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Overall project goal

Danish DU project on REACH Focus on: Paints, Varnishes/Lacquers, Adhesives, Sealants Claus Ankjaergaard and Helle Simon Elbro March 2004. Overall project goal. Preparation of an action plan for the implementation of EU’s chemical policy into the individual companies. As “a side effect”:

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Overall project goal

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  1. Danish DU project on REACHFocus on: Paints, Varnishes/Lacquers, Adhesives, SealantsClaus Ankjaergaard and Helle Simon ElbroMarch 2004 ECB presentation

  2. Overall project goal • Preparation of an action plan for the implementation of EU’s chemical policy into the individual companies. • As “a side effect”: • Identify specific problems of the industry especially concerning ”workability” – is the legislation operational? ECB presentation

  3. Details of project goals • A number of pilot studies • Tools to ease the practical handling of the chemicals policy in the individual companies. • An understanding within each company of the additional “rules” necessary to continue product development and marketing after REACH. • Experience with up- and down-stream dialogue • A seminar comprising education and presentation of the REACH experience from the participating companies • An overview of the consequences, which the chemicals policy will have for the industry • A general action plan for the implementation of the chemicals policy within each company. ECB presentation

  4. Timeframe Today 2003 2004 2005 2006 2007 Length of project ECB presentation

  5. Phase 1: Core project EU Chemical strategy plan Education & Information The industry (decision makers + technicians) Prephase Tools Pilot 1 The industry (decision makers + technicians) The industry (decision makers + technicians) Pilot 2 Pilot 3 The industry (decicion makers + technicians) The industry (decision makers + technicians) + Prof. customers + general public Action plan for implementation of the new EU Chemical policy in the individual company. ECB presentation

  6. Temperature measurement Health test Treatment plan Phase 1: Core project EU Chemical strategy plan Education & Information The industry (decision makers + technicians) Prephase Tools Pilot 1 The industry (decision makers + technicians) The industry (decision makers + technicians) Pilot 2 The industry (decision makers + technicians) Pilot 3 The industry (decision makers + technicians) + Prof. customers + General public Action plan for the individual company for implementation of EU’s chemical policy ECB presentation

  7. Manpower Ad Hoc Consultancy work 100% project leader FDLF:General Project responsibility Project work (100% financed by Danish EPA)    60% 30% 60% Dyrup Companies Danalim Hempel Pilot work (financed by industry) ECB presentation

  8. Steering group • Danish EPA • DU company representatives • Supplier company representatives • Consultants • Supply chain • Risk evaluation • The federation of Danish Industry • Project management ECB presentation

  9. Status Project start Pilot 1: ”Temperature measurement” 2003 2004 2005 Pilot work in companies General information meeting 1 (June) General information meeting 2 (May) 2-day technical workshop For pilot companies (September) ECB presentation

  10. Snowball effect SubstancesRaw materialsRecipes/Products (100x) (100x) (100x) Average: 60 substances per. recipe Average: 3 substances per. Raw mat. Average: 20 raw mat. per. recipe ECB presentation

  11. Measuring high volume substances(HPVC) Substances App. 70 % is HPVC App. 80 % of raw materials contain min. one HPVC. Raw materials 100 % of recipes will be affected by the legislation in 2009. Products ECB presentation

  12. Assumption: 30% of LPVC disappears. Measurement of low volume substances(LPVC) Substances Ca. 30 % is LPVC Ca. 45 % of raw materials contains min. one LPVC. Raw mat. 80 % of the recipes contain min. one LPVC. Products ECB presentation

  13. Potentially the same product must be changed 3 times = suboptimization Time of Registrationdepends on production volume/year/producer Time of Registra- tion > 1 tons > 100 tons > 1000 tons 2009 2017 2012 Many recipies contain substances from all tonnage bands. ECB presentation

  14. Substances of concern • CMR 1-3 • List of dangerous substances (Annex I) • QSAR predictions (Danish EPA) • PBT and vPvB • Working list from EU Commission • US-EPA • Endocrine disrupters • Preliminary list from EU Commission ECB presentation

  15. Present focus • Preparation for next general information meeting in May. • Analysis of temperature measurement for 12 companies in the industry • Detailed reading of REACH (October, 2003) • Dialogue meetings with Danish EPA • Educational overheads • 1:1 follow-up on Pilot 1 • Background understanding of Chemical safety assessment. ECB presentation

  16. Future workPreliminary plans • ”Heat 2” of Temperature measurement • Chemical Safety Assessment • Exposure scenarios • Generic product matrix • Information up- and down-stream • Workshops with suppliers up-stream • Focus group with professional users ECB presentation

  17. EXPOSURE SCENARIOSDU participation in CSA/CSR ECB presentation

  18. Import Goods Preparations Exposure Import Preparations Preparations Goods Consumer Professional Environment Articles Substances Supply chain Import Unintended exposure Waste Chemical Safety Assessment (CSA) Responsibility of Registrant: Assess if substance is used safely in entire supply chain. ECB presentation

