Full text 
Tuesday, 15 November 2005 - Strasbourg OJ edition

25. REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

  President. The next item is the joint debate on

- the report by Mr Sacconi, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) No .../... [on Persistent Organic Pollutants] (COM(2003)0644 C5-0530/2003 2003/0256(COD)) (A6-0315/2005), and

- the report by Mr Sacconi, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) No .../... of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals (COM(2003)0644 C5-0531/2003 2003/0257(COD)) (A 6-0285/2005).


  Günther Verheugen, Vice-President of the Commission. (DE) Mr President, honourable Members of the European Parliament, let me begin this debate by congratulating all those committees, and their many individual members, who have participated in the discussions on REACH, which is one of the most far-reaching proposals that the Commission has ever adopted. The committees and their members have had an enormous amount of work to do in analysing its details and in drafting amendments to improve it.

I am particularly obliged to Mr Sacconi, who, as rapporteur for the lead committee and as a stalwart defender of improvements to the protection of health and the environment, was open to the possibility of compromise. I also wish to thank Mr Nassauer, the draftsman of the opinion of the Committee on the Internal Market and an advocate of competitiveness and innovation as goals for policy, who was equally open to reasonable compromise, and Mrs Ek, who drafted the opinion of the Committee on Industry, Research and Energy, and was equally active in putting forward the objections of industry, albeit without losing sight of the vital importance of protecting health and the environment.

Not least in your House, this legislative project has made enormous demands in terms of organisation, and the Commission itself found it difficult to respond to over 1 000 amendments and come to an agreement. We will be able to explain in detail our position on the compromise package put forward by Mr Sacconi and Mr Nassauer, and also to respond in detail to the amendments that were handed well in advance of the deadline, but I do ask you to understand that the Commission will not be able to consider in full the amendments tabled immediately prior to the deadline for submission, and that, for this reason, I cannot yet give you the Commission’s position on them. We will, however, delay as little as possible in stating our position on those amendments that gain a majority at the vote.

I will now turn to the fundamental questions to which the amendments refer.

The Commission supports Mr Sacconi’s and Mr Nassauer’s proposed compromises on registration and on the exchange of information. We take the view that they strike a very good balance between the demands of our industry’s competitiveness on the one hand and advances in the protection of health and the environment on the other. On the subject of the exchange of information, I would like to stress that any such system must offer the maximum possible incentives, although there will be situations in which – for reasons, among others, of cost – it will not be in businesses’ interests to cooperate and in which the exchange of information could be detrimental to their essential interests. It is for that reason that I am grateful that a system has been devised for the conditions applicable to data exchange to minimise inconvenience for businesses and the Agency.

There is, I would say, a threefold motivation behind the amendments relating to the regulation’s scope. One has to do with substantive clarification of it. A second has to do with creating a derogation from it for a number of other substances that are not regarded as presenting any risk, and a third has to do with the avoidance of duplication of rules.

The Commission accepts the clarifications relating to derogations from the scope of the regulation, notably for waste, food, biocides and pesticides. We also accept the clarification to the effect that REACH cannot alter or circumvent the rules in the cosmetics directive for the avoidance of animal experiments.

We accept the need for the requirements relating to specific substances – that is, minerals, ores, ore concentrates and chemicals occurring in nature – to be expressed with greater clarity.

Turning to the requirements to be imposed on what are termed downstream users, the Commission is in favour of introducing a threshold of one tonne per annum where such users are required to submit a chemical safety report on their own account. This is necessary if they are not to be put at a disadvantage over against their own suppliers and also in order for the system to be made more compatible with their needs.

It is evident that various committees are making strenuous efforts to enhance the Agency’s role in assessing risk. The Commission accepts that such an approach has its merits in terms of more even and more consistent application of the Regulation’s rules, although we must be very cautious as regards the tangible form that this will take. The fact of the matter is that there is only a limited reserve of expertise, much of which is to be found in the Member States – whether in their competent authorities or in their scientific institutions. It is vital that the best possible use be made of these resources for the common good.

The authorisation procedure is one of the most important aspects of the whole REACH Regulation, if not, indeed, its cornerstone. On the one hand, we want to find an efficient way of giving businesses an incentive to substitute viable alternatives for substances of very high concern, but, on the other, we do not want to set up a system that puts chemicals producers within the EU at a competitive disadvantage. This affects a large number of high-tech companies, and the innovative benefit of chemical substances is crucial if they are to remain able to compete with those in the USA, China and other Asian countries. We must also be careful not to overstrain the Agency or the Commission to too little real effect.

The risk element must remain crucial in the authorisation procedure if we are to continue to endeavour to monitor it in an appropriate way. Firms must also be able to demonstrate that they are succeeding in doing that.

We can agree to a procedural step in which the Agency publishes information on its work programme for authorisation, that is to say, relating to its choice of chemicals to be proposed to the Commission as candidates for authorisation within a foreseeable timeframe. That is good for the industry, in that it will give businesses greater confidence in planning ahead. We can also accept the idea of attaching a review clause to the Agency’s authorisation of substances in individual cases.

Discussion of substances in products, to which Article 6 relates, has been made difficult, not through its being in any way politically controversial, but because of the objective facts, in that it involves, on the one hand, creating equal competitive conditions for manufacturers and importers of products, and, on the other, countering the problems arising through the import of products the chemical constituents of which do not have to comply with the same conditions as products manufactured from registered chemicals. These include many components that European industry processes into end products. In the final analysis, compliance with the WTO rules requiring risk-based regulations is unavoidable.

It is for this reason that the Commission is in favour of those proposals that are practicable and conform to WTO requirements. The intended rules for substances intended to be released from products appear to the Commission to be reliable. Other substances in products will require the creation of a system that companies will find easy to use and the primary purpose of which is the identification of risks.

Moving on to the confidentiality of data, a number of amendments have as their objection the enlargement of the list of items of information that should always and in principle be regarded as confidential. Others seek to shorten this list and facilitate the publication of more information on the Internet.

The Commission takes the view that, at the end of the day, its compromise proposal strikes the right balance. Our aim should be to ensure access to information that is really needed to protect public health and the environment. In the course of time, the Agency will have an important part to play in terms of communication and also in informing consumers, even though that is not the express objective of the REACH Regulation.

On the other hand, we must not be naive. Both Europe and the companies have great knowledge and experience in the use of chemical substances, knowledge that would certainly be of great value to competitors outside Europe. Within Europe, too, we must ensure that the competitive position of individual enterprises is not undermined.

We cannot therefore rule out the possibility of having to make a number of amendments to the text in order to bring REACH’s practical implementation into line with the provisions of the Aarhus Convention. I am thinking here, in particular, of the tight deadlines required for appeals decisions.

The amendments also address many other individual issues. Although time does not permit me to mention them all, I would like to draw your attention to the amendments relating to the Agency, which cover a multitude of issues relating to its mandate, the way its committees work together within it, the composition of the Management Committee and the appointment of its Executive Director. The Commission’s view of these amendments is founded on a pragmatic approach. We have an open mind about, and will deal constructively with, proposals aimed at making the Agency more efficient, but we must avoid heaping additional burdens upon it. The more tasks we expect it to perform, the greater the risk that it will not enjoy initial success.

Let me also emphasise to the budgetary authority that giving the Agency additional tasks must, self-evidently, be accompanied by a corresponding increase in its financial resources.

The Commission hopes, then, that the compromise package presented by Mr Sacconi and Mr Nassauer is one to which Parliament will feel able to give its approval. We believe that this package can help to foster widespread support for a piece of legislation that is among the most problematic, complex and, certainly, most controversial in the history of the European Union.

From the very beginning of the discussion of REACH, the Commission has always seen itself as having the role of helping to find a rational and pragmatic solution that struck the right balance between the demands of the economy and the objectives associated with health and the environment, and we do believe that these compromise proposals achieve it rather – and let me make this perfectly clear – than weakening the Commission’s original proposal. We believe that this compromise package makes the proposal more workable, more efficient and also more cost-effective; a better way, indeed, of achieving the environmental and health objectives. It is for this reason that the response from the Commission’s meeting today was so positive, and I hope that will also encourage the Council to adopt the whole package before the year is out. The proposals to which the Commission has given such a favourable response are watertight by comparison with those submitted earlier by the UK Council Presidency, so I do now believe that we have an extraordinarily good chance of successfully wrapping up this very difficult legislative package by the end of the year.


  Stavros Dimas, Μember of the Commission. (EL) Mr President, I should like to start by thanking the European Parliament, which has worked very intensively on this proposal at first reading.

I should like to congratulate in particular the chairman of the Committee on the Environment, Public Health and Food Safety and the committee itself and, of course, the rapporteur Mr Sacconi, whose untiring and consistently constructive efforts have made a decisive contribution towards promoting this proposal. I also thank the Committee on the Internal Market and Consumer Protection and the Committee on Industry, Research and Energy and their rapporteurs, Mr Nassauer and Mrs Ek, for their constructive proposals.

They have all worked together, submitted proposals and reached this compromise which they propose on one of the main elements of the REACH system: registration.

REACH is a very important legislative initiative to improve environmental protection and human health and, when it is applied, it will significantly increase the knowledge which we have about chemicals, improve their safety and strengthen consumer confidence in the chemicals with which they come into contact. In addition, it will give impetus to innovation and will encourage the substitution of products by safer products.

I am particularly satisfied by the fact that the European Parliament and the Council have finalised their positions on the proposal. In this way, the two Community institutions converged in their opinions and now have similar approaches to numerous questions relating to REACH issues.

The compromise package on the question of registration proposed by Mr Sacconi and Mr Nassauer and countersigned by the Group of the European People's Party (Christian Democrats) and European Democrats, the Socialist Group in the European Parliament and the Group of the Alliance of Liberals and Democrats for Europe constitutes positive progress on one of the most complex chapters of the REACH dossier. The compromise package constitutes a balanced proposal. By focusing the proposal on the substances which have the highest risk level, this compromise improves the functionality of the REACH proposal, especially as regards substances produced or used in small quantities. At the same time, it safeguards a high level of environmental protection, by demanding more information where the risk is greatest.

Despite the fact that the approach for substances produced or used in small quantities differs from the Commission proposal, it is nonetheless a significant improvement for the protection of health and the environment compared with the current situation. The Commission supports this package within the framework of efforts to find a compromise.

The compromise package aims in the same direction as the discussions being held in the Council. Similarly, it has many points in common with the compromise proposal tabled by the British Presidency on 28 October, which was broadly accepted in the Permanent Representatives Committee last Friday. The Commission fully supports the objective of the British Presidency to achieve political agreement before the end of the year and to make every possible effort in this direction and to make a positive contribution to this objective.

There are numerous important aspects in the REACH initiative but, due to lack of time, I should like to refer to two of them: the scope of the proposal and the provisions on authorisation.

The scope of the proposal is fairly complicated, mainly due to the large number of Community legislative texts on specific products which contain chemicals. The Commission is in a position to accept several of the amendments proposed by Parliament, such as the exemption from registration of waste, food and ores. However, we cannot accept a number of other amendments which would create a vacuum in the application of the legislation.

As far as authorisation and substitution are concerned, I see with satisfaction that the Members of Parliament have proposed a large number of valuable amendments which set time limits on authorisation and increase the pressure for substitution, thus strengthening protection of human health and the environment. The Commission agrees with the need to authorise substances which cause a similar level of concern about risk as the most dangerous substances referred to in the Commission proposal: carcinogenic, mutagenic, persistent bioaccumulative and very persistent and very bioaccumulative substances. We also agree with the setting of a time limit for authorisations, but this limit will be decided on a case-by-case basis by the European Chemicals Agency.

At the same time, we believe that this arrangement, in conjunction with Article 52, as amended by the British Presidency, will have a positive effect on substitution, as there will be pressure on companies to step up their efforts to find substitutes and safer substances.

To close, I should like once again to thank all the members of the European Parliament who have worked so intensively over the past nine months in order to make progress on the REACH proposal. In this way, the European Parliament is making a decisive contribution to improving the level of protection of health and the environment in Europe, while at the same time maintaining the competitiveness of European industry.


  Lord Bach, President-in-Office of the Council. Mr President, I would like to begin by thanking the Members of this Parliament for their hard work on REACH, and in particular the key committees and their members. It is an honour to be invited here to speak on behalf of the UK Presidency.

Firstly, I would like to emphasise that REACH is a very important dossier for the UK Presidency. This legislation offers a once-in-a-lifetime opportunity to achieve proper protection for humans and the environment while at the same time being workable and maintaining the competitiveness of European industry. We all want to find a good solution on REACH, one that both enhances protection of public health and the environment and maintains industrial competitiveness. This objective can only be attained with the cooperation of all Member States, the European Parliament and stakeholders. REACH will feature strongly at the Competitiveness Council on 29 November, where we plan to hold a serious and substantive policy debate, so your views will be important in feeding into that. We recognise that we are very close to a deal, and we still intend to achieve political agreement before the end of the UK Presidency.

I am heartened by the commitment shown by the European Parliament in having its first reading this week. We welcome the work done by the rapporteurs to achieve a balanced and workable compromise on the key aspect of REACH, namely registration. The main elements of this compromise, co-signed by the three main political groups, are very close to the ideas that the Council is working on. Therefore, adoption of a European Parliament opinion along these lines should pave the way for an early adoption of REACH. This would be good news for the environment and for industry, bringing an end to uncertainty, and indeed good news for everyone. It would finally provide a more effective system for managing the risks presented by chemicals in order to protect human health and the environment.

The Presidency’s compromise text aims to represent a balanced consideration of the views expressed by Member States in the discussions to date. It acknowledges the concerns of industry and meets them. It maintains the objectives of REACH in the field of protecting human health and the environment. We look forward to taking on board contributions from the European Parliament once you have completed your considerations. In explaining the direction the Presidency is taking I hope to further inform this debate.

Let me start at the beginning, with registration. The challenge for us all is to agree a registration package that collects the information necessary to assess the risks. At the same time it must be proportionate. We must avoid forcing companies to provide data just for the sake of it. We all share the same concerns and want to ensure REACH does not adversely impact on small firms.

The following number among our shared proposals on registration: firstly, having a single pre-registration phase to simplify the procedure; secondly, requiring data sharing through ‘one substance, one registration’. This could deliver savings of up to EUR 600 million. We have also introduced flexibility by proposing clear criteria for companies to opt out of submitting a joint information package. It is generally accepted that the sharing of animal test data should be mandatory. However, to simplify the system, the sharing of non-animal data has been made mandatory only if requested by a potential registrant.

Like Parliament, the Council is concerned about the impacts on small firms. To reduce these impacts, a proposal for targeted information requirements for low volume substances has been put forward. Below ten tonnes, a full data set only needs to be provided on a substance if it meets simple criteria identifying it as high risk. Under this approach, not as much information will be provided about the substances as in the original Commission proposal, but it does mean that we can apply a simplified risk-based approach for the 20 000 low volume substances, and focus on those of concern in the first instance. In order to reduce the burden on industry, and particularly on small firms, the Chemicals Agency will provide tools to facilitate the submission of data.

We have reduced the cost of registration in the higher 10-100-tonnage band by removing an expensive test from the data requirements. This led to a saving of around EUR 80 million. In addition, the ability to waive certain tests under Annex VI has been strengthened to minimise the burden for testing at the higher tonnage bands. I want to emphasise that this can be done in a way that still delivers the necessary information about the hazards and risks of substances.

