Classification, labelling and packaging of substances and mixtures - Classification, labelling and packaging of substances and mixtures (amendment of Directives 76/768/EEC, 88/378/EEC, 1999/13/EC, 2000/53/EC, 2002/96/EC and 2004/42/EC) - Classification, labelling and packaging of substances and mixtures (amendment of Regulation (EC) No 648/2004) (debate) 
President
The first item is the joint debate on
the report by Amalia Sartori, on behalf of the Committee on the Environment, Public Health and Food Safety, on a proposal for a regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 - C6-0197/2007 -,
the report by Amalia Sartori, on behalf of the Committee on the Environment, Public Health and Food Safety, on a proposal for a decision of the European Parliament and of the Council amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC in order to adapt them to Regulation (EC) ... on Classification, Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 - C6-0347/2007 -, and
the report by Amalia Sartori, on behalf of the Committee on the Environment, Public Health and Food Safety, on a proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No ... on Classification, Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 - C6-0349/2007 -.
Günter Verheugen
Madam President, ladies and gentlemen, on behalf of my colleague Commissioner Dimas, I would first like to thank the rapporteur, Mrs Sartori, for her thorough work on this difficult proposal. Her hard work made agreement with the Council possible at first reading, which the Commission is delighted about. Once again, we are dealing with chemicals and the protection of people and the environment from their potentially dangerous effects.
Chemicals are not purely a European problem, or a European monopoly. They are produced, traded and used throughout the world, and the risks associated with the use of chemicals are the same irrespective of location. Therefore, it stands to reason that we have endeavoured to achieve a worldwide system to describe and label these hazards. The legislation we are going to adopt today creates the basis for globally uniform environmental, health and safety information relating to potentially dangerous chemicals.
Health and environmental protection will become transparent and comparable worldwide only when harmonised standards of measurement are used to determine and label the dangers posed by chemicals. We must not underestimate the economic advantages either. European enterprises will save money because they will not need to evaluate chemical hazard procedures that apply in different countries according to different criteria and different systems. Professional users of chemicals and consumers throughout the world will also benefit from this harmonisation. People who use chemicals will no longer have to become familiar with several different systems in order to know what level of threat a chemical may pose.
The compromise presented by the rapporteur is balanced and takes particular account of issues such as workability and the clarity of the provisions. Although the amendments proposed by co-legislators are numerous, they do not alter the underlying principles or the basic structure of the original proposal by the Commission in any significant way. Therefore, the Commission is able to go along with these proposals. Even when we were preparing the proposal, the Commission was concerned to leave the current very high level of protection of human health and the environment untouched. I am very pleased that Parliament and the Council share our basic view on this. The close, constructive cooperation between Parliament, the Council and the Commission greatly benefitted the negotiation process and, as I have already said, this means that we can accept all the compromises that Mrs Sartori has suggested.
Amalia Sartori
Mr President, ladies and gentlemen, as I have already reminded the Commissioner, in recent months we have repeatedly addressed the issue of the classification, labelling and packaging of chemical substances and mixtures, a system better known by its abbreviation 'GHS', for which I am rapporteur.
For this reason, instead of discussing the technical details of the dossier again, I would like to begin by thanking my colleagues and the shadow rapporteurs whom I worked with to create a constructive and extremely satisfying dialogue based on extensive collaboration and transparency. I would particularly like to thank everyone for the support and faith shown in me. This gave me enough backing for a successful outcome to the negotiations with the Council and the Commission.
I would also like to thank the draftsmen of the opinions of the relevant committees - Mrs Laperrouze, for the Committee on Industry, Research and Energy, and Mr Schwab, for the Committee on Internal Market and Consumer Protection - who were involved on the basis of an enhanced cooperation procedure. The opinions adopted by these two committees in fact supplemented and enhanced the proposal, making it more efficient and easier for end users: by these I mean consumers, businesses, trade associations, supervisory authorities and Member States. I would like to mention the excellent work carried out by parliamentary officials and members of the groups who assisted us, as well as representatives from the Commission and the Council.
Over the last few months we have all worked towards trying to minimise the number of amendments and to reach a consensus on particular compromises. After two months of tripartite technical discussions with the other institutions, we have achieved a satisfying compromise package with the Council, approved by COREPER on 27 June and which, if today's vote is successful, will allow us to conclude at first reading.
With this new legislation, we need, on the one hand, to maintain the commitments we have assumed at international level - and thus ensure that the UN GHS is consistent with our own legislation in terms of content - and on the other, we must meet the existing deadlines imposed by our own legislation in REACH.
With this new regulation, we will at the same time succeed in both offering better protection to users of these substances and in making our firms more competitive and efficient. Under these new rules, which are identical all over the world, countries will not be allowed to consider the same product more harmful or less harmful than in other countries. So far this has not been the case. Not only is this illogical, given that the same substance presents the same risks no matter where it is, but it is also extremely risky when these products are exported by one country to another and end up being used by people who have no notion of the dangers of the product they are using.
I believe, therefore, that for users and workers in this sector, particularly in the extremely high number of small and medium-sized enterprises, our proposal can be an effective response not only for all of our citizens and all Europeans, but for people all around the world.
Anne Laperrouze
Madam President, Commissioner, ladies and gentlemen, I would first like to congratulate Mrs Sartori, our rapporteur, and the shadow rapporteurs from the other groups. I think the work we have done, though not easy with a text of 2 000 pages, has brought real progress.
I will speak first of all on behalf of the Committee on Industry, Research and Energy, for which I was draftsman of the opinion, and then I will speak on behalf of my political group.
The Committee on Industry has adopted various amendments, and I am briefly going to mention the main ones.
The situation of SMEs had to be taken into account: they expressed their interest in this matter during the preparatory consultation by the Commission. Out of 360 companies, 45%, employing fewer than 250 employees, responded to this online consultation held by the Commission between 21 August and 21 October 2006.
