Action taken on Parliament's positions and resolutions: see Minutes


REACH (Draft Test Methods Regulation) (debate)
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).
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.
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.
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.
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.
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.
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.


Agenda of the next sitting: see Minutes


Written declarations included in the register (Rule 123): see Minutes


12. Trade in goods used for torture (vote)


7. 2007 discharge: European Medicines Agency (


Nominal quantities for pre-packed products (debate)
The next item is the recommendation for second reading from the Committee on the Internal Market and Consumer Protection on the Council common position for adopting a directive of the European Parliament and of the Council laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (13484/1/2006 - C6-0039/2007 - (Rapporteur: Jacques Toubon).
rapporteur. - (FR) Madam President, Mr Verheugen, ladies and gentlemen, the Committee on Internal Market and Consumer Protection recommends that you adopt the Council common position, modified by some amendments: an amendment comprising a safeguard clause at the end of the transitional periods, a provision encouraging the extension of unit pricing, a system for guaranteeing that British bread can continue to be marketed in its current sizes and, finally, a declaration by the Commission that can explain and guarantee exactly the phasing out of stocks of bottles that are off-specification. However, the heart of this directive is, on the one hand, freedom in sizing and, on the other, mandatory sizes, for five years, for milk, pasta, butter and coffee and, for six years, for white sugar. That is what is proposed to you.
How have we reached this point? At first reading, on the basis of its own study, the European Parliament retained mandatory sizes for a number of products, in permanent derogation in relation to the general liberalisation of sizes that was proposed by the Commission. The latter, in a position of principle, set out a revised proposal that was totally opposed to Parliament's text. It was then that I was able to resume talks with the Commission and the Finnish Presidency of the Council. The latter succeeded in achieving the adoption of a common position that took up some of the derogations requested by the European Parliament, but only for a limited period, a transitional period.
I proposed accepting the main points of this position, provided that it was accompanied by two additional guarantees. Firstly, that the Commission can propose continuing to keep certain mandatory sizes for certain mass-marketed products if consumers experienced disruption at the end of the transitional period and, secondly, that the Member States should be encouraged to extend unit pricing to local shops. That is what the Committee on Internal Market and Consumer Protection decided on on the basis of my proposal and it is also what we agreed with the Council and the Commission at the end of two trialogues held over recent weeks.
Furthermore, ladies and gentlemen, I shall draw three lessons from this legislative procedure. Firstly, on this occasion, we have, for the first time, carried out an impact assessment. We commissioned this assessment from an independent body, and it was the first time that Parliament had used this procedure, which has, I believe, a great future. Secondly, what we are doing means that better lawmaking does not necessarily consist in doing away with all legislation because - and this is the third lesson I have drawn - through this debate, we have strictly taken into account the needs of consumers, and, in particular, the most vulnerable consumers.
That is why, ladies and gentlemen, I propose that our Parliament vote tomorrow for the three amendments that have been adopted by the Commission on Internal Market and Consumer Protection.
Vice-President of the Commission. (DE) Madam President, ladies and gentlemen, I should like first of all to thank Mr Toubon for his constructive work on this very difficult legislative proposal and agree with everything that he has just said, particularly when it comes to the lessons to be learnt, that is what we can learn from this dossier. I should like to make one additional point: I hope very much that the Council will see fit to follow Parliament's example and in future, when it is making amendments to legislative proposals, that it will also carry out an impact assessment. This would certainly help us greatly in our ongoing work of creating better regulation.
This is actually just one part of a major project being implemented by the Commission and all of the other institutions: better regulation. We began with the clear political goal of improving and simplifying the European Union's existing body of legislation. Mr Toubon is quite right: improving it does not mean abolishing it. Improving it means making it simpler, more transparent and more manageable. Obviously, however, the levels of protection that we have in place should remain intact. In principle, all of the institutions and certainly also consumers and business agree with this. Despite this agreement of principle, however, there are always specific reservations once a proposal is actually drafted and tabled. Then it becomes clear that a political compromise is needed and I am pleased that in this case we have produced a good solution together.
