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Srijeda, 24. listopada 2018. - Strasbourg Revidirano izdanje

25. Ozbiljne manjkavosti u provedbi europske Uredbe Reach i korištenje neispitanih kemikalija u EU-u (rasprava)
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  President. – The next item is the debate on the Council and Commission statements on the grave lack of implementation of the EU Reach Regulation and use of non-tested chemicals in the EU (2018/2887(RSP)).


  Karoline Edtstadler, President-in-Office of the Council. – Mr President, on the issue at hand concerning the lack of implementation of the REACH Regulation and, as a consequence, the extensive use of non-tested chemicals in the EU, the Presidency and the Council as a whole acknowledged the sentiments expressed by certain Members of this House, as well as the commitment of the other institutions to addressing this issue.

The Presidency takes note of the report from the German Federal Institute for Risk Assessment, which has alerted us to the risks deriving from placing on the market potentially harmful chemicals without correctly assessing whether they are mutagenic, teratogenic or toxic. The Presidency thanks Members for drawing our attention to these risks and the magnitude of the problem. We also take note of the fact that the European Chemicals Agency (ECHA) agrees with the report’s overall assessment, confirming that the quality of data on chemicals in registration dossiers still needs to improve. This view is also shared by the Presidency.

In the 10 years since REACH entered into force, safety in the EU has undoubtedly increased, but there is still much to do. Both industry and the authorities must increase their efforts to improve the quality of safety information on chemicals. It should be stressed though that the Council’s role in this process has recently been very limited as no new legislation in the area of REACH has been proposed since the mid—term review in 2013. ECHA’s Enforcement Forum is currently designing tailored enforcement actions, together with Member States, to increase compliance of the dossiers concerned. In instances such as these, it is to the Commission, in its role as guardian of the Treaties and as enforcer of Union level legislation, that we should turn for guidance and action that is appropriate and justified.

On that note, if you allow me, I would like to draw your attention to the second REACH review, which was discussed in the Council bodies earlier this year. This report showed that, in the 10 years since its entry into force, REACH has become fully operational and is delivering results towards achieving its stated objectives. We should not lose sight of the progress made.

The report, however, also identifies priorities and actions needed to further improve the application of the REACH Regulation. Among these, it was noted that Member States identified the quality of registration dossiers as the main issue that needs to be addressed in a timely manner. Member States expressed concerns about two things; firstly, that some registration dossiers do not comply with the information requirement that the REACH Regulation lays down, and, secondly, how updates to registration dossiers can be ensured.

As to time, in June of this year, the Commission expressed its intention to work with the European Chemicals Agency and the Member States to identify the reasons for the poor quality of dossiers’ updates. The Commission also signalled that it would make the appropriate proposals for improvements to this system by the first quarter of 2019. The Presidency is launching discussions on this issue in the Council working groups concerned. Moreover, the Presidency is convening an international conference on the future chemicals policy in October in Vienna and another one on green chemistry in November. The Presidency will provide a progress report to the Competitiveness Council, as well as to the Environmental Council.

The Presidency would like to join the calls on the European Chemicals Agency, as well as on Member States, to show that they are serious about protecting human health and the environment. We call on both industry and the authorities to increase their efforts on improving the quality of registration dossiers and, of course, the Council also looks forward to any proposal that the Commission may present in the future.

I would like to conclude for now by expressing my gratitude for this opportunity to join in your discussion here today. I look forward to hearing your views and to conveying them back to my colleagues in the Council.


  Phil Hogan, Member of the Commission. – Mr President, I am representing Commissioner Vella, who unfortunately cannot be here this evening. Reach is the most comprehensive chemical legislation in the world. It was designed to address the knowledge gap on the chemicals manufactured and used in Europe and to speed up risk reduction strategies for those substances that are harmful for health and harmful for the environment. The basic condition of Reach is no data, no market. This means that companies must register the chemicals they make or import. Without registration, the substance is not allowed on the market.

In these registration dossiers, the companies must detail the impact of the chemicals on human health and the environment, and how to manage those risks. Prior to registration, the European Chemicals Agency assesses all dossiers for completeness. The Chemicals Agency and the Member States’ competent authorities also carry out targeted evaluations to check that the dossiers comply with the legal requirements. The Commission is aware of recent reports indicating that an estimated one—third of the registration dossiers are non—compliant.