Our Committee was keen to highlight the fact that apart from providing necessary information, the purpose of the GHS is also the protection of consumers and the environment. Our Committee called upon the Member States to introduce a procedure that helps all suppliers, particularly SMEs, in certain sectors of production, to determine the correct classification, labelling and packaging of these substances and mixtures.
Our Committee was also keen on consistency with REACH and therefore tabled amendments concerning tonnage.
Lastly, out of more than just a desire to avoid the duplication of legislation on packaging, our Committee wanted to anticipate the possibility of disputes over the interpretation of the Regulation's requirements, in this case between the supplier and a Member State and the need for a procedure to ensure classification is harmonised.
I now come to my role as shadow rapporteur for the ALDE, and will outline some of the guiding principles of our approach.
Of course we welcome this initiative. A global approach is totally consistent with the objective of protecting health and the environment more effectively while allowing for trade in products.
Since it is a global system, it is important that the future regulation does not introduce constraints on European firms that do not apply to their international competitors. It would be desirable for the proposal to be consistent with REACH as regards both timeframes and a tonnage-based approach, and where the annexes are concerned, not least Annex VI.
As regards the information affixed to finished products, given that the European Commission has chosen to include post-manufacturing, the guiding principle has to be the quality and relevance of information and not the quantity. Our group felt it was important to recognise the existence and value of other sources of information, particularly NGOs and industry, but also the importance of tools for communication such as the internet. The confidentiality of some information must also be protected. Lastly, this legislation must not generate an increase in animal testing.
Because of the tight schedule, but also the complexity of the annexes, I recall that MEPs decided not to amend them. The aim of this was also to facilitate the negotiations. This was a major concession by Parliament. However, we have noticed in this case that one of these annexes raises a serious problem of immediate conformity and implementation for the industries concerned.
Annex VI is a list of substances with harmonised classifications at European level. A similar list already exists, however, and the industry uses this existing list to classify and label mixtures. But when the transfer took place, modifications were made to this list and it will have to be applied as soon the GHS comes into force, though in the case of technical adaptations, the timeframe for this is at least 18 months.
Many SMEs are concerned about this change. It is essential that we reach agreement in the first reading with the Council, and stop publishing provisions as soon as possible to give the industry and users time to adapt to the new system and make it operational by the end of 2008.
Consequently, I am asking the Commission to put forward a solution that gives the industry sufficient time to bring itself into conformity with the regulation's requirements, without having a disproportionate impact.
Following the trialogue, apart from the problem with the Annex, the text being put to the vote seems like a good one to me. I would just like to highlight a few salient points. We have talked a great deal about PBTs. They are not covered by the United Nations GHS. Parliament has secured agreement from the European Commission to push for their classification at United Nations level. Parliament has also secured the removal of the division of the 'eye irritation' category into sub-categories, which would undoubtedly have led to an increase in the number of tests on animals without adding any real value. We can also report that tests on humans for the sole purpose of this regulation are banned, and that the UN's GHS is a dynamic process; a mechanism has been found to enable changes to the UN GHS to be taken into account by the European GHS. Confidentiality is protected in a balanced way.
Consistency with REACH is guaranteed and Parliament has accepted a zero threshold for inventory and notification, though originally we wanted a threshold of one tonne for certain categories of products. This zero threshold was accepted because substances and mixtures exclusively for R&D purposes are excluded from the scope of application.
I think we have done a good job and I am hoping for a good vote and for the GHS to be applied properly.
Andreas Schwab
draftsman of the opinion of the Committee on the Internal Market and Consumer Protection. - (DE) Madam President, Commissioner, ladies and gentlemen, I would first like to say that it gave the Committee on the Internal Market and Consumer Protection great satisfaction to see the compromise presented by Mrs Sartori on behalf of the Committee on the Environment, Public Health and Food Safety. We believe that, with this solution, we have found a very good compromise and a very good solution, both for the chemical companies in the European internal market - most of which operate globally - and for consumers, and that we have also achieved a very good compromise for consumers with sensitivities.
This was possible only because of the amicable, unwavering cooperation between the rapporteurs. I would particularly like to thank Mrs Sartori for the way she led the negotiations - including in trialogue - as in the end, there is no doubt that this was critical to achieving a solution that met everyone's expectations.
I am happy with the result because I believe, from the point of view of the internal market, and of enterprises - particularly chemicals enterprises, whose experience of the European level in terms of REACH has not been 100% positive - that the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), as a universal guideline set up by the United Nations, can be implemented on the European internal market in a very non-bureaucratic way and with a practical orientation. This will bring direct competitive advantages on the internal European market for enterprises that are active on this market, because harmonised labelling is a significant step forward compared to the existing regulation, which still varies in some peripheral areas.
Commissioner, in the trialogue discussions, we also briefly discussed the fact that legislation on the transport of these consumer goods has still not been harmonised and that it would therefore be worth considering whether we should shift our focus to legislation on the transport of chemicals in the coming months.
Secondly, not opening the annexes was the right thing to do - and here I would like to support Mrs Laperrouze of the Group of the Alliance of Liberals and Democrats for Europe, with whom we also enjoyed excellent cooperation - because this move enabled us to prevent the discussion becoming like the one regarding REACH. Even though it meant that certain individual points that we would have liked to improve were missed out, with the wisdom of hindsight, it was indeed the right path to take.
Nevertheless, I would like to lend my express support to Mrs Laperrouze's desire to create a transitional deadline in Annex 6 for the substances that were amended in that annex, because when we started the consultation, we could not predict that they would not be covered by the solution we decided on. Commissioner, I would very much appreciate it if you would comment briefly on this in your answer.
