reach , an american expat’s experience

REACHREACH,,an American expat’s experiencean American expat’s experience

Sean MaharSean Mahar

Euro Safety and HealthEuro Safety and Health

[email protected]@eurosh.com

REACHREACH

• REACH REACH Registration, Registration, Evaluation and Evaluation and Authorisation of Authorisation of CHemicalsCHemicals

REACH ObjectivesREACH Objectives

• Protection of human health and the Protection of human health and the environment environment

• Maintenance and enhancement of the Maintenance and enhancement of the competitiveness of the EU chemical competitiveness of the EU chemical industry industry

• Prevention of fragmentation of the Prevention of fragmentation of the internal market internal market

REACH ObjectivesREACH Objectives

• Increased transparency Increased transparency • Integration with international efforts Integration with international efforts • Promotion of non-animal testing Promotion of non-animal testing • Conformity with EU international Conformity with EU international

obligations under the WTOobligations under the WTO

REACHREACH

• In October 2003, the European In October 2003, the European Commission adopted a proposal for a Commission adopted a proposal for a new EU regulatory framework for new EU regulatory framework for chemicals – REACHchemicals – REACH

• The REACH regulation entered into The REACH regulation entered into force June 1, 2007.force June 1, 2007.

REACH deadlinesREACH deadlines

• 1 June 2007: REACH entry into force 1 June 2007: REACH entry into force

• 1 Dec. 2008: pre-registration ends1 Dec. 2008: pre-registration ends

• 1 Dec. 2010: registration > 1,000 t/y, or 1 Dec. 2010: registration > 1,000 t/y, or CMR 1 or 2 > 1 t/y, or CMR 1 or 2 > 1 t/y, or R50-53 (PBT/vPvB) > 100 t/y R50-53 (PBT/vPvB) > 100 t/y

• 1 June 2013: registration > 100 t/y 1 June 2013: registration > 100 t/y

• 1 June 2018: registration > 1 t/y year 1 June 2018: registration > 1 t/y year

RegistrationRegistration

• of basic informationof basic information– all existing and new substances exceeding all existing and new substances exceeding

a production volume of 1 tonne a production volume of 1 tonne

– submitted by companies and entered in a submitted by companies and entered in a central databasecentral database

EvaluationEvaluation

• of the registered information for all of the registered information for all substances exceeding a production substances exceeding a production volume of 100 tonnesvolume of 100 tonnes– includes development of substance tailored includes development of substance tailored

testing programs testing programs

– focus on the effects of long-term exposurefocus on the effects of long-term exposure

AuthorisationAuthorisation

forfor Substances of very high concern (SVHC): Substances of very high concern (SVHC):Carcinogenic, Mutagenic or toxic to Reproduction Carcinogenic, Mutagenic or toxic to Reproduction

(CMR) classified in category 1 or 2, (CMR) classified in category 1 or 2, Persistent, Bioaccumulative and Toxic (PBT) or Persistent, Bioaccumulative and Toxic (PBT) or

very Persistent and very Bioaccumulative (vPvB)very Persistent and very Bioaccumulative (vPvB)included in Annex XIV of REACH. Once included in Annex XIV of REACH. Once

included, they cannot be placed on the included, they cannot be placed on the market or used after date set “sunset date” market or used after date set “sunset date” unless the company is granted an unless the company is granted an authorisation.authorisation.

REACH actionsREACH actions

Manufacturers/ImportersManufacturers/Importers Registration for all substances >1 tonneRegistration for all substances >1 tonne Chemical Safety Report (CSR) for all substances Chemical Safety Report (CSR) for all substances

>10 tonne>10 tonne Participation in Substance Information Exchange Participation in Substance Information Exchange

Fora (SIEFs)Fora (SIEFs)

REACH actionsREACH actions

Downstream Users (Customers)Downstream Users (Customers) Apply the risk management measures identified Apply the risk management measures identified

in the SDS Exposure Scenario in the SDS Exposure Scenario Make their uses known to Make their uses known to

manufacturers/importersmanufacturers/importers or carry out their own CSAor carry out their own CSA

(confidentiality reasons) (confidentiality reasons)

Contribute to SIEFsContribute to SIEFs

Substance Information Substance Information Exchange Forum (SIEF)Exchange Forum (SIEF)

Mandatory forum created during pre-Mandatory forum created during pre-registration to assist the sharing and data registration to assist the sharing and data collection of REACH compliance information collection of REACH compliance information and studies with other registrants of the and studies with other registrants of the same substance. same substance.