I now turn to evaluation. Here the registration is checked for compliance or referred for further scrutiny. The compromise text gives the Chemicals Agency, based in Finland, a more central role in this phase of REACH. We want to ensure that evaluation is carried out more efficiently and consistently across the EU and that the Agency has the tools and resources to ensure this happens. Again, I do not think that the Council’s position is too far from that of Parliament on this. A similar approach has been taken in the reports from the parliamentary committees which have given their opinion.

A key part of this proposal, of course, is the authorisation stage. REACH requires any substance of very high concern to be banned unless a strong case for authorisation is made justifying its continued use. In the Council, we have clarified the scope and have strengthened the authorisation provisions to provide a greater drive towards substitution.

The compromise proposal retains the possibility of a first authorisation based solely on adequate control – that is, you can continue to use a hazardous substance if you can demonstrate that the risks are contained. But – and it is a big ‘but’ – adequate control must be tightly defined. It is now tighter in our proposal. It is clearer. It is right that all decisions should be made on a case-by-case basis. Therefore, an amendment has been introduced in our proposal to require all authorisations to be subject to a review. This would enable further consideration of the availability of alternatives in the future. In addition, substitution has been further encouraged in our proposal by the requirement to provide an analysis of possible alternatives. I look forward to the opinion from Parliament.

If I have not managed to persuade you of the vital importance to all the citizens of Europe of securing an early agreement on REACH, then I have failed. I hope I have been able to give you an insight into the discussions taking place in Council.

For our part, we will continue working in our role as the Presidency to do all we possibly can to get agreement this year. We believe we can. We look forward to receiving the contribution of the European Parliament.

Let me repeat, this is a once-in-a-lifetime opportunity. Let us not throw it away.


  Guido Sacconi (PSE), rapporteur. – (IT) Mr President, ladies and gentlemen, while listening to the speeches of the two Commissioners and Lord Bach, who represented the UK Presidency, I was reflecting on the distance we have had to travel in order to arrive at this point.

You yourself have heard how close together the respective positions of the three institutions now are. I believe I can say that concerning the themes of registration, authorisation and other aspects that have been mentioned, there are no significant differences of opinion on points of principle. It is difficult to summarise this lengthy process in a few minutes, even though this is the longest time limit that I have been given since I became a Member of this Parliament.

I shall therefore devote only a few words to two key concepts: balance and responsibility. These are words that came to my mind this weekend, which I spent almost entirely doing some soul-searching. Particularly in the light of the attacks last week on the compromise that I initialled, I wondered in truth whether I had taken the right decision and whether a balance really had been achieved; in all conscience I had to reply in the affirmative. We have not only safeguarded but also reinforced the balance between those two essential factors that are close to all our hearts: namely protection of human health and the environment on the one hand and the maintenance of industrial competitiveness in Europe on the other.

It is easier to arrive at such a balance when one is approving a political resolution, since in that instance one is working solely with words. To reach a balance in a regulation of such importance, when so many often-conflicting interests are affected, is, in contrast, rather more difficult. In such circumstances, it is in fact also necessary to take account of technical data of considerable weight and importance.

From this perspective I feel that my conscience is clear. As far as human health and the environment are concerned – and I will confine myself to quoting only a few improvements to the Commission’s proposal to which I attach particular importance – we can bring forward the registration of persistent bioaccumulative substances. Subject to Parliament’s approval, of course, we shall also introduce the chemical safety report for the lower tonnage band, if only for the most hazardous substances. If Parliament endorses on Thursday the positions adopted by the Committee on the Environment, Public Health and Food Safety, we shall define an authorisation mechanism for the substitution of the most hazardous substances, very similar to the mechanism that the UK Presidency referred to a short while ago. I am particularly proud of this.

As for enterprises, I shall mention only the most important things that have been done. While maintaining the burden of proof, we have made the registration mechanisms more flexible for the low tonnage bands and have introduced a very important feature for small enterprises: namely data sharing, which has become obligatory apart from certain mechanisms for opting out.

I should also like to recall that, together with Mr Nassauer, we have at the eleventh hour extended the period envisaged for data protection and for research and development. I believe that these are all concrete actions that are moving in the right direction. In this connection, Mr Nassauer, may I say that during my weekend of reflection and soul-searching I was somewhat struck by the fact that, after the compromise we initialled together, you saw fit to table your earlier block of amendments as well. In this connection I must declare that should our compromise unhappily not be approved, I will naturally support the other block (number 2). I am optimistic about this.

I now turn to my second key concept: responsibility, to which I would add the word autonomy. We have been subjected to much pressure, albeit legitimate pressure, concerning the interests that we all have to represent in some way while seeking the best possible compromise that is acceptable to a majority in Parliament. We have come close to this objective; and meanwhile the positions of various institutions, in particular the two legislative ones, namely the Council and Parliament, have moved very close together. I believe that the ball is now in Parliament’s court, so to speak.

We are aware that many aspects of European integration are in difficulty at present. Nevertheless Parliament could today send out a strong, clear message on such an important subject to its citizens, enterprises and trade unions concerning its ability to decide and to reach a compromise that would by definition be as representative as possible of the wishes of all interested parties.

Mr President, my work comes to an end at this point. I will naturally pay attention to the voting list in the next few hours, but let us say that the greater part of my job is done.

As Lord Bach and Commissioner Verheugen said earlier, we now have to seize the opportunity to speed up the decision-making and legislative process on this matter that has engaged so much of our attention. I said recently that an agreement is like a fruit: if it is not picked at the right time, when it is ripe, it rots and goes bad. Since this morning I have been carrying an apple in my pocket. It is not beautiful; it is small and covered with blemishes, because it was organically grown and contains no fungicides; but I think that it will taste very good and for this reason I shall eat it later.

I accordingly call upon Parliament to pick this fruit; in so doing we shall also help the other institutions, especially the Council, finally to close this file and to send out the message that I spoke of earlier.


  Hiltrud Breyer (Verts/ALE). – (DE) Mr President, I have just a small point of order to raise. It has previously been the custom of this House that rapporteurs present the positions of their committees. As Mr Sacconi is in fact the rapporteur for the Committee on the Environment, Public Health and Food Safety, I would have been glad if what he said had reflected that committee’s attitude. I would ask you in future to indicate from the Chair whether speeches are made in a personal capacity or in the capacity of rapporteur.


  President. You have expressed your concern, but the Presidency cannot treat it as a point of order. The order is established, the rapporteur has the right to the floor and he has spoken as he saw fit, and now the representatives of the committees concerned will speak. The order of the debate will not be altered as a result of your comment.


  Christofer Fjellner (PPE-DE), draftsman of the opinion of the Committee on International Trade. (SV) Mr President, chemicals are important, indeed vitally so. They are part of our everyday life and basic to much of our modern human activity. At the same time, there is a general unease about chemicals. What are they doing to us and to our environment? A certain concern is justified, and I am therefore pleased that we in Parliament are to vote through new European chemicals legislation whereby we shall get to know which chemicals expose us to high risks and which do not do so. I am also pleased that we shall be able to ban chemicals that we need to get rid of and that we shall be able to keep those that we need.

We have helped make REACH give priority to having more attention given to those substances that constitute a serious threat, and we have obtained exemptions for substances we know are not hazardous, such as wood pulp and iron ore. This means that we shall avoid bureaucracy and unnecessary costs but, above all, it means that we shall use our limited resources to bring about the highest possible level of safety.

In Europe, many goals are set which we do not in actual fact achieve. Decisions in this Chamber often promise more than they can deliver. The old chemicals legislation was an excellent example of this. It was supposed to make us safe but has achieved almost nothing. Sometimes, the failures are merely embarrassing but, in the case of chemicals policy, they may be highly dangerous. That is why we need REACH, but a REACH that manages to deliver what it promises.

The great challenge for REACH is to design a policy that does not create barriers to trade and that does not limit other countries’ ability to sell their products on the European market. For it to do otherwise would be a disservice not only to the world around us but also to European consumers. It would be absurd if we in Parliament were to design legislation that was later declared unlawful by the WTO. I therefore hope that the Chamber will take on board the proposals put forward by the Committee on International Trade for reducing trade barriers.

Quite a few members, including the Swedish Social Democrats, appear inclined to stand aloof from the proposal and to vote against it in its entirety while, in the next breath, they accuse the whole Parliament of not bothering about the environment. The Swedish Social Democrats’ most important newspaper even describes Mr Schulz, the chairman of the political group here in Parliament that it supports, as a defector. I find that accusation cowardly, and it does not help improve the environment. Instead, the Social Democrats should ask themselves why they are standing aloof from the proposal. The overwhelming majority, from the right of centre political groups – the Group of the European People’s Party and European Democrats and the Group of the Alliance of Liberals and Democrats for Europe – to the Socialist Group in the European Parliament and now the Commission as well are in agreement, and it is we who shall keep the proposal afloat. I am very pleased to have been involved and to assume responsibility for voting new, firm European chemicals legislation into existence.


  Elisa Ferreira (PSE), draftsman of the opinion of the Committee on Economic and Monetary Affairs. – (PT) The objectives of reducing chemical damage to the environment and to health, raising awareness of the consequences of the use of chemicals, improving consumer access, gradually eliminating and replacing the least safe chemicals and banning tests on vertebrate animals all touch the lives of the citizens whom we represent in this Chamber.

Parliament must therefore welcome the Commission’s initiative and play a proactive and constructive part in improving on what it is proposing. This is what we have done. That a broader undertaking in this regard has been achieved is down to collective responsibility and, more importantly, to Mr Sacconi’s outstanding report. Supporting these proposals will lead to a marked improvement in the Commission’s text and will facilitate its implementation. The core of the text remains intact, namely adopting the principle of responsibility, reducing costs for SMEs, focusing on the most problematic chemicals and the uses thereof, clarifying the Agency’s role, and giving greater precedence to assessing and monitoring the system.

As shadow rapporteur for the Committees on International Trade and Economic and Monetary Affairs, I am delighted that many examples of consensus reached on the text to be submitted for the vote have been included. In this connection, ladies and gentlemen, I wish to draw your attention, and that of the Commission and the Council, to the fact that the EU needs to use its status as the largest trading bloc in the world, and the largest producer of chemicals in the world, to ensure that the rules it adopts internally on environmental and health protection are applied internationally and are seen as prerequisites for free trade.

With regard to REACH, just as many other laws, it should be emphasised that Europe cannot continue to make laws on its internal market as though there were no such thing as globalisation. Unless we keep this in mind, we will destroy Europe as a productive base, destroy its jobs and, hypocritically, export environmental damage outside its territory to other more vulnerable parts of the world. This will be tantamount to shooting ourselves in the foot and Article 6 does not go far enough in addressing this problem.

In this area, as in others, the agreement will fall short of being perfect; it will need to be improved gradually on the basis of practical assessment. This, however, is the agreement that we have managed to reach, and is sufficiently good to warrant Parliament’s clear support. This is the only way in which a balanced institutional solution in the short term can be guaranteed. I therefore lend my backing to it.


  Thomas Mann (PPE-DE), draftsman of the opinion of the Committee on Employment and Social Affairs. (DE) Mr President, REACH, one of the most complex legislative procedures – and not just because it runs to 1 200 pages – kept ten of this House’s committees occupied, and the Committee on Employment and Social Affairs, whose opinion I have drafted, was one of them.

The chemical industry in the EU employs 1.7 million people, while some 3 million more are associated with it as suppliers. In order to get some idea of REACH’s effects on day-to-day working life, I visited 50 companies – not just in Germany – working in the fields of paints and coatings, ceramics, textiles, electrical goods, automobiles and chemicals. The unanimous view expressed by both managers and shopfloor workers was that there was no alternative to protecting health and the environment, and that a clear distinction had to be drawn between hazardous and non-hazardous substances, not least for the employees’ sake.

It has to be said, though, that the costs stated in the Commission proposal are so high, and bureaucracy involved so extensive, that there is the threat of competition with non-EU businesses being distorted, and the possibility of businesses relocating is not to be excluded.

It was our Committee on Employment and Social Affairs that conducted the first of this House’s Hearing’s on REACH; this it did in October 2004, with 200 experts on labour law and health protection, not to mention representatives of the social partners, present. We were also – on 12 July 2005 – the first committee to vote on it, thereby, no doubt, giving important indications as to the future progress of deliberations in the European Parliament.

We are in favour of pre-registration and prioritisation as standard. If there is a batch of core data relating to the actual risk rather than to the quantity of the substance in question, as well as categories for exposure and use, registration with the Chemicals Agency can be accomplished professionally and at no less speed, avoiding not only vast amounts of dead data but also needless red tape, to the benefit of small and medium-sized businesses in particular. Most of us voted in favour of derogations for substances used in research and development and for the new Agency’s powers to be extended.

A modified REACH will make superfluous two dozen European labour law regulations in the field of health and safety at work alone. Priority has to be given to the drafting of safety data sheets and their precise use in places of work, thereby obviating accidents resulting from the improper handling of substances.


  Lena Ek (ALDE), draftsman of the opinion of the Committee on Industry, Research and Energy. (SV) Mr President, chemicals in Europe are regulated by very poor legislation in the case of the 30 000 or so older chemicals and relatively good legislation in the case of the approximately 3 000 new chemicals. The new proposal replaces 43 directives, as well as national legislation in 25 countries – legislation that varies a very great deal, from quite poor to quite good, in terms of quality and of the way in which its application is monitored. At the same time, it is 100 years since we had national markets that were closed. Swedes wishing, for example, to buy toys for their children will find that, although a few are produced in their own country, most are imported.

For all these reasons, new chemicals legislation means a great opportunity for the environment, people and companies. The Committee on Industry, Research and Energy was the first committee to take a decision. We were able to transform the draft Chemicals Directive – lifeless as it was, and very much called into question - into an opportunity actually to reach a decision. I wish to thank the members of the committee for their very constructive and helpful cooperation.

The Committee on Industry, Research and Energy has responsibility for industry, small enterprises and research and has therefore, in accordance with its remit, concentrated on changes that pave the way for new, modern technologies, innovations and modern environmental technology. In Europe, environmentally driven industry is growing twice as fast as industry as a whole and is an incredibly important tool for creating jobs and sustainable growth in a knowledge-based economy.

If REACH is to be this engine of sustainable growth, the proposal needs, however, to be simplified, strengthened and made clearer. It needs to be simplified in order that small enterprises might survive; strengthened in order to bring about a better environment; and made clearer because, in certain respects, it is very unclear indeed. It cannot, for example, be the intention that every load of minerals be analysed individually.

Ladies and gentlemen, we have four major issues in the EU, including the fact that the financial perspective and draft Services Directive are each a mess and that the draft Constitutional Treaty is subject to a ‘period of reflection’. Following seven years’ discussion, we now in actual fact need a decision on the fourth important proposal, namely that concerning European chemicals legislation.

Ladies and gentlemen, uncertainty is very expensive. Therefore, let us vote ‘yes’ on Thursday to the compromises that are on the table.


  Hartmut Nassauer (PPE-DE), draftsman of the opinion of the Committee on the Internal Market and Consumer Protection. (DE) Mr President, ladies and gentlemen, that the environment and the protection of the consumer stand to gain if this REACH law is adopted is not a matter of doubt. If it is, then we will, within eleven years, be in possession of knowledge and information that we have not been able to collect before on some 30 000 substances used by European businesses. That is what makes this such a crucial leap forward.

What brings it about is the fact that we will, in future, be transferring to businesses the responsibility for obtaining information and carrying out tests, along with the costs incurred in doing so. Businesses will be responsible for the safe handling of the substances that they produce and with which they have dealings. That is the crucial change over against the law as it was before, and I think it has to be mentioned that it involves considerable costs, for these tests cost money – up to EUR 200 000! Businesses would in future be required to bear these costs themselves in the interests of the environment and consumer protection, and that means that we have to give some thought to what effect this would have on competitiveness.

