Chemical Safety Assessment

8/3/2019 Chemical Safety Assessment

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RIP 3.2-2 PART A

TECHNICAL GUIDANCE DOCUMENT FOR PREPARING THECHEMICAL SAFETY ASSESSMENT

Part A: Introduction to the TGD

RIP3.2-2, November 2007

Technical Guidance Documents in support of the New EU Chemicals Legislation (REACH)

V: Development of a Technical Guidance Document for preparing the Chemical Safety

Assessment (REACH Implementation Project 3.2-2)

Service Contract Number CCR.IHCP.C432365.X0

Disclaimer: "The present views expressed are those developed by the RIP 3.2-2 contractor for discussion at the relevantStakeholder Expert Group meetings and may not in any circumstances be regarded as a final position nor document"


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RIP 3.2-2 PART A

Within the context of the EU Chemicals policy, REACH, the European Commission has initiatedREACH Implementation Projects (RIPs) with the intention of developing tools and guidance for thenew legislation. REACH Implementation Project No. 3 covers a suite of individual projects allaimed at developing guidance for industry on various aspects of REACH. Under the RIP No. 3.2

phase 2 (3.2-2), a Technical Guidance Document and supporting tools and methods on conducting

the Chemical Safety Assessment and preparing the Chemical Safety Report shall be developed.Within the RIP3.2-2 project, several industry groups have been asked to develop exposure scenarioexamples in selected supply chains (sectors). This guidance is meant to help these groups achievethe following goals:

Feed experience on how companies or sector associations can organise the process in the mostefficient way to develop exposure scenarios

Prepare ES examples that can be used to illustrate the concise TGD. Preparing CSRs around these examples that can be used to illustrate the concise TGD. Testing elements of the draft concise TGD by persons at M/I and DU level that are used during

ES exemplification.

This report is part of the deliverables for the Development of a Technical Guidance Document forpreparing the Chemical Safety Report (REACH Implementation Project 3.2-2 Task IV).

This study was carried out by experts from the Consortium for RIP3.2-2: Cefic, kopol, RIVM,EUPC, TNO Chemistry, DHI Water & Environment, The Federal Institute for Risk Assessment(BfR), Federal Environment Agency (UbA), and the Federal Institute for Occupational Safety andHealth (BAuA).

Convention for citing the current REACH regulation

Where the REACH regulation is cited literally, this is indicated by text in italics between quotes.

Disclaimer: The views expressed in this report are the sole responsibility of the authors. The

content does not reflect any legal interpretation of the Commissions proposal for a Regulation on

REACH nor does it necessarily reflect the opinion of the Commission or its services.


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RIP 3.2-2 PART A

CONTENTS

A.1 HOW TO WORK WITH THE TGD....................................................................................................................3

A.1.1 For whom the guidance is needed................................................................................................................3

A.1.2 How to find your way in the TGD...............................................................................................................3

A.2 KEY CONCEPTS FOR THE CSA .............................................................. ........................................................ 6

A.2.1 Duty to prepare the CSA..............................................................................................................................6

A.2.2 Overall CSA process....................................................................................................................................6

A.2.3 Hazard Assessment......................................................................................................................................10

A.2.4 Concepts related to the development of exposure scenarios........................................................................12

A.2.4.1 Identification of uses and description of use conditions...................................................................13A.2.4.1.1 Identified Use.....................................................................................................................13A.2.4.1.2 Brief general description of use and short titles of Exposure Scenarios ............................ 13A.2.4.1.3 Standard Descriptor for Uses ........................................................... .................................. 14

A.2.4.2 Determinants of release and exposure and exposure assessment ..................................................... 15A.2.4.3 Function and content of exposure scenarios.....................................................................................15

A.2.4.3.1 Function and content of the initial and final ES.................................................................15A.2.4.3.2 Use and Exposure categories..............................................................................................16A.2.4.3.3 Generic versus specific exposure scenarios .......................................................... .............17

A.2.4.4 Exposure Scenarios for substances in preparations............................................................ ..............17A.2.4.5 Exposure Scenarios for substances in articles .......................................................... ........................18

A.2.5 Identification and documentation of control of risks in the CSR.................................................................19

A.2.6 Iterations of the CSA ...................................................... ............................................................... ..............19

A.2.7 Iteration strategy ............................................................. ................................................................ .............20

A.2.8 Updating the CSA........................................................................................................................................21