Users of chemical consumer goods are not, as a rule, conversant with the composition of these goods. When discussing the GHS, we therefore placed particular importance on implementing it in a way that would be practical for consumers. Although it was not possible to consider each individual case in detail, we found a solution - at least for the most common consumer goods, such as washing powder and detergents - that makes consumers aware of the quantities of chemicals these products contain, while also enabling people to use them in the future in the same way as they have done in the past.
Perhaps I can give you an example: it used to be possible to use washing-up liquid only in large bottles containing several litres. Increasingly environmentally friendly technology in the manufacture and use of these products has enabled the quantity of washing-up liquid required to be reduced further and further, so that now, the largest containers found in kitchens are just 300 ml or 500 ml.
No doubt the concentration of the chemicals in these products has increased but for consumers, this is compatible with the present GHS solution because we know that people use these products every day, so we did not need to overclassify them.
That covers all the points relevant to the internal market. Thank you for your attention.
Guido Sacconi
Madam President, ladies and gentlemen, in a situation such as this one, where we are all in agreement, our debate risks becoming repetitive. For my part, I would just like to make three very brief political points, since I fully agree with what my fellow Members have said.
The first point naturally is recognition for the perseverance that our rapporteur has shown since the start. From the very first meetings, she has demonstrated a political determination to close the dossier at first reading, and in fact she has almost forced us to do so, by twisting our arms. However, we were all convinced that this was necessary if we were to introduce legislation swiftly to obtain an immediate classification of all substances and make a real step towards tougher standards to protect consumer health and - I agree on this point - the health of workers who use these substances in many different sectors, particularly in the more difficult context of a small business.
Secondly, we have avoided the increasing danger of reopening old discussions that had been shelved with the adoption of REACH, something that I was particularly keen to see. At an international level, I believe that even the fact that REACH is increasingly being used as a benchmark at international level by other countries, which are using it as a model to adapt their own legislation, is extremely satisfying.
In any case, the provisions relating to the classification of substances that we are about to vote on must be adapted and integrated so that they correspond to the principal regulation on the classification, labelling, and packaging of substances and mixtures without adding any new elements.
Ultimately this means, as all my fellow Members will know, that the GHS is not the last word on the subject of the classification and labelling of substances. There has been much discussion of PDT. We must not forget that this is an ongoing process. For now we are implementing what we already have, and classifying substances on which the UN has already carried out a risk analysis. As soon as we have new risk categories and the results of new studies, the GHS will be updated accordingly, so this is an ongoing process.
Liam Aylward 
on behalf of the UEN Group. - (GA) Mr President, the environment and public health affect every citizen and this legislation is directly connected with both. The Parliament voted in favour of the REACH system which is now in place and which protects people's health and the environment from the danger of chemicals. The aim of REACH is to ensure that manufacturers and importers register, classify and authorize chemicals. An essential part of the system is providing the public with information by labelling these chemicals.
I can only praise this legislation and the Commissioner for giving the EU system equal ranking with the UNGHS (UN Globally Harmonised System of Classification and Labelling). The public will be informed about the dangers of chemicals through pictograms which shall indicate the risks concerning explosions, fire, cancer and poison. There will be advantages for industry as countries all over the world accept the GHS system. And the public will have more confidence in chemicals which have signs and clear and definite labelling.
Carl Schlyter
on behalf of the Verts/ALE Group. - (SV) We talk a great deal about taking the initiative on climate change but, if we really had a holistic approach to the environment, we would have directly copied UN legislation here too. Now we are removing acute toxicity category five. Why are we doing this? Well, for the bizarre reason that otherwise there would be an increase in the number of substances which would have to be classified and labelled. Thus the reason has nothing to do with any kind of environmental logic or health logic. No, we do not want to copy category five because it would mean increasing the number of substances, despite the fact that the point of the whole thing is to have a common global standard which would make things easier for trade and, in this case, also for the environment and information to consumers. I fought for reintroducing acute toxicity category five, but unfortunately I did not succeed.
Another thing which we were behind and actually succeeded in getting through together with the Council was preventing the proposal for a reduced classification threshold of 10 kg. I would like to thank the Council for standing their ground. The Commission also had a positive input. If the proposal had gone through, REACH would have been undermined. REACH was about evaluating chemicals, finding out whether they are dangerous and registering them. However, REACH evaluates and registers only the 30 000 most commonly used chemicals, those with the highest volume. The other 70 000 chemicals we use would be dealt with under this legislation. For this reason it is very good that we retained it and that no lower limit was imposed for when chemicals are to be classified. If the proposal had gone through, REACH would not have had a complement in the GHS. I am very glad that this was not the case and therefore I can support this.
I am also pleased that we succeeded in preventing an unnecessary division into categories for animal testing, e.g. eye irritation tests.
With these two victories under our belt, I can vote in favour of this report. However, I would really like to emphasise that, although we have not succeeded in including the very hazardous PBT chemicals or a priority list for evaluation here and now, at least we have gained a text that says we will promote this at UN level and that it will be included in the UN system. Now I would really like to see the Commission working hard to achieve this aim, because it is very important. Otherwise our chemicals policy will have failed completely. It is very important that these substances are now quickly incorporated in the UN system, as we did not manage to take the first step here.
So what happens for consumers? They won't be as well informed as they could have been about the danger of chemicals, and that is disappointing. But they will at least get a decent standard and basic protection to protect themselves from hazardous chemicals. So in the end it was a compromise which no one is satisfied with, and maybe that is what usually happens.
Avril Doyle
on behalf of the PPE-DE Group. - Madam President, chemicals are a natural and important part of our environment. Even though we often do not think about it, we use chemicals every day. The modern world could not function without them. They keep our food fresh, our bodies clean, they help our plants to grow, they fuel our cars. Properly used and properly handled, chemicals make it possible for us to live longer, healthier lives.