The need to improve compliance of registration dossiers was one of the main findings of the second review carried out earlier this year, and specific actions are already being taken to address this issue. For example, we have asked and tasked the European Chemicals Agency to increase the efficiency of the evaluation procedures by 2019.

We would like to stress that already now when a dossier is found to be non—compliant, it must be remediated by the respective company and brought into compliance. The Reach Regulation requires the Chemicals Agency to check the compliance of at least 5% of all registration dossiers. The Agency does this by targeted compliance checks of the registration dossiers that matter most through its so-called integrated regulatory strategy. We are also looking at incentives to companies to regularly review the registration dossiers and update them when necessary.

We should not lose sight of the fact that the Reach review confirmed that, overall, Reach is functioning and meeting its objectives, notwithstanding what I have just said. By the last registration deadline in May this year, more than 21 000 substances in 90 000 registration dossiers were registered at the European Chemicals Agency. This is a large amount of information unique in the world and it represents much more and better information on substances that are on the EU market, in 10 years.

The Reach review also confirmed that Reach improved risk management of chemicals by companies as well as communication and safety along the supply chains.

Reach has also led to the listing of 191 substances of very high concern on the candidate list. This is in addition to the 68 entries on the restrictions list which represents hundreds of hazardous substances that are now banned.

Altogether, this means that hazardous chemicals are being replaced by safer alternatives.

The evaluation procedure will help identify more substances of concern, I have no doubt. Enforcement is, of course, of huge importance and this is the responsibility of Member States. Coordination of their activities through the enforcement forum is proving reasonably satisfactory at EU and national level.

Based on the findings of the Reach review, I strongly believe that Reach has already contributed to the protection of EU citizens’ health and the environment, but there is much more work needed to be done to improve implementation. I am calling on the constructive cooperation of all parties involved to improve the effectiveness of our legislation.


  José Inácio Faria, em nome do Grupo PPE. –Senhor Presidente, Senhor Comissário, é graças ao REACH que a Europa tem uma das mais extensas bases de dados químicos do mundo, mas o progresso dos últimos dez anos não tem sido rápido nem transparente o suficiente e os desafios que tínhamos em 2009 na avaliação dos dois anos da abertura da agência são os mesmos que temos hoje.

Veja-se, aliás, que das 40 mil submissões de registo apenas quatro terão sido rejeitadas, o que é muito menos do que as rejeições antes da implementação do REACH. É claro que temos de ter em que linha de conta que a ECHA só tem de fazer verificações de seguimento em cerca de 5% dos dossiês, sim, só em 5%.

A Comissão pensará que o procedimento REACH é um sucesso, porque impõe barreiras à entrada através dos requisitos de acesso ao mercado e daí que só haja quatro rejeições, mas não.

Da avaliação conduzida pelo Instituto Federal Alemão de Avaliação do Risco e pela Agência do Ambiente alemã, concluiu-se que o número de substâncias conformes nunca ultrapassou os 50% nos critérios de gradação biótica e abiótica de bioacumulação e de ecotoxicidade. Mais, a avaliação deste instituto considerou que os requisitos-padrão não estão bem aplicados nos dossiês por usarem dados experimentais ou dados paralelos, ou não apresentarem justificação cabal para a ausência de dados.

Os produtos químicos têm de ser levados mais a sério e cabe à ECHA maior responsabilização pela avaliação que faz. Um terço dos produtos químicos de grande volume, fabricados ou importados na União desde 2010, não cumprem as regras destinadas a proteger a saúde e o ambiente. Estamos a falar de substâncias mutagénicas com toxicidade ambiental que afetam a biodiversidade e com toxicidade humana que podem induzir problemas de saúde como doenças metabólicas, oncológicas e endócrinas.

A Comissão sabe, certamente, que há outros químicos perigosos que usamos regularmente com uma malha legal muito mais apertada, os medicamentos, mas aqui a colaboração entre os Estados—Membros é muito maior.