A.2.9 Chemical safety report.................................................................................................................................21

A.2.10 Exposure Scenario annexed to the Safety Data Sheet...............................................................................21

A.3 COMMUNICATION IN THE SUPPLY CHAIN................................................................................................23

A.3.1 Shared responsibility and communication in the market ................................................................ .............23

A.3.2 Organise dialogues in the supply chain........................................................................................................23

A.3.3 Key tasks in the supply chain.......................................................................................................................25

A.4 CSA FOR DIFFERENT ACTORS .............................................................. ........................................................ 29

A.4.1 CSA for a so-far unsupported use by a Downstream User ............................................................. .............29

A.4.2 CSA to support registration by a producer or importer of articles from which substances are intended to bereleased or where the Agency has required a registration ....................................................... .......................30

A.4.3 CSA to support the request for authorisation of substances of very high concern.......................................33

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FIGURES

Figure A-1: Structure of the technical guidance document ........................................................ .................................. 4

FigureA- 2: Overview of the steps in the Chemical Safety Assessment.......................................................................8 FigureA- 3: Overview of dialogues in the supply chain. .............................................................. ................................24Figure A-4: Overview of key tasks to be implemented along the supply chain. ................................................... .......28

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A.1 HOW TO WORK WITH THE TGD1

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A.1.1 For whom the guidance is needed

For substances manufactured or imported at 10 tonnes per year (tpa) or more, aregistrant needs to submit a Chemical Safety Report (CSR) as part of his registrationdossier. General guidance on registration is given in the guidance on registration,while this guidance is meant to outline how to prepare the Chemical SafetyAssessment (CSA) and document it in the CSR and the Safety Data Sheet (SDS).

The guidance is intended for registrants who always need to prepare a CSA, and forregistrants who are required to do so under certain circumstances. A CSA is alwaysrequired for manufacturers of substances, importers of substances on their own or in

preparations > 10 tpa (Chapter A.2, A.3). A CSA is required under certaincircumstances for

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Down stream users (DUs) who need or want to make their own safety assessment Producers or importers of articles containing substances that are intended to be

released from the article, if not already registered for that use. Manufactures/Importers (M/I) or DUs preparing a CSA as a part of an

authorisation application

The guidance is also intended to be the reference for the activities of the EuropeanChemicals Agency (ECHA) and EU member state authorities related to assessmentand control of risks under the evaluation, authorisation and restriction procedures.

A.1.2 How to find your way in the TGD

This guidance sets out a framework for the chemical safety assessment. The guidanceconsists of two major parts (Figure A-1): concise guidance (Parts A G) andreference guidance (Part R.).

Part A starts with the general introduction to the chemical safety assessment. Part Bcontains concise guidance on the hazard assessment, which covers the informationrequirements under REACH, the integrated testing strategies for each endpoint andthe possibilities of adapting these, and how to conclude on suitability of data for thechemical safety assessment, conclude on suitability of information for the PBT/vPvBassessment (see below) and the suitability of data for classification and labelling. The

complete guidance on the information requirements in REACH concerning the hazardassessment is covered in Chapters R.1 to R.10.

Part Ccontains the concise guidance on how to assess whether or not a substance is a persistent, bioaccumulative and toxic substance (PBT) or very persistent and very bioaccumulative substance (vPvB). The complete guidance on the PBT and vPvBassessment is covered in Chapter R.11.

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RIP 3.2-2 PART A

A: Introduction

B:Hazard Assessment R.1-R.10: Hazard Assessment

C: PBTand vPvB Assessment R.11: PBT/vPvB Assessment

D: Exposure Assessment R.13-18:Exposure assessment

E:Risk Characterisation R.19:Uncertainty Assessment

F:Chemical Safety Report

G: Extension of the SDS

R.12: Exposure based waiving

Concise guidance Reference guidance

External Example Depository

A: Introduction

B:Hazard Assessment R.1-R.10: Hazard Assessment

C: PBTand vPvB Assessment R.11: PBT/vPvB Assessment

D: Exposure Assessment R.13-18:Exposure assessment

E:Risk Characterisation R.19:Uncertainty Assessment

F:Chemical Safety Report

G: Extension of the SDS

R.12: Exposure based waiving

Concise guidance Reference guidance

External Example Depository

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Figure A-1: Structure of the technical guidance documentThe REACH regulation allows for several options to adapt the standard informationrequirements. Both hazard and exposure information is needed to decide if certaininformation requirements can be waived. This so called exposure-based waiving isdiscussed briefly in Part A and Part B and is further detailed in Chapter R.12.

