REACH, an introduction Sean Mahar, PhD, CIH, CSP, PE MIOSH, MFOH.

REACH,REACH,an introductionan introduction

Sean Mahar, PhD, CIH, CSP, PESean Mahar, PhD, CIH, CSP, PE

MIOSH, MFOHMIOSH, MFOH

Course DescriptionCourse Description

• The aim of this course is to enable the The aim of this course is to enable the student to understand the implementation of student to understand the implementation of Registration, Evaluation, Authorization and Registration, Evaluation, Authorization and Restriction of Chemicals regulation Restriction of Chemicals regulation (REACH). Information will be provided on (REACH). Information will be provided on the status of the Substance Information the status of the Substance Information Exchange Fora. What comprises a Exchange Fora. What comprises a Chemical Safety Report will be described Chemical Safety Report will be described along with requisite assessments.along with requisite assessments.

Course DescriptionCourse Description

• The requirements for exposure assessment The requirements for exposure assessment under the REACH Regulation will be under the REACH Regulation will be discussed with information provided on how discussed with information provided on how to construct Exposure Scenarios. The to construct Exposure Scenarios. The meaning of Risk Management Measures meaning of Risk Management Measures (RMM) under the REACH Regulation will be (RMM) under the REACH Regulation will be described along with how they must be described along with how they must be applied to adequately control risks to human applied to adequately control risks to human health and the environment.health and the environment.

Course OutlineCourse Outline

• Introduction to REACHIntroduction to REACH

• Substance Information Exchange ForaSubstance Information Exchange Fora

• Chemical Safety Assessments Chemical Safety Assessments

• The Chemical Safety ReportThe Chemical Safety Report

• Human Health Hazard AssessmentsHuman Health Hazard Assessments

• Occupational Exposure AssessmentsOccupational Exposure Assessments

Course OutlineCourse Outline

• Exposure ScenariosExposure Scenarios

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

• RMM for occupational, consumers and RMM for occupational, consumers and environmentenvironment

• The RMM libraryThe RMM library

• Overall risk reduction strategyOverall risk reduction strategy

Learning OutcomesLearning Outcomes

Upon completion, the participants will be able to:Upon completion, the participants will be able to:

• Gain a broad understanding of the REACH Gain a broad understanding of the REACH Regulation and how it is implemented.Regulation and how it is implemented.

• Describe the requirements for exposure Describe the requirements for exposure assessment under the REACH Regulation, and assessment under the REACH Regulation, and how to construct Exposure Scenarios.how to construct Exposure Scenarios.

• Identify the requirements for exposure assessment Identify the requirements for exposure assessment under REACHunder REACH

Learning OutcomesLearning Outcomes

• DescribeDescribe how exposure assessments fit into the how exposure assessments fit into the risk characterization and management processrisk characterization and management process

• Compile ESs for typical activitiesCompile ESs for typical activities• List how DNELs and DMELs are derivedList how DNELs and DMELs are derived• Apply RMM in occupational exposure situations, Apply RMM in occupational exposure situations,

and be aware of RMM applied to consumers and and be aware of RMM applied to consumers and environmental emissions.environmental emissions.

• Define how RMM fit in an overall risk management Define how RMM fit in an overall risk management strategystrategy

Sean MaharSean Mahar

• BS, Sacred Heart UniversityBS, Sacred Heart University

• MS, Texas A&M UniversityMS, Texas A&M University

• PhD, University of IowaPhD, University of Iowa

• Certified Industrial HygienistCertified Industrial Hygienist

• Certified Safety ProfessionalCertified Safety Professional

• Professional EngineerProfessional Engineer

ExperienceExperience

• Euro Safety and Health, 5 yearsEuro Safety and Health, 5 years

• U of Wolverhampton, 7 yearsU of Wolverhampton, 7 years

• Ohio University, 3 yearsOhio University, 3 years

• Worksafe Iowa, 3 yearsWorksafe Iowa, 3 years

• US Navy, 9 yearsUS Navy, 9 years

• Tracor, 1 yearTracor, 1 year

Introduction to REACHIntroduction to REACH

REACHREACH

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

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

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

RegistrationRegistration

• RegistrationRegistration of basic information of 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