A regulação não tem de ser a mesma para produtos químicos e farmacêuticos, mas para defender a saúde pública. Precisamos de agências europeias que possam agir enquanto autoridades competentes e que sejam impermeáveis aos interesses da autorregulação do mercado.


  Carlos Zorrinho, em nome do Grupo S&D. – Senhor Presidente, segundo um estudo recentemente publicado pela Agência Alemã do Ambiente, desde 2010 que um terço dos químicos produzidos ou importados para a União Europeia viola as normas europeias destinadas a proteger a saúde pública ou o meio ambiente.

Apenas 31% dos químicos investigados foram declarados como legalmente conformes. Muitas empresas estão, por isso, em incumprimento do REACH ao não informarem a Agência Europeia de Produtos Químicos se as substâncias que comercializam são cancerígenas ou nocivas. Milhões de toneladas dessas substâncias foram escoadas para a produção de todos os tipos de bens industriais e de consumo, desde pintura, embalagens, móveis a materiais de construção.

A exposição a muitos tipos de produtos químicos industriais, principalmente através da respiração da pele, constitui uma das principais causas das taxas crescentes de doenças metabólicas, cancros hormonais e doenças neurológicas.

O relator especial da ONU sobre substâncias perigosas e resíduos alertou para que a exposição incessante a substâncias tóxicas pode criar uma pandemia silenciosa de doenças.

É, por isso, urgente mudar este cenário. São necessárias ações concretas de verificação e reforço da implementação do REACH. Devemos pôr em prática o princípio «sem dados, sem mercado», isto é, pôr fim à concessão automática de registos não conformes ou insuficientes.

Temos regras de proteção da saúde e do meio ambiente adequadas e exemplares a nível mundial. Por isso, Sr. Comissário, temos de garantir a sua aplicação.


  Bas Eickhout, on behalf of the Verts/ALE Group. – Mr President, I have to say I do get a bit of a ‘dieselgate’ feeling. When I hear the Council speaking, they are saying: well, it’s the responsibility of the Commission and we are going to listen to what the Commission is going to do. And I hear the Commission speak: no, no the implementation is the responsibility of the Member States so they should do their work. We are pointing fingers again at this very serious matter. We are looking here at noncompliance of chemical companies putting chemicals on the market and they are non—compliant, not because of quality of data, but because the data is not there. It’s incomplete data and we are also not talking about just random data missing, we are talking about data that is missing on the most important issues for human health. Companies are non-compliant with REACH – one third of them. The important data is not there, and we all know that REACH is based on one principle – and you said it, Mr Commissioner: no data, no market. And still we see it is on the market. So please, here is a big problem and it’s nice that the Council is saying: ‘we take note of the report’, but that’s not enough. Taking note – we do that every day, don’t we? The question is, what are the Member States now finally going to do because the European Chemicals Agency (ECHA) has already been notifying Member States for years that companies are non—compliant so it’s not new. We know it and Member States know it. What are the Member States going to do to those companies who are non—compliant? A very simple question you have to answer now. What are you going to do to those companies that are non—compliant?

And then to the Commission, please, we do know that ECHA do a 5% check, but they only revoked four files of the 40 000 since 2010. That’s totally not in relation with what we hear now on the one third problem. So what is the Commission going to do to increase the inspections? And secondly on transparency – make clear which companies are non—compliant and what is the Commission going to do in order that they are compliant? That’s your role.


  Younous Omarjee, au nom du groupe GUE/NGL. – Monsieur le Président, après les scandales du glyphosate, des perturbateurs endocriniens, du Dieselgate, voilà maintenant le scandale du contournement de Reach.

Les citoyens seront épouvantés d’apprendre qu’un tiers des substances chimiques utilisées en Europe sont mises sur le marché sans que leur dangerosité ne soit testée, alors même que le règlement Reach l’exige.

Cela signifie, pour parler clairement, que l’industrie chimique viole en toute impunité la loi en ne fournissant pas les informations qui sont pourtant exigées sur le caractère cancérigène, mutagène ou dangereux des substances qu’elle utilise notamment pour la production des emballages alimentaires, des vêtements ou encore des jouets, c’est-à-dire des produits de consommation de tous les jours.

