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Source: ECHA, Tony Musu ETUI, ETUC, KM (the individual opinions by Kari Mäkelä)

The current state of discussion on REACH, CLP and ECHA. IN Work Environment Network 31 st January and 1 st February 2013. Source: ECHA, Tony Musu ETUI, ETUC, KM (the individual opinions by Kari Mäkelä). Why we work on REACH? REACH in nutshell State of play on REACH implementation

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Source: ECHA, Tony Musu ETUI, ETUC, KM (the individual opinions by Kari Mäkelä)

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  1. The current state of discussion on REACH, CLP and ECHA IN Work Environment Network 31st January and 1st February 2013 Source: ECHA, Tony Musu ETUI, ETUC, KM (the individual opinions by Kari Mäkelä) TEAM/ Kari Mäkelä

  2. Why we work on REACH? REACH in nutshell State of play on REACH implementation Commission review on REACH REACH and nanomaterials Trade union's work on REACH and in ECHA Conclusions REACH, nano and IN? TEAM/ Kari Mäkelä

  3. Why trade unions work on REACH ? • ~1.3 million workers in the EU chemical industry • + Millions of jobs in downstream sectors (building, textile, automotive, electronic, etc...) • Chemicals contribute to the economic prosperity in terms of trade and jobs • But on the other side: • 16 % of workers in Europe declare to handle hazardous products and 22 % to breath in toxic vapours (Dublin Fd, 2008) • Around 30% of all occupational diseases recognised each year in EU are related to exposure to chemicals (ETUI, 2006) • 74 000 work-related deaths per year in EU-27 due to exposure to hazardous substances (OSHA, 2009) • The risks must be managed • BUT • using the effective, reliable and feasible RMOs • which don’t destroy the competitiveness of industry TEAM/ Kari Mäkelä

  4. REACH: basic principles • Shifting the burden of proof: Manufacturers of chemicals will have to prove that their substances can be used safely • No data = No market • Manufacturers will have to register their substances and provide data if they want them to stay/be on the market • Substances of very high concern • to be progressively replaced by suitable alternatives where these are economically and technically viable TEAM/ Kari Mäkelä

  5. REACH in a nutshell Registration: Manufacturers and importers of chemicals > 1 tpa are required to register their substances to demonstrate they can be used safely Evaluation of some substances by Member States / European Chemicals Agency Authorisationonly for substances of very high concern Restrictions when risks are unacceptable TEAM/ Kari Mäkelä

  6. Timeline for REACH registration TEAM/ Kari Mäkelä 6

  7. Progress 5 years later • Key findings • REACH and CLP are working well: commitment and collaborative work between ECHA, EU Member States, European Commission, industry and stakeholders • ECHA: REACH Report on operations • Eurostat Baseline study 5 years update: “marked increase in quality of data & better control of risk” • REACH review by the European Commission is ongoing • 12 thematic studies launched, including a review of ECHA • Outcome will be presented in February 2013? • Possible practical approaches to better implement the current legislation • Review of REACH 2012 TEAM/ Kari Mäkelä

  8. REACH review: Some of key results • BASELINE • Information available on registered substances significantly improved • REGISTRATION • Registration process a success but more needs to be done to ensure compliance • COSTS • Costs for registrants higher due to extra charges for reusing existing information and lower use of QSAR • SMEs • Suffer from poor transparency of SIEFs and “sticky” costs of registration • ECHA • Good start-up, tackled well pre-registration, registration and C&L notification. Now focus on resource efficiency TEAM/ Kari Mäkelä

  9. Progress on Registration & C&L • From the 1st registration deadline • more than 4 700 substances registered from 28 000 dossiers • chemicals produced in high volumes, CMR over 1 tonne per year and substances toxic to the environment over 100 tonnes per year • 43% are registered for substances produced outside EU (23% by importers and 20% by Only Representatives) • Registered substances – ECHA • Registration statistics - ECHA • C&L inventory • information on 120 000 substances from 5.3 million notifications • Classification & Labelling Inventory - ECHA TEAM/ Kari Mäkelä

  10. 2013 Expectations • Information:REACH 2013 - ECHA • List of substances available at • Substances identified by industry to be registered by 31 May 2013 - ECHA TEAM/ Kari Mäkelä

  11. Progress on Evaluation • Dossier evaluation by ECHA • 566 Testing proposals submitted for 2010 deadline assessed by Dec 2012 • 989 Compliance checks (5% of 2010 registrations) by end 2013 • 261 concluded; 215 ongoing; 513 to go • Substance evaluation by the EU Member States • Community Rolling Action Plan (CoRAP) lists substances to be examined • 90 substances over 2012-2014, incl. 20 suspected endocrine disruptors, 2 substances with nanoform • first evaluation reports early 2013 • next update of the CoRAP in February 2013 • Community Rolling Action Plan - ECHA TEAM/ Kari Mäkelä

  12. Dissemination TEAM/ Kari Mäkelä

  13. 2nd Regulatory Review on Nanomaterials Commission Communication 3 Oct 2012 Commission Staff Working Paper Types and uses of NM’s, including safety aspects Background COM Communication on Regulatory Aspects of NM’s 2008 EP Resolution, Council Conclusions MS initiatives (e.g. national registers on NM’s) COM definition of NM’s – 20 Oct 2011 TEAM/ Kari Mäkelä