• EvaluationEvaluation of the registered information of the registered information for all substances exceeding a for all substances exceeding a production volume of 100 tonnesproduction volume 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

• AuthorisationAuthorisation of substances which are of substances which are carcinogenic, mutagenic or toxic to carcinogenic, mutagenic or toxic to reproduction (CMRs), persistent, bio-reproduction (CMRs), persistent, bio-accumulative and toxic (PBTs), very accumulative and toxic (PBTs), very persistent, very bio-accumulative (vPvBs) persistent, very bio-accumulative (vPvBs) and Endocrine disrupting substances on and Endocrine disrupting substances on a case by case basisa case by case basis

RestrictionRestriction

Restriction in the use of chemicals to Restriction in the use of chemicals to manage risks that have not been manage risks that have not been adequately addressed by another part adequately addressed by another part of the REACH systemof the REACH system

REACH ImplicationsREACH Implications

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 In the absence of available information, tests may In the absence of available information, tests may

have to be conductedhave to be conducted Data sharing (in particular for vertebrate tests)Data sharing (in particular for vertebrate tests) Substance Information Exchange Fora (SIEFs)Substance Information Exchange Fora (SIEFs)

REACH ImplicationsREACH Implications

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

REACH GuidanceREACH Guidance

REACH Implementation Projects (RIPs)REACH Implementation Projects (RIPs)

RIP 1: Process descriptionsRIP 1: Process descriptions

RIP 2: Development of IT systems (IUCLID RIP 2: Development of IT systems (IUCLID database and REACH-IT)database and REACH-IT)

RIP 3: Guidance Documents for industryRIP 3: Guidance Documents for industry

RIP 4: Guidance Documents for authoritiesRIP 4: Guidance Documents for authorities

RIP 5/6: Setting up the AgencyRIP 5/6: Setting up the Agency

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

SIEF RolesSIEF Roles

• • SIEF Formation FacilitatorSIEF Formation Facilitator

• • Lead RegistrantLead Registrant

• • Legal Entity UserLegal Entity User

• • Invited ExpertInvited Expert

• • Data HolderData Holder

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).”

Chemical Safety AssessmentsChemical Safety Assessments

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).

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

Uncertainty arising from the variability in Uncertainty arising from the variability in the experimental information and from the experimental information and from intra- and inter-species variation;intra- and inter-species variation;

the nature and severity of the effect;the nature and severity of the effect;

the sensitivity of the human (sub-) the sensitivity of the human (sub-) population to which the quantitative population to which the quantitative and/or qualitative information on and/or qualitative information on exposure appliesexposure applies

Derivation of DNELsDerivation of DNELs

1.1. Derivation of typical dose descriptor(s) Derivation of typical dose descriptor(s) (NOAEL, NOAEC, etc.)(NOAEL, NOAEC, etc.)

2.2. Modification of the dose descriptor(s) to Modification of the dose descriptor(s) to the correct starting pointthe correct starting point

3.3. Application of Assessment factors to Application of Assessment factors to the correct starting point to obtain the the correct starting point to obtain the DNEL(s)DNEL(s)

4.4. Selection of the leading DNEL/Health Selection of the leading DNEL/Health EffectEffect

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

PNECPNEC

Calculated by applying an appropriate Calculated by applying an appropriate assessment factor to the effect values assessment factor to the effect values (e.g. LC(e.g. LC5050 or NOEC). or NOEC).

The assessment factor expresses the The assessment factor expresses the difference between effects values difference between effects values derived for a limited number of species derived for a limited number of species from laboratory tests and the PNEC for from laboratory tests and the PNEC for each environmental sphere.each environmental sphere.