What is this really about? We are dealing here with regulations from the 70s and 80s. At that time mandatory sizes were laid down for a large number of prepacked products. These included such varied goods as toothpaste, detergent, fish fingers, tomato puree, solvents and even dry and wet dog and cat food.
At the time of their adoption around 30 years' ago, this was the best way of achieving two aims: firstly, to open up the internal market for goods even more, as provided for in the Treaties of Rome, and secondly to ensure the necessary level of consumer protection in the cross-border trade of these goods.
Since then, however, we have significantly developed the internal market and consumer protection within the European Union.
Now it is a question of following suit by simplifying and harmonising the regulations on packaging sizes. Here, less European regulation means more innovation and greater competitiveness.
I am convinced that this proposal will have a positive impact, in particular for consumers. Consumers will gain greater freedom of choice. Furthermore, thanks to the existing directive on unit pricing (pricing per kilogram or litre), they will also continue to be able to compare the prices of different packaging sizes easily in the future.
I am grateful to the rapporteur for his commitment. I also think that we have agreed on transitional rules. As Parliament has requested, the Commission will review the situation in a few years' time. There is therefore nothing to prevent an agreement at this second reading.
on behalf of the PPE-DE Group. - Madam President, with slightly more time at my disposal I would like to congratulate you on becoming a Vice-President. As a valued colleague of the Committee on the Internal Market and Consumer Protection, it is a pleasure to speak with you chairing the sitting here tonight.
I would also like to thank Jacques Toubon, who I think has led an outstanding review of this process, as the Commissioner has indicated. I also echo what the Commissioner said about the way that we approached this. I think we were one of the first committees in Parliament to commission an impact assessment on our proposed amendments. Some of the issues raised by that have now been reflected in the amendments which we shall support tomorrow, particularly concerning what I might call the safeguard clauses that the Commission will be observing in order to closely observe the behaviour of the market.
Overall we are very much in support of your aims, Commissioner, in wanting to push forward to remove unnecessary legislation, much of which dates back 20 or 30 years, as you indicated. Now that consumers are better informed, we want them to take advantage of that and to have information about pricing.
We want to give manufacturers the flexibility to produce products in different sizes that would suit different family sizes. I am bound to say that in my own country - and I suspect in others - it is such a surprise for them to find the Commission producing a deregulatory measure. As you will see from some colourful newspaper stories in my stories in my own country, this directive has been freely misinterpreted as in many cases preventing British consumers from having access to their preferred sizes for products. I think that you as a Commission need to work on the fact that misrepresentation is so easy, because at the moment this is such an unusual proposal. In that context I am very grateful to you and to the Council for giving consumers of pre-packed bread in the United Kingdom - that is over 80% of regular eaters of bread every day - assurances that their traditional sizes of loaf, which they perceived to be under threat from this proposal, are guaranteed and that they will still be able to enjoy and consume every morning with their marmalade toast made in their traditional sizes of pre-packed bread.
on behalf of the PSE Group. - (DE) Madam President, Commissioner, Mr President-in-Office, ladies and gentlemen, I believe that the piece of legislation that we are debating today is very important, because the reason why this directive was created in the past was of course to open up the market for goods.
Opening up the market and producing nominal quantities have now been replaced by consumer protection. How we deal with this proposal is therefore extremely important and that is why the European Parliament has stated clearly that simply doing away with all of the regulations in this sector could lead to difficulties, particularly for people with disabilities, especially the partially sighted. If we look round large supermarkets, for example, we note that prices are not always displayed as clearly as they might be.
