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Staying on the REACH Road: Consultancy Support

Staying on the REACH Road: Consultancy Support. Raluca POPESCU-ERDMANN. On the REACH Road – The 5th Anniversary of REACH 23-24 November 2011, Warsaw, Poland. This is me. Raluca POPESCU-ERDMANN REACH Team. Background Environmental Engineer 2003 Romanian Environmental Inspectorate

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Staying on the REACH Road: Consultancy Support

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  1. Staying on the REACH Road: Consultancy Support Raluca POPESCU-ERDMANN • On the REACH Road – The 5th Anniversary of REACH • 23-24 November 2011, Warsaw, Poland

  2. This is me Raluca POPESCU-ERDMANN REACH Team • Background • Environmental Engineer • 2003 Romanian Environmental Inspectorate • 2007 Austrian Federal Environmetal Agency (UBA) • 2007 ECHA • 2010 UMCO • Internal focus • REACH • International Cooperation • Thematicareas • REACH legal issues • Consortiamanagement • Partnerships

  3. REACH Road My REACH Road 2010 UMCO • 2010: 1st registration deadline • 2007: entry into operation • 2006: publication in OJ • 2003: 1st public consultation • 2001: White Paper 2007 ECHA (FI) 2007 UBA / EPA (AT) 2003 Env. Insp. (RO)

  4. Content

  5. Content

  6. Facts

  7. History Staring point of services around German Immission lrequirements and major accidents ordinance (BImSchG/TA Luft/StörfallV) Foundation as Spin-Off of a medium sized coating and paint factory in Hamburg Management Buy-Out , separation from office in Magdeburg Start of UMCO Compliance Solution (Software) European project on REACH Foundation office Magdeburg 1982 1985 1987 1990 1991 1996 1997 2001 2004 2005 2008 First IT-solution for large scale compilation of safety data sheets IT-network version for compilation of safety data sheets Focus on environmental services Inauguration of the UMCO site in Köln 24-hours emergency number "GlobalChem24" and starting point for seminar/workshop services

  8. Your situation Certification, audits, general support and supervision Risc minimisation, assicuration of legal compliance Definition of compliance cycle and system developement Review of requirements, examination and assessment of risks Public opinion Regulations, acts and ordinances Client-audits and restrictions EU-regulations UN recommendations Supplier examination Liabilities Sector requirements Requirements and conditions Responsible Care Developement Acquisition Production Storage and distribution DistributionTransport

  9. Our services – All in one hand Developement Developement Production Production Acquisition Acquisition Storage/distribution Storage/distribution Distribution/transport Chemical management REACH SHE-Management Dangerous goods Emergency service

  10. The multi-dimensional UMCO network Organisations Partnershpis REACH - Consultancy - Network Regional expansions Horizontal andverticalextensions Interdisciplinar

  11. REACH • Management oftheregistrationprocess • Strategic advice • Dossier compilationandsubmission • SIEF- andconsortiummanagement • Communication in thesupplychain • Developementofstrategiesforcommunicationwithsuppliersandcustomers • Implementationofexposurescenarios in the operational practice • Adviceandconsultation on substancesofveryhighconcern in articles • Seminars andworkshops

  12. UMCO REACH Clients Manufacturers, importers, recyclers, formulators, re-sellers Large companies, SMEs EU, multinational, non-EU Lead and non-lead registrants Individual companies, consortia Wide range of industries: from petrochemical to astronautics

  13. Content

  14. 2010 Registration Deadline UMCO experience • High number of late requests for support • SIEF* communication: • high volume of information: we developed our own IT tool to handle the data • sometimes chaotic • The conditions for buying LoAs** were easily accepted • REACH understanding is good within large companies, but low for SMEs • REACH IT worked well *SIEF = Substance Information Exchange Forum **LoA = Letter of Access

  15. 2010 Registration Deadline UMCO • Over 150 registrations • Registration management for 9 lead registrants • Secretariat of the Selenium & Tellurium REACH Consortium → First obstacle successfully passed!

  16. SIEFs – Legal Arrangements Mechanism • SIEF agreement • Liabilities • Confidentiality • Data & Cost sharing principles • LR* (formal appointment) • Ownership rights • Jurisdiction • Access to the lead dossier via Letter of Access (LoA) upon • Signing of the SIEF agreement • Payment * LR = Lead Registrant

  17. SIEFs – Legal Arrangements Available Guidance • ECHA: • not involved, very limited advise • some guidance within the Draft Guidance on Data Sharing • Cefic • SIEF management • Model for SIEF agreement • Cost and data sharing • Compliance with competition rules

  18. SIEFs – Legal Arrangements Practice • SIEF agreements: vast majority according to Cefic model (by experience) Recommendations for LR / consortia • Use Cefic model for SIEF agreements • Known and widely accepted • Save resources (LR / consortia and non-lead members) • Validity date beyond the last registration deadline (31 May 2018) • Article 29, REACH: SIEF shall be operational until 1 June 2018 • but post-registration obligations

  19. SIEFs – Cost Sharing REACH: Article 27(3) Registrants “shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. (...) Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements” ECHA Guidance on Data Sharing: Section 7.4. "(...) companies cannot be forced to pay for studies that they do not need and they also cannot be forced to pay before they actually need them in their respective tonnage band.“