If a substance meets the criteria for classification as dangerous according to Directive67/548/EEC or 1999/45/EC, or is a PBT or vPvB substance, an exposure assessmentis needed.

Part D details how to develop exposure scenarios and subsequent exposure

estimation. This part contains detailed workflows on how to identify uses in thesupply chain, how to develop exposure scenarios and finalise them based on theexposure estimation. How to generate exposure estimates based on Tier 1 exposureestimation tools is introduced in Part D. Specific attention is given to the conditions ofuse, i.e. operational conditions and risk management measures. Details on Riskmanagement measures are given in chapter R.13. The full technical detail on exposureestimation and relevant tools is given in the chapters R. 14 to R.18.

Part Econtains the guidance on the risk characterisation. In the risk characterisation,information on hazard and exposure is combined in the risk characterisation ratio.Both types of information contain uncertainty which needs to be assessed in order to

decide on the robustness of the risk estimate.

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This is further detailed in chapter R.19. The chemical safety assessment can beconcluded when the risk characterisation shows that risks to human health and theenvironment are controlled.

Part Fdetails the format and requirements for preparing the chemical safety report,

which documents the results of the entire chemical safety assessment. Thedevelopment of this TGD was accompanied by an exemplification process where M/Iand DU companies cooperated to apply the guidance under real life conditions. Thishas delivered chemical safety report examples to illustrate the work processes definedin parts A-G of this guidance. The examples will be made available for public accesson the Cefic web site, and a process will be started together with the EuropeanChemicals Agency to ensure that the examples are appropriate to accompany theguideline. Additional examples (e.g. on exposure-based waiving) can be added to thisdepository once these become available.

Part G contains the guidance on preparing the extensions to the safety data sheet(SDS). This contains information on how the exposure scenario is communicated andimplemented in the supply chain.

1.3 Aim of this module

The aim of this module is to provide an introduction to

the technical guidance document for preparing the chemical safety assessment(Chapter 1)

key concepts needed for understanding the chemical safety assessment (Chapter 2) communication and tasks in the supply chain related to the chemical safety

assessment (Chapter 3) Chemical safety assessment for different actors in the supply chain (Chapter 4).

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A.2 KEY CONCEPTS FOR THE CSA83

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A.2.1 Duty to prepare the CSA

A chemical safety assessment is required when a substance is manufactured orimported at 10 tonnes or more per year. The assessment shall be documented in aCSR to be submitted as part of a registration dossier, in accordance with Articles 10and 14 of REACH. Annex I of REACH sets out the general provision for assessingthe substances and preparing CSRs. One of the primary aims of carrying out a CSA isto define the conditions of use (operational conditions and risk management) underwhich the risks can be controlled (see section 2.5).

The registrant can be a manufacturer, importer of a substance on its own or in a preparation, a down stream user or a producer or importer of articles. The generalCSA process is discussed in this section, while a CSA is required under certaincircumstances for

Down stream users (DUs) who need or want to make their own safety assessment

Producers or importers of articles containing substances that are intended to bereleased from the article, if not already registered for that use.

Manufactures/Importers (M/I) or DUs preparing a CSA as a part of anauthorisation application.

Chapter A.4 provides greater detail on the CSA for each of these different actors inthe supply chain.

The basis for the CSA is the information on the quantity that the individual registranthas manufactured himself or imported and how this amount is used by the registrant,by downstream users to which the substance is supplied or by actors in the service lifeor waste phase of the substance. For substances with a widespread or dispersive use, itcan be useful on a voluntary basis to consider exposure resulting from emissions ofthe same substance manufactured or imported by other registrants (i.e, the overallestimated market volume). This could be considered if registrants decide to jointlyregister their CSA (Article 11(1)). On a voluntary basis, the participants in the SIEFcould decide (e.g. or reasons of confidentiality) to ask a third party evaluate their jointvolume for risks to man or environment of substances with a widespread or dispersiveuse. This could prevent community action if risks are expected due to the overall

market volume.

A.2.2 Overall CSA process

The CSA normally proceeds in the following sequence (Figure A-2):

1. Human health hazard assessment; including classification and derivation ofderived no effect levels (DNELs) (or where that is not possible otherindications of the potency of the substance - see chapter B.8 and Chapter R.8).