This proposed regulation, which complements REACH and aligns the EU system for classification, labelling and packaging of substances and mixtures with the UN Globally Harmonised System, is a reasonable and balanced proposal.
If we want to utilise the benefits of chemicals at a reasonable cost then we have to accept that there will be risks. We need therefore to strike a balance between risks and benefits and control the risks of chemicals through careful labelling, science-based regulation and innovative technologies. We also need to strike a balance between properly implementing the European Union's international obligations signed up to at the United Nations Economic and Social Council at the World Summit on Sustainable Development which was held in Johannesburg in September 2002, while at the same time avoiding unnecessary burdens on business through impractical and over-demanding labelling.
To this effect, I tabled several amendments to the proposal. I feel it is particularly important to ensure that classification of products does not lead to confusion among consumers or health care providers. Too much information is equal to no information. This is why I tabled an amendment on the packaging of products, for example, with awkward shapes or that are so small that it is technically impossible to attach a label. In these cases, hazard labelling information should be supplied in some other appropriate manner such as tie-on tags.
I would like to thank particularly the rapporteur, Mrs Sartori, for supporting my amendments and for the excellent work she has done on this report.
While existing regulations on identifying and communicating the hazardous properties of chemicals are similar in many respects, some differences are significant enough to result in different classification, different labelling and safety data sheets (SDS). The Globally Harmonised System (GHS) will hopefully merge these different classifications in an effective way. The benefits of chemical use far outweigh the risks and this is especially so since the introduction of the registration, evaluation and authorisation of chemicals legislation known as REACH.
We must all be aware that chemicals, through the different steps from their production to their handling, transport and use can pose potential risks to human health and the environment. In this context, the UN-EU GHS agreement is expected to be an improvement in human health and environmental protection and will also offer greater clarity to enterprises, particularly those involved in international trade.
The potential but manageable risks involved with chemicals underline the need for our legislation on a globally harmonised approach to packaging and labelling of chemicals, and it is in this respect I am pleased that the Council and Parliament agreed to a text on 27 June, and I congratulate again our rapporteur on the work done on this complex but very important file.
Jens Holm
on behalf of the GUE/NGL Group. - (SV) Those who work in chemicals manufacturing will be particularly severely affected. According to a Finnish study, around 32 million EU citizens are exposed to carcinogenic chemicals in their workplace every day.
It is our duty to ban the most dangerous chemicals and exercise control over all chemicals in general. This was the very purpose of the chemicals legislation REACH which we decided on last year. The result of REACH can be debated. I myself thought that the final result was watered down and lobbied to pieces by industry, but at least it is there, the world's most wide-ranging chemicals legislation.
The GHS, the Globally Harmonised System of Classification and Labelling of Chemicals, continues and complements REACH. The GHS aims to pass information about chemicals on to workers and consumers. The aim is to classify and label the thousands of substances and mixtures which surround us. The GHS is in fact a UN Convention which we must now implement at EU level. Once the GHS has been passed - unfortunately not until 2010 for substances and as late as 2015 for mixtures - all chemicals will be easy to identify. It is about better information for the millions of workers who come into contact with chemicals every day, for consumers who must be able to know what they are buying. Labelling will also help to improve public health in general and the environment.
Industry will be able to enjoy more consistent legislation which will facilitate international trade. This is a major step forward and that is why we in the Confederal Group of the European United Left/Nordic Green Left support this compromise.
However, it is a pity that we did not go as far as we could have done. Chemicals which are persistent, bioaccumulative and toxic, PBTs, will not be labelled. Instead this compromise means that the question of PBTs will be dealt with at UN level. This is a serious flaw in the agreement. Why not decide that PBT chemicals are to have the same status as all the others and also be labelled. Now we have to hope that other countries exert pressure on the question of PBTs. I also believe that this will be the case in the long term.
Despite this, this is a decent compromise which will lead to millions of Europeans, workers and consumers, receiving more information about the tens of thousands of chemicals around us. This is a major and important decision for everyone suffering from cancer, allergies or skin diseases as a result of chemicals.
Graham Booth
on behalf of the IND/DEM Group. - Madam President, with the REACH Regulation now beginning to take its terrible toll on productive industry, especially on smaller businesses, and the numbers of animal experiments rising sharply, here in the form of come some more instructions from the world-government zealots of UNESCO on how to classify, label and package the results of its previous idea.
Being equally thirsty for anti-democratic global domination, the commercial and political elite which constitutes the European Union hastens to implement these instructions, just as they did to implement REACH. They made a barrage of assurances of their good intentions which may for the moment protect or delude their so-called stakeholders, but which will not satisfy the great number of the unemployed which these measures are already beginning to produce.
A crumb of recognition for public opinion falls from the master's table in the form of Amendments 10, 12, 39 and 42, to place reducing animal experimentation in certain circumstances before adherence to the letter of the legislation. I understand that this is due to pressure from the influential environmental groups upon which the EU depends for so much of its support, and placing the welfare of non-human primates above that of humans, as expressed in Amendment 40, is surely going too far to placate them, but finding anything deserving of a positive vote in the oppressive and obsessive process of EU legislation is a rarity worthy of note.
For the rest, there is no reason why sensible standards of safety should not be adopted voluntarily by democratic nation states with independent judiciaries and free public access to judicial systems. Supranational edicts may appear to be an easy option, but the centralised unaccountable power they contribute, directive by unmandated directive, is not just their sting in the tail but their principal awful effect.
The claim put forward in recital 7 to the effect that this legislation will provide a competitive advantage to industry and, as Amendment 1 adds, in particular to small and medium-sized enterprises, is simply ludicrous. As always, the EU's big business overlords will benefit from the failure of their smaller competitors. They will become even larger fish in a smaller pond or flee abroad, and far from kowtowing to the EU and its ridiculous restrictions, traders overseas will trade much more profitably with each other than they will with us. The boom is over. The recession has begun and under the burden of EU regulation such as, our economies are sinking like stones.