Where no-effect levels cannot be determined, Where no-effect levels cannot be determined, the risk characterization is based on other the risk characterization is based on other methods: methods:

• Semi-quantitative or Semi-quantitative or

• qualitative qualitative

assessment of the likelihood that adverse assessment of the likelihood that adverse effects are avoided. effects are avoided.


For PBT and vPvB substances:For PBT and vPvB substances:

• risks are controlled when the emissions and risks are controlled when the emissions and exposures are minimized by the exposures are minimized by the implementation of the exposure scenario.implementation of the exposure scenario.

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


Physicochemical Hazard AssessmentPhysicochemical Hazard Assessment• ExplosivityExplosivity• FlammabilityFlammability• Oxidising potentialOxidising potential


Environmental Hazard AssessmentEnvironmental Hazard Assessment

• Evaluation of informationEvaluation of information

• Classification and LabelingClassification and Labeling

• Derivation of the PNECDerivation of the PNEC


PVB and vPvB AssessmentPVB and vPvB Assessment

• Comparison with the CriteriaComparison with the Criteria

• Emission CharacterizationEmission Characterization


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

– 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

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

For non-threshold effects (e.g. non-threshold For non-threshold effects (e.g. non-threshold mutagens and non-threshold carcinogens):mutagens and non-threshold carcinogens):

• Derived minimal effect level (DMEL) a Derived minimal effect level (DMEL) a reference risk level considered to be of reference risk level considered to be of very low concern could be usedvery low concern could be used

End result is a Semi-quantitative Risk End result is a Semi-quantitative Risk CharacterisationCharacterisation

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.


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 StructureES Structure

• Short title to flag the contentShort title to flag the content

• Processes and activities coveredProcesses and activities covered

• Duration and frequency of use (as Duration and frequency of use (as relevant for workers, consumers and the relevant for workers, consumers and the environment)environment)


• Physical form of the product containing Physical form of the product containing the substance and concentration of the the substance and concentration of the substancesubstance

• Amounts used over a given period and/or Amounts used over a given period and/or activity (as relevant for workers, activity (as relevant for workers, consumers and the environment)consumers and the environment)

• Other operational conditions of useOther operational conditions of use


• Risk management measures for uses at Risk management measures for uses at industrial sites (workers & environment)industrial sites (workers & environment)

• Risk management measures for uses Risk management measures for uses outside industrial sites (workers & outside industrial sites (workers & environment) environment)

• Risk management related to uses by Risk management related to uses by consumers and the general public consumers and the general public (consumer & environment)(consumer & environment)


• Waste management measures related to Waste management measures related to the uses covered in the exposure the uses covered in the exposure scenarioscenario

• Predicted exposure and source of Predicted exposure and source of prediction prediction

• Advice to downstream users on how to Advice to downstream users on how to check whether or not they work within the check whether or not they work within the boundaries defined in the exposure boundaries defined in the exposure scenarioscenario

ES ProcessES Process

1.1. Map uses of substance (in-house Map uses of substance (in-house information)information)

2.2. Compile available information on Compile available information on conditions of useconditions of use

3.3. Select appropriate process and product Select appropriate process and product categoriescategories

4.4. Build initial ES and run first exposure Build initial ES and run first exposure estimationestimation


5.5. Complete initial ES (short title, covered Complete initial ES (short title, covered activity, OCs, RMM) activity, OCs, RMM)

6.6. Invite and receive feedback from Invite and receive feedback from representative DUsrepresentative DUs

7.7. Identify additional information (if Identify additional information (if needed)needed)

8.8. Carry out further CSA runs (iterations) Carry out further CSA runs (iterations) with the selected toolwith the selected tool


9.9. Decide whether measured data or Decide whether measured data or higher tier model neededhigher tier model needed

10.10. Apply other models or measured data Apply other models or measured data if needed, run CSAif needed, run CSA

11.11. Conclude exposure estimation and Conclude exposure estimation and risk characterizationrisk characterization


12.12.Derive integrated ES by linking all OCs Derive integrated ES by linking all OCs and RMMsand RMMs