Reference has already been made to the compromise that Mr Sacconi and I have been able to hammer out, and to which our respective groups have been good enough to give their approval. It makes the requirement for data in the range between one and one hundred tonnes, which is of particular importance for small and medium-sized enterprises, more dependent on the potential risk from a substance, rather than only on the quantity in which it is produced. That is a vitally important development for small and medium-sized producers and users; I am very pleased indeed that we have been able to achieve it, and it does of course have our unconditional backing. We have tabled old amendments only against the possible eventuality of our not getting a majority for it.

It has to be said, though, that this compromise relates only to registration, which is the most important part of REACH, and certainly not to the whole thing. Matters relating to authorisation and scope are still outstanding, and I hope we will manage to come to an agreement on them too.


  Kurt Lechner (PPE-DE), draftsman of the opinion of the Committee on Legal Affairs. (DE) Mr President, ladies and gentlemen, in the brief two minutes available to me, I shall have to focus on only a few points.

I will start with a general comment on the package as a whole. Europe, with what will soon be a population of 500 million people, constitutes a considerable economic area, and it is right that we should be forerunners in giving this area a single binding legal framework in the field of environmental protection. Europe is not, however, some isolated part of the world and there is no intention that it should become one; on the contrary, it has to compete with other major industrial areas, and it is of no benefit to our objectives, of which the protection of the environment is one, no matter how good our intentions, if, in future, production is removed to other parts of the world with the potential for making their environmental problems even worse, for we would be no less affected by them while sustaining considerable economic damage as well.

The economic damage to which I have referred affects by no means only the production of chemicals, but rather all goods in the production of which chemicals are used, and they are certainly not few in number.

This aspect is also relevant to one important topic in the Regulation, that being the protection of intellectual property and of confidential data, which loomed particularly large in the Legal Affairs Committee, and about which I should like, briefly, to say something. The Commission proposal as it stands at present does not take adequate account of this and does not go far enough. Commission Verheugen did mention it earlier on, and, on the assumption that I did not misunderstand him, I think he got it broadly right. The fact is that guaranteed mutuality is completely absent.

If European businesses disclose a lot of data, outsiders can see them and infer things from them; the reverse is not the case, and it is because that state of affairs goes against the idea of globally fair competition that the Legal Affairs Committee decided to adopt a series of amendments to take that into account. Some of them found their way into the overall package, notably the ones relating to the extension of deadlines, to which Mr Sacconi made brief reference earlier. Amendments aimed at improving the confidentiality of data – specifically Amendments 43, 45, 46 und 48 – did not make it, and I would like to take the opportunity to ask that they be incorporated now.


  Hiltrud Breyer (Verts/ALE), draftsman of the opinion of the Committee on Women's Rights and Gender Equality. (DE) Mr President, I do indeed intend to put forward the position of the Committee on Women's Rights and Gender Equality rather than do as some Members have done and misuse my speaking time to express my personal views.

The Women’s Committee endorses, by a large majority, the Commission’s proposal on REACH. Women are particularly affected by chemical pollution, because the fat in their bodies more readily absorbs dangerous substances. Chemicals build up in the body and can cause cancer. The incidence of breast cancer has doubled in Europe over the last twenty years; one woman out of every nine in Europe suffers from cancer, and this is in many cases attributable to chemicals. Chemicals can also harm embryos and impair fertility; 15% of all couples want children but cannot have them. Men’s sperm quality has halved over recent years; genes can be altered and allergies triggered.

Chemicals have an effect on children’s health, too. The incidence of cancer in children is increasing by 1% per annum, and it has become the second most common cause of death in childhood. Women, without wanting to do so, pass on the whole chemical cocktail to their children during pregnancy and breast-feeding.

The Women’s Committee therefore regards REACH as a unique opportunity to better protect people and their environment from hazardous chemicals. Not only has it endorsed the idea that REACH should be clear, but it has made a particular point of calling for rigorous registration, going on, indeed, to propose that chemicals should be registered from a lower limit of 10 kilograms right up to one tonne. The Women’s Committee wants substitution to be made mandatory, and imported products to be registered as well. It is in no doubt about its desire for limited registration and demands a clear substitution ...

(The President cut off the speaker)




  David Hammerstein Mintz (Verts/ALE), draftsman of the opinion of the Committee on Petitions. (ES) Mr President, the Committee on Petitions received the signatures of a million British women. Lord Bach, a million British women wrote to Parliament concerned about the effect of chemical substances on their bodies and on their lives.

The European trade unions have called for a strong REACH, as have several million European health workers and doctors. You have said that this Regulation may be our only opportunity. Let us not spoil it.

Nevertheless, I fear that we are going to spoil it, because there has been unacceptable pressure here, some shameful positions, which are turning their backs on millions and millions of Europeans who are expecting this Parliament, these institutions, to provide measures that have a positive impact on their daily lives.

We cannot – as has been said – apply a system for the risk assessment of substances, according to the compromise proposal, when, as a result of that compromise, we will never know anything about more than 90% of the substances. Never. With all of the exemptions, with all the loopholes, with all the opt-outs, we will never have any information.

This compromise only promotes ignorance and obscurity. Let us put an end to toxic ignorance once and for all, please. Today, this week, we have the opportunity to do so. We cannot spoil it.


  Satu Hassi (Verts/ALE), draftsman of the opinion of the Committee on Economic and Monetary Affairs. (FI) Ladies and gentlemen, chemicals legislation was supposed to protect the public’s health, but it appears to be turning into a great disappointment, a watered down result and a victory for the chemical industry lobby, using its enormous wealth as a weapon. The agreement between conservatives and socialists will mean that no chemicals in consumer products will be tested. This is a scandal, as we know that chemicals cause a third of occupational diseases and a significant proportion of allergies, asthmas, infertility and cancer.

The role played by the Commission, and in particular by the Directorate-General that Commissioner Verheugen heads, has been truly curious. It has been like a Kinder Easter Egg: you never know what surprise will pop out this week. Nearly every week we have had totally conflicting messages in the name of the Commission: the Commission supports its original proposal, does not support it, does support it, does not support it. A lot of information has come from the Commission that runs counter to its official decisions.

Ladies and gentlemen, this is not good management and it does not set a good example to Turkey, which is aspiring to membership. I would ask you all to support the proposal by the Committee on the Environment, Public Health and Food Safety and the example set by the Group of the Greens/European Free Alliance, which would guarantee that chemicals used in consumer products have been tested. Then we would be creating a competitive edge for European industry. Everywhere in the world people would know that European products are safe, and small companies could also safely use chemicals protecting their own employees.


  Ria Oomen-Ruijten, on behalf of the PPE-DE Group. (NL) Mr President, I will start by expressing my respect for the rapporteur’s – Mr Sacconi’s – working spirit and resolve, but I am also indebted to the tenacious attitude displayed by a number of Members, including Mr Nassauer, Mr Vidal-Quadras Roca, Mrs Herczog, Mrs Erika Mann, Mr Thomas Mann, Mr Langen, Mrs Roth-Behrendt, Mr Goebbels, Mr Manders and others, because without them as fellow fighters for a workable REACH, we would not have reached a result.

In our modern-day society, chemicals are all around us. Chemical substances or techniques are used for body care, food and health products. Chemicals in Europe are of major significance, accounting, as they do, for EUR 440 billion of the GNP. Since 1.3 million workers are employed in 27 000 companies in that industry, it has a positive impact on the economy, but that does not take away the fact that there is a sense of unease among the European public about the effects and risks of chemicals on our everyday life, the work place and our environment. With this mammoth legislative project, we can instil renewed confidence and provide convincing arguments.

The regulation as originally proposed by the Commission was too bureaucratic, involved too much documentation and was costly without it being able to actually improve the result. I think that we must offer guarantees for a workable project that in eleven years’ time will provide society with products that are absolutely safe.

One thing still causes me concern. A number of compromises have been struck, and I welcome them. With regard to the authorisation, new compromises have been tabled, including some compromises by four of the groups. The Members of the Group of the Alliance of Liberals and Democrats for Europe, and possibly those of the Socialist Group in the European Parliament may think that there is a little more room to manoeuvre in those compromises, but nothing could be further from the truth. Rules have been stepped up in the compromises, so much so that in some respects, they are even stricter than those that were voted on in the Committee on the Environment, Public Health and Food Safety. I would therefore ask you not to get the wool pulled over your eyes, but to have another good look at the documents.


  Werner Langen (PPE-DE). – (DE) Mr President, I wanted to point out that Mrs Hassi was not presenting the opinion of the Committee on Economic and Monetary Affairs, but solely her own personal opinion, on which it was not possible for a majority to vote.


  Robert Goebbels, on behalf of the PSE Group. (FR) Mr President, let us review REACH calmly, being careful to avoid both naïve green optimism and industrial pessimism. Chemistry is neither left-wing nor right-wing. It is an indispensable element of the universe. Certain chemical compounds are harmful to humans, whether they occur naturally or are man-made.

The most basic prudence demands a cautious approach to new chemical substances. I prefer prudence to the precautionary principle, which is too frequently used to evade all responsibility. According to the publications of organisations such as Greenpeace, the truly dangerous substances are already known, because they are condemned day in, day out. Why, therefore, do we want to make REACH a cumbersome, bureaucratic system; why do we not concentrate on attacking the extremely worrying carcinogenic, mutagenic, toxic and bioaccumulative substances? For all of these substances, the substitution principle is a necessity.

The compromises drawn up by Mr Sacconi safeguard this objective. The flexibility condemned by some will still involve the responsibility of the European Chemicals Agency, whose powers will be extended. It is not giving in to the industrial lobbies to want to take account of the legitimate interests of SMEs and to limit expensive and often useless tests. Hence the need for the principle of ‘one substance, one registration’.

The language of chemistry is universal, and each chemical formula is unique. Protection of the environment and protection of health remain prime objectives. However, whatever the fear merchants may claim, the natural environment in Europe is constantly improving and, each year, the life expectancy of Europeans increases by, on average, three months. Humans are, nevertheless, mortal. It is therefore wrong to claim that a stricter REACH system will save thousands of lives and create, so to speak, immortality.

REACH is necessary, if only for the benefit of workers in the sector. It is a matter of protecting not only their health but also their jobs. The European chemical industry is the best in the world. The preservation of a competitive European chemicals sector remains an honourable objective, even though we need to remind the industrial lobbies that cleaner production procedures and non-problematic products would constitute a real competitive advantage on the global market.

Faced with often extreme claims, our rapporteur, with the help of others, has been able to strike a balance between the imperatives of health, the environment and the economy. Even those who will not vote for the compromises proposed by Mr Sacconi cannot fail to recognise that Europe is in the process of developing, on the subject of chemistry, the most progressive and most ambitious legislation in the world.


  Lena Ek, on behalf of the ALDE Group. (SV) Mr President, the background to why we need new chemicals legislation in Europe has been eloquently described. I shall not therefore go into more detail about it. In the Group of the Alliance of Liberals and Democrats for Europe, we have identified ten thorny political issues. I wish therefore, instead, to describe some of these.

Credible evaluations of the draft legislation have been undertaken, and these have shown that there are special problems for small enterprises where 1-10 tonne volumes are concerned. There is therefore a need for simplified registration for small enterprises when it comes to non-hazardous chemicals. At the same time, stricter requirements need to be made of those chemicals suspected of being dangerous. The compromise means that further information is required about approximately 30% of the substances, while simplified registration is enough for the remaining substances. I think that this is a good balance – perhaps not perfect, but acceptable – and, when it comes to such important matters, something good should not be jeopardised by pursuit of the ideal. It is often said that what characterises a good compromise is the fact that everyone is equally dissatisfied with the result. I believe that the opposite is, in actual fact, true in this case, that is to say that most people are reasonably satisfied with the result.

The proposal needs also to be strengthened in a number of ways. Each individual consumer must have the right to know whether there are any dangerous chemicals in the goods that he or she purchases. Therefore, our compromise also contains rules concerning the duty of care, which clearly lies with companies. The ALDE Group also proposes an addition clearly stating that the burden of proof should lie with companies.

One important issue concerns authorisation, that is to say the actual decisions concerning chemicals. It is important to have a strong substitution principle for hazardous chemicals that can be replaced by less hazardous alternatives. Those chemicals that need to be authorised are not just any old ones. They are chemicals that can cause cancer, that damage people’s reproductive functions and that become concentrated in the human body – in other words, the worst of the worst offenders. Those companies lowest down in the chain, known as downstream users, need also to have access to better information, and consumers need to have the right to be informed. I am therefore pleased that the relevant provisions are included.

REACH needs, moreover, to be made clearer. The mining industry is wrong to believe that it has to test every lorry-load of iron ore taken out of a mine. The proposal contains similar grey areas and odd features which all three of the major political groups have been very much in agreement about removing.

I should like to thank Commissioners Verheugen and Dimas. For a moment, I was concerned when they came up with this ‘room paper’, but I am very pleased that the Commission has now decided to support the main policy represented by the big three groups in Parliament.

I should also like to congratulate Great Britain on the sterling work it has done and continues to do and also to congratulate Luxembourg on the work it did earlier on when it held the Presidency. The decision I hope we shall vote through on Thursday here in the Chamber greatly resembles the proposal put forward by the Presidency. This means that we now have the opportunity both to stabilise the whole issue and to reach a decision considered by the ALDE Group to be incredibly important. We shall support the compromise proposals on the table.


  Carl Schlyter, on behalf of the Verts/ALE Group. (SV) Mr President, I wish to thank Mr Sacconi for his work on REACH and for the compromises that, with our help, he has brought about on the subjects of authorisation etc. The attacks on REACH by Mr Nassauer, Mr Schulz, Mr Poettering and Mrs Ek are, however, a policy of appeasement of the German chemicals industry, which destroys the environment and public health and makes things impossible for workers and all small enterprises that want actually to know about the effects of the chemicals they are buying and about their consequences for us.

As long as four years ago, the European Parliament, through Mrs Schörling’s report, demanded that REACH be couched in stronger terms. For a year, the Committee on the Environment, Public Health and Food Safety has worked in an efficient and balanced way with a view to protecting public interests, health and the environment. Now, the whole of Parliament appears to be hypnotised by the German chemical industry’s lobbying ploy, with Mr Nassauer as the first wielder of the magic wand.

How can you in the Group of the European People’s Party (Christian Democrats) and European Democrats defend the Nassauer compromise’s attack on small enterprises whereby data is not fully shared with them and whereby they have an extra five years in which to pay for information available to the large companies? How can you defend no longer having the registration fee dependent on volume and justify the lack of clarity there now is in connection with costs? You should snap out of the spell you are under and vote in favour of the alternative compromise.

How can you in the Socialist Group in the European Parliament defend the way in which the testing of low volume chemicals has been hugely undermined? How can you defend woolly criteria according to which high volume chemicals too can be exempted from tests designed to detect cancer risks? How are we to protect workers when we have no information and no clear requirements governing the working environment? Stop being so bewitched and vote against Mr Nassauer and in favour of the alternative compromise.