2. Physicochemical hazard assessment; including classification.3. Environmental hazard assessment; including classification and derivation of

predicted no effect concentrations (PNECs).4. PBT and vPvB assessment

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If, as a result of the hazard assessment, it is found that a substance meets the criteriafor classification as dangerous according to the criteria of directive 67/548/EEC or1999/45/EC, or is a PBT or vPvB substance, then exposure assessment andsubsequent risk characterisation is required

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5. Exposure assessment (covering development of exposure scenarios andexposure estimation)6. Risk characterization

CSA iterations might be needed to be able to document that risks are controlled:

7. Potential CSA iterations.

1 The Commission states that this does not mean that exposure must be assessed for all hazards, neitherdoes it mean that exposure should only be assessed for hazards related to the classification orPBT/vPvB properties triggering the exposure assessment in the first place, as the absence ofclassification for a particular endpoint does not mean that there is no hazard. Finally, it is noted that

further details on what exactly a hazard means is a matter of technical assessment. The Commission isworking on a proposal for practical implementation of this issue.

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Gather and share existing information

Consider information needs

Identify information gaps

Generate new data/ propose

testing strategy

Environment [3] Estimation ofExposure [5]

Risk Characterisation[6] based on control of risks: Human exposure < DNEL or PEC < PNEC For non-threshold substances, assess likelihood

that effects are avoided

For PBT/vPvB substances: minimise emissions and exposure

Use uncertainty analysis to test robustness of results

6. Control of Risks?

If classified

dangerous

or PBT/vPvB

Make Chemical Safety Report (CSR)

If substance is classified dangerous or PBT/vPvB, the CSR also

Includes Exposure Scenario(s) describing control of risks by OCs and RMMs Implement RMMs for own manufacture or use Communicate ES with OCs and RMMs down the supply chain with

Safety Data Sheet (SDS)

YES

Exposure

Scenarios [5]

NONO

7. ReviseHazard

Information

7. Reviseconditions of

use or

exposure

Information

or scope of ES

PBT/vPvB

Assessment [4]

physico-chemical [2]

Human Health [1]

exposure basedwaiving

Gather existing information

on uses, conditions of use,

emissions and exposure


Exposure AssessmentHazard Assessment

exposuretriggered testing

Gather and share existing information


Identify information gaps

Generate new data/ propose

testing strategy

Environment [3] Estimation ofExposure [5]

Risk Characterisation[6] based on control of risks: Human exposure < DNEL or PEC < PNEC For non-threshold substances, assess likelihood

that effects are avoided

For PBT/vPvB substances: minimise emissions and exposure

Use uncertainty analysis to test robustness of results

6. Control of Risks?

If classified

dangerous

or PBT/vPvB

Make Chemical Safety Report (CSR)

If substance is classified dangerous or PBT/vPvB, the CSR also

Includes Exposure Scenario(s) describing control of risks by OCs and RMMs Implement RMMs for own manufacture or use Communicate ES with OCs and RMMs down the supply chain with

Safety Data Sheet (SDS)

YES

Exposure

Scenarios [5]

NONO

7. ReviseHazard

Information

7. Reviseconditions of

use or

exposure

Information

or scope of ES

PBT/vPvB

Assessment [4]

physico-chemical [2]

Human Health [1]

exposure basedwaiving

Gather existing information

on uses, conditions of use,

emissions and exposure


Exposure AssessmentHazard Assessment

exposuretriggered testing

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FigureA- 2: Overview of the steps in the Chemical Safety Assessment.

OC = operational conditions, ES = exposure scenario, RMM = risk management

measures DNEL = derived no-effect level, PNEC = predicted no-effect

concentrations, PEC = predicted environmental concentrations.

A CSA is flexible, depending on the available information on substance properties,

the outcome of the hazard assessment, the classification and labelling and theexposure estimation. The M/I or DU should determine the most effective and efficientway to control risks and to document this.

The CSA starts with the collection of all available physicochemical, environmentalfate, toxicological and ecotoxicological information that is relevant and available tohim regardless of whether information on a given endpoint is required or not at thespecific tonnage level. The registrant should also collect information on exposure, useand risk management measures. This may require more details on, e.g., manufacture(if within EU), use, handling and disposal of the substance or of articles containingthe substance (i.e. covering its whole life cycle) as well as the nature of the exposures,

i.e. routes, frequency and duration. Considering the information that is collected theregistrant will be able to determine the initial need to generate further information.