For Parliament, it is of great importance to appeal to the Member States and say that it is not enough to display prices in units of litres or kilograms in the large supermarkets, but that it would also be appropriate to introduce this pricing method in other outlets. They should identify ways of achieving this, as it is particularly important for vulnerable customers. It was very important for us to make this appeal and it is good that it has been heard.
The second point that is particularly close to our hearts as social democrats has just been mentioned by my fellow Member, Mr Harbour. It concerns loaves of bread in the United Kingdom. At no stage have either the Commission, the Council or the European Parliament wanted to call into question these packaging sizes, but the debate in the United Kingdom has taken on a life of its own. To make this clear to the people of the United Kingdom it was important to include a corresponding recital in this legislation, so that we really could ensure - and British Members, in particular from the Labour Party, have asked me to stress this once more - that bread in the United Kingdom will not be affected in any shape or form, but that it will continue to be able to be sold in the forms that the British public is used to.
A third issue in this context concerned the fact that we wanted to ensure that these nominal quantities would not be abolished automatically after a certain time, but that the European Commission would assess the consequences and the possibilities beforehand and would consider by means of an impact assessment whether this was appropriate, what consequences could arise as a result and how we might respond to any disruption of the market. The detergent market has provided us with an example of what happens when there are no nominal quantities, and in that case we could consider what action might be taken.
on behalf of the ALDE Group. - (FR) Madam President, Mr Verheugen, Mr Lütke Daldrup, ladies and gentlemen, I should like first of all to congratulate our rapporteur and also to thank him because Mr Toubon has worked in a spirit of complete cooperation with all his colleagues. Consequently, we have always been informed of his positions and of the progress of the dossier after every discussion with the Commission and the Presidency of the Council. Mr Toubon has sought our opinion, providing us in good time with clear, precise notes, which have enabled us to make up our minds with full knowledge of the facts.
At the time of the vote at first reading, the Group of the Alliance of Liberals and Democrats for Europe took a stand against maintaining packaging sizes insofar as these mandatory categories did not exist in the 27 Member States and these obligations could hamper innovation and competition by limiting consumer choice. The ALDE Group has, however, come round to the Council common position and supports the idea of transitional periods for certain categories of product.
On the other hand, the ALDE Group did not necessarily want a revision clause to be entered into the actual body of the directive, as it felt that the reference to this review clause in a recital sufficed. Recognising, however, the persuasive powers of the rapporteur, the ALDE Group will support him on this point as, I might add, it will support his amendments as a whole.
Aside from this vote, however, may I express my regret that none of the institutions has taken up the idea of concordance tables, which appeared in Article 8 of the basic proposal. In accordance with the 'Better lawmaking' interinstitutional agreement, the Member States are in fact encouraged to establish for themselves and in the Community interest their own concordance tables between the directives and the transitional measures and, above all, to make them public. This point is particularly important for the ALDE Group, which is very committed to improving information for consumers and, beyond that, which is fighting for better information for European citizens.
(SV) Madam President, the Swedish Members of the Group of the European People's Party (Christian Democrats) and European Democrats are opposed to a Packaging Directive. Ideally, we would want to do away with the whole directive. I have made efforts to rescue Swedish milk packages, reduce bureaucracy and prevent a debate on milk snatching.
The rapporteur, Mr Toubon, has negotiated, and reached a compromise, with Members of the European Parliament and with the Council. The compromise now looks quite different.
Today's date is 9 May, a day of peace for Europe. The motto is jaw not war, and in that spirit I shall try to do my bit. Negotiations presuppose compromise. Whoever is able to compromise contributes to the development of Europe. It is more difficult to say yes in the right place than to say no. I personally am in favour of Mr Toubon's compromise, irrespective of whether or not my Swedish fellow Members are. This is my way of celebrating 9 May, that is to say by showing some additional willingness to compromise on the issue of a Packaging Directive, for it is in that way that modern Europe is being built - stone by stone, compromise by compromise. I also want to try to help, so I am agreeing to the proposal and would conclude by saying:
(FR) My respects, Mr Toubon.
In fact, Mrs Cederschiöld, Mr Toubon is behind you on the other side. In any event, the debate is closed.
The vote will take place tomorrow.