Nous demandons de la transparence sur cette affaire et nous demandons que soit publiée la liste des noms des entreprises concernées tout comme nous demandons, Monsieur le Président, que les États soient rappelés à leurs obligations.


  Martin Häusling (Verts/ALE). – Herr Präsident! Ja, ich denke auch, das ist das Diesel-Gate der Chemieindustrie. Das muss man auch so bezeichnen. Ich muss auch sagen: Ich bin entsetzt, dass man sich hier die Verantwortung hin und herschiebt. Der Rat ist nicht schuld, die Kommission weiß von nichts, und man wäscht sich die Hände in Unschuld. Ich kann nur sagen, dass das auch NGO an den Tag gebracht haben, ist ein weiteres Indiz dafür, dass es sich hier entweder um Kontrollversagen handelt, Arbeitsverweigerung, oder was noch? Ich weiß es nicht.

Aber man spielt mit der Gesundheit der Menschen. Es geht hier um mehr als 600 Chemikalien, die ungeprüft auf den europäischen Markt kommen. Mehr als 600, die Krebs auslösen können, die hormonelle Veränderungen herbeiführen können – und dann zuckt man mit den Schultern.

Wir haben ein gutes Gesetz mit REACH. Wenn man es nicht mit Leben erfüllt oder erfüllen will, machen wir uns unsere eigene gute Gesetzgebung am Ende des Tages kaputt. Das darf nicht passieren. Deshalb die Aufforderung auch an die Kommission, Ross und Reiter zu nennen. Wer liefert keine vernünftigen Unterlagen? Welche Chemiefirmen schlampen? Das muss ans Tageslicht, damit wir auch diejenigen zur Verantwortung ziehen können, die sehr – ja, willentlich – europäische Gesetze missachten.


Catch-the-eye procedure


  Νότης Μαριάς (ECR). – Κύριε Πρόεδρε, η χημική βιομηχανία της Ευρωπαϊκής Ένωσης βρίσκεται σε σκληρό ανταγωνισμό με τρίτες χώρες, με την Κίνα, την Ινδία, τη Βραζιλία, τη Νότια Κορέα και την Τουρκία. Αυτό, βεβαίως, δεν σημαίνει ότι πρέπει να μην τηρεί τον κανονισμό REACH, που από τα αρχικά του σημαίνει reigistration (καταχώριση), evaluation (αξιολόγηση), authorisation (αδειοδότηση) των χημικών. Διότι, αν δεν υπάρχει έλεγχος, τα χημικά οδηγούν σε καρκινογόνες καταστάσεις, σε τερατογενέσεις και σε άλλα προβλήματα, σοβαρά για την υγεία. Αυτό, όμως, που καταγγέλλεται πλέον είναι ότι υπάρχουν 600 χημικές ουσίες που κυκλοφορούν στην Ευρωπαϊκή Ένωση χωρίς άδεια, ότι το ένα τρίτο των εταιρειών δεν τηρεί τις προδιαγραφές της οδηγίας, και επομένως είναι δεδομένο ότι υπάρχει τεράστιος κίνδυνος για την υγεία και το περιβάλλον. Έχουμε πλέον ένα νέο σκάνδαλο; Αυτή τη φορά σκάνδαλο της χημικής βιομηχανίας; Ποιος έχει την ευθύνη; Δεν μπορεί να έχουμε μια πολιτική από τον Άννα στον Καϊάφα, από το Συμβούλιο στην Κομισιόν και στα κράτη μέλη. Ποιος έχει την ευθύνη; Ποιος θα πάρει συγκεκριμένα μέτρα για την προστασία των πολιτών;