SIEF MembersSIEF Members

• Potential RegistrantsPotential Registrants

• Third Party RepresentativesThird Party Representatives

• Data HoldersData Holders

• OthersOthers

CEFIC SIEF CodesCEFIC SIEF Codes

• LeadingLeading

• InvolvedInvolved

• PassivePassive

• DormantDormant

European Chemical European Chemical Industry CouncilIndustry Council

Brussels-based Brussels-based organization organization representing the representing the European chemical European chemical industry.industry.


• LeadingLeading “This is a substance of high “This is a substance of high strategic importance for my company and I strategic importance for my company and I have available resource to (co) lead and have available resource to (co) lead and drive registration to completion.”drive registration to completion.”

• InvolvedInvolved “My company is registering and “My company is registering and may be actively involved. My company will may be actively involved. My company will receive a SIEF progress report, an invoice receive a SIEF progress report, an invoice and an invitation to comment.”and an invitation to comment.”


• PassivePassive “My company has the intention to “My company has the intention to register this substance. My company will register this substance. My company will receive a SIEF progress report and an receive a SIEF progress report and an invoice.”invoice.”

• DormantDormant “My company has no intention to “My company has no intention to register nor to spend money. My company register nor to spend money. My company will receive no communications and no will receive no communications and no invoice (besides mandatory data sharing).”invoice (besides mandatory data sharing).”

Registration Dossier Registration Dossier

ContentsContents::• a a technical dossier,technical dossier, for substances in for substances in

quantities of 1 tonne or more per year, quantities of 1 tonne or more per year, and, in addition, and, in addition,

• a a chemical safety report, chemical safety report, for substances for substances in quantities of 10 tonnes or more per year.in quantities of 10 tonnes or more per year.

The Chemical Safety ReportThe Chemical Safety Report

The main goal of the chemical safety report The main goal of the chemical safety report (CSR) is to document the chemical safety (CSR) is to document the chemical safety assessment (CSA), including its conclusions assessment (CSA), including its conclusions and results.and results.

Required for all substances >10 tonneRequired for all substances >10 tonne

Chemical Safety Assessment Chemical Safety Assessment (CSA)(CSA)

1.1. Human Health Hazard AssessmentHuman Health Hazard Assessment

2.2. Human Health Hazard Assessment of Human Health Hazard Assessment of Physicochemical PropertiesPhysicochemical Properties

3.3. Environmental Hazard AssessmentEnvironmental Hazard Assessment

4.4. PBT and vPvB AssessmentPBT and vPvB Assessment

5.5. Exposure AssessmentExposure Assessment

6.6. Risk CharacterizationRisk Characterization

Chemical Safety AssessmentChemical Safety Assessment

The goal of the CSA is to identify and describe The goal of the CSA is to identify and describe the conditions under which the risks are the conditions under which the risks are controlled. controlled.

Risks are regarded as controlled when the Risks are regarded as controlled when the estimated exposure levels do not exceed estimated exposure levels do not exceed the derived/predicted no effect levels (DNEL the derived/predicted no effect levels (DNEL or PNEC). or PNEC).


Exposure AssessmentExposure Assessment

• Generation of exposure scenario(s) or Generation of exposure scenario(s) or the generation of relevant use and the generation of relevant use and exposure categoriesexposure categories

• Exposure estimationExposure estimation


Exposure EstimationExposure Estimation

– emission estimationemission estimation

– assessment of chemical fate and assessment of chemical fate and pathwayspathways

– estimation of exposure levels.estimation of exposure levels.


Risk CharacterizationRisk Characterization

• human exposure comparison with DNELhuman exposure comparison with DNEL

• environmental exposure comparison environmental exposure comparison with PNECwith PNEC

• assessment of the likelihood and assessment of the likelihood and severity of an event from severity of an event from physicochemical propertiesphysicochemical properties

Risk Characterisation Ratio Risk Characterisation Ratio (RCR)(RCR)

PEC – predicted environmental concentrationPEC – predicted environmental concentration

DNEL

Exposureor

PNEC

PECRCR

DNELDNEL

Derived no effect levelDerived no effect level

““the level of exposure the level of exposure above which above which humans should not humans should not be exposedbe exposed””

DNEL factorsDNEL factors

Exposure pattern:

• population likely to be exposed,

• frequency and duration of exposure,

• route of exposure

PNECPNEC

Predicted no effect concentrationPredicted no effect concentration

““the concentration of the substance below the concentration of the substance below which adverse effects in the which adverse effects in the environmental sphere of concern are environmental sphere of concern are not expected to occurnot expected to occur””

PNECPNEC

SpheresSpheres

• aquatic (including sediment)aquatic (including sediment)

• terrestrialterrestrial

• atmosphericatmospheric

• food-chain accumulationfood-chain accumulation

• microbiological activity of sewage microbiological activity of sewage treatment systemstreatment systems

Exposure Scenarios (ES)Exposure Scenarios (ES)

• a set of information describing the a set of information describing the conditions under which the risks conditions under which the risks associated with the identified use(s) of a associated with the identified use(s) of a substance can be controlled. substance can be controlled.

• in CSRin CSR

• in Extended Safety Data Sheetin Extended Safety Data Sheet


Two facetsTwo facets

• Operational conditionsOperational conditions

• Risk management measures (RMM)Risk management measures (RMM)


Operational conditionsOperational conditions

• processes involvedprocesses involved

• activities of workers and consumers and activities of workers and consumers and environmentenvironment

• duration and frequency of exposureduration and frequency of exposure


Risk management measures (RMM)Risk management measures (RMM)

• to reduce or avoid direct and indirect to reduce or avoid direct and indirect exposure of humans and the exposure of humans and the environment during use and disposalenvironment during use and disposal

ES contributing scenariosES contributing scenarios

industrial spray paintingindustrial spray painting

• conditions for mixing and filling of equipment (manually)conditions for mixing and filling of equipment (manually)

• conditions for mixing and filling of equipment (automated)conditions for mixing and filling of equipment (automated)

• conditions of cleaning the equipment (manually)conditions of cleaning the equipment (manually)

• conditions of cleaning the equipment (automated)conditions of cleaning the equipment (automated)

• manual spraying with LEV and no respiratory/skin protectionmanual spraying with LEV and no respiratory/skin protection

• manual spraying without LEV, but respiratory/skin protection manual spraying without LEV, but respiratory/skin protection appliedapplied

• robot-spraying (closed-automated)robot-spraying (closed-automated)

• conditions during drying of coated article (closed-automated)conditions during drying of coated article (closed-automated)

• conditions during drying of coated article (open-ventilated)conditions during drying of coated article (open-ventilated)

Occupational Exposure Occupational Exposure AssessmentsAssessments

Three elementsThree elements

1.1. emission estimationemission estimation

2.2. assessment of chemical fate and assessment of chemical fate and pathways;pathways;

3.3. estimation of exposure levels.estimation of exposure levels.

Occupational Exposure Occupational Exposure AssessmentsAssessments

Exposure Modeling ToolsExposure Modeling Tools

– ECETOC TRA ECETOC TRA

– Stoffenmanager Stoffenmanager

– EMKG/ BauA-COSHH EMKG/ BauA-COSHH

– ART “Advanced Tool” for inhalation exposure ART “Advanced Tool” for inhalation exposure assessment assessment

– RISKOFDERMRISKOFDERM

– BEAT (Bayesian Exposure Assessment Tool) BEAT (Bayesian Exposure Assessment Tool)

– ECHA’s CSA-Tool Chesar ECHA’s CSA-Tool Chesar

ECETOC TRA ToolECETOC TRA Tool

StoffenmanagerStoffenmanager

www.stoffenmanager.nlwww.stoffenmanager.nl

3 different versions: 3 different versions:

• control banding of chemical risks;control banding of chemical risks;

• quantitative exposure assessment, andquantitative exposure assessment, and

• REACH worker exposure assessment.REACH worker exposure assessment.

http://www.youtube.com/v/iBsgjJVo-6c&hl=en_US&fs=1&rel=0

StoffenmanagerStoffenmanager

https://www.stoffenmanager.nl/Authorized/Roadmap.aspx

EMKG/ BauA-COSHH ToolEMKG/ BauA-COSHH Tool

http://www.reach-clp-helpdesk.de/reach/en/Exposure/http://www.reach-clp-helpdesk.de/reach/en/Exposure/Exposure.htmlExposure.html

• part of the “Easy-to-use workplace control part of the “Easy-to-use workplace control scheme for hazardous substances” (EMKG scheme for hazardous substances” (EMKG “Einfaches Maßnahmenkonzept für “Einfaches Maßnahmenkonzept für Gefahrstoffe”) of the Federal Institute for Gefahrstoffe”) of the Federal Institute for Occupational Safety and Health (BAuA). Occupational Safety and Health (BAuA).