13.13.Merge different ES into a broader ES if Merge different ES into a broader ES if appropriateappropriate

14.14. DocumentDocument

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

CSR FormatCSR Format

PART APART A

1. Summary of Risk Management Measures1. Summary of Risk Management Measures

2. Declaration That Risk Management 2. Declaration That Risk Management Measures Are ImplementedMeasures Are Implemented

3. Declaration That Risk Management 3. Declaration That Risk Management Measures Are CommunicatedMeasures Are Communicated


PART BPART B

1. Identity of Substance & Physical & 1. Identity of Substance & Physical & Chemical PropertiesChemical Properties

2. Manufacture And Uses2. Manufacture And Uses

3. Classification And Labelling3. Classification And Labelling

4. Environmental Fate Properties4. Environmental Fate Properties

5. Human Health Hazard (HHH) Assessment5. Human Health Hazard (HHH) Assessment


PART BPART B

6. HHH Assessment of Physicochemical6. HHH Assessment of Physicochemical

7. Environmental Hazard Assessment7. Environmental Hazard Assessment

8. PBT And VPVB Assessment8. PBT And VPVB Assessment

9. Exposure Assessment9. Exposure Assessment

10. Risk Characterization10. Risk Characterization

Human Health Hazard Human Health Hazard AssessmentAssessment

ObjectiveObjective

• to determine the classification and labelling to determine the classification and labelling of a substance in accordance with Directive of a substance in accordance with Directive 67/548/EEC; and67/548/EEC; and

• to derive levels of exposure to the to derive levels of exposure to the substance above which humans should not substance above which humans should not be exposed (DNEL).be exposed (DNEL).

Human Health Hazard Human Health Hazard AssessmentAssessment

StepsSteps

1.1. Evaluation of non-human informationEvaluation of non-human information

2.2. Evaluation of human informationEvaluation of human information

3.3. Classification and LabellingClassification and Labelling

4.4. Derivation of DNELsDerivation of DNELs

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.


Hierarchy for estimation of exposure levels:Hierarchy for estimation of exposure levels:

1.1. measured data, including the quantification measured data, including the quantification of key exposure determinantsof key exposure determinants

2.2. appropriate analogous/surrogate data, appropriate analogous/surrogate data, including the quantification of key exposure including the quantification of key exposure determinantsdeterminants

3.3. modeled estimatesmodeled estimates


European Centre for Ecotoxicology and European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Toxicology of Chemicals Targeted Risk Assessment (ECETOC TRA)Assessment (ECETOC TRA) ToolTool

StoffenmanagerStoffenmanager

Easy-to-use workplace control scheme for Easy-to-use workplace control scheme for hazardous substances (EMKG/ BauA-hazardous substances (EMKG/ BauA-COSHH)COSHH)

ECETOC TRA ToolECETOC TRA Tool

Available at www.ecetoc.orgAvailable at www.ecetoc.org• Screening tool: intentionally conservative Screening tool: intentionally conservative

assumptions to prevent false negativesassumptions to prevent false negatives• Risk-based, tiered approachRisk-based, tiered approach• Evaluates uses and identifies handling Evaluates uses and identifies handling

procedures associated with safe useprocedures associated with safe use• Covers worker, consumer and Covers worker, consumer and

environmental exposuresenvironmental exposures


Based on Estimation and Assessment of Based on Estimation and Assessment of Substance Exposure (EASE) modelSubstance Exposure (EASE) model

• Established UK Health and Safety Executive Established UK Health and Safety Executive occupational exposure modeloccupational exposure model

• Categorizes exposure based upon historical Categorizes exposure based upon historical data in National Exposures Databasedata in National Exposures Database

• Exposure predicted based upon conditions of Exposure predicted based upon conditions of use and physical- chemical propertiesuse and physical- chemical properties


www.stoffenmanager.nlwww.stoffenmanager.nl

EMKG/ BauA-COSHH ToolEMKG/ BauA-COSHH Toolwww.reach-helpdesk.dewww.reach-helpdesk.de

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

The RMM libraryThe RMM library

an EXCEL spreadsheet with three parts:an EXCEL spreadsheet with three parts:

1.1. The library containing RMMs / OCs and The library containing RMMs / OCs and details of their effectiveness; anddetails of their effectiveness; and

2.2. Lists of information sources for consumers, Lists of information sources for consumers, environment and occupational measures.environment and occupational measures.

