Local view for "http://purl.org/linkedpolitics/eu/plenary/2000-04-11-Speech-2-276"
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". – Mr President, when I started at the Commission last autumn I realised very quickly that the directive on the deliberate release of GMOs would be one of the most sensitive dossiers under my responsibility.
Let me comment further on Amendment No 1 and Amendments Nos 13, 14 and 28, which all relate to the biosafety protocol and obligations for imports and exports of GMOs. The European Community was one of the driving forces in the successful adoption of the Cartagena Protocol on biosafety in January. The Commission therefore welcomes the spirit of Amendment No 1. This refers to the need to submit the appropriate proposals for the implementation of the protocol when ratified – work has already begun. However, the Commission cannot accept the inclusion of provisions on import and export obligations in the text of the directive. We believe that the implications of the protocol on the overall European Union legislative framework have yet to be fully assessed. Amendments Nos 13, 14 and 28 are therefore not acceptable in the present revision.
Let me now turn to the issue of liability, and I know that this is an important political subject for all of you. When I made my presentation to Parliament in the autumn I promised that I would make particular reference to GMOs in the White Paper on environmental liability. The Commission did exactly that when adopting the White Paper this year. The Commission is of the opinion that a horizontal approach is the most efficient way to guarantee a comprehensive responsibility regime for environmental damage. This will provide clarity for complainants and prevent loopholes. This is also the best way to complement the existing horizontal system for product liability already covering GMOs.
I can assure you that I will do my utmost to be able to present a proposal for legislation on liability before the end of 2001. I can therefore accept Amendments Nos 2, 36 and 46 in principle, as far as they refer to the Commission White Paper. Let us be clear, if this is put in this directive, rules will have to be made to ensure legal clarity, and how long will that take? It must be seen in that context.
However, I cannot accept Amendments Nos 33, 40 and 45. I am also fully aware of the political importance of certain other aspects raised by the proposed amendments. It is clear that antibiotic resistance marker genes need to be phased out and be replaced with alternatives as soon as practically possible. A phase-out is already foreseen in the common position. The Commission agrees to strengthen this political message. The Commission cannot agree to a general ban of GMOs containing antibiotic resistance marker genes. At the moment there is no scientific evidence that all GMOs of this type present adverse effects to human health and the environment. Instead, we should continue to carry out a comprehensive case-by-case risk analysis.
Within these limits, Amendments Nos 11, 37, 48 and 52 are therefore acceptable in principle. The Commission can also accept in principle Amendments Nos 3, 4, 8, 24 and 35 to the extent that they are in line with the logic of the texts and fit within the overall legislative framework. The Commission can therefore agree to a recital concerning socio-economic aspects which refers to the reporting obligation of the Commission. This will be done every three years under Article 30.
The Commission welcomes Amendments Nos 38 and 49 concerning gene transfer. They constitute a balanced approach between a total prevention and a permissive approach. However, the wording should be aligned with the text of the directive. In addition, the Commission reference should be deleted since the Commission does not necessarily play a role under Part B – national consent.
However, the Commission cannot accept Amendment No 12 concerning the prevention of gene transfer. Gene transfer between organisms is, as we know, a common phenomenon in nature. Instead we need to ensure that potential risks from gene transfer are thoroughly assessed before GMO products are released for research or placed on the market.
The Commission cannot accept Amendments Nos 22 and 23 as they stand, since the provisions foreseen in these amendments would not be workable within the authorisation system established by the directive. This is both for administrative and legal reasons.
The Commission, however, acknowledges that these amendments aim at addressing the possible problems that certain industries might face with strict time-limited consent. This concerns in particular the plant breeding industry. The Commission will therefore consider how due account can be taken of these concerns while ensuring political, legal and administrative consistency. In this context, Amendment No 26 is also not acceptable since this would limit the flexibility of the optional time limitation of consent for the renewal.
Amendment No 25 seeks to introduce a provision which allows for the introduction of differentiated procedures under Part C of the directive. This builds on the original proposal as presented at first reading in Parliament. However, this amendment goes beyond the Commission proposal and is therefore not acceptable to the Commission as it stands. The Commission is, however, willing to reconsider this amendment in the light of its original proposal and within the framework of an overall compromise.
Genetically modified products and biotechnology give rise to a number of questions and concerns. The most important are perhaps: what are the benefits? What are the risks? How do we best avoid possible negative effects? How do we ensure that we have access to all the relevant information?
Finally, I should like to deal as a package with the amendments I have not yet addressed. The Commission cannot accept Amendment No 21 since the legal basis of future legislative measures is subject to its content and cannot be established in advance by this directive.
Amendment No 6, concerning a centralised Community procedure, is not acceptable. However, I should like to stress that careful evaluation of a centralised procedure would be done in the Commission report required under Article 30 of the directive.
Access to the work of the European Group on Ethics and their opinions is an important of the general evaluation. The Commission is, however, of the opinion that this is already appropriately covered in the Rules of Procedure of the Committee. Amendment No 32 is therefore not acceptable.
Amendments Nos 5, 7, 10, 15, 16, 18, 20, 27, 30, 31, 34, 39, 41 to 44, 50 and 51 are also not acceptable since they would introduce legal and technical uncertainty or jeopardise the overall balance achieved in the common position.
To conclude, we urgently need a revised Directive 90/220. It has to ensure a high level of protection for human health and the environment and, at the same time, allow society to profit from the benefits of these new technologies. To strike the right balance between these two justified concerns we need a transparent process, a wide dialogue and strong political leadership. We all have to take our responsibilities in achieving this, and this is the only way in which we will win the trust and confidence of our citizens.
To tackle these three concerns raised by our citizens we need a wide and open debate where all key players participate and the discussion cannot be limited only to the experts. Here the European institutions, the Member States, industry and science all have to take their responsibilities.
The basis for meeting these new challenges has to be an efficient and transparent legislative framework.
I should especially like to thank the rapporteur, Mr Bowe, and the Committee on the Environment, Public Health and Consumer Policy for their hard work in making a rapid and important contribution.
Our role as European policymakers should be to provide for a balanced response to these new challenges. We need a regulatory framework, based on safety and the precautionary principle which ensure a high level of protection for human health and environment. At the same time, it has to allow society to benefit from the development of modern biotechnology.
Our European legislation on GMOs guarantees an individual and thorough risk assessment of each GMO product placed on the European market.
We are here today to strengthen and improve the existing framework. The sensitivity and complexity of the matter might explain why we are confronted with a total number of 52 amendments at second reading.
The Commission can accept in their entirety Amendments Nos 9, 17, 19, 29 and 47, which improve the quality and the clarity of the texts. The Commission can also accept in principle Amendments Nos 1 to 4, 8, 11, 24, 35 to 38, 46, 48, 49 and 52. They further strengthen the intention of the Commission to establish an efficient transparent and balanced regulatory framework for GMOs."@en1
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