Eversheds SHINE Reach, September 2013 presentation slides
 

Eversheds SHINE Reach, September 2013 presentation slides

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This webinar is a brief introduction to REACH (EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals). It is intended to help you understand REACH and its impact on ...

This webinar is a brief introduction to REACH (EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals). It is intended to help you understand REACH and its impact on your business whether you are based inside or outside the EU and whatever your role in the supply chain. To watch a recording of the webinar visit: http://www.eversheds.com/global/en/what/services/in-house-counsel/webinars/2013/reach-impacting-business.page

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Eversheds SHINE Reach, September 2013 presentation slides Eversheds SHINE Reach, September 2013 presentation slides Presentation Transcript

  • Is REACH impacting on your business? Elizabeth Shepherd, Partner, Sonya Veitch, Associate Eversheds LLP 26 September 2013
  • Is REACH impacting on your business? Today’s speakers Elizabeth Shepherd Partner Sonya Veitch Associate
  • Is REACH impacting on your business? • What is REACH? • REACH Registration • Supply Chain Communication • Enforcement and penalties • Overlaps with other regimes e.g. CLP and biocides • REACH – the future Agenda
  • Is REACH impacting on your business? • REACH Regulation No. 1907/2006 • Registration, Evaluation, Authorisation, and Restriction of Chemicals • In force 1 June 2007 • ECHA • Affects substances manufactured or imported into EU 1 tonne or more per year • European Economic Area e.g. includes Norway • “REACH is a journey that takes place over the years up until 2020” (ECHA's Kevin Pollard) What is REACH?
  • REACH Registration Do you have the registrations you need?
  • Is REACH impacting on your business? Which company could potentially be caught by REACH? A. EU Chemicals manufacturer B. Importer of shoes into EU C. Oil and gas service company operating in EU D. All of the above Polling question
  • Is REACH impacting on your business? • D - All of the above • Wide variety of companies affected • Includes toy shops, fireworks display companies and mining and quarrying companies The answer is...
  • Is REACH impacting on your business? • Manufacturer • Importer • Downstream user • Only Representative - Non-EU manufacturer Key roles under REACH
  • Is REACH impacting on your business? 1. One registration per substance, per legal entity 2. Only an EU importer or EU manufacturer must register 3. Late pre-registration may be an option, depending on the type and quantities of the substance being imported or manufactured Registration – the rules
  • Is REACH impacting on your business? • Who is the “importer”? – not necessarily a straightforward question – REACH definition not the same as customs – keep under review • Legal entity basis – not business units/plants Are your pre-registrations/registrations held by the correct company?
  • Is REACH impacting on your business? Outside EU EU Registration obligations – practical example Non-EU manufacturer Company B (facility 2) Group Company A Company B (facility 1) Imports 200 tonnes per calendar year Imports 110 tonnes per calendar year Imports 120 tonnes per calendar year
  • Is REACH impacting on your business? Company A and B are in the same group. Which one of the following statements is true? A. The non-EU manufacturer must register B. Either Company A or Company B can register for the group C. Each of Company A, Company B (facility 1) and Company B (facility 2) must register (ie 3 registrations) D. Company A and Company B must each register in respect of its own imports Polling question
  • Is REACH impacting on your business? • D – both Group Company A and B will need their own registrations for the quantities they import • The registration for Company B will cover imports to both facility 1 and facility 2 • The non-EU manufacturer cannot hold registrations/pre- registration • More about Only Representatives later... The answer is...
  • Is REACH impacting on your business? • Acquisitions, supply chain restructuring, moving your HQ outside the EU? • Re-evaluate your REACH compliance • Limited circumstances where registrations can be transferred - is it a qualifying legal change? • KEY QUESTION: Do you have the registrations/pre-registrations that you need? Registration obligations – issue spotting
