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REACH and Downstream Users

Understand REACH registration for Downstream Users, requirements for substances in articles, Annex V testing, exposure scenarios, and more. Learn about tools like CSA, CSR, and SDS for adequate risk control.

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REACH and Downstream Users

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  1. REACH and Downstream Users Marie McCarthy REACH GI Inspector Health and Safety Authority

  2. Am I a Downstream User ?

  3. Registration As it applies to Downstream Users (DUs)

  4. Registration - A Phased Process • Non-phasein Substances Registration required before manufacture/import/use • Phase-in Substances • 3 years > 1000 t/yr CMRs Cat 1&2 >1 t/yr R50/53 > 100t/yr • 6 years>100 t/yr • 11 years > 1 t/yr

  5. Registration of Substances in Articles Required where • Substance is present at > 1 t/yr per producer or importer • Substance is intended to be released under normal or forseeable conditions Unless substance has already been registered for that use

  6. Notification of Substances in Articles Required where • Substance meets criteria in Art 54 and is identified according to Art 56(1) • Substance present at > 1 t/yr/M or I • Substance present at > 0.1% w/v Unless M/I can exclude exposure to humans & environment under normal & forseeable conditions of use.

  7. Low Volume (1-10 t/a) Substances Annex V testing required for • Non phase-in substances in all cases • Phase-in substances meeting one or both criteria in Annex I ( c ) - Likely to meet criteria for CMR Cat 1,2 or • Wide dispersive use and likely to be classified as dangerous Phase-in substances not meeting criteria in Annex I ( c ) only need physicochemical studies

  8. Tools used by Industry • CSA used to determine which risk management measures and operational conditions are necessary to ensure risks to human health and environment are adequately controlled • CSR used to document the appropriate risk management measures and operating conditions to ensure adequate control • Exposure scenario (ES) is a description of the set of conditions for use of a substance so that risks are adequately controlled. This must reflect the outcome of the CSA, be documented in the CSR and annexed to SDS • SDS used to communicate risk management measures downstream.

  9. Chemical Safety Assessment • CSA(Annex I) at > 10t/yr • Registrant must ensure that risks are adequately controlled for manufacture and/or each identified use • Must specify risk management measures for each exposure scenario • DU has a right to identify use to M/I • M/I includes this in his CSR if he can support the use • DU may choose not to identify use but may have to notifyChemicals Agency & perform CSA

  10. Exposure Scenario - conditions ensuring adequate control • Physicochemical characteristics • Process description • Operating conditions • Risk management measures • Populations exposed • Must cover entire life cycle including use in articles, consumer use, waste disposal etc. • Process-specific conditions >>>> broad, generic ESs covering multiple uses/substances

  11. Derivation of an Exposure Scenario Existing Knowledge/data Exposure Scenarios Hazard Identification Classification and labelling Exposure Assessment Hazard Assessment Risk characterisation Adequate control Exposure Scenarios (final) Documented in CSR and SDS

  12. Substance X in Paints for Brushing/Application by Roller Standardised exposure scenario for group of substances outlining • Protective clothing • Maximum periods of exposure • Cleaning of brushes/rollers etc • Disposal of waste

  13. Substance X used in Spray-painting of Cars Process- specific exposure scenario outlining • Maximum periods of exposure • Minimum requirements for the equipment (booth, breathing apparatus) • Filtering efficiency • Cleaning frequency and procedures • Protective clothing • Hygiene measures • Waste disposal

  14. Is my use covered by my supplier’s registration ?

  15. Am I covered by Suppliers CSA ? SDS + Exposure Scenarios (ES) Am I inside ES? Make use known to the supplier Apply ES DU No Yes No Notify Agency Do targeted CSA and CSR

  16. Do I need to act? DU takes no further action in the following situations: • He is using less than 1 t/yr • He is operating within the conditions of an exposure scenario communicated via SDS and has implemented recommended RMM on his site • SDS not required for substance (e.g. not dangerous) • CSR not required for M/I ( e.g. < 10 tonnes/yr) • He is using it for PPORD

  17. I need to act The DU must complete a CSR and report to Agency in the following situations: • CSR required and • He is operating outside exposure scenario communicated in an SDS or • He has chosen to keep his use secret or M/I has not taken account of it • Methodology for DU CSA in Annex XI • Must implement appropriate Risk Management measures (RMM) on own site and inform DUs of appropriate RRM for their use

  18. DU Report • DU Report is not a registration • Limited information on identity of DU and supplier, identity of substance and generic use description • In limited circumstances, testing proposal may be required – dossier evaluation • Reporting not required for small quantities (< 1 tonne)

  19. Information Flow Through the Supply Chain

  20. Information flow through the Supply Chain • SDS main tool Extended scope & role • All dangerous substances and prepartions placed on the market • PBTs/vPvBs identified by Annex XII criteria • Must be consistent with CSA • Exposure scenarios annexed to SDS • Information flow up and down supply chain

  21. Roles for DUs under REACH • Check compliance with suppliers exposure scenario • If not covered, and where necessary, report to Agency and carry out a CSA • Comply with any authorisation and restriction conditions • Communication upstream & downstream

  22. Supports for DUs & SMEs • Guidance for downstream users (RIP 3.5) • Guidance on articles (RIP 3.8) • Tools for SMEs • Trade Associations - development of standardised use descriptions • National helpdesk – Health and Safety Authority • Agency helpdesk

  23. Benefits for DUs & SMEs • Improved access to information • Better quality of information • Informed decision-making • Improved worker safety • Reduced liability and compensation costs • Increased innovation

  24. Risks for SMEs and DUs • Increased costs • Withdrawl of substances • Disclosure of confidential business information

  25. Timelines • Nov 2005 EP First Reading • Dec 2005 Council political agreement • Autumn 2006 Second Reading • 2006/2007 Development of IT tools and guidance for industry & MS • April 2007 Entry into force • April 2008 Agency operational. Registration and other provisions commence

  26. What should I do now ? • Monitor development of REACH and Guidance documents • Assess your use of chemicals • Think about implications of REACH for your business • Dialogue a.s.a.p!!!

  27. Useful Websites Commission Websites http://europa.eu.int/comm/enterprise/reach http://europa.eu.int/comm/environment/chemicals/reach ECB Website http://ecb.jrc.it/ Health and Safety Authority Website www.hsa.ie Queries on REACH wcu@hsa.ie

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