Danish DU project on REACH

Focus on: Paints, Varnishes/Lacquers, Adhesives, Sealants

Claus Ankjaergaard and Helle Simon ElbroMarch 2004Bilag 3

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Overall project goalPreparation of an action plan for the implementation of EUs chemical policy into the individual companies. As a side effect: Identify specific problems of the industry especially concerning workability is the legislation operational?

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Details of project goalsA number of pilot studiesTools 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 industryA general action plan for the implementation of the chemicals policy within each company.

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Timeframe20032004200520062007Length of projectToday

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Education & InformationThe industry(decision makers + technicians) The industry(decision makers + technicians)The industry(decision makers + technicians) + Prof. customers+ general publicPhase 1: Core projectEU Chemical strategy planAction plan for implementation of the new EU Chemical policy in the individual company. ToolsPilot 1Pilot 2Pilot 3The industry(decision makers + technicians) PrephaseThe industry(decicion makers + technicians)

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Education & InformationThe industry(decision makers + technicians)The industry(decision makers + technicians)The industry(decision makers + technicians)+ Prof. customers+ General publicPhase 1: Core projectEU Chemical strategy planAction plan for the individual company for implementation ofEUs chemical policyToolsPilot 1Pilot 2Pilot 3The industry(decision makers + technicians) PrephaseThe industry(decision makers + technicians)

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ManpowerHempelDanalimDyrupProject work(100% financed by Danish EPA) 30%60%60%Pilot work (financed by industry)100% project leaderAd HocConsultancy workCompaniesFDLF:GeneralProject responsibility

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Steering groupDanish EPADU company representativesSupplier company representativesConsultantsSupply chainRisk evaluationThe federation of Danish Industry

Project management

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Status200320052004ProjectstartGeneral informationmeeting 1 (June)2-day technical workshopFor pilot companies (September)Pilot work incompaniesGeneral informationmeeting 2 (May)Pilot 1: Temperature measurement

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Snowball effectSubstances Raw materials Recipes/Products(100x) (100x) (100x)Average:3 substancesper. Raw mat.Average:20 raw mat.per. recipeAverage:60 substancesper. recipe

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Measuring high volume substances(HPVC)SubstancesRawmaterialsProductsApp. 70 % is HPVCApp. 80 % of raw materials containmin. one HPVC.100 % of recipes willbe affected by the legislation in 2009.

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Measurement of low volume substances(LPVC)SubstancesRaw mat.ProductsCa. 30 % is LPVCCa. 45 % of raw materials containsmin. one LPVC.80 % of the recipescontain min.one LPVC.

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Time of Registrationdepends on production volume/year/producer2009> 1000 tons> 100 tons> 1 tons20122017Time of Registra-tionMany recipies contain substances from all tonnage bands.

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Substances of concern

CMR 1-3List of dangerous substances (Annex I)QSAR predictions (Danish EPA)PBT and vPvBWorking list from EU CommissionUS-EPAEndocrine disruptersPreliminary list from EU Commission

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Present focusPreparation for next general information meeting in May.Analysis of temperature measurement for 12 companies in the industryDetailed reading of REACH (October, 2003)Dialogue meetings with Danish EPAEducational overheads1:1 follow-up on Pilot 1Background understanding of Chemical safety assessment.

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Future workPreliminary plansHeat 2 of Temperature measurementChemical Safety Assessment Exposure scenariosGeneric product matrixInformation up- and down-streamWorkshops with suppliers up-streamFocus group with professional users

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EXPOSURE SCENARIOS

DU participation in CSA/CSR

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Chemical Safety Assessment (CSA)Responsibility of Registrant:Assess if substance is usedsafely in entire supply chain.

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Communication of CSA

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Communication in supply chain

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Chemical Safety AssessmentHazard AssessmentHealth/EnvironmentalNo classificationNo PBT or vPvBClassificationPBT or vPvB

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Exposure scenario:CompositionConcentration of substance x < 10%. No organic solventsUse characteristicsSpray paintingDuration and frequency8 hours/day, 200 days/yearCleaningEquipment can be cleaned with hot water and detergentRisk management measuresWear mask and gloves during useProvide ventilation in rooms, with a replacement rate of 1 per hourContainers and other waste must be treated as hazardous waste that is, delivered to a collection systemLiquid 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.Ref: ECB presentation 10-11-2003Paint for indoor useConditions for use for the exposure scenario:

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ONE SUBSTANCE

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Chemical Safety Assessment..Hazard assessmentNo ClassificationNo PBT or vPvBClassificationPBT or vPvBExposure assessmentExposure scenarioIncl. Risk reduction measuresRisk characterisationPNEC/DNEL

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Exposure scenario - exampleSupplychainProfessionalExposure

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Exposure scenario example Exposure routesProfessionalSkin contactInhalationOralPreparations

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Exposure scenario example Plant operationsMixerReceivalLoadingFillingPreparationsProfessional

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Exposure scenario example ProfessionalMixerManual loading of raw materialQuantity loaded: 45 kg/ day

Substance A: 100% (liquid)

No gloves

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Chemical Safety Assessment..Hazard assessmentNo ClassificationNo PBT or vPvBClassificationPBT or vPvBExposure assessmentExposure scenarioIncl. Risk reduction measuresRisk characterisationPNEC/DNEL

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Exposure assessmentCalculationMixerGeneric exposure:X mg/kgQuantity loaded:45 kg/dayProfessionalBody weight70 kgSpecific exposure of Substance A:

X mg/kg x 45 kg/day / 70 kg =

? mg substance A / kg / day100%

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Generic Exposure valuesProfessionalMixerExposure scenario:Manual loading of raw materialGranulatesPowderLiquidExposure valuesmg raw materialon hands

Pr kg raw materialloaded21 mg50 mg250 mg

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Exposure assessmentCalculationMixerGeneric exposure:250 mg/kgQuantity loaded:45 kg/dayProfessionalBody weight70 kgSpecific exposure of Substance A:

250 mg/kg x 45 kg/day / 70 kg =

161 mg substance A / kg / day100%

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Chemical Safety Assessment.Hazard assessmentNo ClassificationNo PBT or vPvBClassificationPBT or vPvBExposure assessmentExposure scenarioIncl. Risk reduction measuresRisk characterisationPNEC/DNEL

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Derived No Effect Level (DNEL)

Maximum amount of substance (mg)Pr. bodyweigthPr. daywhere no toxic effect is observedDNEL is found in SDSAssumption:100% bio-availability and uptakeMargin of safety is included in DNEL

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Chemical Safety Assessment.Hazard assessmentNo ClassificationNo PBT or vPvBClassificationPBT or vPvBExposure assessmentExposure scenarioIncl. Risk reduction measuresRisk characterisationPNEC/DNEL

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Risk characterisationRQ = Risk Quotient

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Chemical Safety BoxPrinciplesQuantity loaded (kg/day)Level of manual involvementPPE45GlovesNoglovesManual3015Automated

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Level of manual involvementPPE45GlovesNone usedManual3015Automated1075418362718981To be compared with:DNEL = 50 mg/kg/day53161Quantity loaded (kg/day)Chemical Safety BoxExposure values

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45GlovesNone usedManual3015Automated2,11,10,40,70,50,40,21,61,13,2= Safe= UnsafeChemical Safety BoxRisk Quotients (RQ)

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Fundamental questionHow to communicate safe use in a simple way when description needs several dimensions:Degree of automationPPEQuantity loaded

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The complexity of the exposure assessmentLoadingDermal exposure

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SIMPLE PREPARATION

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ProfessionalSame simple exposure scenario:Manual loading of raw materialQuantity loaded: 45 kg/ dayNo glovesRisk characterisation for a preparationSubstance by substanceMixer

Safe

Unsafe

ABCPhysical formLiquidLiquidLiquidConc. 100%100%100%Conc. in preparation10%20%70%HazardSkinSkinNoneDNEL (mg/kg/day)50105000

Calculated exposure(reference 161)1632113

Risk quotient0,33,2

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Risk characterisation for a preparationConsidered as a mixtureABCPhysical formLiquidLiquidLiquidConc. 100%100%100%Conc. in preparation10%20%70%HazardSkinSkinNoneDNEL (mg/kg/day)50105000Calculated exposure(reference 161)1632113Assumption:Same exposure route(regardless of target organ)SafeUnsafeSafe

Risk quotient0,33,20,02

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Risk characterisation for a preparationExample 2ABCPhysical formLiquidLiquidLiquidConc. 100%100%100%Conc. in preparation10%7%83%HazardSkinSkinNoneDNEL (mg/kg/day)50105000Calculated exposure(reference 161)1611,2SafeUnsafe133,8SafeConcentration of substance B is decreased from 20 % to 7 % w/wAssumption:Same exposure route(regardless of target organ)

Risk quotient0,31,10,03

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Fundamental questionsRisk 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?

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Total exposure for preparationLoadingExposure scenario nReceivalFillingDermal exposureInhalatory exposure,,,,,,,,,,,,,,,,,,,,Oral exposureDermal exposureInhalatory exposureDermal exposureInhalatory exposureOral exposureDermal exposureInhalatory exposureDermal exposureInhalatory exposureOral exposureDermal exposureInhalatory exposureDermal exposureInhalatory exposureOral exposureDermal exposureInhalatory exposureAll exposureroutes forone substance

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Chemical Safety Box for a preparationSame principle as for a single substanceCurrent preparation:A: 10%B: 20%C: 70%

Current use is Un-safe

Action is required

e.g. R.M.M.

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Working with exposure scenariosSubstance ASubstance BPreparation A+B?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 DNELmixSubstance ASubstance BPreparation A+B?

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Fundamental questions

How to combine conditions for use for several hazardous substances in single exposure situations?

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THE END

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Jeg vil dog ikke vise nogle resultater fra dette fordidels er ikke alle kriteriesttene fastlagte endnu der var ex. ndringer fra Maj til oktober forslaget hvor vi endeligt s at CMR 3 stoffer ikke er karakteriseret som potentielt problematiskeDels er det flsomme data for den enkelte virksomhed (lad vre med at sige at vi ikke nogen branche opsamling af disse)Men platformen er der for at den enkelte virksomhed selv kan begynde at agere overfor sine problematiske stofferBemrk at klassifikationen er et ja/nej svar Men ved den efterflgende riskokarkateristik kan det vre ndvendigt at gentage fare-vurderingen, og s laver man et (nyt )tox. Forsg og forbedrer derved sikkerhedsmargen eks. Fra QSAR til egentlig test forsg.

TOXdata DNEL og PNEC som indgr i Risiko vurderingenTOXdata Klassifikationen som indgr i det indledende ja/nej om produktet skal klassificeres.

CLAUS: Husk at indstte de rigtige vrdier for granulater etc ogsl.

De str som xx i jelbikket.