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Depending on the iterations of the CSA, additional information may need to becollected or generated.

Steps 1-4 of the CSA shall be conducted for all substances manufactured or importedin a quantity of 10 tonnes per year. The standard information requirements on

inherent properties under REACH are primarily determined by tonnage triggers. Theymay be adapted, omitted (waived), replaced or triggered due to hazard, exposure orrisk considerations as well as difficulties in testing the substance or availability ofalternative information (REACH Annex VI to XI, see part B). For those humaneffects and environmental spheres for which it is not possible to determine a DNEL ora PNEC, the CSA has to assess the likelihood that effects are avoided.

If a substance is assessed to be a PBT or vPvB, all emissions throughout the lifecycleof the substance resulting from manufacture and identified uses need to becharacterised and risk management measures and operational conditions should berecommended that minimise emissions and subsequent exposure of humans and theenvironment.

In REACH Annexes VII to X specific rules are given for adaptation of informationrequirements, according to which the required standard information requirements forindividual endpoints may be modified. The required standard information set mayalso be adapted according to Annex XI of REACH e.g. in cases where testing is nottechnically possible, or testing does not appear scientifically necessary, or based onexposure considerations. Based on adequate information on exposure, a decision can

be taken whether it is possible to waive tests (exposure based waiving), or if thistriggers the need for additional information including exposure based testing.

If, as a result of the hazard assessment and PBT/vPvB assessment it is found that a

substance meets the criteria for classification as dangerous (according to directives67/548/EEC and 1999/45/EC) or is considered to be a PBT/vPvB, an exposureassessment is required. The exposure assessment consists of the development ofexposure scenarios and the related exposure estimation (see part D). If the substanceis not classified as dangerous or is not a PBT/vPvB, an exposure assessment is notneeded and the registrant can directly go to documentation of the hazard assessmentand PBT/vPvB assessment in the chemical safety report.

The exposure assessment shall cover manufacture and all identified uses of thesubstance and the life cycle stages resulting from these identified uses. This includes,where relevant, service-life of articles and the waste life stages of the substance on its

own, in preparations or in articles.The instrument to communicate the practical conditions ensuring control of risksthroughout the supply chain is the Exposure Scenario (see part D). Exposure scenariosare developed in an iterative approach, as part of the exposure assessment, and need asubsequent risk characterisation (part E) to progress from initial exposure estimates tofinal exposure estimates based on control of risks.

The exposure scenario documents the relevant operational conditions and riskmanagement measures that lead to control of risks for all hazards identified. Therelevant information is to be communicated to the downstream users. This is i) to

provide practical advice on suitable measures to control risks and ii) to enable theDUs to check whether they in practice comply with the conditions defined in theCSA.

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In the risk characterisation (see part E) appropriate reference levels for hazards tohuman health and the environment are compared to the exposure estimates for allrelevant combinations of human and environmental exposure estimates, and physico-chemical hazards are evaluated. In addition the risk characterisation needs to considerrisks from combined exposure via different routes of exposure or via different

sources. If control of risks is not demonstrated, further iterations of the CSA areneeded (step 7).

Different options are available to iterate (see also sections A.2.6 and A.2.7).

Hazard information can be revised or generated taking the legal obligations oninformation requirements into account.

Exposure information can be collected from the supply chain or it can be decidedto generate new exposure data on a voluntary basis (e.g., measurements at sites orin the environment).

Or both types of information may be revised.

Once control of risks is demonstrated, the final exposure scenarios including therecommended Operational Conditions (OCs) and Risk Management Measures(RMMs) for the manufacture and identified uses are to be documented in the CSR(see part F) and communicated to downstream users of the substance annexed to theSDS (see part G).

The following sections provide further details on key concepts for the chemical safetyassessment.

A.2.3 Hazard Assessment

The chemical safety assessment starts with a hazard assessment. The informationcollected or generated in the CSA will be used for classification and labelling,PBT/vPvB assessment (see part C) and for deriving threshold or non-threshold levelsfor human health and the environment.

The chemical safety assessment within REACH is fundamentally dependent on anadequate conclusion on classification and PBT/vPvB assessment since exposureassessment and risk characterisation are triggered by classification and fulfillment ofPBT/vPvB criteria. If the substance is not classified as dangerous and does not fulfillPBT/vPvB criteria, exposure assessment of the identified uses is not necessary.

