REACH (Draft Test Methods Regulation) (debate) 
President
The next item is the debate on the oral question by Mr Sacconi, on behalf of the Committee on the Environment, Public Health and Food Safety, to the Commission: Draft REACH Test Methods Regulation (B6-0158/2008).
Guido Sacconi
author. - (IT) Mr President, ladies and gentlemen, Commissioner, you are well aware that, within a few days, ten to be precise, the first implementation phase of REACH will begin. This is the phase for the pre-registration of substances. In view of, shall we say, this solemn moment, we, as you know, were annoyed about the definition of testing in the REACH implementing regulation. This was because one of the objectives of REACH which we secured with no small difficulty in the course of the legislative process and inter-institutional negotiations was precisely the promotion of alternative methods to animal tests.
When we saw that the draft implementing regulation did not include a series of tests scientifically validated by the ECVAM (European Centre for the Validation of Alternative Methods) because, firstly, they have not yet been approved for regulatory purposes, and secondly, some of them, three of the five, were referred back for validation to the OECD, we were, I repeat, very cross. It is only right that REACH should proceed as scheduled, but it is also right for it to set off on the right foot in terms of compliance with the spirit and purpose of this most important regulation.
In the meantime, as you know, there have been talks between us and on 5 May Parliament received a letter, signed by Commissioner Dimas on your behalf and on behalf of the Commissioner for Research as well, which gave interesting and binding responses to our questions and to our notional opposition to this regulation. We must acknowledge that a solid way of accelerating, rationalising and where necessary, making these processes for validating alternative methods more transparent is envisaged
Our debate this evening will now become a touch more formal. I am sure that you will confirm these undertakings and thus make it possible for us to adopt our resolution tomorrow, as amended in the meantime. Upon so doing, in light of the commitment which I am asking you to confirm, there will cease to be any opposition to the regulation. Instead, note will be taken of those undertakings, but we will continue the call both for confirmation of those commitments as a matter of urgency and for the regulation to be amended as soon as possible so that it can, at the earliest opportunity, include the alternative tests, which will have been fully validated in the meantime.
Thank you, I think I have even finished before time, allowing us to proceed more quickly with our work.
Günter Verheugen
Vice-President of the Commission. - (DE) 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.
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.
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.
Thomas Ulmer
on behalf of the PPE-DE Group. - (DE) Mr President, Commissioner, Mr Sacconi, ladies and gentlemen, my Group supports the motion for a resolution. At the same time, I would like to thank Mr Sacconi for his work. REACH, as you have just said, is intended to be the world's best, most dynamic and most advanced chemicals legislation; that is precisely how we envisage it in our Lisbon Process. That is why it is also important now that implementation should proceed with the same dynamism and at the same pace. We can also help to eliminate a great deal of red tape by streamlining structures and speeding up procedures. It is the wish of all parties that animal experiments remain a last resort and that the number of animal experiments be sharply reduced.
Vertebrates and primates enjoy special protection. It is imperative that the validation of alternative and non-animal tests be speeded up and simplified. In order to save time, there must be scope for decisions on individual cases, for example. Accordingly, implementation must involve the pre-selection of test methods, ranked by quality; in other words, the method that seems to have the greatest likelihood of success would be validated first. It is important that phase-in periods be shortened and that the number of stages in the phase-in process be reduced, that Directors-General be involved in the decision-making process, that our agencies be more closely interlinked, that procedures be transparent and that information, including information to Parliament, be imparted without delay.
I am very hopeful at the present time, partly because of the content of the letter you wrote to us, Mr Verheugen, along with Commissioners Dimas and Potočnik, that we can make rapid progress in this matter and that REACH really will prove in practice to be the world's most dynamic chemicals legislation.
Satu Hassi
on behalf of the Verts/ALE Group. - (FI) Mr President, a big thank you goes to Mr Sacconi for having achieved a good result from negotiations on this subject as rapporteur appointed by the Committee on Environment, Public Health and Food Safety.
When the EU's new legislation on chemicals, REACH, was being discussed, one of the greatest public concerns was that it would lead to more tests on animals. There was complete consensus among the political groups in the European Parliament on the legislation being established in such a way that everything would be done to minimise the number of animal tests, including the introduction of other, alternative test methods, as much as that was possible.
We were delighted when there was news from the European Centre for the Validation of Alternative Methods (ECVAM) that a number of methods proposed as an alternative to animal experiments had been scientifically validated. We were therefore bewildered when the Commission was a long time giving its administrative approval to these same alternative test methods. In talks between the Committee on the Environment and the Commission it emerged that the Commission was going to wait for these tests to be approved by the Organisation for Economic Cooperation and Development as a whole, where just one country could torpedo the decision. The Committee on the Environment made it very clear to the Commission that such a delay was not acceptable and that we were prepared to exercise our right of veto under the new comitology procedure.
I am very pleased that the talks that followed between the Committee's appointed rapporteur, Mr Sacconi, and the Commission led to a happy outcome and that the Commission is now committed to speeding up introduction of the alternative methods so as to reduce the number of tests on animals and the suffering that goes with them. This letter by the Commission, signed by Commissioners Dimas, Verheugen and Potočnik, has now also been incorporated into the decision proposal which Parliament is to adopt tomorrow.
It is very important that the EU is prepared to take decisions itself if the OECD delays the processes. Although we might encounter difficulties the end result will be a happy one.
Marios Matsakis
Mr President, I should just like to add that Mr Sacconi has earned a reputation of trust, efficiency and respect in everything to do with REACH. He therefore deserves, and will have, our full support in the present draft REACH test method regulation as well. I wish to thank him for all the hard work he has been doing in this field.
President
I have received one motion for a resolution pursuant to Rule 108(5) of the Rules of Procedure.
The debate is closed.
The vote will take place on Thursday.
