parties - consumers, agriculture, industry, NGOs, science, governments, European Institutions and trading partners.
(see also background MEMO/00/43)
GMOs and the use of modern biotechnology in food and plants is currently the focus of intense public and political debate. Growing concerns have particularly focused on potential risks to human health and the environment. A "de facto moratorium" applied by Member States has implied that no new GM products have received approval under the EU procedure since October 1998. Five Member States have banned already approved GM products, under Art 16 of Directive 90/220. This article enables Member States to ban or restrict use/sale of specific GMO products temporarily, on certain conditions.
Approvals of GMO products in the EU is based on both general and specific legislation. 18 products have been approved to date under the general Directive (Directive 90/220/CEE), while 14 are pending approval. This Directive is currently under revision. The second reading in the European Parliament was completed in April, and a conciliation procedure between Council and European Parliament is scheduled to be launched on 19 September.
Rapid agreement between the European Parliament and the Council could result in adoption of the revised Directive by autumn 2000 with transposition in national law by spring 2002.
Pia Ahrenkilde : 02/299.12.23
Beate Gminder : 02/296.56.94
Andrea Dahmen : 02/296.04.86
Catherine Bunyan : 02/299.65.12
Lone Mikkelsen : 02/296.05.67
Released on 13/07/2000