Safer chemicals within REACH

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Por Beverley Thorpe
Clean Production Action

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  • Substances with properties of very high concern will be made subject to authorisation; the Agency will publish a list containing such candidate substances. Applicants will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants must also analyse whether there are safer suitable alternative substances or technologies. If there are, they must prepare substitution plans, if not, they should provide information on research and development activities, if appropriate. The Commission may amend or withdraw any authorisation on review if suitable substitutes become available.
  • 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>http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm </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: www.chemsec.org </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>www.cleanproduction.org </li></ul>
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