  • Is REACH impacting on your business? Restructuring – practical example EU Outside EU Company A1 (manufacturer) Company A2 Original supply chain Company B (manufacturer) Manufacturing relocated outside the EU
  • Is REACH impacting on your business? Despite the changes to the supply chain no changes to the REACH registrations are required. A. True B. False Polling question
  • Is REACH impacting on your business? • False • Company A2 should now hold the registration • The registration/pre-registration held by A1 is no longer effective • It is only possible to transfer registrations where a qualifying legal entity change occurs The answer is...
  • Is REACH impacting on your business? • Are you entitled to appoint an Only Representative? • Understanding your role in the supply chain for REACH purposes – non EU-manufacturer – toll manufacturing – distributor Non-EU manufacturers and distributors
  • Is REACH impacting on your business? • “R” = Registration • Places burden on industry • Data sharing – key requirement • “E” = Evaluation • 5% of dossiers – targeted checking • REACH Review: “many dossiers non-compliant” • Industry asked to improve quality • Updating dossiers when required Registration dossiers
  • Supply chain communication What should you be doing?
  • Is REACH impacting on your business? • Recognised as a challenge – significant cost for companies – lack of understanding of requirements – Safety Data Sheets (“SDSs”) have doubled in length • Industry must respond Supply chain communication
  • Is REACH impacting on your business? • Would your SDSs stand up to regulatory scrutiny? • Dutch State Supervision of Mines guidance on common problems • Ensuring systems in place to review and update Focus on SDSs
  • Is REACH impacting on your business? • Particular challenge • IT systems inadequate • Long and complex supply chains • 30 – 100 pages • Mixtures – different approaches • Costly translations Focus on exposure scenarios
  • Is REACH impacting on your business? • Passing information up and down the supply chain • “Less aware of their role in REACH” (REACH Review) • Have you considered your duties? • Do your suppliers understand their duties? • SDSs – is your use covered? – what are your options if not – challenge of managing exposure scenarios Focus on downstream users EU Supplier DU Communication of uses SDS
  • Other challenges Confidential information and keeping up to date
  • Is REACH impacting on your business? • ECHA dossier dissemination – public database – extra information now published • Only certain information can be kept confidential • Registration – using Third Party Representatives • SDSs – alternative chemical names • Non- EU suppliers Confidential business information
  • Is REACH impacting on your business? • 2010, 2013 registration deadlines have passed • SIEFs active until 2018 • Monitoring tonnage bands • New ECHA Guidance • SVHCs – additional obligations Keeping up to date
  • Enforcement and penalties What’s the risk?
  • Is REACH impacting on your business? • “no data, no market” (Article 5) • Member State level • Variations across the EU • Range of civil and criminal penalties • Forum for exchange of information on enforcement Enforcement and penalties
  • Is REACH impacting on your business? • Business interruption • Contractual/customer relations • Negative PR Potential business consequences
  • Overlaps with other regimes Biocidal Products Regulation, CLP
  • Is REACH impacting on your business? • Classification, Labelling and Packaging (CLP) – transitional provisions until 2015 – closely linked to REACH • Biocides – still under the scope of REACH – new Biocidal Products Regulation (September 2013) – ECHA regulator Overlaps with other regimes
  • REACH Key points to take away
  • Is REACH impacting on your business? • Ongoing obligations • 2018 Registration deadline – 1 tonne or more • More companies must register • New issues e.g. application for authorisation • Nanomaterials – future developments • Adopting REACH principles around the world – K-REACH – co-ordinated global approach Looking to the future
  • Is REACH impacting on your business? • REACH is Law - ensure you comply • Business changes – monitor, review and update • Addressing particular challenges • Enforcement – withstanding regulatory scrutiny Key points to take away
  • Is REACH impacting on your business? Any questions
  • Is REACH impacting on your business? Elizabeth Shepherd DD: 0845 497 8215 elizabethshepherd@eversheds.com Sonya Veitch DD: 0845 497 8159 sonyaveitch@eversheds.com Contact us