  Stanislav Polčák (PPE). – Pane předsedající, nařízení REACH vyžaduje, aby průmysl vyráběl, dovážel a používal chemické látky bezpečně. Aby se tak dělo, musí být k dispozici dostatečné informace o nebezpečných chemických látkách. Je skutečností, že mnoho chemických látek bylo uváděno na trh EU, někdy i ve velmi vysokých množstvích, bez dostatečných informací o nebezpečí, které představují pro lidské zdraví a životní prostředí. V dnešní době však již existuje široké spektrum používaných testovacích metod, přičemž snahou by mělo být vyhnout se testování na laboratorních zvířatech a upřednostňovány by měly být alternativní způsoby testování. V této souvislosti je třeba uvést, že provádění legislativy REACH včetně řádného testování chemických látek je v kompetenci a povinnosti členských států. Každý členský stát má povinnost nastavit kontrolní mechanismy včetně sankcí za porušení ustanovení nařízení REACH. Určitou roli zde sehrává také Evropská chemická agentura, která je v kontaktu s národními dohledovými orgány a upozorňuje je na případná zjištění nedostatků. Takto je celý systém nastaven a jsem přesvědčen, že je nastaven dobře, nevidím důvod k revolučním změnám. Správnou cestou je důsledné uplatňování stávajících pravidel. Chci zde vystoupit na obhajobu legislativy REACH, kterou považuji za nejvyspělejší a nejkomplexnější právní předpis o chemických látkách na světě. Příkladem EU se ostatně inspirovalo mnoho dalších států světa. Průmysl EU nyní vyrábí chemické látky, jež jsou pro občany i životní prostředí bezpečnější. Naším úkolem je nyní spíše zajistit, aby výrobci v EU nebyli konkurenčně znevýhodněni oproti výrobcům ze zemí mimo EU.


(End of catch-the-eye procedure)


  Phil Hogan, Member of the Commission. – Mr President, I would like to thank the speakers who have expressed concerns in relation to this issue, and to assure Mr Eickhout that we are not ping—ponging at all with the Council. We are just out setting out the facts of the situation, Mr Eickhout. The issue of non—compliance of registration of dossiers is not unexpected and was foreseen by the decision—makers with the compliance check process. This is the reason why the second review was carried out and, arising from that review, there were recommendations made and I just want to tell you about some of them that have been implemented. So it’s not that there’s nothing happening.

The European Chemicals Agency (ECHA), with the support of the Member States and the Commission, has been working on the effectiveness and the efficiency of the process. The Commission has requested ECHA to significantly increase the efficiency of the evaluation procedures by 2019 – that’s not far away – by identifying reasons for non—compliance and developing the necessary remedies to improve the procedures and the work—sharing with the Member States.

This is not happening in the best possible way at the moment, but we want to ensure that the processes do work – and can work in parallel – and, importantly, to address the groups of substances where appropriate.

So concrete changes in decision—making are already taking place and a first 14 substance group compliance check decisions are in the final adoption stage in ECHA. The Commission has encouraged as well, of course, the updating of registration dossiers by the first quarter of 2019 to specify further the situations that trigger updates, as well as to set precise deadlines. We have an implementing regulation, supporting the implementation of REACH Article 22, being considered by the Commission and this work is ongoing.

Enhanced enforcement is very important and you and other speakers have raised this. So, by the first quarter in 2019, the Commission will consider further measures that are necessary in order to ensure that we have better enforcement. The objective of the action is wider, but we will also address the issue of registration dossier compliance.

The work of the German Institute is very welcome. I stress though that the German Institute’s project was established to estimate the data quality. It was not the legal compliance of the dossiers that it was asked to do. This is a matter for ECHA. Nevertheless, it is a very valuable contribution towards bringing this issue up the agenda and ensuring that we all have to do better in order to make sure that the dossiers are registered and that there is full compliance with what was intended in relation to the REACH proposals in the past.


  Karoline Edtstadler, President-in-Office of the Council. – Mr President, thank you for giving me the floor again and I thank you for your valuable contribution to this discussion. Thank you, Commissioner, for pointing out that it has nothing to do with finger pointing at each other, but there are some rules of different institutions in the European Union and that is exactly what we are doing, and I think we shouldn’t lose sight that this is a good legislation and that we did already make a good improvement, that we have a database, but however, this does not prevent us from improving the implementation and that is exactly what we have tried to do during our presidency and I pointed out that we are organising discussions and also international conferences to raise the awareness, and with the help of the Commission and with working together, I think we can improve the situation for all of us and for our health. I take this opportunity again to reaffirm that the Presidency is ready and willing to work with the other institutions towards implementing any course or action that will be ultimately recommended by the Commission. The Presidency remains available for exchanges on the subject as needed.


  President. – The debate is closed.

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