  19. CSA to be documented in: Extract from CSR: • Chemical Safety Report (CSR) • Part A • Summary of Risk Management Measures • Declaration that Risk Management Measures are Implemented • Declaration that Risk Management Measures are Communicated • Part B • Identification of the substance and Physical and Chemical properties • Classification and Labelling • Environmental Fate Properties • Part C • Human Health Hazard Assessment • Human Health Hazard Assessment of Physicochemical Properties • Environmental Hazard Assessment • PBT and vPvB Assessment • Exposure Assesment (Scenario 1, Scenario 2, etc) • Risk Characterisation SDS (1-16) Annex 1 Exposure scenario 1 Risk reduction measures In supply chain Agency(or kept at site) Downstream user Communication of CSA ECB presentation

  20. Goods SDS (1-16) SDS (1-16) Annex: Exposure scenarios Risk reduction measures Annex: Exposure scenarios Risk reduction measures Goods Information on identified use Supply chain Communication in supply chain ECB presentation

  21. All identified uses from supply chain Exposure scenario (incl. Risk Reduction Measures) Iterations Exposure assessment PNEC/DNEL Risk characterisation To be documented in a Chemical Safety Report Chemical Safety Assessment Hazard Assessment Health/Environmental No classification No PBT or vPvB Classification PBT or vPvB ECB presentation

  22. Conditions for use for the exposure scenario: Exposure scenario: Paint for indoor use • Composition • Concentration of substance x < 10%. No organic solvents • Use characteristics • Spray painting • Duration and frequency • 8 hours/day, 200 days/year • Cleaning • Equipment can be cleaned with hot water and detergent • Risk management measures • Wear mask and gloves during use • Provide ventilation in rooms, with a replacement rate of 1 per hour • Containers and other waste must be treated as hazardous waste – that is, delivered to a collection system • Liquid waste, including cleaning water, may be disposed of via the sewage system, if connected to a sewage treatment plant (unless other paint constituents require differently); otherwise it must be treated as hazardous waste. ECB presentation Ref: ECB presentation 10-11-2003

  23. ONE SUBSTANCE ECB presentation

  24. Chemical Safety Assessment Hazard assessment No Classification No PBT or vPvB Classification PBT or vPvB . . Exposure scenario Incl. Risk reduction measures Exposure assessment PNEC/DNEL Risk characterisation ECB presentation

  25. . Import Goods Preparations Import Preparations Preparations Goods Consumer Environment Articles Substances Import Unintended exposure Waste Exposure scenario - example Exposure Professional Supply chain ECB presentation

  26. . Exposure scenario – example Exposure routes Oral Preparations Professional Inhalation Skin contact ECB presentation

  27. . Substance A (100%) Storage Exposure scenario – example Plant operations Preparations Professional Receival Loading Filling Mixer ECB presentation

  28. . Substance A Exposure scenario – example Manual loading of raw material Quantity loaded: 45 kg/ day Substance A: 100% (liquid) No gloves Professional Mixer ECB presentation

  29. Chemical Safety Assessment Hazard assessment . No Classification No PBT or vPvB Classification PBT or vPvB Exposure scenario Incl. Risk reduction measures . Exposure assessment PNEC/DNEL Risk characterisation ECB presentation

  30. Substance A Exposure assessmentCalculation Body weight 70 kg Specific exposure of Substance A: X mg/kg x 45 kg/day / 70 kg = ? mg substance A / kg / day Professional Generic exposure: X mg/kg 100% Quantity loaded: 45 kg/day Mixer ECB presentation

  31. Substance A Generic Exposure values Exposure values mg raw material on hands Pr kg raw material loaded Granulates Exposure scenario: Manual loading of raw material 21 mg Powder 50 mg Professional Liquid Mixer 250 mg ECB presentation

  32. Substance A Exposure assessmentCalculation Body weight 70 kg Specific exposure of Substance A: 250 mg/kg x 45 kg/day / 70 kg = 161 mg substance A / kg / day Professional Generic exposure: 250 mg/kg 100% Quantity loaded: 45 kg/day Mixer ECB presentation

  33. PNEC/DNEL Chemical Safety Assessment Hazard assessment . No Classification No PBT or vPvB Classification PBT or vPvB Exposure scenario Incl. Risk reduction measures Exposure assessment PNEC/DNEL Risk characterisation ECB presentation

  34. Derived No Effect Level (DNEL) • Maximum amount of substance (mg) • Pr. bodyweigth • Pr. day where no toxic effect is observed • DNEL is found in SDS • Assumption: • 100% bio-availability and uptake • Margin of safety is included in DNEL ECB presentation

  35. Chemical Safety Assessment Hazard assessment . No Classification No PBT or vPvB Classification PBT or vPvB Exposure scenario Incl. Risk reduction measures Exposure assessment PNEC/DNEL Risk characterisation ECB presentation