3.3. A practical guide to use the libraryA practical guide to use the library

cefic.org/en/reach-for-industries-libraries.htmlcefic.org/en/reach-for-industries-libraries.html

RMM – Basic PrinciplesRMM – Basic Principles

Hierarchy of control (Chemical Agents Hierarchy of control (Chemical Agents Directive 98/24/EC)Directive 98/24/EC)

• Article 6 Specific protection and Article 6 Specific protection and prevention measures, requires that risk prevention measures, requires that risk be eliminated or reduced to a minimum be eliminated or reduced to a minimum by by substitutionsubstitution

• If not substitution isn’t possible then by If not substitution isn’t possible then by protection and preventionprotection and prevention

Hierarchy of control Hierarchy of control

(a) design of appropriate work processes and (a) design of appropriate work processes and engineering controls engineering controls

(b) application of collective protection (b) application of collective protection measures at the source, such as adequate measures at the source, such as adequate ventilation and appropriate organizational ventilation and appropriate organizational measures;measures;

(c) application of individual protection (c) application of individual protection measures including personal protective measures including personal protective equipment.equipment.

RMM – Basic PrinciplesRMM – Basic Principles

Principles of Good Control Practice from the Principles of Good Control Practice from the Control of Substances Hazardous to Health Control of Substances Hazardous to Health Regulations (COSHH) Schedule 2ARegulations (COSHH) Schedule 2A

COSHH Good Practice PrinciplesCOSHH Good Practice Principles

(a)(a) Design and operate processes and Design and operate processes and activities to minimise emission, release activities to minimise emission, release and spread of substances hazardous to and spread of substances hazardous to health.health.

(b)(b) Take into account all relevant routes of Take into account all relevant routes of exposure- inhalation, skin absorption and exposure- inhalation, skin absorption and ingestion- when developing control ingestion- when developing control measures.measures.

(c)(c) Control exposure by measures that are Control exposure by measures that are proportionate to the health riskproportionate to the health risk

(d)(d) Choose the most effective and reliable Choose the most effective and reliable control options which minimise the escape control options which minimise the escape and spread of substances hazardous to and spread of substances hazardous to health.health.

(e)(e) Where adequate control of exposure Where adequate control of exposure cannot be achieved by other means, cannot be achieved by other means, provide, in combination with other control provide, in combination with other control measures, suitable personal protective measures, suitable personal protective equipment.equipment.


(f)(f) Check and review regularly all elements of Check and review regularly all elements of control measures for their continuing control measures for their continuing effectiveness.effectiveness.

(g)(g) Inform and train all employees on the Inform and train all employees on the hazards and risks from the substances hazards and risks from the substances with which they work and the use of control with which they work and the use of control measures developed to minimise the risks.measures developed to minimise the risks.

(h)(h) Ensure that the introduction of control Ensure that the introduction of control measures does not increase the overall measures does not increase the overall risk to health and safety.risk to health and safety.


COSHH EssentialsCOSHH Essentials

The Health and Safety Executive The Health and Safety Executive developed COSHH Essentials as a developed COSHH Essentials as a tool for Small to Medium Enterprises tool for Small to Medium Enterprises (SMEs) to use for risk assessments:(SMEs) to use for risk assessments:

www.coshh-essentials.org.ukwww.coshh-essentials.org.uk

It is useful for many operations and can It is useful for many operations and can serve as a screening tool, but is not a serve as a screening tool, but is not a substitute for a risk assessment.substitute for a risk assessment.


