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Safer chemicals within REACH


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Por Beverley Thorpe
Clean Production Action

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Safer chemicals within REACH

  1. 1. Safer chemicals within REACH Beverley Thorpe Clean Production Action Oct 1, 2009
  2. 2. The problem that REACH addresses: unregulated chemicals <ul><li>50,000 to 100,000 chemicals in use today </li></ul><ul><li>Prior to 1981 no requirements for health and environmental impact data </li></ul><ul><li>Only 5% of total chemicals in use today have full health and environmental data </li></ul><ul><li>Burden of proof on regulators to show harm </li></ul><ul><li>No level playing field: Innovative safer chemicals not competitive with untested older hazardous chemicals </li></ul>
  3. 3. REACH into force June 2007 <ul><li>R egistration – E valuation – A uthorisation – Ch emicals </li></ul><ul><li>Any chemicals used or imported over 1 tonne or more per year per company into Europe must be registered and the supplier must now identify all risks </li></ul><ul><li>Chemical producers must produce safety data sheets for 30,000 large volume chemicals </li></ul><ul><li>Hazardous chemicals (substances of very high concern –SVHC) will have to be authorised if supplier wishes ongoing use in the market </li></ul><ul><li>REACH replaces 40 pieces of legislation with more streamlined regulation and creates new European Chemicals Agency </li></ul><ul><li> </li></ul>
  4. 4. Scope of REACH <ul><li>A substance </li></ul><ul><li>Used on its own </li></ul><ul><li>Used in a chemical mixture (formulation); or </li></ul><ul><li>Used in an article (used in another product than a chemical) </li></ul><ul><li>Shall not be </li></ul><ul><li>Manufactured; </li></ul><ul><li>Placed on the European market </li></ul><ul><li>(including import); </li></ul><ul><li>Or used </li></ul><ul><li>Unless it complies with restrictions of REACH </li></ul>
  5. 5. Substances of Very High Concern <ul><li>What are they? </li></ul><ul><li>CMR: carcinogens, mutagens, reproductive toxins </li></ul><ul><li>PBT: persistent, bioaccumulative and toxic </li></ul><ul><li>Substances of equivalent concern: </li></ul><ul><ul><li>Endocrine disrupting chemicals (to be assessed in future) </li></ul></ul><ul><ul><li>Nanotechnology (to be assessed in future) </li></ul></ul><ul><li>SVHC must be authorised </li></ul><ul><li>Chemical producer must register all chemicals and have them evaluated. Chemicals that fit definition of ‘substances of high concern’ must be authorised </li></ul>
  6. 6. What does this mean for products? <ul><li>European Chemicals Agency </li></ul><ul><li>More product information </li></ul><ul><li>All substances that are intended to be released in articles under normal or intended use must be registered </li></ul><ul><li>SVHC present in articles above 0.1% by weight and present above 1 tonne/yr must be notified to Agency </li></ul><ul><li>Manufacturers, importers, and customers must have access to information </li></ul>
  7. 7. Many downstream users supported substitution principle in REACH <ul><li>Example: Water treatment industry </li></ul><ul><li>“ To minimise priority substances in the society and therefore also in the water cycle, it is necessary to use the product substitution principle. It should be clearly stated that where a safer alternative exists no, or time limited only, authorisation will be given.” </li></ul><ul><ul><ul><li>European Union of National Associations of Water Suppliers and Waste Water Services (EUREAU) </li></ul></ul></ul><ul><li>Case studies: </li></ul>
  8. 8. How REACH promotes substitution of hazardous chemicals “ My goal has been achieved: all dangerous substances will be dealt with in a way that can or will lead to substitution” – Guido Sacconi – negotiator for European Parliament position. Dec 1, 2006
  9. 9. Two routes to authorisation <ul><li>PBT and vP vB </li></ul><ul><li>No adequate control allowed </li></ul><ul><li>Socio economic reasons and availability of alternatives govern possible granting of authorisation – or not. </li></ul><ul><li>ALL AUTHORISATIONS </li></ul><ul><li>ARE TIME LIMITED </li></ul><ul><li>CMR and P and B </li></ul><ul><li>an authorisation shall be granted if the risk to human health or the environment …is adequately controlled. </li></ul><ul><li>If no adequate control, “an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies.” </li></ul>10/05/09
  10. 10. How REACH promotes substitution <ul><li>Reluctance of downstream users to use authorised chemicals </li></ul><ul><li>Chemical producers and users must prove safe thresholds and adequate control if they wish to continue using a chemical </li></ul><ul><li>Authorisation application will be transparent and web-based allowing interested third parties to submit info on safer substitutes. </li></ul>
  11. 11. Downstream companies supported REACH
  12. 12. Down stream users: Right to Know <ul><li>Downstream users can now request Safety Data sheet for any authorised chemicals found in products at more than 0.1% by weight </li></ul><ul><li>Consumers can then ask retailer for information; companies required to respond within 45 days </li></ul><ul><li>All registered chemicals will be on publicly available database </li></ul>10/05/09
  13. 13. REACH authorisation list begins: <ul><li>Seven chemicals now defined in first batch for authorisation: </li></ul><ul><li>the fragrance musk xylene </li></ul><ul><li>short-chained chlorinated paraffins </li></ul><ul><li>flame retardant hexabromocyclododecane (HBCDD) </li></ul><ul><li>the resin hardener 4,4’-Diamino diphenyl methane (MDA) </li></ul><ul><li>and three phthalate plasticisers DEHP, BBP and DBP. </li></ul>
  14. 14. Some Timelines <ul><li>June 2007 REACH becomes operational </li></ul><ul><li>June 2008 European Chemicals Agency (Helsinki) becomes operational </li></ul><ul><li>June 2009, 2011, 2013, 2015, 2017, 2019, 2021 Authorisation working lists published in timed batches </li></ul><ul><li>Nov 2010 Registration deadline for CMRs </li></ul><ul><li>June 2022 implementation finished </li></ul>Clean Production Action 2007
  15. 15. Ex: REACH and leather <ul><li>Leather has no chemicals that will </li></ul><ul><li>be ‘intentionally released’ </li></ul><ul><li>BUT: Tanners operating from the EU or for the EU need to check with their suppliers to see if SVHC listed chemicals are purchased or used in their process </li></ul><ul><li>If so, and if the content is 0.1% then must comply with regulations </li></ul>
  16. 16. What needs to be done now by tanners operating from or for the European Market? <ul><li>Step 1: Ensure all chemical products being used will be registered </li></ul><ul><li>Step 2: Confirm that no SVHC are present in chemicals used </li></ul><ul><li>Step 3: Ensure all end uses of chemicals are defined </li></ul>
  17. 17. Thank you for listening <ul><li>Beverley Thorpe </li></ul><ul><li>International Director </li></ul><ul><li>Clean Production Action </li></ul><ul><li>[email_address] </li></ul><ul><li>+1 514 933 4596 </li></ul><ul><li> </li></ul>