  14. Nano Review - General Conclusions NM’s are similar to normal chemical substances – some may be toxic and some may not Possible risk related to specific NM’s and specific uses Case by case risk assessment appropriate Current methods are applicable but work on particular aspects required Overall COM remains convinced that REACH sets the best possible framework for NM’s as substances and mixtures ETUC statement: very critical; review against precautionary principle, no practical proposals to legislation etc. TEAM/ Kari Mäkelä

  15. Nano Review - REACH & CLP Registrations for 7 substances 18 C&L notifications ”Can partly be explained by the absence of detailed guidance…and the general wording of REACH annexes” COM will in the REACH review assess relevant regulatory options, in particular possible amendments of REACH annexes, to ensure clarity on how NM’s are assessed and safety demonstrated in registrations COM does not consider necessary to amend rules on when CSA is required (i.e. no lower tonnage limit) TEAM/ Kari Mäkelä

  16. Nanomaterials, REACH, ECHA • Nanomaterials are covered under REACH • No explicit nanomaterial-specific requirements • Nanodefinition provides clarity to our work as well as for the registrants • So far only few registration dossiers received containing nanomaterial-specific information • Registrants to provide nanomaterial-specific information where relevant • ECHA has updated its guidance on Information Requirements and Chemicals Safety Assessment to cover NM’s • ECHA nano webpages TEAM/ Kari Mäkelä

  17. Authorisation procedure Classification (CLP) Consultation Substances of very high concern: PBTs, vPvBs, CMRs (1&2), equivalent concerns Intention by member state or ECHA for SVHC Dossier by member state or ECHA for SVHC Member state committee Consultation • Uncertainty! • Which uses? • The behaviour • of the down stream users? • Do they apply the authorisation? • What are the costs of • authorisation? • What is the future of the • manufacturer if the substance • has many uses? Authorisation List (Annex XIV) Substance can no more be used without authorisation 6 substances (1 carcinogen) SVHC Candidate List Information obligations for suppliers 53 sustances (35 carcinogens) Prioritization TEAM/ Kari Mäkelä

  18. The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) • concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection to humans and the environment. • The new text was adopted on 22 May 2012 and will be applicable from 1 September 2013, with a transitional period for certain provisions. It will repeal the Biocidal Products Directive (Directive 98/8/EC). • New activities for ECHA TEAM/ Kari Mäkelä

  19. Trade Union representatives in ECHA's activities ? TEAM/ Kari Mäkelä

  20. REACH training material for workers' reps • Content: • REACH, why was a Regulation needed ? • What are my firm's obligations ? • REACH & the EU worker's protection laws • How can trade unions make REACH work for them ? • hard copies and on line version available in different EU languages TEAM/ Kari Mäkelä

  21. Impact of the TU Priority List ? • 50 out of 73 substances currently on the Candidate List are also on the TU list • 131 substances in common with the Member States List • Many inquiries from industry What is IndustriALL policy on this List? Is our focus on authorisation? Do we want to speed up the authorisation? TEAM/ Kari Mäkelä

  22. Workers' reps ambassadors for REACH and CLP • Many companies still unaware of their obligations under REACH and CLP • ETUC/EMCEF awareness campaign with ECHA & EU-OSHA on Sept 13th 2010 • ETUC/IndustriALL awareness campaign autumn 2012 -> • http://www.etuc.org/a/10087 • Objective: use workers' reps to inform employers • “Call to action” leaflet available in 22 EU languages TEAM/ Kari Mäkelä

  23. A new leaflet campaign spring 2013 TEAM/ Kari Mäkelä

  24. Conclusions 1 • REACH and CLP implementation have started with 2 first deadlines successfully managed by industry & ECHA • Data on registered chemicals and chemicals classified as hazardous will progressively be available on ECHA website • The second registration phase is more challenging because of the SMEs • More practical advices are needed; simple tools also for down stream users • Trade unions are key players in REACH implementation • The challenge for workers' reps (in ECHA but mainly in companies) is to make sure REACH delivers its potential benefits for occupational health & safety • New knowledge about chemicals hazards, exposures and risks • Better risk management measures (Exposure scenario is problematic!) • Substitution of dangerous substances by flexible and feasible way TEAM/ Kari Mäkelä

  25. Conclusions 2 • More human resources are needed in the trade union network around REACH and ECHA • Should we organize an official IndustriAll chemical network with regular communication, contacts and meetings? • If you like to influence you must follow what is going on in different processes and in ECHA • http://echa.europa.eu/ • Consultations http://echa.europa.eu/consultations_en.asp • Registry of intentions http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/registry-of-intentions • E-news http://echa.europa.eu/news_en.asp TEAM/ Kari Mäkelä

  26. REACH, nano and IN? • Analysis of the REACH review statement? •  IN statement preparation (work env and ind pol) •  in collaboration with IndustriAll • IndustriAll nanopolicy • Drafting by Iris Wolf and a small working group • Industry policy committee in spring 2013 • IN common opinion to the nano policy • Role in the REACH leaflet campaign? • Active participation to the IndustriAll chemicals network? TEAM/ Kari Mäkelä

  27. Thank You! TEAM/ Kari Mäkelä

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