Each traveller on this gravy train can tell his electorate whatever he likes in their own language without fear that they will overhear what his colleagues in other states are telling their electors. There is no general EU electorate and there cannot be one until perhaps in a century or two everyone speaks one language, and until that time comes EU democracy will be a joke, and a dark and dangerous joke at that. But your privileges are enormous. Why should you care about this or the crazy counterproductive laws you continually rubber stamp? And why should I care, because I am retiring at the end of this month? When I read Amendment 28 it made me realise why I have had enough of all this nonsense. It says: 'Preparation means a mixture or solution composed of two or more substances. Mixture and preparation are synonyms'. Well, however would we survive without this supernanny state explaining such things to us, and how on earth have I survived to the ripe old age of 68 when I spent my infant years chewing the leaded paint off the wooden frame of my cot? I suppose it gave my antibodies something to do in the days when we actually had antibodies.
Each leaden edict brings the collapse of the EU closer. I rejoice in that, but I deplore the damage which you are inflicting on 27 former democracies, year by disastrous year.
Jim Allister
Madam President, it makes clear sense to me that, since chemicals are manufactured and traded globally, the description of hazards on their packaging should not differ between countries, as that is both prejudicial to consumers and a disadvantage to those who accurately describe the hazard.
However, I note that at present the 'globally-harmonised' system is not very global. It is more sporadic than global. I wonder whether other countries will follow the EU's example in embracing this UN system, and what the impact might be for businesses in Europe if they do not.
In implementing these measures we need to strike a balance. Firstly, it is crucial for there to be no over-classification of products, which would confuse consumers and health-care providers.
Secondly, we need to implement these international obligations without placing unnecessary burdens on our businesses. A number of companies have raised concerns over the cost of implementation. There will be high IT and training outlays and repackaging costs, which we must not underestimate, especially in the case of small business. I would echo the concern that SMEs could fall victim, especially if they trade overseas, in which case these costs may well be more than they can bear.
Eija-Riitta Korhola
(FI) Madam President, the debate on the very recent European Chemicals Regulation, REACH, is still in our memories. It was one of the toughest legislative packages this term. The regulation on the classification, labelling and packaging of substances and mixtures we are now dealing with is partly based on, and complements, the REACH Regulation that has just entered into force. That is why it gave rise to a lot of questions beforehand.
The Commission's desire for an agreement at first reading initially seemed a bit too ambitious, given that Parliament had previously indicated its interest in legislation on chemicals. I can therefore only admire the creditable work and leadership of my colleague, Mrs Sartori, with respect to this technical report, and how she managed to avoid the temptation of revising the regulation too much and, for example, incorporating new paragraphs and classifications of substances in the annexes, which would have slowed down and even prevented the regulation's entry into force.
The report which we worked through on the committees is likely to achieve the targets set for the regulation, especially regarding the harmonisation and simplification of legislation. GHS and REACH complement one another and do not just facilitate the work of the producers and distributors of chemicals. Instead, clear and safe labelling will mean a return to consumer confidence in them.
When the work of the Committee began, people were worried that the GHS Regulation would mean that a large number of detergents, for example, would have to be classified as corrosive in the same way. This way, for example, agents for unblocking pipes and washing-up liquids would have the same classification and package labelling, with the result that consumers would not be able to distinguish between hazardous products and milder detergents. Now, however, the classifications of substances reflect their actual potential danger as well as can be expected.
The aim of this system, based as it is on a UN agreement, is that the same criteria should apply to the classification and labelling of chemicals and the regulations on the transportation, sales and use of chemicals all over the world. Under the agreement it would be fully operative by 2008. We still have a few months left to go.
Gyula Hegyi
Madam President, the global harmonisation of the classification, labelling and packaging of substances and mixtures is to be welcomed, and the European Union should play a leading role in protecting our citizens against dangerous chemicals. The whole initiative comes from the United Nations, and is therefore a global project. The globally harmonised system is a promising sign of global cooperation in environmental issues. That is why I support the adoption of the compromise on the Sartori report.
I have tabled more than 20 amendments in order to ensure the appropriate labelling and safe use of chemicals. Seventeen of those amendments were approved by the ENVI Committee. However, the same Environmental Committee also adopted several amendments from the rapporteur which would weaken consumers' rights regarding information on the hazards of the chemicals in products.
The Socialist Group and I voted against those proposals because the interests of consumers are vital to us. I am satisfied that the new compromise does not include these anti-consumer amendments, and I therefore propose to accept it. I am not totally happy with the compromise, but we cannot delay putting the GHS into our legislation.
Let us accept, as a basic principle, that companies should not invoke business confidentiality when they place hazardous chemicals on the market. Concerning hazards, consumers must have the right to have all necessary information.
Of course, the devil is in the details, so we will see how the GHS will work in practice, how hazard signs will be indicated on the products by industry, and whether consumers understand the signs and warnings. The information should be clear and easily understandable. Altogether, I hope that GHS will be a good tool to present the outcome of REACH to the public, so that chemicals are trusted much more by consumers, which will help our industry as well.
My assistant Gergely Simon, who has done much work on this and other dossiers, will leave Parliament in the near future. I would like to thank him for his contribution to our common goal, which is a chemically safer Europe.
Hiltrud Breyer
(DE) Madam President, we all know that chemicals are produced and traded throughout the world, and the dangers and risks are global too. Therefore, we need guidelines in the form of clear classifications and labels, which apply globally. I would have liked the European Union to be the engine driving very clear labelling and strong consumer protection, but I have heard many speakers here that say that, rather than being the engine, the EU should be sitting in the brake van.