EMKG/ BauA-COSHH ToolEMKG/ BauA-COSHH Tool

Advanced Reach Tool (ART)Advanced Reach Tool (ART)

www.advancedreachtool.comwww.advancedreachtool.com

• Incorporates a mechanistic model of Incorporates a mechanistic model of inhalation exposure and a statistical facility inhalation exposure and a statistical facility to update the estimates with the user’s own to update the estimates with the user’s own data. data.

• ““This combination of model estimates and This combination of model estimates and data produces more refined estimates of data produces more refined estimates of exposure and reduced uncertainty.“exposure and reduced uncertainty.“

Advanced Reach Tool (ART)Advanced Reach Tool (ART)

http://www.advancedreachtool.com/

RISKOFDERMRISKOFDERM

http://product-testing.eurofins.com/media/18263/http://product-testing.eurofins.com/media/18263/toolkit_setup.ziptoolkit_setup.zip

• Eurofins was responsible for a Working Eurofins was responsible for a Working Group that developed a toolkit providing Group that developed a toolkit providing employers with means of ranking dermal employers with means of ranking dermal exposure risks in workplaces and with exposure risks in workplaces and with guidance on control measures for improved guidance on control measures for improved protectionprotection

RISKOFDERMRISKOFDERM

Bayesian Exposure Bayesian Exposure Assessment Tool (BEAT)Assessment Tool (BEAT)

http://xnet.hsl.gov.uk/download/http://xnet.hsl.gov.uk/download/

• an advanced probabilistic model for an advanced probabilistic model for predicting dermal exposure. TNO is predicting dermal exposure. TNO is developing BEAT together with the UK developing BEAT together with the UK Health &Safety Executive. Health &Safety Executive.

CHEmical Safety Assessment and CHEmical Safety Assessment and Reporting tool (CHESAR) ToolReporting tool (CHESAR) Tool

http://chesar.echa.europa.eu/http://chesar.echa.europa.eu/

• developed by the European Chemicals developed by the European Chemicals Agency (ECHA) to support industry in Agency (ECHA) to support industry in preparing a Chemical Safety preparing a Chemical Safety Assessment (CSA) and Chemical Safety Assessment (CSA) and Chemical Safety Report (CSR)Report (CSR)

CHEmical Safety Assessment and CHEmical Safety Assessment and Reporting tool (CHESAR) ToolReporting tool (CHESAR) Tool

http://chesar.echa.europa.eu/

Tool TestTool Test

Cleaning with MEKCleaning with MEK

Full shift (300 min), dailyFull shift (300 min), daily

Wipe applied to large surfacesWipe applied to large surfaces

No ventilation or PPENo ventilation or PPE

Large roomLarge room

Tool TestTool Test

ARTART 10,000 mg/m³ 10,000 mg/m³

4 measurements (11, 4.1, 9.3, 2.6) 5.7 mg/m³ GM 4 measurements (11, 4.1, 9.3, 2.6) 5.7 mg/m³ GM

ART BayesianART Bayesian 17,000 mg/m³ 17,000 mg/m³

Stoffenmanager 3,693 mg/m³Stoffenmanager 3,693 mg/m³

Risk Management Measures Risk Management Measures (RMM)(RMM)

PurposePurpose

• To mitigate hazards identified To mitigate hazards identified for for occupational users, consumers and to the occupational users, consumers and to the environmentenvironment

CLPCLP

Regulation on Classification, Labelling Regulation on Classification, Labelling and Packaging of Substances and and Packaging of Substances and MixturesMixtures

• Implements GHS in EuropeImplements GHS in Europe• Applies to substances from 1 Dec 2010Applies to substances from 1 Dec 2010• Applies to mixtures from 1 June 2015Applies to mixtures from 1 June 2015

Extended Safety Data Sheet Extended Safety Data Sheet (SDS)(SDS)

Where ESs developed as a result of Where ESs developed as a result of conducting a CSA, they must be annexed conducting a CSA, they must be annexed to the SDS and passed down the supply to the SDS and passed down the supply chain. chain.

Supplier informs his customer about the RMM Supplier informs his customer about the RMM recommended for safe uses of the recommended for safe uses of the substance.substance.

http://guidance.echa.europa.eu/guidance_en.htmhttp://guidance.echa.europa.eu/guidance_en.htm

reach , an american expat’s experience

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