A “DIY” approach for SME’s in Five Steps:A “DIY” approach for SME’s in Five Steps:

1.1. Getting StartedGetting Started

2.2. Factors to decide control approachFactors to decide control approach

3.3. Find the correct control approachFind the correct control approach

4.4. Find task-specific control guidance sheetsFind task-specific control guidance sheets

5.5. Implement action and reviewImplement action and review


1.1. Getting StartedGetting Started• What is in use?What is in use?• How is it used?How is it used?• Where is it used?Where is it used?


2.2. Factors to decide control approachFactors to decide control approach• Possible health effectsPossible health effects• Amount in useAmount in use• Dustiness or volatilityDustiness or volatility


3.3. Find the correct control approachFind the correct control approach• Matrix ofMatrix of

Hazard groupHazard groupAmountAmountVolatility or DustinessVolatility or Dustiness

AmountAmount Dustiness or volatilityDustiness or volatility

LowLow MediumMedium HighHigh

SmallSmall 11 22 22

MediumMedium 22 33 33

LargeLarge 22 44 44

Hazard group C:Hazard group C:


4.4. Find task-specific control guidance sheetsFind task-specific control guidance sheets


5.5. Implement action and reviewImplement action and review

The RMM libraryThe RMM library

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.

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.

Technical Dossier Technical Dossier

Contains information on the properties and Contains information on the properties and classification of a substance as well as on classification of a substance as well as on uses and guidance on safe use. uses and guidance on safe use.

The information required varies with the The information required varies with the tonnage in which the substance is tonnage in which the substance is manufactured or imported. manufactured or imported.

The higher the tonnage the more information The higher the tonnage the more information on the intrinsic properties of the chemical on the intrinsic properties of the chemical is required.is required.

Chemical Safety ReportChemical Safety Report

Documents the hazards and classification of Documents the hazards and classification of the substance and the assessment as to the substance and the assessment as to whether the substance is PBT or vPvB. whether the substance is PBT or vPvB.

If the substance is classified as dangerous or is If the substance is classified as dangerous or is PBT or vPvB, then an exposure assessment PBT or vPvB, then an exposure assessment and risk characterisation shall be performed and risk characterisation shall be performed to demonstrate that the risks are adequately to demonstrate that the risks are adequately controlled. This exposure assessment is controlled. This exposure assessment is done using ESs for each use.done using ESs for each use.

TopicsTopics

• REACHREACH

• SIEFSIEF

• CSA CSA

• CSRCSR

• HHH AssessmentsHHH Assessments

• Occ. Exp. Occ. Exp. AssessmentsAssessments

• ESES

• RMMRMM

• RMM for occ., RMM for occ., consumers and env.consumers and env.

• RMM libraryRMM library

• Overall risk Overall risk reduction strategyreduction strategy

OutcomesOutcomes

Can we?Can we?• Understand the REACH Regulation and Understand the REACH Regulation and

how it is implemented.how it is implemented.• Describe the requirements for exposure Describe the requirements for exposure

assessment under the REACH Regulation, assessment under the REACH Regulation, and how to construct Exposure Scenarios.and how to construct Exposure Scenarios.

• Identify the requirements for exposure Identify the requirements for exposure assessment under REACHassessment under REACH

OutcomesOutcomes

• DescribeDescribe how exposure assessments fit into the how exposure assessments fit into the risk characterization and management processrisk characterization and management process

• Compile ESs for typical activitiesCompile ESs for typical activities• List how DNELs and DMELs are derivedList how DNELs and DMELs are derived• Apply RMM in occupational exposure situations, Apply RMM in occupational exposure situations,

and be aware of RMM applied to consumers and and be aware of RMM applied to consumers and environmental emissions.environmental emissions.

• Define how RMM fit in an overall risk management Define how RMM fit in an overall risk management strategystrategy

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

http://guidance.echa.europa.eu/docs/http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htmguidance_document/information_requirements_en.htm

Questions?Questions?

Date post:	21-Dec-2015
Category:	Documents
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