I can live with this political agreement, but I am not very happy with it. Yes, we managed an important step towards greater safety for people and the environment. I am also pleased that, despite the report by the Committee on the Environment, Public Health and Food Safety in connection with threshold values for labelling, which was all too industry-friendly - the volumes of data used for the classification should have been included on the label - we managed to limit the damage in the negotiations with the Council and the Commission. I am glad that there are no longer any tonnage-based threshold values for the requirement to label and also no more accepted loopholes for industry, and that the proposed classification system redirects the focus towards alternatives to experiments on animals.
However, I would have liked to see the labelling of persistent, bioaccumulative and toxic substances improved, and a new 'acute toxicity' category created, because that is extremely topical and a matter on which we ought to have shown willingness to take action. I believe that we have sent out an important signal for greater safety for people and the environment today, but we cannot rest on our laurels. Obviously this topic is going to keep us busy in the future, as there is plenty of room for improvement.
Jean-Claude Martinez
(FR) Madam President, there are already global accounting regulations, global food standards in the Codex Alimentarius, global tax standards and UN model double taxation conventions. Now we are going to get global standards for the labelling, classification, packaging and tonnage of chemical substances.
The 2002 global legislation of the UN Social and Economic Council, the general harmonised system, is being transposed into Community law.
There is certainly some value for everyone in global harmonisation - for consumers, users, SMEs - but beyond these 2 000 pages and procedures, annexes and lists, the regulation shows that European standardisation is not enough to deal with globalised problems. Global problems need global solutions, which means that the British Prime Minister, Gordon Brown, is right: between UN level and global level, the European level is increasingly out of date, obsolete and, ultimately, useless.
Zuzana Roithová
(CS) Ladies and gentlemen, it is no longer tolerable for differing national legislation on trade, in particular in hazardous substances, to be in force within the single European market. Unification of the classification and labelling of hazardous chemicals and mixtures is good news for consumers, since the proposed harmonisation improves the protection of their health and the environment. It is also good news for the competitiveness of European industry that this complex regulation relating to the transportation, supply and use of hazardous substances will apply not only in the European Union, but also in other countries around the world thanks to UN recommendations.
The regulation ties in with REACH, but it also introduces hazard classes and categories. Labels will contain instructions for handling and compulsory graphic symbols and pictograms which will be intelligible to people anywhere in the world. New requirements for packaging and fastenings will provide protection against vessels being opened by children and also provide for markings for the blind. Critics warn of the high costs of re-labelling, the creation of 'safety data sheets' and the introduction of new packaging technologies. I am, however, convinced that these short-term expenses will be lower than the long-term savings in costs associated with the repeal of the present differing labelling of products depending on the destination. The implementation time, which is staggered over the period 2010 to 2015, is also sufficiently considerate for industry.
I greatly appreciate that Amalia Sartori has managed to reach an excellent compromise within Parliament and also with the Council. After many months of discussions on the provisions of the Commission's proposal, she has managed to achieve a great improvement and balance and therefore I urge that we adopt the proposal tomorrow at first reading. It is an example of the splendid work carried out by the parliamentary rapporteurs with the Council and Commission teams.
Genowefa Grabowska
(PL) Madam President, today we are discussing a very important regulation that arose from a debate, and later a UN decision. In this debate, which was crowned by the adoption by the Economic and Social Council of a globally harmonised system of chemical classification and labelling, all Member States, and not just the UN, played a very active and significant part, particularly the European Union, and also the Commission. This means that the system that was hammered out there is our system too. It is therefore good that today we are adapting our regulations on the use of chemicals to conform to this system, while at the same time we are ensuring and wish to ensure that our citizens - EU citizens - are protected and that our environment too is protected from the consequences of the use of hazardous substances, because the aim of this harmonisation, classification and labelling of hazardous substances is meant to be an improvement to the level of health protection, and also to the state of the environment.
Chemistry affects people the same way the world over. When you buy a product, you do not have to know what is in it. You should know, however, that you are buying a safe product. You should be able to trust the manufacturer and the product acquired. Here our role lies in labelling, which still differs to a great extent. A product labelled as hazardous in one state is toxic in another, and harmful in a third. It is unthinkable that the economy and trade in chemical substances should function in this way. This is why I am pleased to welcome our report and discussion today. I believe we are engaged in something very important.
I would like to draw attention to one final matter, namely the consequences linked to the need to provide information on labelling. I am talking about information that all those who manage waste need to know. Chemical product waste, which is and will continue to be a matter of enormous importance in our environment, must also be included in this section, which closes the whole cycle of chemical product and substance management and, subsequently, of hazardous product waste disposal. Let us give European citizens a good product, and let us give them a sense of chemical security.
Luca Romagnoli
(IT) Madam President, ladies and gentlemen, Mrs Sartori's excellent work looks like the best legislative outcome for updating and therefore ensuring better regulation of certain aspects of chemical processing. The report is praiseworthy not only because it satisfies the UN's harmonisation programme; it seems coherent, addressing the needs of producers and consumers, as well as the environment of course, in so far as this is objectively possible.
As usual, some of my fellow Members are not completely satisfied. I get the impression that this is due to an ideological radicalisation in the face of technological and scientific progress that all too often, on the pretext of environmental protection, tries to coerce us. Coincidentally, for completely different reasons to those mentioned, countries outside the European Union, not least China, are putting the economy first by allowing chemicals to be manufactured, transported and stored under conditions that are in serious breach of everything that we quite rightly want to protect here.
The Sartori report is a fundamental step forward, harmonising the classification of substances and the labelling and packaging standards of hazardous substances and mixtures. Doubtless this will help improve safety and prevent risks to the health and safety of consumers and workers and the environment.
It is currently possible for countries to classify the same substance very differently, according to different classification systems in force, and these differences can be so great as to present a risk. Substances that in Europe are classified as hazardous may, in countries such as China for example, not carry any warnings on their labels.
