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Preparing for REACH: First steps a company can take.

Preparing for REACH: First steps a company can take. Aoife Clarke Executive, REAChAid. Aims of this session. Outline step by step what companies should do to prepare Go through Pre-registration process Case Study – Pre registration of Ethylene. Timeline of REACH.

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Preparing for REACH: First steps a company can take.

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  1. Preparing for REACH:First steps a company can take. Aoife Clarke Executive, REAChAid

  2. Aims of this session • Outline step by step what companies should do to prepare • Go through Pre-registration process • Case Study – Pre registration of Ethylene

  3. Timeline of REACH • June 2007 – Entry into force • June 2008 – European Chemicals Agency becomes operational • 1st June 2008 – Start Pre registration • 1st Dec – End pre registration • Nov 2010 – End registration CMRs, >1000 tonnes etc • June 2013 – End registration > 100 t • June 2018 - End registration > 1 t

  4. Practical steps for everyone • Make inventory of individual substances & preparations • For each – define your status & position • For each – Divide into three categories • Manu. by your company in EU • Imported by your company into the EU • Purchased by your company by supplier established in EU i.e. downstream user

  5. Practical steps for everyone • Polymers – List of monomers (>2%) contained within the polymer • Establish annual volumes of substances • Identify CAS, EINECS & ELINCS number (if appropriate) • Identify and list your suppliers or customers • Initiate communication

  6. Manufacturer/Importer • You are the registrant • Pre-registration • Technical Dossier • >10t CSR & CSA • For each substance gather as much of the information on the intrinsic properties • In House, Publicly available • Define missing data list • Data used in the framework for waiving • Column 2 in annexes VII to X • Is any data based on vertebrate tests?

  7. Manufacturer/Importer • Classification & Labelling Information • Safety Data sheet compliant with existing legislation • Key tool for communication in supply chain • Ensure compliant • Care to be taken with data owned by company • Formal contract in place • Clarity needed on ownership • In groups establish legal entity

  8. Importers of Preparations • List your preparations and suppliers • Determine origin • EU based supplier • You import into EU • Check current SDS & other sources to identify components • Establish annual tonnages for each • If source outside EU investigate alternative supply

  9. Downstream User • If not manufacturing or importing • At this stage; • Identify and list your suppliers • Per substance • Per preparation • Start initial communication up and down the supply chain

  10. Final steps at this stage • For both Manufacturers/Importers and Downstream Users • Compile information on uses and conditions • Exposure to environment • Own workforce • Customers workplaces • Final uses

  11. Final steps at this stage • Broad categories • Industrial uses • Professional use • Consumer use • Initially Inventory complete

  12. Pre-Registration • 1st Step in REACH • Transitional period for “phase in” substances • Required Registration times • CMR’s, High tonnage 2010 • >100 t/a 2013 • >1t/a 2018 • But only if substance is pre-registered • If there is no pre-reg done then company has to submit registration without delay

  13. What needs Pre-registration • substance to be pre-registered can be e.g. • a single chemical or • a component in a preparation or • a substance in an article • preparation consisting of several substances will require separate pre-registrations for each of these substances • pre-registration only for phase-in substances • Listed in EINECS • Manufactured in one current EU MS within last 15 years but not on market e.g. intermediates etc

  14. Pre-registration – When? • Start: 12 months after REACH is in force • End: 18 months after REACH is in force • only a 6 month period for the actual pre-registration process • 1st June 2008 – 1st December 2008

  15. Pre-Registration – Who? • M/I of • Substance • Preparation • Article – intentionally released under normal conditions or reasonably foreseeable • Appoint 3rd party Representative • To protect confidential business info

  16. Pre- Registration Data • Required data for pre-registration comprises of • name of the substance including e.g. • EINECS or ELINCS number (if available and appropriate) • CAS name and CAS number (if available) • name and address of the potential registrant • name of the contact person • the envisaged deadline for the registration • the name(s) of substance(s) for which the available information is relevant for Grouping of substances and/or (Q)SAR

  17. What then? • The Agency will publish the names of the pre-registered substances, as well as the substances intended to be used for read-across approach, on its website. • From this SIEFs and consortia will be formed • The final format for the submission of the pre-registration data and how the SIEF etc will work is yet unknown.

  18. Case Study - Ethylene • Ethylene - flammable gas (C2H4) derived from natural gas and petroleum – used in chemicals, anesthetic • Phase In substance – listed on EINECS 3 • Eligible for Pre- registration • Company – Different locations that manufacture, import or use the substance • Holding company & HQ in Switzerland • 2 legal entities in EU – Germany, Belgium • 1 legal entity outside EU - Russia

  19. 1. Identify the roles of each legal entity

  20. 2. Identification of Pre-Registration Possibilities

  21. 2. Identification of Pre-Registration Possibilities (continue)

  22. 2. Identification of Pre-Registration Possibilities (continue)

  23. Only Representatives • Non EU companies can appoint one • External – not part of the group of companies • Internal – legal entity within group of companies • OR will act as an importer and will fulfil all the legal obligations • OR should have “sufficient background” in the practical handling of ethylene and its information • In our example – Belgium most obvious choice for “Only Representative” for Russia

  24. Data submission by the Belgian subsidiary (all Options)

  25. Data submission by the external OR for the Russian subsidiary (Option B1)

  26. Data submission by the German subsidiary (option A)

  27. 4. Submit the data • Pre-registration data submitted online via the internet at the Agency website • Commission have not yet finalised system.

  28. Summary • Preparation is the key • Is there someone in the company to take this on • Get inventory in order • Know what substances • Know what volumes • Start gathering basic data • Start dialogue - upstream & downstream

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