In general information gathering consists of the following steps (REACH Annex VI,

Chapter R.2):

Gather and share existing information; Consider information requirements and further information needs (Annexes IV to

IX of REACH); Identify information gaps; Generate new data / propose testing strategy

Different types of information may need to be collected or generated for conducting aCSA. Such information may be obtained from a variety of sources such as in-housedata of companies, or by sharing information with other manufacturers and importers

of the substance by cooperation in a SIEF (REACH Article 29).

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The hazard assessment shall be conducted based on all available information, and onthe basis of the information required in accordance with Annexes VI-XI of REACH(based on tonnage and possible adaptations, see part B.

Alternative information may be available or generated that can be used instead of in-

vivo test data. Such information includes results of in-vitro tests and informationobtained by use of non-testing methods (incl. QSAR, SAR, read-across,categorisation, etc.). Separate guidance is available on intelligent test strategies (ITS)in Part B and Chapter R.7.

In some cases, minimal or negligible exposure and risk can be expected to certaintarget groups. When such low-risk exposure situations exist, waiving of hazard datamay be possible. Specific guidance on this issue is available in Chapter R.12.Additional information may be needed as a result of the outcome of the exposureestimation and risk characterisation, so called exposure-triggered testing. If risks toman or the environment are indicated in the CSA, additional data may need to becollected or generated in order to refine the hazard information. At any particularstage, proposals for further testing may be developed so that the necessaryinformation is obtained. Before proposing additional animal testing, use of alternativemethods and all other options must be considered.

Dangerous substances and preparations must be classified and labelled according toDirectives 67/548/EEC and 1999/45/EC respectively. These Directives will bereplaced in the near future with an EU Regulation for Classification, Labelling andPackaging of Substances and Mixtures (CLP) labelling that will be implementedthrough the Globally Harmonized System.

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human health hazard assessment

Based on the available information, a derived no effect-level (DNEL) has to beestablished. The DNEL is expressed as an external exposure level below which anadverse effect on human health is not expected. For derivation of the DNEL theleading health effect for a given exposure pattern/route needs to be selected. The

N(L)OAEL for this health effect needs to combined with specific assessment factorfor derivation of the DNEL. Since DNELs are population, route and frequencydependent, there might be a need for derivation of more than one DNEL (see ChapterR.8).

For some effects N(L)OAEL values are usually not available, e.g. for genotoxic

substances, sensitisers, corrosive substances or skin/eye irritants. For genotoxiccarcinogens a threshold exposure level cannot be identified and REACH then requiresa qualitative assessment. If data allow, the development of an additional(semi)quantitative reference value (DMEL, derived minimal effect level) may beconsidered (Section B.8.1). The derivation and use of dose-response relationships foreach of the effects to be considered are discussed in detail in Chapter R.8.

For those human effects and environmental spheres for which it is not possible todetermine a DNEL or a PNEC, the CSA has to assess the likelihood that effects areavoided. It may for carcinogenic substances involve setting a so-called Derivedminimum effect level (DMEL). If a substance is assessed to be a PBT or vPvB, allemissions throughout the lifecycle of the substance resulting from manufacture andidentified uses need to be characterised and risk management measures and

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operational conditions shall be recommended for minimising emissions andsubsequent exposure of humans and the environment.

During the hazard assessment, the registrant has the choice to conduct a qualitative orquantitative exposure assessment and risk characterisation, in order to waive specific

information requirements (not only for human health). This may require thatadditional exposure data is gathered at an early stage in the CSA, before it is decidedif the substance is finally classified as dangerous or is found to be a PBT or vPvB.This is the trade-off between doing the testing or obtaining better information onexposure to provide a qualitative or quantitative justification for exposure basedwaiving. Specific guidance on this issue can be found in Chapter R.12.

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Human health hazard assessment due to physicochemical properties.

According to the REACH proposal, the chemical safety assessment shall also includethe human health hazard assessment of physicochemical properties. The potentialeffects to human health shall be assessed for at least the following physicochemical

properties: explosivity, flammability, and oxidizing potential. (see Part B and ChapterR.7 and R.9).