Not only does this situation create an unfair competitive advantage, but it is a serious threat to consumers everywhere and this, ladies and gentlemen, although you often criticise it, is unfortunately especially true in a global market.
Åsa Westlund
(SV) Madam President, before I started working on environmental issues, I have to admit that my knowledge of chemicals was relatively limited. However, the more I have learned, the more sceptical I have become about our use of such a large amount of chemicals in society today. Not very long ago I read, for example, that consumption of chemicals used in cleaning in ordinary households has increased dramatically in my country, Sweden. No one knows the true effect this is having on our health. What we do know is that already many children, not only in Sweden, are now taken to casualty every year because they have swallowed household chemicals which are acutely toxic, despite the fact that the chemicals today bear a warning label which says that this is the case.
Thanks to our decision later today, this warning will now unfortunately disappear from many products. Together with some colleagues, I tried to change this and ensure that this labelling of common household products would remain. This will now not be the case. I deeply regret this, as it means that important consumer information will be lost.
Nevertheless, I welcome the fact that the EU is now getting harmonised classification, labelling and packaging legislation to complement REACH, and that it has been drawn up on the basis of the voluntary international system which already exists. This makes things easier for consumers and companies alike. Once we have reached this decision today, it will be of the utmost importance for all nationally responsible authorities to take responsibility for getting information about the new labelling system out not only to companies but also, more widely, to different consumer groups.
I would therefore like to take the opportunity to urge the Commission and Commissioner Verheugen to follow up how, and how successfully, this is actually carried out so that we know whether the consumers of Europe understand what the labelling means from now on.
Rovana Plumb
(RO) Madam President, this proposal for a regulation, together with the other two, the regulation on detergents and the decision to amend the downstream legislation, represent the harmonisation of the European and the world legislation on classification, labelling and packaging of chemicals. Their enforcement shall have beneficial effects on human health, environmental protection and chemical industry and the development of trade under conditions of safety and the information of consumers is very important.
The GHS implementation must be correlated with the enforcement of REACH Directive for producers, approximately 27,000 in the European Union, of which 95% are SMEs, and with the development of trade with non-EU countries, namely 25% of the European Union's volume. I request the Commission not to give up the proposal for enforcing the new regulation, during the entire product management cycle, including when the product becomes waste.
I congratulate the Rapporteur on her work.
Edit Herczog
(HU) Thank you very much, Madam President. Firstly, I would like to congratulate the Commission and the rapporteurs, because they have managed to bring about a constructive debate on the UN proposal and the REACH plan that we adopted previously, and this has resulted in progress. The greatest benefit is standardised labelling, from the perspective of the Committee on Internal Market, consumers and companies. Let us not forget that chemical substances will not be safer because of the labelling! Safer use and better choices by consumers create greater safety, so we must establish that this draft legislation is a step forward in this respect and should be welcomed. Finally, I would like to say and to draw your attention to the fact that we have joined forces behind the UN as the European Union, and we must now do everything, in collaboration with the UN, to ensure that the rest of the world also adopts it. I propose this so that we may find followers for our legislation on the chemicals industry in the rest of the world, at the Transatlantic Economic Council and in other international fora. Thank you very much for your attention.
Alessandro Foglietta
(IT) Madam President, ladies and gentlemen, I would like to congratulate the rapporteur, Mrs Sartori, together with her shadow rapporteurs and the Council and the Commission for reaching an agreement on the GHS package at first reading.
We have managed to achieve the target that had been set for us, which was to get the new system up and running quickly and in line with the REACH Regulation, while at the same time ensuring a high level of protection of human health and the environment, as well as meeting the commercial needs of firms, which can now target foreign markets more easily.
Once the GHS is in operation, firms will be able to operate based on a single classification system for substances, harmonised at international level, and which, among other things, will allow easier access to legislation on substances via the European Chemicals Agency. With this regulation, which applies international criteria for the classification and labelling of hazardous substances and mixtures in the European Union, we will ensure that our firms are ready to open up to the global market. There will also undoubtedly be benefits for the consumer, who will be able to recognise hazardous substances such as toxic and corrosive substances and irritants more easily.
The GHS labelling system, with its uniform pictograms, that are easy to understand, will help identify the risks of substances contained in everyday products such as detergents and soaps. In addition, the GHS, which for many substances requires special safety devices to seal packaging, will help protect our children from dangerous accidents in the home due to the accidental ingestion of toxic or corrosive substances.
Of course, the GHS will require a certain amount of effort from firms, particularly small and medium-sized enterprises, which should have confidence in the new system. The system will in fact introduce seven new risk categories and a new classification for the transport system. This is why we are particularly pleased with the agreement reached with the Council, which also took into account the support, information and running-in requirements, particularly for SMEs.
The agreement also took account of the consensus of all parliamentary groups on the need to minimise animal testing and any duplication of these tests as far as possible. For all of these reasons, my group will be voting in favour of the package tabled.
Carl Schlyter
(SV) I would just like to reply to what my fellow Member Mr Booth said here about the environmental movement wanting to protect people but not animals. He seems to have misunderstood this. It is a question of classification. The texts to which Mr Booth refers state that you must not manipulate a chemical mixture solely for the purposes of classification in order to come in under a certain threshold, that you must not be allowed to do lots of animal tests just to avoid labelling. This would lead to us seeing chemical mixtures which contain dangerous substances, but of different kinds, and which therefore do not exactly reach the threshold for labelling. In these cases the aim would thus be to carry out animal testing solely in order to get out of labelling. It is for this reason that we need these texts.
Here animal health and human health are going hand in hand. Animal testing is avoided but people gain proper information about the chemicals so that they can take the correct action to protect themselves against them. Mr Booth has really misunderstood this!
Günter Verheugen
Vice-President of the Commission. - (DE) Madam President, ladies and gentlemen, this vigorous, lively debate has shown that we are dealing with an important and far-reaching subject. I think we can say today that taking this step concludes the intensive legislative work carried out in relation to the chemicals industry and the manufacture and use of chemicals in Europe - work that has taken many years.