  36. Exposure Specific exposure: 161 mg/kg/day RQ = = Hazard DNEL: 50 mg/kg/day RQ > 1: Concern RQ < 1: No concern RQ > 1 Use is unsafe Modification of exposure scenario Risk characterisationRQ = Risk Quotient ECB presentation

  37. Exposure value (mg/kg/day) Manual 161 No gloves 45 Chemical Safety BoxPrinciples Level of manual involvement Manual Automated PPE No gloves Gloves Quantity loaded (kg/day) ECB presentation 15 30 45

  38. Chemical Safety Box Exposure values Level of manual involvement To be compared with: DNEL = 50 mg/kg/day Manual Automated 54 107 161 PPE None used 18 36 53 81 Gloves 9 18 27 Quantity loaded (kg/day) ECB presentation 15 30 45

  39. Exposure RQ = DNEL 161 = 50 Chemical Safety Box Risk Quotients (RQ) Manual Automated 1,1 2,1 3,2 = Safe None used = Unsafe 0,4 0,7 1,1 1,6 Gloves 0,2 0,4 0,5 ECB presentation 15 30 45

  40. Fundamental question How to communicate safe use in a simple way – when description needs several dimensions: • Degree of automation • PPE • Quantity loaded ECB presentation

  41. Receival Filling Exposure scenario n Dermal exposure  Dermal exposure Dermal exposure ….. Total systemic exposure = Oral exposure Oral exposure Oral exposure Oral exposure ….. Inhalatory exposure Inhalatory exposure Inhalatory exposure Inhalatory exposure ….. The complexity of the exposure assessment Loading Dermal exposure ECB presentation

  42. SIMPLE PREPARATION ECB presentation

  43. Substance C Substance B Substance A Risk characterisation for a preparationSubstance by substance Same simple exposure scenario: Manual loading of raw material Quantity loaded: 45 kg/ day No gloves Professional Safe Unsafe Mixer ECB presentation

  44. conci DNELi Annex 1b: DNELmix= = 0.1*50 + 0.2*10 + 0.7*5000 = 3507 RQ = 161 / 3507  0  Safe  conci DNELi 0.1*50 + 0.2*10 Annex 1b: DNELmix= Version 2 Only including hazardous substances = = 17  conci 0.1 + 0.2 RQ = 48 / 17 = 2.8  Unsafe Risk characterisation for a preparationConsidered as a mixture A B C Assumption: Same exposure route (regardless of target organ) Physical form Liquid Liquid Liquid Conc. 100% 100% 100% Conc. in preparation 10% 20% 70% Hazard Skin Skin None DNEL (mg/kg/day) 50 10 5000 Calculated exposure 113 (reference 161) 16 32 Safe Unsafe Safe ECB presentation

  45. conci DNELi 0.1*50 + 0.07*10 Annex 1b: DNELmix= Only including hazardous substances = = 34  conci 0.1 + 0.07 RQ = 27,2 / 34 = 0,8  Safe Risk characterisation for a preparationExample 2 A B C Concentration of substance B is decreased from 20 % to 7 % w/w Physical form Liquid Liquid Liquid Conc. 100% 100% 100% Conc. in preparation 10% 7% 83% Hazard Skin Skin None DNEL (mg/kg/day) 50 10 5000 Assumption: Same exposure route (regardless of target organ) Calculated exposure 133,8 (reference 161) 16 11,2 Safe Unsafe Safe ECB presentation

  46. Fundamental questions Risk calculation: How to characterise the risk for a preparation? Does annex Ib adress the problem adequately? How to obtain DNEL for non-hazardous substances? Is it scientifically sound to treat different target organs on an equal basis? ECB presentation

  47. All substances Total exposure for preparation Receival Loading Filling Exposure scenario n ,,,,,  Dermal exposure Dermal exposure Dermal exposure Dermal exposure Dermal exposure Dermal exposure Dermal exposure Dermal exposure ,,,,, Oral exposure Oral exposure Oral exposure Oral exposure ,,,,, All exposure routes for one substance Inhalatory exposure Inhalatory exposure Inhalatory exposure Inhalatory exposure Inhalatory exposure Inhalatory exposure Inhalatory exposure Inhalatory exposure ECB presentation ,,,,,

  48. Alternative version 1: A: 10% B: 20% C: 70% Substance is delivered as granulate (instead of liquid)  Exposure is decreased Alternative version 2: A: 10% C: 70% D: 20% Substance B is substituted with substance D DNELD > DNELB Hazard is reduced Chemical Safety Box – for a preparationSame principle as for a single substance • Current preparation: • A: 10% • B: 20% • C: 70% • Current use is • Un-safe • Action is required e.g. R.M.M. ECB presentation

  49. Working with exposure scenarios Comparing conditions for use for each substances in the preparation  and finding the common area where both can be used safely. Comparing total exposure with DNELmix Substance A Preparation A+B? Substance B ECB presentation Substance A Preparation A+B? Substance B

  50. Fundamental questions How to combine ”conditions for use” for several hazardous substances in single exposure situations? ECB presentation

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