Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-05-21-Speech-3-461"
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"en.20080521.30.3-461"2
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Mr President, ladies and gentlemen, Mr Sacconi has certainly put me in a slightly awkward situation. As you know, Mr Sacconi, what you criticised was not part of my own portfolio, since I share overall responsibility for the REACH project with Mr Dimas. That is why I thought it appropriate to be here this evening and to confirm the precise points you have raised.
Mr Sacconi, you will know from our joint work on REACH how much importance I personally attach to very rapid progress on the alternative methods. Indeed, we were both in agreement that the world’s most advanced legislation on chemicals which we adopted in the REACH regulation must not lead to such a sharp increase in the number of animals used for experimental purposes. You may therefore count on my continued personal commitment in this matter.
The Commission will provide the necessary procedural clarifications – and I stress the word ‘necessary’ – and I am extremely grateful to you for bringing these problems and issues to our attention and for your very personal and important contribution that has helped us to resolve these problems.
So what are we going to do? The Commission’s internal procedures for the validation and regulatory acceptance of new alternative test methods will be significantly streamlined and speeded up. To this end, the Commission will begin by introducing a preliminary analysis of regulatory relevance, which will help us to focus the process of scientific validation on those test methods that are best suited as a basis for subsequent regulatory acceptance.
Secondly, we shall reduce the number of procedural steps and introduce clear time-limits to simplify and accelerate the current process. This applies especially to the work of the advisory committees and to consultation with the Member States.
Thirdly, all important procedural decisions to be taken by the Commission will be taken by the Directors-General themselves.
Fourthly, we shall ensure that the new sequence of procedures is more transparent. A website that will be set up by the Joint Research Centre will constantly provide information on the current status of proposed alternative methods. Rejection decisions, in other words decisions to discontinue the analysis of a particular test method, will also be explained on the website. This will enable anyone to follow the progress of each method in detail.
The Commission will also adopt measures to optimise the institutions involved in the process of validation and regulatory acceptance. First of all, this means improving the participation and interaction of agencies such as the European Chemicals Agency and the European Medicines Evaluation Agency, which we are currently trying to link into a network.
Moreover, cooperation with the OECD can also be improved in many respects, and that is what we shall do. This includes not only the secondment of staff to work on the OECD Test Guidelines Programme but also the provision of funds for the TGP secretariat.
The firm priority is, and will remain, regulatory acceptance of alternative test methods. At the same time, we shall monitor progress within the OECD framework with a view to conducting the process of regulatory acceptance within the Community in the event of undue delays at the international level."@en1
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