As for you Liberals, you should break the spell and stand up for a liberal policy. Allow consumers the opportunity and the knowledge to vote hazardous chemicals out of existence. Vote against the Nassauer compromise and the way it undermines consumer protection. It is in danger of making guinea pigs of us all by removing the explicit protection that exists against consumers being exposed to research chemicals. Moreover, the compromise bases consumer protection on risk assessment being required to be carried out using available data, but it was precisely this lack of data that REACH was supposed to remedy. That does not constitute your compromise. I would therefore ask you to break the spell of the German chemical industry’s misleading siren calls concerning growth. If REACH is undermined, all that will grow are cancerous tumours in our citizens. It would take me an hour to list all the organisations that want to see REACH couched in stronger terms. You should, emphatically, listen to them. You will only be given the opportunity to vote in favour of a stronger REACH if you vote against the Nassauer compromise and in favour of the alternative proposal.


  President. Before I continue, I would like to point out that Rule 145 of the Rules of Procedure concerning personal statements enables Members whose names are mentioned in the speeches to request the floor, which would be granted to them at the end of the debate. If everyone mentions Mr Nassauer’s name, it is clear that at the end of the debate he could ask to make dozens of personal statements.


  Jonas Sjöstedt, on behalf of the GUE/NGL Group. (SV) Mr President, I speak on behalf of the overwhelming majority in my political group. The Left in the EU want to see REACH couched in strong terms. We want to see a REACH whereby we are told about the effects of chemicals, including those manufactured in smaller volumes. We want to see a chemicals policy that makes it compulsory to phase out and ban the most hazardous chemicals of all. We want companies to have clear responsibility for their products. This is in the interests both of public health and of employees’ safety. Every serious analysis shows that the benefits of an efficient chemicals policy greatly exceed the often hugely exaggerated costs of chemicals policies in general. It should be self-evident that REACH is a good thing. Companies need to know what they are doing and to accept responsibility for what they do.

In the Committee on the Environment, Public Health and Food Safety, we arrived at what in the main was a constructive compromise. I deeply regret the fact that socialists and liberals have run away from that compromise and chosen instead to reach a settlement with the Right. The Nassauer/Sacconi compromise drastically weakens what we aspired to achieve in terms of an efficient REACH. It means that we shall not learn about the effects of chemicals. A full 90% of low volume chemicals may be exempted, and chemicals within the higher volume band are also exempt from proper tests. This means that we shall not be able to obtain the knowledge required for an efficient chemicals policy.

We believe that this is wholly unacceptable. Our political group will never be able to agree to chemicals policy being weakened in such a way. We have therefore chosen to join with the Group of the Greens/European Free Alliance in putting forward the alternative proposal.

Many Members of this Parliament have in practice acted as mouthpieces for the chemical industry’s lobbyists. I think that this has sometimes been depressing to see.

To Mrs Ek I should like to say the following: you talk about the environment but, at every possible opportunity, you have consistently made efforts to weaken and impair this draft legislation. This is the most important proposal on environmental issues that we have dealt with for many years in the EU system. What you are advocating is not an environmental policy.

To the European Commission I should like to say the following. You have lost credibility on environmental issues. You are running away from your own proposal. You are not even standing up and defending what you yourselves proposed as recently as a few years ago. That is weakness, in my view. You no longer have any credibility on environmental policy.

Finally, Sacconi’s apple. If you have been given this apple by Mr Nassauer, then I would look out. It is probably chock-full of dangerous chemicals and insecticides and presumably rotten inside.


  Johannes Blokland, on behalf of the IND/DEM Group. (NL) Mr President, rarely will a proposal be discussed here that is as complicated as this one. The Commission’s REACH proposal must be improved. We are all agreed on this, but, when it comes to how this improvement is to be carried out, opinion in this House is very much divided. On 4 October, we in the Committee on the Environment, Public Health and Food Safety reached an acceptable compromise. Although aspects that are important to me, including risk and volume-based registration, have not made it to the finishing line, I still voted in favour at the final vote. I am now also endorsing in the plenary the compromise that was reached in the Committee on the Environment, Public Health and Food Safety. In my view, the ‘Sacconi-Nassauer compromise’ is inadequate. With this approach, we lose the results achieved in the Committee on the Environment, Public Health and Food Safety to some extent. Nevertheless, I should like to express my appreciation to the rapporteur for his approach and good cooperation. Given the little support it received at the final vote, I can understand why he chose his approach after the vote in the Committee on the Environment, Public Health and Food Safety.

I can endorse the thrust of the Rescue Reach Plan of the Group of the Greens, although I do not support the removal of use and exposure categories. I should like to draw you attention to a number of points again, because I consider them so important. An appropriate solution must be found to the problem of inorganic substances. Metals, ores and concentrates cannot be dealt with in the same manner as organic chemical substances. I expect the Council to address this problem and to have resolved it by second reading.

The burden on small and medium-sized enterprises must be manageable. Following the vote, another cost and benefit analysis must be carried out in order to map out the effects of the vote on the burden on SMEs. The forming of consortia must be promoted, partly in order to keep the costs down. Volume and risk go hand in hand. It is precisely about the most dangerous substances that most information is required, and these need not involve large volumes. That remains a major problem.

Finally, whilst animal tests must be avoided where possible, progress remains necessary. If this wish list is fulfilled, I think we will be well on our way of achieving our goal.


  Liam Aylward, on behalf of the UEN Group. Mr President, I am sure there is nobody in this House who disputes the need for REACH, whose primary concern is the health of the people of Europe, its future generations, its young people in particular, and the environment. Today there are more than 100 000 chemical products on the European market, a large majority of which have never been evaluated with regard to their long-term effects. More and more scientific research shows that modern-day illnesses such as asthma, allergies, certain types of cancer and work-related illnesses are often the result of chemical products in the environment.

REACH will make it easier to develop and market new and safer substances and it will greatly reassure European consumers as manufacturers, producers and importers register chemicals and supply information about their properties. REACH will encourage the replacement of most hazardous substances. It will apply not only to products within all EU Member States, but will also apply to imported products.

While there is unanimous approval for REACH’s aims, there is far less agreement over the means of achieving them, especially regarding the obligations it imposes on the chemical and pharmaceutical industries. In my own country, Ireland, pharmaceutical industries account for EUR 37.4 billion in exports and account for almost 40 000 jobs directly and indirectly. We must therefore avoid crippling small and medium-sized European industries with over-stringent obligations and regulations. In modern life, chemicals play an essential role in the economy. We all need chemicals as part of everyday life, but we also need to guarantee their safety. REACH can provide that guarantee and information, but we must be careful not to destroy these industries as well.

The key to this debate is balance. I believe that, with the amount of effort that various members of committees have put in, particularly my own committee, the Committee on the Environment, Public Health and Food Safety, we have achieved that balance and I believe that this proposal should be acceptable to the House.


  Irena Belohorská (NI). – (SK) Ladies and gentlemen, I would like to pay tribute to the painstaking work undertaken by the rapporteur Mr Sacconi in preparing this report. As a doctor, I am aware of the considerable rise in the incidence of serious diseases recorded over the last decade, much of which is due to the hazardous use of chemicals. Often, however, problems arise from a failure on the part of manufacturers to provide information concerning the effects of chemicals.

It is important to realise that the REACH directive is not only about the conflict between the chemical industry and the environment, but also about the competition between large corporations and small to medium-sized enterprises in the chemical sector. I welcome the fact that the REACH directive will ban some substances and have them replaced by less dangerous substitutes. However, most of the chemical substances mentioned in the report will not be eliminated from the environment. I hope that people will be directly informed, on the basis of tests, of the dangers they pose. Needless to say, I am also thankful for the fact that people will be more careful when handling such substances.

I do, however, have one serious reservation regarding a kind of discrimination against the ten new Member States. These states have been party to the discussions on the REACH directive for only one year, as a result of which their level of readiness is lower than that of the EU-15, which have been discussing the issue for three years. The Slovak Republic supports and recommends the approval of the ‘one substance, one registration’ system because it contributes to reducing overall testing costs and eliminating unnecessary bureaucracy.

Since the objective of REACH is to reduce the risks posed by chemical substances while avoiding price increases in final products brought about by high testing costs, I believe that it would be appropriate also to standardise testing charges, due account being taken of the weaker economies of the new Member States.


  Werner Langen (PPE-DE). – (DE) Mr President, the Commission proposal is both too bureaucratic and too expensive; it harms small and medium-sized businesses and, unless substantially amended, is utterly indefensible. As it was not these two Commissioners, but rather their predecessors, who presented the proposal, the new change in attitude is to be welcomed.

The second thing I want to say is that the additional proposals brought in by the Committee on the Environment, Public Health and Food Safety may well keep big businesses happy, but they will have no such effect on small ones. The line taken by the Greens and others, again and again, exemplifies their hostility to small businesses.

There are a number of principles on which certain committees have agreed by large majorities. The first is that businesses bear responsibility, but must also take precautions. The second is that the minimum requirements and the available data are more readily accessible; it takes up to 18 months. Thirdly, assessments should be flexible and on the basis of risk; the exposure and use categories must be accessible right down to the end of the user chain. Fourthly, voluntary cooperation must be encouraged; there must be no mandatory consortia of the kind that the British Presidency keeps on proposing. Fifthly, repeated experiments on animals should be avoided. I shudder at the thought of all the thousands of animal experiments – all of them unnecessary – that would have to be carried out if the proposals from the Greens were to be adopted.

Fair competition must be safeguarded, and one particular way in which this may be done is through the handling of imports, which is the subject of Article 6. There must be no time limit to authorisation, which must be capable of being reviewed under certain circumstances. Greater attention needs to be paid to the needs of small and medium-sized businesses. I would indeed argue that it is only these changes that will make the whole thing a defensible proposition, and I wish to express my gratitude to all those who, in various committees and in various capacities, have worked on it. It is only when we have a sensible compromise that enjoys general support that this House will be able to wield the clout to which it is entitled, for neither the Commission nor the Council have hitherto been in a position to do so.


  Béatrice Patrie (PSE). – (FR) Mr President, ladies and gentlemen, in France, almost 10% of cancers developed by workers each year are related to their exposure to chemicals at their place of work. In the absence of useable data on these chemicals, however, only a tiny proportion of these cancers are recognised as occupational diseases and dealt with as such. More generally, we are seeing an exponential increase in the incidence of cancer affecting the whole of the population, particularly children, which has led many scientists to conclude that these cancers are directly related to chemical production. That demonstrates the importance attached to the entry into force of a system of assessment, authorisation and substitution of chemicals.

All of us here are keen to guarantee the competitiveness of the European chemical industry and thus to protect jobs. For my part, I have always advocated the idea that the system adopted should be technically and economically sustainable for business and, to this end, promote consortiums. However, we do not want a REACH on the cheap.

In order for REACH to make it truly possible to eliminate harmful substances from the European market, there are two conditions. First, the determination of the nature and the potential risks of substances is directly dependent on the quality of the information supplied during registration. No amendment must result in the registration aspect being rendered powerless and, in this regard, derogations from the obligation to provide data must be exceptional and strictly limited, including for substances produced in small quantities. The burden of proof must lie with the companies.

Secondly, we must give all the citizens of Europe, and all workers, the assurance that harmful substances will be removed from circulation and replaced with safe products. The implementation of a substitution requirement, and not just a recommendation, is non-negotiable. Thus, a harmful substance must not be granted authorisation for placing on the market if an alternative product exists.

In my view, it is in the light of these requirements that we must consider our vote at first reading. The socialists in the Committee on the Internal Market and Consumer Protection for whom I am the shadow rapporteur were satisfied with a compromise fairly similar to the one we have before us today. On the other hand, other members of our group, particularly the French socialists, would have liked a more ambitious compromise.

To conclude, I would like to thank our rapporteur, Mr Sacconi, for the hard work he has put in.


  Chris Davies (ALDE). – Mr President, there have been two early casualties of REACH, the first of which is truth. Too many in the chemicals industry, and particularly its German lobbying arm, seem to believe that if you are going to tell a lie, then lie big; the costs of REACH have been grossly exaggerated from beginning to end. The second casualty has been the Commission’s claim to be neutral in its support both for economic developments and for environmental protection at one and the same time.

After Commissioner Verheugen’s quite disgraceful attempts even to undermine the position taken by the British Presidency, we are entitled to believe that the balance in the Commission is now firmly anti-environment. A word of praise from our political opponents for the British Presidency: it has done well to secure an agreement between the 25 Member States without sacrificing nearly as many of the original objectives as some of us feared. I hope it secures a common position before the end of December and I hope that this Parliament votes on Thursday in a way that will bring it close to the Presidency’s position. However, we cannot yet be certain. There are still Members here who reject the very idea that industry should bear the burden of proving that the chemicals it puts on the market are safe.

There are still Members here who would strip away the testing requirements almost completely: ‘Trust us, they are chemical companies’ is their argument. There are Members here who still believe that chemicals of high concern should continue to be sold even when safer substitutes are readily available.

Mr Sacconi and Mrs Ek have negotiated compromises that will meet the genuine concerns of industry while still setting high standards of environmental protection. However, we have yet to see if they command majority support.

There is one matter that has hardly been considered: we are leaving a host of issues here to the new Chemicals Agency, but we have no idea what criteria it will adopt or whether it will be lax or rigorous in its interpretation. So, if you think the lobbying over the past year or more has been intense, wait until the industry starts trying to stuff the Agency with its own people. We will have to watch that process like hawks.


  Caroline Lucas (Verts/ALE). – Mr President, many in my group have highlighted the enormous weaknesses in the Sacconi-Nassauer compromise in terms of health and the environment and of course I agree with them. However, I want to focus on the additional weaknesses of that compromise from an animal welfare perspective. Concerning data sharing, for example, the compromise provides far too many loopholes. While groups of companies would be permitted to bring forward a single registration, separate registrations would still be allowed, making it much more likely that repeat animal tests will take place.

The proposal would allow data over ten years old to be freely shared, reducing if not eliminating the possibility that repeat tests would take place. The compromise, by contrast, only allows data over 15 years old to be shared, again increasing the likelihood that repeat tests would be undertaken. This is completely unacceptable since, as well as being extremely cruel, animal testing is crude and inefficient. The problems of extrapolating test results from animals to people and from laboratory doses to real life are now well documented. Just last week an article in the scientific journal Nature described regulatory animal testing as being ‘stuck in a timewarp, largely based on wasteful and poorly predictive animal experiments’. That is why I tabled amendments to Annexes V to VIII of REACH. Many of these were adopted in the Committee on the Environment, Public Health and Food Safety, a move that has already helped to increase the pressure on the Commission and industry to push for further work on non-animal tests.

However, if we are to seek a better approach we must not let this opportunity to force greater scrutiny of animal tests to pass us by. We must challenge conventional assumptions about animal test methods and scrutinise test methods with as much rigour as we scrutinise other aspects of this proposed new chemicals policy, because exposing animal tests to scrutiny will prompt the kind of debate we cannot afford to ignore. If we ignore it, then REACH and all future chemicals regulation will be tied to test methods that deserve only to be consigned to history.

Lord Bach said that the vote on REACH is a once-in-a-lifetime opportunity. I agree and that is why it is so important we get it right.


  Dimitrios Papadimoulis (GUE/NGL).(EL) Mr President, the history of REACH is a history of constant weakening of the Commission's initial proposal and every time the Commission comes along and celebrates a different proposal from the initial proposal it submitted.

A month ago, the Committee on the Environment, Public Health and Food Safety voted by a very large majority for a strong REACH, worthy of its name. Today, under pressure from the chemical industry lobby – which no one here can pretend they know nothing about – and certain Member States, led by Germany, we have before us a poor compromise by the Group of the European People's Party (Christian Democrats) and European Democrats, the Socialist Group in the European Parliament and the Group of the Alliance of Liberals and Democrats for Europe, a compromise which, with a gun to Mr Sacconi's head, weakens the proposal by the Committee on the Environment.

