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REACH , an American expat’s experience

REACH , an American expat’s experience. Sean Mahar Euro Safety and Health sean@eurosh.com. REACH. REACH Registration, Evaluation and Authorisation of CHemicals. REACH Objectives. Protection of human health and the environment

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REACH , an American expat’s experience

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  1. REACH,an American expat’s experience Sean Mahar Euro Safety and Health sean@eurosh.com

  2. REACH • REACH Registration, Evaluation and Authorisation of CHemicals

  3. REACH Objectives • Protection of human health and the environment • Maintenance and enhancement of the competitiveness of the EU chemical industry • Prevention of fragmentation of the internal market

  4. REACH Objectives • Increased transparency • Integration with international efforts • Promotion of non-animal testing • Conformity with EU international obligations under the WTO

  5. REACH • In October 2003, the European Commission adopted a proposal for a new EU regulatory framework for chemicals – REACH • The REACH regulation entered into force June 1, 2007.

  6. REACH deadlines • 1 June 2007: REACH entry into force • 1 Dec. 2008: pre-registration ends • 1 Dec. 2010: registration > 1,000 t/y, or CMR 1 or 2 > 1 t/y, or R50-53 (PBT/vPvB) > 100 t/y • 1 June 2013: registration > 100 t/y • 1 June 2018: registration > 1 t/y year

  7. Registration • of basic information • all existing and new substances exceeding a production volume of 1 tonne • submitted by companies and entered in a central database

  8. Evaluation • of the registered information for all substances exceeding a production volume of 100 tonnes • includes development of substance tailored testing programs • focus on the effects of long-term exposure

  9. Authorisation for Substances of very high concern (SVHC): Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2, Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) included in Annex XIV of REACH. Once included, they cannot be placed on the market or used after date set “sunset date” unless the company is granted an authorisation.

  10. REACH actions Manufacturers/Importers • Registration for all substances >1 tonne • Chemical Safety Report (CSR) for all substances >10 tonne • Participation in Substance Information Exchange Fora (SIEFs)

  11. REACH actions Downstream Users (Customers) • Apply the risk management measures identified in the SDS Exposure Scenario • Make their uses known to manufacturers/importers • or carry out their own CSA • (confidentiality reasons) • Contribute to SIEFs

  12. Substance Information Exchange Forum (SIEF) Mandatory forum created during pre-registration to assist the sharing and data collection of REACH compliance information and studies with other registrants of the same substance.

  13. SIEF Members • Potential Registrants • Third Party Representatives • Data Holders • Others

  14. Leading Involved Passive Dormant European Chemical Industry Council Brussels-based organization representing the European chemical industry. CEFIC SIEF Codes

  15. CEFIC SIEF Codes • Leading “This is a substance of high strategic importance for my company and I have available resource to (co) lead and drive registration to completion.” • Involved “My company is registering and may be actively involved. My company will receive a SIEF progress report, an invoice and an invitation to comment.”

  16. CEFIC SIEF Codes • Passive “My company has the intention to register this substance. My company will receive a SIEF progress report and an invoice.” • Dormant “My company has no intention to register nor to spend money. My company will receive no communications and no invoice (besides mandatory data sharing).”

  17. Registration Dossier Contents: • a technical dossier, for substances in quantities of 1 tonne or more per year, and, in addition, • a chemical safety report, for substances in quantities of 10 tonnes or more per year.

  18. The Chemical Safety Report The main goal of the chemical safety report (CSR) is to document the chemical safety assessment (CSA), including its conclusions and results. • Required for all substances >10 tonne

  19. Chemical Safety Assessment (CSA) • Human Health Hazard Assessment • Human Health Hazard Assessment of Physicochemical Properties • Environmental Hazard Assessment • PBT and vPvB Assessment • Exposure Assessment • Risk Characterization

  20. Chemical Safety Assessment The goal of the CSA is to identify and describe the conditions under which the risks are controlled. Risks are regarded as controlled when the estimated exposure levels do not exceed the derived/predicted no effect levels (DNEL or PNEC).

  21. Chemical Safety Assessment Exposure Assessment • Generation of exposure scenario(s) or the generation of relevant use and exposure categories • Exposure estimation

  22. Chemical Safety Assessment Exposure Estimation • emission estimation • assessment of chemical fate and pathways • estimation of exposure levels.