  20. SIEFs – Data / Cost Sharing Disputes Before 2010 Deadline • Few data sharing disputes (UMCO: 2 cases, both settled) • No serious cost sharing disputes (by experience) • Little experience • Time pressure • Large companies After 2010 Deadline • No concerns for data sharing disputes for now (UMCO: no case) • Already some cost sharing disputes • Expect more cost sharing disputes

  21. SIEFs – Cost Sharing Disputes Difficulties • Costs are not transparent enough • Often, the cost sharing mechanism is clear, but the actual costs are not explained • Sometimes, the costs are provided to the SIEF members only on request and only own costs are given → Cost sharing might be fair - clarifications could close the dispute • “Fairness” is not legally defined and has a wide interpretation • Principles known and not accepted by one party (non-lead member) → Can generate long, unproductive discussions

  22. SIEFs – Cost Sharing Disputes Example: - LoA in 2010: 35.000 Euro - LoA in 2013: 42.000 Euro - LoA in 2018: 49.000 Euro

  23. SIEFs – Cost Sharing Recommendations • Check cost sharing principles and ask for explanations if not clear • If not sure, ask for a second opinion (e.g. consultant) • If disagreement, engage a lawyer (e.g. communication to LR / consortium) • Consider / propose mediation by a neutral party • Document all communication with LR / consortium • If agreement / compromise cannot be reached, find alternative: • Opt out partly: → develop own dossier and ask ECHA for access to studies involving tests on animals → announce the SIEF of your dispute and intention to opt out • Opt out completely (not recommended, only if good justification and as a last resort)

  24. SMEs Main difficulties • less knowledge and experience • lack of resources Support • within SIEFs (e.g. initiative, work and instructions by LR) • consultants(e.g. strategy, knowledge, actual work) • REACH • if compliant with SME definition (Commission Recommendation 2003/361/EC) • if can justify (documents)

  25. SMEs Status – ECHA Verifications Documents requested (clarified with German and ECHA Helpdesks) • Ownership structure of the enterprise • Certificate / information showing the composition of headcount • Copies of (consolidated) official annual financial accounts Administrative fee Support for our clients • no UMCO service, only facilitator • external financial expert involved by UMCO • further clarifications on documents needed • evaluation of company size (certificate) • workflow established

  26. REACH Impact Outside EU Trade • Imports into EU - non-EU manufacturers: • must provide information to EU clients • get involved in REACH processes to protect business and support EU clients (OR appointment, contribution to registration) • Exports from EU • more data available • costs include REACH compliance efforts Legislative systems • REACH like • In countries that prepare for EU membership – Turkey and Serbia • In other countries: e.g. China, Korea, Taiwan • Recognition of REACH registrations: e.g. Philippines

  27. UMCO International Cooperation Objective • Ensure compliancesolutionsfor a safeworldwidedistributionofchemicalsubstancesandtheirusage How? • Partners (bilateral cooperation) • Global Chemical Consultant Network http://www.gcc-network.org/

  28. The Road to 2013 Deadline • More SME registrants • More SMEs will need to be LR (less resources & expertise) • Less known substances (more data to be generated) • Smaller SIEFs • Costs will create higher pressure - might result in higher number of • consortia • cost sharing disputes → Lessons learned, but many challenges ahead. The road will not be easy!

  29. The Road to 2013 Deadline Recommendations • Check if your substance is registered • ECHA website: http://apps.echa.europa.eu/registered/registered-sub.aspx • within SIEF • If not, get informed on the status of the work within your SIEF • work should be on track by now to be able to meet the deadline • if there is no activity in the SIEF, ask for qualified advise (e.g. consultant) Make sure there is somebody in charge!

  30. The Road to 2013 Deadline Recommendations • Prepare / plan now, if not already done: • your strategy • resources • arrangements for compiling your dossier There is not Make sure you are equipped!

  31. The Road to 2013 Deadline Recommendations • Start to prepare now, the road is clear! Move ahead!

  32. The Road to 2013 Deadline Recommendations • Do not wait until the last moment • Limited number of consultants • Possible reduced LoA prices for early buyers Don’t be late!

  33. The Road to 2013 Deadline Recommendations • Inform yourself on developments • Follow LR / ECHA instructions Make sure you know the way!

  34. The Road to 2013 Deadline Recommendations • Share data: • within your SIEF (mandatory) • with other SIEFs & data owners (can reduce costs) Do not work in isolation!

  35. The Road to 2013 Deadline Recommendations • Be prepared for enforcement • Forum projects • Regional initiatives Ensure compliance!

  36. The Road to 2013 Deadline Recommendations • Get support if: • knowledge is not available in house • you don’t have practical experience • there are complex issues Good aid is crucial!

  37. Thank you for your attention and have a safe trip!

  38. We are looking forward to cooperating with you Hamburg UMCO Umwelt Consult GmbH Georg-Wilhelm-Straße 183 21107 Hamburg Tel: +49 (0)40 / 7902 363 00 Fax: +49 (0)40 / 7902 363 57 E-Mail: umco@umco.de Köln UMCO Umwelt Consult GmbH Moltkestraße 35 42799 Leichlingen Tel: +49 (0)21 75 / 1 69 45 0 Fax: +49 (0)21 75 / 1 69 45 12 E-Mail: koeln@umco.de

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