I would like to make this very clear, thinking about the very useful image that Mrs Breyer used. Who is sitting in the engine, and who is sitting in the brake van? One thing is certain: as far as legislation on chemicals is concerned, the European Union is the engine for the whole world. Nowhere else are there regulations such as we have introduced, and nowhere else are demands being made of the chemicals industry such as we are making. Therefore, the Commission strongly believes that, in connection with the horizontal legislation for this sector, we now need a few years in which to put into effect what we have already decided, and that we should not immediately embark on any other major projects. It is with good reason that the REACH legislation provides for review periods, and we should observe the periods decided on by the legislator very closely. This means that the Commission will always present the reports and suggestions on time. As far as major horizontal initiatives are concerned, let me repeat that the Commission does not intend to make any further proposals within the foreseeable future.
I can also reassure you about the global effectiveness of this system. All the information available to me shows that all around the world, all those involved are indeed working hard to implement the system decided upon by the United Nations. We are definitely at the forefront when it comes to actual implementation. I think many major countries have been waiting for exactly what has happened here today, because they want to base their own legislation and their own implementation on what we do in the European Union. I expect that we will now see these procedures being brought to completion in many other countries.
Mr Schwab raised a very interesting question - that of whether we should have transitional deadlines for the conservation threshold values in Annex 6 that have been deleted as a consequence of the compromise between the parties. I can only say that the Commission does not have a problem with transitional deadlines. Personally, I believe they are essential and appropriate, but this omission in the law has not come about by chance. It is part of an overall compromise and, taking all the circumstances into account, I do not think it would have been proper for the Commission to allow the question of transitional deadlines for a few products to cause the compromise to fail. However, we will make sure that what the legislators wanted is achieved in an appropriate form.
I share the concerns of those who have voiced their misgivings about animal testing. I very much hope that this legislation does not lead to an increase in the number of tests on animals. It is important that testing on primates is absolutely prohibited in connection with this legislation. I want to say again, emphatically, that the Commission will put all its energy into restricting animal testing as much as possible. For me, this means that we must keep increasing our efforts to find recognised alternative methods to replace animal testing. Everyone who has concerns about this will find me on their side.
In conclusion, let me say that I believe that we have a piece of legislation before us that represents a 'win-win' situation for everyone involved. I am very grateful to everyone who contributed to it.
Amalia Sartori
Madam President, ladies and gentlemen, I am extremely satisfied with the debate that we have had. I would like to thank all of my fellow Members who have contributed today and I would also like to thank them for their words of support for the work that I carried out, which was only possible with their help, and with the help of the shadow rapporteurs and draftsmen of the opinions of the Committees on Industry, Research and Energy and the Internal Market and Consumer Protection. It seems that the vast majority of Members who spoke are satisfied with the results that we achieved.
I welcome the view of the person who said that even the GHS is an ongoing process, and moreover it is a working method that we have established. In these situations it is precisely that and we are aware that the world will continue to change and develop and that is the reason why in this regulation, as in REACH and other regulations, we were careful to provide a very specific and precise regulatory framework and to leave room for future modification based on these criteria, although the criteria themselves are predetermined. This is what I understood from the Commissioner who spoke just before me on the possibility of endorsing part of the debate that has taken place.
We are conscious of the fact that we are today ratifying a regulation that enjoys broad support, which will help bring benefits for consumers and workers in this sector, who represent the vast majority of the population. We know that these are rules that will be used as a framework and as an unquestionable and unassailable point of reference. Again, this is a constantly changing world, and with reference to these rules that will be handled by the Commission.
President
The joint debate is closed.
The vote will take place today.
Written statements (Rule 142)
Daciana Octavia Sârbu  
The proposal for a decision enforcing the Globally Harmonised System of Classification, Labelling and Packaging of Chemicals (GHS) represents an important step in the protection of the environment, the consumers, who will have more power to choose, as well as of companies that want to enter the international market.
The harmonised use of labels and the uniform description of dangers generated by chemicals ensure greater confidence of consumers in such products, also facilitating international trade, since industry shall be able to enforce the same labels for all the regions where it exports. Moreover, the harmonised system of classification of substances is an essential factor for ensuring the free movement of goods in the internal market.
Nevertheless, we have to make sure that this regulation does not increase the number of tests on vertebrate animals for the purpose of harmonising the classification criteria, but that they shall be performed only if there are no alternative solutions guaranteeing the same quality.
The Globally Harmonised System of Classification should allow the use of methods not involving tests on animals, even if their validation supposes a long and costly bureaucratic process. Since tests on animals have never been validated officially, the authentication of alternative tests seems a burden, but research in this field should be encouraged.
Richard Seeber  
in writing. - (DE) Increasingly frequently in the modern world, consumers come into contact with different substances, and sometimes also hazardous substances.
When using some products, including those used daily by many, information about the substances they contain is vital if they are to be used safely and in a way that does not endanger health. The Globally Harmonised System of Classification and Labelling of Chemicals (GHS), developed in 2002 at UN level with active participation by the EU, is to be implemented this year by all Member States. One of the main advantages of this system is the use of universal hazard pictograms. Consumers and traders can thus see at a glance whether a product contains certain substances that can also be dangerous. In addition, the GHS introduces standardised definitions, such as LD50 (lethal dose 50), that clearly indicate the hazard associated with the substance. The Community, and we in the European Parliament, have made it our goal to restrict animal testing for the purposes of assessing substances as much as we possibly can.
Furthermore, the definitions have been stated more precisely and clearer guidelines worked out for the authorities in the Member States. Successful implementation of the GHS represents an important milestone in making the European internal market a reality and will also be of benefit in terms of international trade.