With this negative agreement, not only is the protection of public health and the environment not being put first; on the contrary, it is being subjugated to the demands of a poor perception of competitiveness.

We in the Confederal Group of the European United Left/Nordic Green Left do not intend to vote for this poor agreement.


  Urszula Krupa (IND/DEM).   (PL) Mr President, we believe that the House should reject this draft. Even the abbreviation by which it is known makes it sound as if it has come about purely for the benefit of the rich. After giving much thought to the matter, these latter have thought up a procedure that is authoritarian and centralist in its very concept. It goes without saying that they have packaged it as a noble attempt to protect health and the environment, yet it will mean bankruptcy for small and medium-sized enterprises, and cannot fail to deprive hundreds of thousands of people of their jobs.

Few will benefit from the market being taken over by large chemical companies. Furthermore, any hypothetical health benefits from environmental improvements, which themselves are pure theory at present, would be vanishingly small compared to the health problems suffered by those who have been left unemployed. These people would be frustrated by the loss of their livelihood, their means of existence, their opportunities for development and their hope. More information and a supposed increase in consumer confidence in products are not worth having if the cost in economic and social terms is so large.

Proof of this cunning scheme to ruin the weaker members of society can be seen in the fact that chemical companies have pre-empted the proposal for a directive by carrying out the recommended tests on toxic substances, without any consensus having been reached on whether their findings should be shared. Tests should be performed centrally on the most toxic substances in order to obtain reliable data, and these substances should be withdrawn from the market, in particular if they are carcinogenic or harmful to the reproductive system or other systems.

We support the international campaign ‘Objection!’, which has been launched in protest at the costs that will be incurred for no good reason due to REACH. A proposal that is genuinely aimed at protecting human health and the environment should be drafted to replace the current proposal, which is primarily concerned with business-related factors. Another question I should like to ask is how anyone with a clear conscience can be in favour of a proposal for a directive to which only somewhat over 1 000 amendments have now been tabled, out of a former total of 2 000 or 3 000. On top of that, establishing which amendments have gained the approval of the House during the course of the debate is physically and mentally impossible.


  Alessandro Foglietta (UEN). – (IT) Mr President, ladies and gentlemen, I should like to take my cue from Mr Sacconi’s reflections: he spent last Sunday thinking over this measure, which is certainly a compromise but which also entails considerable responsibility.

In my view, however, Mr Sacconi has made some fundamental mistakes, especially in terms of relations with others. Thus to reach a compromise he should have shared his reflections with the Committee on the Environment, Public Health and Food Safety: otherwise his position is a purely personal one, not one shared by the committee. That is why, Mr Sacconi, I think you have taken the wrong route in deciding not to seek a solution of the most general application possible.

In this connection I should like to make some observations concerning the OSOR (one substance, one registration) system. I think that we ought to try to find a solution that separates the OSOR system from the REACH package, because as things stand, as has been emphasised several times, small and medium-sized enterprises are not protected.

It would furthermore be useful to speak about tonnage in cases where costs become too high. I nevertheless believe that in the case of hazardous products, the costs of tonnage should be duly taken into account without ever losing sight of the danger aspect. Moreover, I do not agree with the decision to split the list of products into two parts, since this would discriminate against some hazardous products and some firms.


  Ashley Mote (NI). – Mr President, once again we are faced with legislation designed for one purpose but dressed up as something else. Who could argue with the need for control of the use of chemicals and the protection of public safety? Registration – maybe; evaluation by scientists – of course; but authorisation by officials in a chemicals agency? A nightmare!

REACH is not about the control of chemicals; it is about bureaucrats responding to the multinationals, both sides of an unspoken agreement happy to exploit the insatiable desire for yet more social engineering and centralised control. REACH has been sold to a naive public as a panacea for a better world, ‘switch selling’, I suggest, of the shoddiest kind.

If REACH passes, even as it stands, with the compromise, any small enterprise with a new idea or a product that might really make this world a better place is likely to find the price of entry into the marketplace impossibly high. The law of unintended political consequences already says that the effect of REACH will be to export jobs. Enterprise in this sector will be stifled in the European Union and will emerge in other countries that are not hamstrung by crushing legislation. That will be the effect and it is the antithesis of what is needed.


  Alejo Vidal-Quadras Roca (PPE-DE). – (ES) Mr President, the day after tomorrow the European Parliament will vote on the REACH Regulation, following two long years of legislative procedure.

From the moment when we got to work until today, all the Members involved have spent vast numbers of hours in order to achieve a result that, with the greatest possible consensus within this House and with the other institutions, adequately protects consumer health and improves the quality of the environment, all without jeopardising the competitiveness of our industry.

I must admit that, at the outset, such a result seemed very difficult to achieve, but I am pleased to note that, a few hours before the vote, the positions of the main political groups are relatively close.

The compromise on registration, signed by the Socialist Group, by our group and by the Liberals, demonstrates that the European Parliament can be a match for the circumstances and take responsible decisions with regard to our citizens and our industry. Because, at the end of the day, that is what we are talking about: sending a message of confidence to the citizens, demonstrating that their welfare is a priority for the Union’s institutions.

It is also our duty to legislate to promote the competitiveness of our industry, in accordance with the commitment we made in Lisbon and as we repeated a few months ago.

Mr President, many Members here today, representing various political groups, have jointly presented amendments which we believe to be essential in order to ensure that REACH is an example of how European legislation can be coherent, take responsibility for the health of the citizens and promote innovation and competitiveness at the same time.

I hope that the great majority of this House supports them.


  Erika Mann (PSE). – (DE) Mr President, I can certainly endorse what Mr Vidal-Quadras Roca has said. In the Committee on Industry, External Trade, Research and Energy, we devoted ourselves to hammering out compromises, and it is evident to us from looking at the compromise package negotiated by Mr Sacconi and Mr Nassauer that they and we have in fact been thinking along similar lines. By that I mean that, on the one hand, we wanted to do everything possible to manage a proper energy policy, to develop it and to maintain competitiveness, while, on the other hand, not forgetting the second pillar, with its protection for health, the environment and people at work. The two are directly connected. I believe that these things are present in the compromise, but they are all becoming difficult, and we shall see how our negotiations proceed tomorrow, for we have another day to go before we vote.

While we do, indeed, have a compromise package, it covers only registration, and we shall have to see what we can achieve in the other areas, with everything from authorisation to the issues about how to handle data protection and many other aspects. The Council Presidency has made suggestions. I would be happy if these negotiations could bring us, before the end of the year, to a proper compromise both here and in the Council, so that the topic does not end up being shelved.

I would also advise all those Members who have made comments about Germany today to stop and consider for a moment the fact that there is a connection between the pursuit of a proper national energy policy in a particular Member State – which, I would add, applies in the case of the Nordic countries – and the sort of proper energy policy that we are constructing in Europe, and it can be summed up in the word ‘competitiveness’. Germany is the third-greatest chemicals producer in the world – behind the USA and Japan, but ahead of France, China and Italy; within the European Union, it accounts for over 25% of the turnover from chemical products and for one in every four jobs in the chemicals sector. These are figures of which you simply have to take note, for they are important, not only for Germany, but also for the European Union, when it comes to maintaining jobs.

In 2004 alone, EUR 7.7 billion were invested in research. We are always talking expansively about how much we want research and how we want businesses to invest in it – so let us go ahead and support it! Let me just give you one, final, figure, on the size of chemicals businesses in Europe: 92.5% of them are small or medium-sized. That is another statistic of which we should take note.


  Alexander Lambsdorff (ALDE).(DE) Mr President, when we come to vote on REACH, we do so at the end of a debate that has lasted almost two years and was, at its outset, conducted along strongly ideological lines. I say that with reference not only to the previous Environment Commissioner’s inglorious sensationalism, but also to some of the views emanating from the Greens today. They need to be told, gently, that there is more to politics than the Committee on the Environment, Public Health and Food Safety, that there is more to Parliament than the Group of the Greens/European Free Alliance, and that there is more to the European Union than Scandinavia.

I would like to say that I agree with Mrs Mann in so far as we, in this House, are working in Europe’s interest. I assume that that is what my fellow Members from other countries are doing and would claim that for myself. It has to be said, though, that ideology was initially introduced into the debate by the business world as much as by anyone else, for there were many in it who felt obliged to prophesy that REACH would be industry’s downfall, exaggerated though that certainly was. The debate has since become more rational, and it was indeed necessary that it should. In particular, I would like to thank Mr Nassauer and Mr Sacconi for having managed this difficult dossier really well.

It must be abundantly clear to us that most small and medium-sized businesses, in particular those at the end of the production chain, will be significantly overstretched if the legal requirements are not simplified, if they get no outside support – which will be expensive, if the means of implementation are not practicable, and if the Commission draft remains in its original form. That is why we support ‘Objection!’, a European alliance of SMEs, which has taken an active part in the debate and demonstrated in practical terms what REACH will really mean at grass-roots level.

Even now, the legislation we pump out of Brussels has become so complex that it is often beyond the capacity of SMEs to handle it. It follows, then, that if we do not succeed, in the course of implementing REACH, in making the information and assessment processes less complex, the existing transposition deficit will become all the greater, and that really is not in the interests of anyone in this House.

In moving over to an approach to registration that focuses more on risk, the compromise proposal accomplishes a necessary paradigm shift, and rightly too, for that is where the crucial weakness is to be found in the Commission’s draft. The fact is that this would give cause to fear that requiring data without reference to risk would result in substances being lost to the market solely for reasons of cost. Were that to happen, REACH would not only have failed to achieve an essential objective, but would also have weakened European industry’s capacity for innovation. So let us get serious, let us have better regulation, let us be discerning in adopting REACH. I might add that I believe that we should be conducting this debate in Brussels rather than in Strasbourg.


  Hiltrud Breyer (Verts/ALE). – (DE) Mr President, the draft REACH regulation would lose its bite if it were watered down in any way, shape or form. The misguided compromise hammered out between Mr Schulz and Mr Poettering is nothing less than a wish come true for the German chemical industry. Industry would win the day, while the environment and consumer protection would lose out. The compromise would be the final nail in the coffin for this reform of chemicals policy.

We need a hard-hitting REACH and the equivalent of an MOT for chemicals, and we must not consent to companies being rewarded for their failure to provide information or for their lack of transparency. Surely it cannot be right that of the 30 000 substances that the regulation was originally intended to cover, only 12 000 are left. This would represent a complete abandonment of the fundamental principle underpinning REACH, namely that no substance may be marketed unless safety data is available.

One of the mainstays of REACH is the reversal of the burden of proof, yet there are those in this House who even want to do away with this idea. I would call on Members to free themselves from the clutches of the German chemical industry, and to avoid setting yet another precedent that would mean that we would be treated in future as a carbon copy of the grand coalition in Berlin.

Without a hard-hitting REACH, people will become guinea pigs for untested chemicals, and the principle of flying blind, guided only by ignorance, would be enshrined in law. Without REACH, the risk of cancer and the incidence of environmental illnesses will increase. I would therefore call on you to voice your support for a hard-hitting REACH. Industry must not be left to decide for itself what data it does and does not provide. It is a curious fact that all those Members of the House who have claimed to be acting out of concern for small and medium-sized enterprises have tabled amendments that would make matters worse for these latter.

(The President cut off the speaker)


  Jiří Maštálka (GUE/NGL).   (CS) As a member of the Committee on the Environment, Public Health and Food Safety, and in particular as a doctor, I should like to voice my support for a hard-hitting version of the new REACH regulation on chemical substances. During my time as a doctor, I have seen many cases of illness caused by chemical substances, and I am well aware of the fact that such substances have become so widespread that they are to be found in our children as well as in cleaning products. A great many of them also still need to be tested in order to ascertain the effect they may have in the future on humans or on the environment.

In my opinion, the amendment seeking to ensure that industry would not have to provide information on small-volume substances undermines the very essence of REACH. As rapporteur on the Framework Directive on Health and Safety at Work (89/391/EEC), I believe we must adopt a hard-hitting version of REACH if we are to implement this Directive in practice. I am quite sure that we will not improve people’s health by means of a REACH that has lost its bite.


  Hélène Goudin (IND/DEM). – (SV) Mr President, it is regrettable that powerful forces in this Parliament are working hard to ensure that chemicals legislation is as watered down as possible. REACH is a cross-border issue affecting both the environment and the internal market. EU measures are thus justified. I believe that the requirements to provide information about chemical substances in lower volumes must be strengthened. If that is not done, much of the point of REACH will be lost. I also support a strong substitution principle. Sweden has already introduced this, and to a large degree it is operating well.

I believe that consumers should be entitled to information about the chemicals present in goods. That is a precondition of consumers being able to make active and informed choices. It is also important for us to make it clear that it is industry, and not the authorities, that must be responsible for evaluating the registered chemicals and assessing the risks they may present. There is no contradiction between a REACH couched in strong terms and an efficient market. Taking a lead on this issue will mean a competitive advantage in the long term. Hence, I shall vote against the compromise proposal devised by the Socialist Group in the European Parliament, the Group of the European People’s Party (Christian Democrats) and European Democrats and the Group of the Alliance of Liberals and Democrats for Europe.




  Mogens N.J. Camre (UEN). – (DA) Mr President, it is unacceptable that, in our relatively enlightened times, we permit a huge number of chemical substances in our environment, without having registered them and without being aware of their harmful effects. It is unacceptable that we have no clear rules for replacing dangerous substances with less dangerous ones. We are in a situation in which this Parliament is divided, and the whole complicated proposal constituted by REACH could collapse into nothing. I belong to a party that would like to have seen action taken on the basis of the Committee on the Environment, Public Health and Food Safety’s position, as it stood before the compromises that have now been entered into. We must note with regret that there is no majority in favour of the original proposal by the Committee on the Environment. Negotiations regarding a compromise have, however, been conducted in a truly democratic way. I do not believe that REACH is the last piece of legislation we shall adopt in this area because we are always acquiring new knowledge about the need to protect our planet’s environment. The proposal now acceptable to Parliament’s large groups represents clear progress, however, and is far better than the present lack of clear legislation. I am therefore able to support the compromise proposal.


  Jan Tadeusz Masiel (NI).   (PL) Mr President, the debate that has been held so far on REACH, both within the House and outside it, has revealed that Europe is not yet ready to adopt this directive in its present hard-hitting form.

We would all like to lead healthier and safer lives in greater harmony with nature, but financial realities and common sense should not be left out of the equation. At the same time, however, we do not want to turn down this opportunity to improve the situation for Europeans in legislative terms. Fortunately, the rapporteur has drafted a compromise proposal, which reconciles the interests of small, medium-sized and large enterprises, as well as those of consumers and workers who care about the environment. I will vote in favour of it for the sake of future generations, although it will mean financial losses for my country.

Europe needs common regulations that are observed both by its Member States and by its foreign partners.


  John Bowis (PPE-DE). – Mr President, I should like to thank the rapporteur. Sir Tom Blundell, Chairman of the Royal Commission on Environmental Pollution, said that, given our understanding of the way chemicals interact with the environment, you could say we are running a gigantic experiment with humans and other living things as the subject. That was the reason for bringing forward this proposal. However, he said that if we followed the initial proposal, this huge backlog would take 50 years and see some 6 million animals destroyed.

Therefore, the key is to get prioritisation, to make the system workable, to protect health, to reduce the number of animal tests and to achieve it all in ten years. We are embarking on this because most chemicals are safe and we depend on them, but some must be handled with care, some are so dangerous that we need to find safe alternatives.