  23. Chemical Safety Assessment Risk Characterization • human exposure comparison with DNEL • environmental exposure comparison with PNEC • assessment of the likelihood and severity of an event from physicochemical properties

  24. Risk Characterisation Ratio (RCR) PEC – predicted environmental concentration

  25. DNEL Derived no effect level “the level of exposure above which humans should not be exposed”

  26. DNEL factors Exposure pattern: • population likely to be exposed, • frequency and duration of exposure, • route of exposure

  27. PNEC Predicted no effect concentration “the concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur”

  28. PNEC Spheres • aquatic (including sediment) • terrestrial • atmospheric • food-chain accumulation • microbiological activity of sewage treatment systems

  29. Exposure Scenarios (ES) • a set of information describing the conditions under which the risks associated with the identified use(s) of a substance can be controlled. • in CSR • in Extended Safety Data Sheet

  30. Exposure Scenarios (ES) Two facets • Operational conditions • Risk management measures (RMM)

  31. Exposure Scenarios (ES) Operational conditions • processes involved • activities of workers and consumers and environment • duration and frequency of exposure

  32. Exposure Scenarios (ES) Risk management measures (RMM) • to reduce or avoid direct and indirect exposure of humans and the environment during use and disposal

  33. ES contributing scenarios industrial spray painting • conditions for mixing and filling of equipment (manually) • conditions for mixing and filling of equipment (automated) • conditions of cleaning the equipment (manually) • conditions of cleaning the equipment (automated) • manual spraying with LEV and no respiratory/skin protection • manual spraying without LEV, but respiratory/skin protection applied • robot-spraying (closed-automated) • conditions during drying of coated article (closed-automated) • conditions during drying of coated article (open-ventilated)

  34. Occupational Exposure Assessments Three elements • emission estimation • assessment of chemical fate and pathways; • estimation of exposure levels.

  35. Occupational Exposure Assessments

  36. Exposure Modeling Tools • ECETOC TRA • Stoffenmanager • EMKG/ BauA-COSHH • ART “Advanced Tool” for inhalation exposure assessment • RISKOFDERM • BEAT (Bayesian Exposure Assessment Tool) • ECHA’s CSA-Tool Chesar

  37. ECETOC TRA Tool

  38. Stoffenmanager www.stoffenmanager.nl 3 different versions: • control banding of chemical risks; • quantitative exposure assessment, and • REACH worker exposure assessment.

  39. Stoffenmanager

  40. EMKG/ BauA-COSHH Tool http://www.reach-clp-helpdesk.de/reach/en/Exposure/Exposure.html • part of the “Easy-to-use workplace control scheme for hazardous substances” (EMKG “Einfaches Maßnahmenkonzept für Gefahrstoffe”) of the Federal Institute for Occupational Safety and Health (BAuA).

  41. EMKG/ BauA-COSHH Tool

  42. Advanced Reach Tool (ART) www.advancedreachtool.com • Incorporates a mechanistic model of inhalation exposure and a statistical facility to update the estimates with the user’s own data. • “This combination of model estimates and data produces more refined estimates of exposure and reduced uncertainty.“

  43. Advanced Reach Tool (ART)

  44. RISKOFDERM http://product-testing.eurofins.com/media/18263/toolkit_setup.zip • Eurofins was responsible for a Working Group that developed a toolkit providing employers with means of ranking dermal exposure risks in workplaces and with guidance on control measures for improved protection

  45. RISKOFDERM

  46. Bayesian Exposure Assessment Tool (BEAT) http://xnet.hsl.gov.uk/download/ • an advanced probabilistic model for predicting dermal exposure. TNO is developing BEAT together with the UK Health &Safety Executive.

  47. CHEmical Safety Assessment and Reporting tool (CHESAR) Tool http://chesar.echa.europa.eu/ • developed by the European Chemicals Agency (ECHA) to support industry in preparing a Chemical Safety Assessment (CSA) and Chemical Safety Report (CSR)

  48. CHEmical Safety Assessment and Reporting tool (CHESAR) Tool

  49. Tool Test Cleaning with MEK Full shift (300 min), daily Wipe applied to large surfaces No ventilation or PPE Large room

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