However, we do not know which is which. Since 1981 we have regulated new chemicals, but that covers only some 3 000 substances out of the 100 000 in existence and it has taken 40 different regulations and directives to do that. Hence we want to make it simpler: we want a single regulation, more understandable ways of establishing which substances are among the estimated 20% that will need proper assessment and authorisation. Industry needs certainty and clarity. So, with our compromises and our amendments, we go for prioritisation, pre-registration, ‘one substance, one registration’, data sharing, a balance between volume and risk, special account of the needs of small firms without sacrificing public safety, and mandatory data sharing to reduce and phase out animal testing.

We also need to ensure that our European industries are not disadvantaged, so we must go as far as we can to ensure that substances in articles imported to Europe are covered by the same rules as those produced here, without infringing WTO rules. We must also take account of the very real worries among developing countries, especially on the issue of minerals and mining, and ensure that we do not damage their fragile economies.


  Mary Honeyball (PSE). – Mr President, very seldom in the history of this Parliament has there been such a high level of interest in our legislative work. Quite rightly so, because this legislation, along with the other points mentioned in this debate, provides us with a tremendous opportunity to lead the world in the regulation and authorisations of chemicals, and to influence what goes on not only within the European Union, but also beyond our borders with other chemical producers across the world. This is something that we need to take seriously because we really can have an impact. That is why it is so important to support the Sacconi-Nassauer compromise and ensure the passage of this legislation through Parliament, so that we can improve human health and the environment across the world, while at the same time maintaining our own industrial competitiveness.


  Patrizia Toia (ALDE). – (IT) Mr President, ladies and gentlemen, when one is faced with a measure as wide-ranging as this one it is important to establish the right balance between on the one hand the overriding necessity to protect the health of citizens, workers and consumers and on the other hand the need to sustain the importance of the European chemicals industry in the economy and the labour market. This industry is represented not only by the large enterprises of some countries but also by the small, sometimes very small, and medium-sized enterprises of countries such as my own, Italy.

That is why I believe that the work towards achieving convergence and narrowing the gap between positions that were originally far apart, work that has consisted of compromises, can be considered in a positive light since it takes on board all the many reasons and realities in question.

In my view the important points are the need to protect people’s health; information for consumers; support for small and medium-sized enterprises while REACH is being put into effect, inter alia by means of support for research; the creation of a powerful agency with genuine powers; the streamlining of procedures for small and medium-sized enterprises; and, finally, the importance of the OSOR (one substance, one registration) programme. Not too many exceptions should be provided for, since I consider that data sharing and the apportioning of costs constitute important elements for our small and medium-sized enterprises.

Finally, I believe that there should be specific and definite rules for imported products, since the rules for these products should be the same as those applied to European products.


  Marie Anne Isler Béguin (Verts/ALE). – (FR) Mr President, we have made a great deal of progress since the launch of the REACH project. We have discovered that we were using more than 100 000 chemical compounds without knowing what effects they have. We have understood that our fellow citizens have been made ill by toxic substances that contribute to our jobs, our comfort and our happiness. About 20 years ago, when toxicological studies first showed that polar bears were contaminated with dioxins, we were shocked and indignant, but, of course, we were not going to stop progress just because of a few polar bears!

Today, the medical profession is certain: it is humans, all over the planet, who are intoxicated. Recent studies have shown that we women, as mothers, are passing a toxic heritage on to our children through the umbilical cord. It is the future of the human race that is in danger, whatever some of my fellow Members here today may say. This is a matter of urgency, if we do not want to be responsible for a health disaster attributable to chemicals.

The initial REACH project allowed us to meet this challenge. Unfortunately, the blackmail of delocalisation and pressure from industry have poisoned our debates and misrepresented the ambitions of REACH. The rapporteurs’ compromise is an illusion, an imbalance between health and competition, because health is worth much more than high-pressure bargaining, and neither the Commission nor the Council has put a figure on the health costs of a weakened REACH.


  Roberto Musacchio (GUE/NGL). – (IT) Mr President, ladies and gentlemen, the forces opposing REACH demonstrate a sheer obstinacy that can be defined as anti-European. They are the forces of the uncontrolled market, of deregulation and of profits that speculate with public health and the environment. All these forces represent negative values that go against the underlying principles of a Europe harmonised in respect of social and environmental issues.

Frankly, we do not have a high regard for Mr Barroso’s conduct. We think that a firm and decisive response to these forces is called for. For this reason we did not share, and we strongly criticise, the bad compromises that have been reached: they run the risk of gravely weakening REACH, without even resisting the forces that would like to kill it off.

We are therefore – with the consent, in my view, of the vast majority who at this time are trying to ensure that this Parliament passes the best laws possible – retabling all the texts that are necessary for a strong REACH regulation, that is to say one that will be of genuine service to a modern Europe.


  Godfrey Bloom (IND/DEM). – Mr President, buried deep in the committee opinions attached to the Sacconi report we find a slim contribution from the Committee on Budgets showing funding forecasts for the proposed European Chemicals Agency. Those forecasts appear as an admirably clear table covering the years 2006 to 2016 and allowing for EUR 78 million of taxpayers’ money over this period to support the Agency. Curiously, this amount is spread very unevenly over the ten years in question with most of it, more than EUR 50 million, concentrated in 2014 and 2015. Even curiouser, no one on the Budgets Committee, including the chairman, seems to know anything about these figures, even though they appear in the Budgets Committee’s opinion. Why is this? And why is the Agency expected to use two-thirds of its ten-year budget in only two years of the next decade?


  Lydia Schenardi (NI). – (FR) Mr President, in view of the European Parliament’s first reading of the draft regulation concerning the registration, evaluation, authorisation and restriction of chemicals, and whilst we approve of the role to be played by the European Agency, we must take a cautious position, because this text, even with all the amendments made to it, is full of holes and is far from being a success.

In addition, it does not seem to strike the desired balance between the three fundamental principles: protection of health and the environment, the competitiveness of business, innovation and substitution. This lack of precision results from the cost distortions that such a regulation would cause, which apparently range from EUR 3 to 180 billion, and from the benefits, which are estimated to amount to between EUR 5 and 230 billion. This disparity in the costs announced by the Commission, just like the costs put forward by the industry, is enormous. However, we must not forget that these costs will be borne solely by the industry, that this directive affects 5 million jobs and that it will have serious consequences. That is why we will not allow ourselves to be influenced by purely political statements and why we will assess the various amendments put forward on a case-by-case basis.


  Cristina Gutiérrez-Cortines (PPE-DE). – (ES) Mr President, I would like to thank Mr Sacconi, the coordinators and the rapporteurs for the immense efforts they have made, but also the whole of the technical team and the officials, all of whom have allowed us to reach an agreement on such a complex issue. This is a sign that politics works and that this Parliament works when it comes to a truly important task.

We are dealing with a complex document, not just because it encompasses a huge number of policies, but because, furthermore — and this is what I am going to argue here — it is an open document. I believe that the issue is being dealt with as if the whole policy of chemical products ended with REACH; nevertheless, the policy on chemical products, if it is intended to promote the health and wellbeing of the citizens, must complement other Union policies and other policies of the countries and, therefore, we cannot take the view that everything begins and ends with REACH. And I believe that it will be the ideal instrument for producing consensus policies.

What are the advantages of REACH? I believe that it has created the basis for a common European policy in the chemical field and has been a victory for coordination and common policy in the field.

Secondly, it has created an Agency which is being given authority, competences, responsibility and the capacity to coordinate, which I believe is an extraordinary victory for the citizens.

Thirdly, REACH is entirely founded upon the recognition of science and the value of science and of studies, which guarantees objectivity for the future and also opens the doors to information for citizens and companies. I believe that that is the other important point we have to be pleased about.

Furthermore — and I would like to end here — I believe that it is absurd to believe that the responsibility for the health policy must fall entirely to companies; companies are being blamed for everything that happens in the world of health and chemical products. I believe that, in this case, they are being given greater responsibility than before and they are being obliged to carry out studies, but the health policy with regard to new chemical products can only be implemented if we combine good research by the States and good health research and if the Agency emerges, with a group of experts, as a receptacle for the information which has to be communicated to the industries.


  Edit Herczog (PSE). – (HU) Mr President, I see that we are all striving to create an effective, workable and successful system to improve the safety of chemical substances. To achieve this, it is crucial to ensure rapid implementation of pre-registration. This will enable the European Chemicals Agency to alert all manufacturers, importers and consumers at once if any new knowledge emerges regarding a substance.

At the same time, however, we must not allow the draft REACH directive to engender discrimination between manufactured and naturally occurring substances, between particular geographical areas, or between Member States – here I am thinking of the new Member States, where industry is less capital-rich – or between large and small enterprises.

REACH affects industry throughout the whole of Europe; in other words, we are talking about several million jobs. The statistical evidence confirms that one of the biggest dangers to human health and longevity is unemployment. The only kind of legislation that we can accept is one that creates at least as many new jobs as it might eliminate. Innovation, research and development are important for the discovery and economically efficient production of better quality substances. When tabling our proposed amendments, we in the Committee on Industry, Research and Energy were guided by a concern for protecting the environment, protecting health and safeguarding jobs. I call upon you to support these amendments. Lastly, if you will permit, I would like to give Guido Sacconi a much nicer – and much healthier – apple from my own garden!


  Anne Laperrouze (ALDE). – (FR) Mr President, like most of the speakers before me, I very much welcome REACH, which should guarantee that the substances we use in daily life do not present risks to human health and the environment. The authorisation of a harmful substance must, in my view, be an essential stage in the regulation. How is the product used? How can it be identified? How can we prevent its use by an unsuspecting public? How, too, can we draw up a study plan with a view to the substitution of a dangerous substance?

REACH must also extend knowledge on chemicals by forming a European database and stimulate innovation by encouraging the substitution of substances of concern. REACH will be a good regulation if, based on the knowledge and expertise of the chemical industries, it gives rise to new technologies, new substances and new businesses. We will have succeeded if we adopt a proportionate, simple, effective system that is practicable for business. We will have succeeded if, on Thursday, we adopt a balanced text that enables businesses to retain their leading position at a global level and that protects the health of people and the environment.


  Karl-Heinz Florenz (PPE-DE). – (DE) Mr President, Commissioner, I should like to extend my sincere thanks to Mr Sacconi for his excellent work, even if it may well be the case that our opinions on the issue did not always coincide. At the same time, I should also like to thank Mrs Ek and Mr Nassauer for having drafted key opinions on behalf of other committees consulted.

If I may, I should like to comment briefly on the significance of REACH. I have had the pleasure of being a Member of this House for 17 years, and I believe that this is one of the largest and most significant reports that we have ever debated in this Chamber. This report will also have far-reaching implications for health – or at least we hope it will – and for industry. For once there is a point upon which Commissioner Verheugen and I do not see eye to eye, and I am glad that he is present in the Chamber again. The new Commission’s work on this dossier has been first-rate, but little information and few explanations were provided when this 1 200-page report was first put before the House. This meant that a very watered down and bleak version of the debate was presented over the following months by the other parties involved beyond the confines of this House. I am delighted that we are now well on the way to reconciling REACH’s two priorities, namely consumer protection and industrial policy, since this will ensure that the legislation is genuinely forward-looking and groundbreaking. It will be hard to ignore the implications of 1 200 pages.

I am delighted that we have managed to incorporate the concept of exposure to chemicals into the report, at least up to a limit of 100 tonnes. This is exactly the approach I believe should be adopted to draw attention to an issue that lies close to my heart, namely the testing of chemicals in tobacco and cigarettes. The issue at stake here is neither tobacco nor a ban on smoking; instead, I am calling for nothing other than for tests to be carried out on the hand-mixed chemicals in cigarettes and cigarette papers. We fear that these substances could be mutagenic, carcinogenic and addictive.

This issue is one of great concern to me, and I would urge the Members of the House to lend it their support. I should like to thank the rapporteur and draftsmen once again.


  Manuel Medina Ortega (PSE). – (ES) Mr President, I would like firstly to thank Guido Sacconi for the work he has done on such a complicated subject. I believe that Parliament has done good work, because REACH is an important regulation.

It should be noted that for many people it is bad that there is a chemical industry, but, if we think about it, in those countries in which there is no chemical industry, the average lifespan is approximately a half or a third that of the developed countries. I therefore believe that we should implement legislation which, on the one hand, guarantees quality of life and quality of products, but which, at the same time, makes it possible for this chemical industry from which we live and on which pharmaceutical progress depends to continue operating.

I believe it is a question of balance and that Guido Sacconi and the rapporteurs of the different committees have examined the different elements and I believe that next Thursday we will be in a position, here in this Parliament, to vote on a text that has the full support of all sectors of Parliament.


  Frédérique Ries (ALDE). – (FR) Mr President, in exactly two days’ time, Parliament will have a golden opportunity to reconcile Europeans with Europe by adopting this ambitious REACH directive, which really will protect our health and our environment. The choice is therefore simple: either we turn our backs on the concerns of the citizens by giving in to the wails of a certain industry or by voting in a traditional left-right split that is completely obsolete here, or the European Parliament transforms the draft produced by its Committee on the Environment, Public Health and Food Safety into a strong REACH project able to carry the hopes of the citizens and of the many innovators in the industry who have placed their bets on clean chemistry.

We therefore need an ambitious REACH, which will make it possible to stem the increase in the incidence of cancer and other diseases, as two million doctors in Europe are demanding, and which will also protect the millions of workers exposed every day. With an extra-small registration system and an extra-large opt-out from the OSOR, in other words with the maximum opportunities to evade a system of ‘one substance – one registration’, how can you talk today, Mr Sacconi, Mr Verheugen, about an ambitious compromise? Myself, I call that a defeat. I hope that, on Thursday, our Parliament will take the modern risk of combining health and sustainable employment instead of futilely continuing to set them up in opposition to each other.

I will conclude, if I may, Mr President, with a brief, friendly response to Mr Goebbels: I, as a liberal, do not feel particularly ‘green’ for making this choice, which is neither left-wing nor right-wing, but is a bet on the future.


  Antonios Trakatellis (PPE-DE).(EL) Mr President, Commissioner, the science of chemistry and the chemical compounds produced by this science have helped man in his life to resolve problems; that is a fact, just as it is a fact that today we have thousands of compounds and products which circulate and many of these compounds are dangerous and may cause damage to the environment and to health.

Consequently, the time has come for us to apply a policy in this sector and this policy is expressed in the REACH regulation. Similarly, this regulation gives us an opportunity to test in practice and to be tested on a series of questions of concern to the Union and its citizens. I refer to the questions of environmental protection and public health and to the need to adapt to the new circumstances being created with the introduction not only of quantitative but also of qualitative criteria, such as the dangers inherent in chemical compounds.

This regulation must also regulate matters relating to environmental protection and public health while, at the same time, allowing the European chemical industry to adapt during the planned transitional stage.

Basically, therefore, with this regulation we can have a tangible example of application in practice of the model of sustainable development, which supports and is supported by a harmonious combination of the three pillars which are, I would remind you, protection of the environment and public health, economic development, social cohesion and increased employment. I repeat, 'we can have a tangible example of application' mainly by expressing the expectation that the European chemical industry will respond in the way it knows best – in other words with innovation – so that not only will it adapt but also it will strengthen both its competitiveness and jobs.

Innovation, by which I mean the composition of new compounds which are friendly to the environment and to health, is the key to achieving the harmonious updating of the three pillars of sustainable development.

To close, I should emphasise that I have confidence in and I am relying on the codecision procedure in order to bring together all the aspects of this complex issue, so that we can achieve the best possible regulation.


  Dorette Corbey (PSE). – (NL) Mr President, I should first of all like to express my warm appreciation and thanks to Mr Sacconi who has, I think, done an excellent job. The REACH proposal means that 30 000 substances must be tested. As such, it is a source of innovation, but also of simplification. Since 40 directives will be withdrawn when REACH enters into effect, it will benefit both the environment and innovation.

There are many fine amendments to make REACH more workable and less expensive, and to restrict the number of animal tests, but there are, unfortunately, still quite a few companies that are opposed to innovation and prefer to wallow in the unknown and do not feel like searching for safer and cleaner alternatives. Quite frankly, I think it is rather disappointing that they receive a good deal of political support. We all took up the challenge of Lisbon. Innovation is at the heart of European industry’s strong competitive position. Without continuing innovation to make products cleaner, safer and healthier, the European industry will end up losing out to China, India and the United States.

The Dutch Social Democrats cannot back the compromise that is now before us. It represents a huge setback, if instead of 30 000 substances, only 8 000 are subjected to the full test regime of REACH, for then the uncertainty among consumers will remain, and the risk of allergies, cancer, and illnesses contracted at work will be perpetuated unnecessarily and potentially toxic substances will remain in the environment. Last but not least, with this, an incentive for continuing innovation in European industry is also being thrown overboard.


  Holger Krahmer (ALDE). – (DE) Mr President, one of the key elements of this regulation is data requirements for registration. A very satisfactory compromise has been put before the House on this issue, and it has gained the support of the three main groups in Parliament.

In this context, and addressing my comments in particular to the Group of the Greens/European Free Alliance, I should like to reiterate the point that a compromise backed by such a large parliamentary majority is an entirely normal democratic procedure. Accusations that this House has been hypnotised by the chemical industry are insulting, and we should voice our protest at them.

The Group of the Alliance of Liberals and Democrats for Europe has always championed a workable version of REACH. Our key demand is a system that cuts costs significantly for businesses, especially small businesses, and avoids unnecessary red tape, without sacrificing the goals of environmental and consumer protection. As recently as one year ago, our position was branded industry-oriented; it is now the consensus view. It involves the introduction of exposure categories, a significant relaxation of the rules for low-tonnage substances and the granting of derogations for research and OSOR.

At the same time, however, the other key element of REACH, namely the authorisation of chemicals, must not fall prey to a political success story where registration is concerned. The point is that REACH does not only affect the chemical industry, and I say this particularly for Mr Nassauer’s benefit, since this is something he is wont to stress most emphatically. Instead, it affects all sectors that process chemical substances.

The Group of the Alliance of Liberals and Democrats for Europe has retabled the proposal of the Committee on Industry, Research and Energy concerning authorisation, since it is eminently sensible. Businesses need clear criteria in order to comply with legislation and plan ahead. Hazardous substances should only be replaced if scientific evidence indicates that safe alternatives exist. Furthermore, a flexible approach must be taken to the temporary authorisation of chemicals, with due consideration for sector-specific product cycles.


   Amalia Sartori (PPE-DE). – (IT) Mr President, ladies and gentlemen, the proposal that we are discussing today numbers the protection of human health and the environment among its main objectives.

Nevertheless it has also set itself the objective of maintaining and reinforcing the competitiveness of the European Union’s chemicals industry and of increasing transparency in the interests of consumers. This being so, we must emphasis the impact that this new regulation will have on small and medium-sized enterprises in the Member States, which more than most other concerns will be overburdened with the new administrative and bureaucratic costs arising from it.

What I have said should be linked to the economic role played by small and medium-sized enterprises in the chemicals industry. Ninety-six per cent of the 22 000 chemical firms in Europe are SMEs, which contribute 28% of total production. It is therefore necessary to reflect on the negative impact of production costs, which will turn out to be more onerous for SMEs. We should also reflect on the loss of competitiveness within and outside the common market owing to the greater cost of the finished products.

In the light of what I have said, I attach great importance to the application of the principle of OSOR (one substance, one registration) and the possibility of forming consortia of enterprises to enable cost reduction and fewer superfluous experiments; but at the same time I am suspicious about the numerous opting-out possibilities foreseen in the compromise proposal on registration, which seem to me to negate the principle itself.

Secondly, I consider it essential for the implementation of the priorities and objectives that REACH is aiming for that all imported products should be subjected to safety regulations that are equivalent to those in force for products manufactured in the European Union.

In this instance I should have liked the European Union, which in environmental matters is often in the forefront of difficult battles – we need only think about climate change and the Kyoto Protocol – to stand up for these requirements and to negotiate with the World Trade Organisation for an extension of these regulations to all countries that produce chemical substances and articles, insisting on the need to apply the principle of traceability of substances. That is why I am against the exemption for products intended for third countries.


  Karin Scheele (PSE). – (DE) Mr President, I should like to extend my warmest thanks to Mr Sacconi for his excellent work. Unfortunately, however, I have to say that I take a rather less optimistic view than him of the compromise on registration we have before us. I should also like to congratulate a large number of Members of this House on their clairvoyant powers, since they have voiced their wholehearted support for a priority list of chemical substances even though there is no way of knowing which chemical substances are hazardous and which are not.

I also find it hard to believe those Members who claim that what matters is the survival of small and medium-sized enterprises. If that is the case, it is hard to understand why some of the amendments and wordings in the compromise work to the disadvantage of these small and medium-sized enterprises. In my opinion, this is a clear-cut case of Members protecting the interests of big business.

I should like to conclude by drawing the House’s attention to a study carried out by the European Trade Union Confederation, which found that 50% of cases of occupational asthma and skin disorders would be prevented by a hard-hitting version of REACH. A Member pointed out earlier that millions of workers were employed in this sector. The same Members should be able to work out for themselves what savings would in that case be made by the state and by all of us.


  Anders Wijkman (PPE-DE). – (SV) Mr President, just like other speakers, I welcome the fact that we are obtaining stricter legislation in this area. It is curious – to put it mildly – that this area has been so relatively free from rules for such a long period. We are aware of the risks presented by chemicals. Each time we have come up against a serious problem, for example PCBs, DDT or CFCs – we have been taken completely by surprise. A very great deal of harm has been caused. We must therefore have a significantly more cautious approach. Companies must obviously accept responsibility both for providing information and for replacing hazardous substances by less hazardous ones, when such exist. I wish to emphasise that the substitution principle has operated well in Sweden for almost 15 years. I believe that this principle needs to form part of the new legislation. I hope that as many colleagues as possible, including in my own group, agree with me on this point.

The debate about REACH has been complicated. It is said that the devil is in the details. In few areas is that more apposite than in this particular one. There are masses of difficult details of which many Members do not have a good grasp, and this has made it that much more difficult to arrive at constructive solutions. The eleventh-hour compromise reached on the subject of registration is not perfect. It deviates in several respects from the line I myself would ideally have chosen. In the light of the requirements and of what the alternative might be – that is to say, a policy in which the main responsibility for gathering information were imposed on the chemicals authority, I must, in spite of everything, take a positive view of the compromise. I repeat that I am not satisfied, but the most important thing of all must, for all that, be for us to obtain a policy in this area that we can work with so that, step by step, we can put some order into the chemicals jungle.

I want finally to congratulate Mr Sacconi, who I think has done some excellent work over a very long period under complex conditions.


  Dan Jørgensen (PSE). – (DA) Mr President, tens of thousands of chemicals surround us in our everyday lives. They are everywhere. They are in our clothes. They are in our cars. They are in the ball-point pen I am holding. They are even in our children’s toys. Unfortunately, we do not know very much about the effects of these substances. We do not know what damaging effects they have on our environment. We do not know what damaging effects they have on our health. With REACH, this is something we now at last have an opportunity to set right. With REACH, we are being given the opportunity to obtain the basic data and to adopt a number of principles, which will be incredibly important.

For me, the most important principle is that of the reverse burden of proof whereby, before industry is given permission to market a substance, we shall in future require it to prove that the substance is safe. It will thus no longer be up to the authorities – as it is today – to prove that a substance is dangerous with a view perhaps to withdrawing it from the market. The second and very important principle whose implementation we need to arrange for is the substitution principle. If there is a substance on the market that is dangerous and another that is not so and is thus a better alternative, it shall be compulsory to exchange the dangerous substance for the less dangerous one.

Finally, I want to say that those who think there is a contradiction between competitiveness and sound, stringent chemicals legislation are mistaken. On the contrary, it is the chemical industry’s only hope for the future that REACH be worded with just such stringency and that it force the chemical industry to innovate, to invest in research and fully to commit itself to those parameters within which it will have to compete in the future.


  Péter Olajos (PPE-DE). – (HU) Mr President, we need a strong and effective REACH, a REACH that protects both people’s health and the environment, that reduces the number of experiments on animals, and at the same time safeguards the competitiveness of the chemical industry and increases transparency, strengthening the internal market while at the same time complying with WTO regulations.

The question is whether or not there is a common denominator here. Can we achieve a radical improvement as regards our health without placing too heavy a burden on small and medium enterprises? REACH will only be a success if our answer is yes. This is why we need to support the British-Hungarian proposal referred to as OSOR (one substance, one registration) and must not allow it to be diluted. Common sense and the interests of small and medium enterprises suggest that data-sharing should be mandatory, while of course respecting commercial confidentiality in the strict sense of the term. The ultimate goal of REACH is the substitution and withdrawal of substances that pose a danger to health and the environment. This is why we must move forward as boldly as possible with legislation in this area.

As a chemist, I know that technological constraints impose limits on what we would like to achieve, but let us not shy away from being as rigorous as we possibly can within these limits. I also oppose the attempts that are being made to soften registration, and support the position of the Committee on the Environment, Public Health and Food Safety. I am convinced that this is the only way to ensure that our children and our environment are comprehensively protected.

The key to an effective and viable REACH lies in the ability of those affected to implement it. This is why I also support the proposal to limit expenditures on REACH to 0.2 per cent of annual income in the case of small and medium enterprises, as this will guarantee that the legislation can be implemented. There is no sense in exiling the European chemicals industry to other regions of the world, because at the global level this will not solve our problems, indeed quite the contrary. For this reason, we must go to the very limits of what is possible, and we must not stop short of this. I did not bring an apple for Mr Sacconi, but I ask him to accept my congratulations.


  Riitta Myller (PSE). – (FI) Mr President, the EU’s Chemicals Regulation (REACH) will ensure above everything else the protection of people’s health and standards of environmental protection that are as excellent as possible. Quite a big step backwards has been taken with regard to these principles since the Commission’s original proposal. This is mainly due to the fact that the political and ideological power relationships have clearly changed in all the institutions of the European Union since the last elections.

Amid this difficult situation, Guido Sacconi, rapporteur for the Committee on the Environment, Public Health and Food Safety, has to my mind done an excellent job, and the result obtained in the Committee was an indication of how valuable his work has been. I would have hoped that there would no longer be any need to go back from this compromise.

I wish to thank the country that holds the Presidency, particularly for promising to support tighter regulation than is contained in the Commission’s proposal for compensation for dangerous and harmful substances. This will help the chemicals industry and increase its capacity for innovation in Europe.


  Avril Doyle (PPE-DE). – Mr President, in response to criticism that the existing regime for regulating chemicals – a complicated maze of some 40 separate directives – was slow, overly rigorous and stifled innovation, you only have to witness the 14-year saga on zinc-risk analysis, yet to be concluded, the European Commission proposed a new chemicals regime in October 2003, following extensive stakeholder consultation.

This REACH regulation aims to maintain a strong chemicals industry within the internal market, while providing a high level of protection for human health and the environment. It proposes to simplify the procedure for registering new and existing substances and it will increase our knowledge of their effects and ensure safe use at all stages in their lifecycle. Downstream users of chemicals, which include the vast majority of SMEs, will benefit significantly from this information.

With only two minutes available to me, I have to be selective. I support the compromise on registration, together with the amendment to limit the cost for SMEs, and the minimisation of animal testing. I also feel that inorganic substances must be handled differently to organic chemicals. We need the highest possible level of confidentiality for business, while not compromising human health and the environment, by allowing registrants to use third-party representatives where possible and by protecting against the publication of sensitive business information on the Agency’s website.

I would, however, like to focus on the proposal to include the chemicals used in tobacco products under REACH. It is very much in the interests of smokers to know exactly what chemicals are contained in tobacco products and for them to be able to exercise informed choice. Article 3 of the Tobacco Products Directive sets limit values for tar, nicotine and carbon monoxide only. It does not limit the use of the other 2 000 or so chemicals used in cigarettes. Article 6 of the same directive only requires cigarette manufacturers and importers to list the chemicals contained in cigarettes and to report on the toxicological data available to them to the Member States, who are then required to inform the Commission. This allows tobacco manufacturers to continue to plead ignorance of any detrimental effects on human health of these additives.

I will conclude, Mr President: this is why it is essential that each and every one of the chemicals added to cigarettes goes through the centralised registration and authorisation procedure envisaged in REACH. I urge you to support my amendments. We in the European Parliament, the Council and the Commission cannot renege on our responsibility here. I thank Mr Sacconi and all involved in this very difficult piece of legislation: a work in progress.


  Adam Gierek (PSE).   (PL) Mr President, the Commission’s proposal for a regulation contains a methodological flaw. Although the title refers to chemical compounds, Article 3 makes no mention of them, and instead gives a definition of a substance. This broadens the scope of the regulation substantially to include the kind of matter that, as we all know, is not energy. It also makes it less clear.

The second point I should like to make is that no definition is given of the subject of the regulation, or in other words hazardous chemical compounds and their chemical activity in living organisms.

Thirdly, the proposal fails to define hazard classes, for example on the basis of medical criteria. It would make sense to attempt to define hazard levels in terms of probability by assigning substances to different groups on the basis of tonnage if they all posed the same threat, yet this is by no means the case.

My fourth point is that a number of traditional products should be excluded from the scope of the regulation, since their chemical activity is almost zero under normal conditions.

There is an urgent need for the REACH regulation, but it should be limited to very narrow definitions of hazard classes for chemical compounds. It should also establish a European Chemicals Agency, which would draw up detailed specifications for chemicals and issue certificates and registrations in line with this interpretation.


  Marianne Thyssen (PPE-DE). – (NL) Mr President, ladies and gentlemen, the proposal for a regulation we are discussing here is not only complex and far-reaching, but also very ambitious. And that is how it should be, for it is, after all, about health and the environment. In order to achieve those goals, we must not only aim high, but the proposal must also be made simple to implement and given a practical dimension. Mr Sacconi was right to mention balance and responsibility as being the two key words in this area.

The fact that we have an eye for the impact of competitiveness, for cost effectiveness, for the specific concerns of SMEs, for the innovativeness and competitiveness of our industry and for data protection with legal certainty is not going against REACH but forms an integral part of it.

A plethora of amendments have been tabled – too many, in fact, for a plenary sitting – but we have to take decisions at some stage. Let us therefore press for sound consultations from now until Thursday, so that we can reach a voting result that is consistent at all levels and is widely supported, because a widely supported voting result will also culminate in a balanced legal document.

In this area, we are deliberately – and rightly – opting for a common European approach. We should therefore capitalise on the European added value and give the Agency the necessary competences to reach a uniform approach without, however, overlooking the Member States’ know-how. Let us also ensure that when we come to enforce the regulation, the approach is sufficiently harmonised.

If we do a good job this week, then our environment in 11 years’ time will be quite different from now and we will have caused nothing short of a revolution in the Union. We will have information on all chemicals and we will use them far more sensibly. We will have contributed to better public health and a healthier living environment. Let us accept our responsibility to achieve those goals in an ambitious and realistic manner.

I would like to finish off by saying, as some fellow Members have already pointed out, that our political persuasion is really not relevant in this case. We should move away from that dimension and ensure that we vote wisely on Thursday.


  Evangelia Tzampazi (PSE).(EL) Mr President, benefits for public health and the environment, the production of safer products more friendly to man, benefits from the development of new innovative products, protection for the European chemical industry against competitors from third countries, improved transparency, increased consumer confidence in industry, benefits for small and medium-sized enterprises, which are the main users rather than producers of chemicals, protection for the health of workers in the chemical industry, fewer accidents, an anticipated regulatory system and reasonable implementation cost. This is REACH, this is Mr Sacconi's REACH of balance and sensitivity, this is the REACH of Parliament which we owe to European citizens. Citizens are entitled to REACH, which tomorrow we may need to redefine further to the left and make greener; but today we need REACH.

I thank the Commissioners and the Greek Commissioner for their support on this major issue.


  Åsa Westlund (PSE). – (SV) Mr President, in most of what we use, there is a large number of chemicals, and we do not know how these substances affect us. We know, however, that cancer and allergies have become more common and that many industrial injuries are due to people having been exposed to chemicals in the workplace.

On Thursday, we shall have the opportunity to change this by voting in favour of safe chemicals legislation enabling us genuinely to detect and phase out the dangerous chemicals. I hope that a majority of us will take the opportunity to fly the flag for European competitiveness but, above all, to put an end to the experiment with people’s health and the environment constituted, in actual fact, by current legislation.

In common with the consumer, trade union and environmental movements, we Swedish Social Democrats shall not support the compromise on registration reached between the Socialist Group in the European Parliament, the Group of the Alliance of Liberals and Democrats for Europe and the Group of the European People’s Party (Christian Democrats) and European Democrats. It exempts too many chemicals from testing, and such requirements for testing as are in fact laid down are not strict enough to enable hazardous chemicals to be detected and phased out. We cannot therefore support the compromise.

Finally, I wish to say a big thank you to Mr Sacconi who has done some sterling work on this matter.


  Guido Sacconi (PSE), rapporteur. – (IT) Mr President, ladies and gentlemen, I should like to make just three very quick points. First of all I should like to respond to the criticisms made by various fellow Members including Mrs Breyer and Mrs Foglietta, who allege that I have expressed my personal viewpoint and not that of the Committee on the Environment, Public Health and Food Safety. It is possible that I have made a mistake and in that case I offer my sincere apologies.

However, as the principal rapporteur of Parliament I feel that I have a responsibility to the House to work towards the broadest and most solid majority that can be achieved. It is above all for this reason that I considered the compromise that we have discussed at such length to be useful, feasible and necessary.

To achieve REACH we have had to arrive at a compromise. Before assessing whether REACH is or is not a strong regulation – we shall have time after the vote to carry out a careful analysis – we urgently need to have a REACH regulation at our disposal; and we know how much deep-seated hostility it has attracted even in recent weeks.

On the other hand it seems to me that the points of principle that I have publicly declared to be insuperable have not been resolved, given that the burden of proof for lower tonnage bands has been maintained: this means that 30% of those substances must be covered by complete documentation. I challenge anyone to contradict my assessment on this point. In this connection I should like to cite the example of the principle of ‘one substance, one registration’, which for the first time, thanks to the compromise, is largely supported in Parliament, whereas hitherto it had been adopted only by the Committee on the Environment, Public Health and Food Safety. The criteria for opting out have certainly been retouched, but the final ruling on applications for authorisation not to participate in data sharing rests with the Chemicals Agency.

Finally I should like to thank all Members, especially the rapporteurs, but above all the extremely important staff that we should perhaps value more highly: namely Parliament’s officials and Secretariat. If we have got this far the credit must also, and perhaps principally, go to so many officials who have carried out this exceptional work.


  Lord Bach, President-in-Office of the Council. Mr President, this has been an excellent debate, with honourable Members speaking with knowledge, experience and passion. Sixty-one separate Members of the European Parliament have spoken and I have listened with care on behalf of the Council to all of them.

It is vitally important that the burdens which REACH imposes on industry are as low as possible. This is an industry that employs many hundreds of thousands of our European citizens, but it is important that the burdens are consistent with meeting our shared goals of protecting human health and the environment, and we believe that the emerging views of Parliament, the Council and Commission do this.

A focus of many speakers has been the needs of small firms in the chemical and related industries. The Council shares that concern, and in its compromise the Presidency has attempted to put forward a range of measures to help them. These include ‘one substance, one registration’, the role of the agency in assisting small firms and a number of measures to help them capitalise on their innovation.

Many Members have mentioned the word ‘balance’ this afternoon. REACH is in many ways a balancing act and we believe the emerging consensus between our three institutions represents the only achievable balance on this delicate, complex and very important dossier.

I very much welcome and share the widespread support expressed here today for the need to avoid unnecessary animal testing. Clearly, for now, non-animal alternatives do not exist for all the tests we need, so the role of ‘one substance, one registration’ to avoid duplicate testing is key. We also want the scope to amend the list of test methods approved as rapidly as possible as non-animal alternatives come forward.

In its amended form, REACH will target the most hazardous substances; PBTs, VPs and VBs will be registered early. They, CMRs and other substances of very high concern, such as endocrine disrupters, will be subject to a rigorous authorisation process, including substitution.

A key principle of the REACH approach is to lay the responsibility for demonstrating the safety of chemicals firmly upon the chemical industry. The reversal of the burden of proof will mark a positive and dramatic improvement on the current regime and is something that Member States and the Council have seen as vitally important. REACH is a significant improvement on the status quo. It will give us the information we need to address substances of concern. It will promote innovation in the industry itself through reducing the current existing burdens on companies wishing to introduce new and greener chemicals and through promoting substitution of older, more polluting substances. Europe has been debating REACH since 1998. We have come a long way in understanding both the substances and the concerns of all stakeholders. I argue that now is the time to seize this once-in-a-lifetime chance to agree on what is before us and overcome the problems of sound chemicals management.

The current regime for chemicals is flawed, bureaucratic and slow and, in too many circumstances, it is frankly ineffective. More than 40 laws, over 100 000 substances and almost 40 years after the EU first started to address chemicals, we still have not got there. Chemicals pose a huge challenge and a huge opportunity to modern society and we need to take this on now. REACH, as it is emerging in Parliament, the Council and the Commission, is the best tool we have to do this, hence its importance to us all.



  Günther Verheugen, Vice-President of the Commission. (DE) Mr President, ladies and gentlemen, the Commission too believes that this was an important and persuasive debate. At the risk of repeating myself, what mattered to us was to find a solution, or to help find a solution.

It is impossible to make everyone happy in a case such as this one. There can be no such thing as a true compromise between those who are afraid of losing their jobs and of what the future brings, and those who are worried about the health of their children. A perfect compromise is an impossibility, and indeed compromise by its very nature means meeting one another halfway. This comment is directed at those on both sides who voiced controversial opinions during this debate.

In my opinion, it would be wrong to want to lay down rules the like of which the world has never seen before with no thought for the competitiveness and future prospects of one of Europe’s most important industries. At the same time, however, it would also be wrong for us not to do everything in our power to achieve the best possible outcome for the health of our fellow citizens and for the environment in which they live.

The Commission would like to reiterate its belief that the compromise on the table strikes a good balance, and I must once again protest most vigorously against accusations that this proposal waters down the objectives contained in the Commission’s original proposal. As I see it, it should be left up to the Commission to decide what it thinks of the amendments that have been made to its proposal. We are debating a Commission proposal, and the Commission does not believe that the amendments that have been tabled before the House weaken or water down its proposal. Instead, it believes that the proposal’s real objectives have in fact been strengthened. I would point out that requirements have even been made more stringent in the low-volume, 1-100 tonne category, which covers the most substances and is therefore the most crucial.

At the same time, however, it is also true that practical tools have now been found that will make it easier for businesses, and especially for small and medium-sized enterprises, to contend with this extremely demanding body of legislation. Several of the speakers referred to the fact that the chemical industry in Europe is dominated by small and medium-sized enterprises. This is a point I should like to make to those Members who have responded to proponents of other views by saying that the compromise before us, or the solution laid out therein, represents a setback for the interests of the large-scale chemical industry in Europe. This is nonsense, not least because the chemical industry in Europe is not controlled by large companies. You will no doubt be amazed to hear that the average chemical company in Europe employs only 74 people. What this means is that the structure of this industry is very much dominated by small and medium-sized enterprises, and we must think very carefully about the demands we should and should not place on businesses.

No one anywhere has experience of implementing a body of legislation like this, and we should be aware from the outset that only practical experience will reveal whether our assumptions are right or wrong. We should remain open to improvements, not only during these debates, but also during the implementation phase that will follow them.

On behalf of the Commission, I can assure you that we will not shirk our responsibility, in particular as far as the agency is concerned. The latter will in fact have to carry out the bulk of the work, and the Commission will take the necessary steps to ensure that it can get down to work as quickly and as effectively as possible.



  Stavros Dimas, Μember of the Commission. (EL) Mr President, I shall be very brief. First I should like to thank everyone who took part in this evening's debate, which was very important and very interesting and which will contribute towards the adoption of the proposal which we are debating for the benefit of the health of European citizens and the environment.

I should like once again to congratulate the rapporteur, Mr Sacconi, and Mrs Ek and Mr Nassauer, for the truly huge effort which they made to bring us to this compromise, which relates to one of the most important aspects of REACH.

The Commission fully supports this compromise and I am certain that equally extensive support will be expressed during the vote on Thursday.

There are of course certain other issues, such as the issue of authorisation and substitution, which are the concern of the European Chemicals Agency, issues on which I am certain that Parliament will decide with the same transparency.

The Commission welcomes the convergence being developed between Parliament and the Presidency and will work to facilitate the achievement of an agreement on REACH, so that REACH becomes law as quickly as possible.

Similarly, the Commission supports the rapporteur's amendments on the time limit on authorisations, but with the precondition that the limit will be determined on a case-by-case basis by the European Chemicals Agency.

As regards chemicals in products, the rapporteur is aiming for a more specific and operational solution which is similar to that sought by the UK Presidency and which the Commission will be able to accept.

Thank you very much for your attention and for taking part in such an important debate.


  Paul Rübig (PPE-DE). – (DE) Mr President, I should like to thank the House for the serious debate that has taken place. I find it intolerable that an exhibition being held on Parliament’s premises should include an image of Mr Verheugen poisoning a child while Mr Barroso looks on, and I would call on the Conference of Presidents to remove this poster from Parliament without delay.


  President. The debate is closed.

The vote will take place on Thursday.



  Miloslav Ransdorf (GUE/NGL) , in writing (CS) Due to problems of internal democracy within the Confederal Group of the European United Left/Nordic Green Left, I did not get the chance to speak during the joint debate on REACH. Of the total of 52 amendments I tabled, 30 have made it to the final vote, and these amendments have been welcomed by experts in the field. My goal was and is to strike a balance between the various approaches to the matter, and I am very much opposed to extremes of opinion.

The end effect of the position advanced by the Committee on the Environment, Public Health and Food Safety would be to prevent us achieving the Lisbon goals, and to weaken the position of small and medium-sized enterprises. Pressure will grow on the new Member States, which have traditionally imported goods from the countries of the former Soviet Union, to replace these latter with imports from Western Europe, which would mean extra costs. Several studies carried out in the Czech Republic indicate that as many as one fifth of jobs could be lost, with profits also falling in related sectors, such as the automobile industry.

I am glad that this initiative has emerged, but I believe that it must be implemented over an appropriate period of time. I would also call for the costs of testing to be met by public funding, as this is the only way to avoid negative repercussions, in particular on small manufacturing firms.

I am in favour of the compromise that was reached within the Committee on Industry, Research and Energy. REACH is not a confrontation between left and right; instead, it is a conflict of interests that raises the question of whether a balance can be struck between the economic, social and environmental aspects of the Lisbon Strategy.


Annex – Position of the Commission


Sacconi report (A6-0315/2005)

The Commission can accept in full all the amendments of the PPE-DE/PSE/ALDE compromise package on registration, including the amendment on OSOR; these are amendments 367 to 413 (inclusive).

The Commission can also accept in full the following amendments: 40, 73, 74, 79, 117, 119, 125, 128, 148, 158, 273, 276, 291, 292, 317 and 324.

The Commission can partially accept amendments 10, 322, 327, 333, 335, 336, 340, 345 and 347.

The Commission can accept in principle amendments 4, 8, 11, 14, 16, 18, 21, 26, 34, 36, 39, 50, 59, 60 61, 62, 63, 64, 67, 68, 72, 76, 78, 81, 83, 87, 97, 101, 102, 104, 105, 107, 108, 115, 116, 120, 121, 123, 124, 126, 139, 140, 145, 146, 147, 149, 159, 171, 172, 175, 176, 183, 184, 185, 186, 187, 188, 190, 191, 193, 202, 203, 204, 205, 207, 208, 209, 211, 213, 215, 217, 220, 221, 235, 236, 248, 249, 259, 265, 270, 277, 278, 286, 293, 297, 299, 300, 301, 302, 306, 308, 310 and 323.

The Commission can accept in principle and in part amendments No. 19, 20, 41, 53, 65, 88, 89, 103, 122, 130, 132, 141, 142, 144, 157, 158, 161, 163, 180, 181, 192, 194, 195, 196, 197, 198, 199, 200, 201, 210, 285, 290 and 294.

The Commission cannot accept amendments 1, 2, 3, 5, 6, 7, 9, 12, 13, 15, 17, 22, 23, 24, 25, 27, 28, 29, 30, 31, 32, 33, 35, 37, 38, 42, 43, 44, 45, 46, 47, 48, 49, 51, 52, 54, 55, 56, 57, 58, 66, 69, 70, 71, 75, 77, 80, 82, 84, 85, 86, 90, 91, 92, 93, 94, 95, 96, 98, 99, 100, 106, 109, 110, 111, 112, 113, 114, 118, 129, 131, 133, 134, 135, 136, 137, 138, 143, 150, 151, 152, 153, 154, 155, 156, 160, 162, 164, 166, 167, 168, 169, 170, 173, 174, 177, 178, 179, 182, 189, 206, 212, 214, 216, 218, 219, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 250, 251, 252, 253, 254, 255, 256, 257, 260, 261, 262, 263, 264, 266, 267, 268, 269, 271, 272, 274, 275, 279, 280, 281, 282, 283, 284, 287, 288, 289, 295, 296, 298, 303, 304, 305, 307, 309, 311, 312, 313, 314, 315, 316, 318, 319, 320, 321, 325, 326, 328, 329, 330, 331, 332, 334, 337, 338, 339, 341, 342, 343, 344, 346, 348, 350 and 351.

The Commission reserves its position on two linguistic amendments, namely amendments 127 and 165.

The Commission also reserves its position on all those amendments tabled on 9 November with the exception of those of the PPE-DE/PSE/ALDE compromise package as mentioned before. These are amendments 352 to 366 (inclusive) and amendments 414 to 1038. The Commission position will be made available after the vote on all those amendments which are adopted.

Sacconi report (A6-0285/2005)

The Commission cannot accept any of the four amendments tabled to the proposal for a directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals. These are Amendments 1 to 4.

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