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Environmental hazard assessment

Based on the available information, the environmental hazard assessment focusses onhazards for ecosystems in any environmental sphere (water, soil, sediment or soil). Inaddition, hazards for predators in the food chain (secondary poisoning) areconsidered. Hazards to the microbiological activity of sewage treatment systems areevaluated because proper functioning of sewage treatment plants (STPs) is importantfor the protection of the aquatic environment.

The PNEC for a specific environmental compartment is regarded as a concentrationbelow which adverse effects on ecosystems will not occur and is derived on the basisof the available information on toxicity to species from relevant environments. ThePNEC is derived from toxicity test endpoints (LC50s or NOECs) using appropriateassessment factors (cf. chapters B.2 and R.10).

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PBT assessment

The PBT assessment is meant to identify substances that are persistent,bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).These substances are required to undergo further evaluation as the potential for long-

term effects, is difficult to predict and the effects such as (bio)accumulation in theenvironment would be practically difficult to reverse. For PBT/vPvB substances, allemission sources need to be identified in order to determine effective measures tominimise emissions. Potential PBT or vPvB substances are identified at a screeninglevel and a testing strategy is followed to verify this screening assignment by theinclusion of more data. The PBT assessment is introduced in Part C and furtherdetailed in Chapter R.11.

A.2.4 Concepts related to the development of exposure scenarios

This section details several concepts to facilitate the use of new REACH terms and

concepts for the development of exposure scenarios.

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A.2.4.1 Identification of uses and description of use conditions326

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A.2.4.1.1 Identified Use

Under REACH the use of a substance means any processing, formulation,

consumption, storage, keeping, treatment, filling into containers, transfer from onecontainer to another, mixing, production of an article or any other utilisation (REACHarticle 3(24)). Thus, use has a very broad meaning. However, there are two morespecific terms which are key for the registration and the communication in the supplychain:

Registrant's own use: means an industrial or professional use by the registrant

(REACH article 3(25));

Identified use: means a use of a substance on its own or in a preparation, or a use

of a preparation, that is intended by an actor in the supply chain, including his

own use, or that is made known to him in writing by an immediate downstream

user (REACH article 3(26));

According to this definition, there are three ways that a use can become an identifieduse. An actor in the supply chain:

intends to use (or actually uses) a substance on its own or in a preparation in hisown processes or in products manufactured by him or

places it on market for certain use(s) (directly or via distributors)or is informed by one of his immediate downstream users on an existing or intended

use..

Making a use known to a supplier does not automatically mean that the supplier has to

carry out a CSA and/or that the supplier includes the use into his registration. Thesupplier may decide:

That his existing Exposure Scenarios are already sufficiently covering the newlyidentified use and supplies the DU with the existing ES. Inclusion of the new useinto section 2 of the existing CSR by the M/I can be useful for future registrationupdates.

To carry out a CSA and develop a new or modified Exposure Scenario, coveringthe newly identified use, and to update the registration file accordingly if theregistration has already taken place.

To not support a use. If this decision is based on a CSA and he is unable to

demonstrate control of risks for man or environment using available informationthis needs documentation and must also include a response to the customer and theAgency in writing. Uses advised against have to be documented under heading 3.7of the technical dossier and under heading 16 of the SDS.

To communicate the use further up the supply chain (if the supplier is not theM/I).

A.2.4.1.2 Brief general description of use and short titles of Exposure Scenarios

Any registrant under REACH is obliged to provide a brief general description of theidentified uses in his registration dossier (REACH Annex VI Section 3.5). He

furthermore has to update his registration dossier in case of a new identified use ornew uses advised against, where the conditions of use are not covered by an ES in the

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369370

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383

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392393394395396

397398399400401

402403404405406

407

408409410411

registration. This may imply adaptation of existing ESs or addition of new ESs to thedossier.

When a downstream user makes a use known to a supplier in writing with the aim ofmaking it an identified use, he should at least provide a brief general description of

such use to start the dialogue on appropriate conditions of use to control the risks.If the registrant has to carry out a CSA including development of exposure scenarios,the final exposure scenarios shall be presented under the relevant heading in the CSR,and included into an annex to the Safety Data Sheet. The registrant shall give theExposure Scenario an appropriate short title giving a brief general description of theuse(s) covered by the ES, consistent with those given in the registration dossier.

The short title for an ES and/or the brief general description is not an ExposureScenario itself because the ES provides a description of the conditions of use ensuringcontrol of risk. Hence the short title is meant to support communication anddocumentation, and is not sufficient information to satisfy the needs of safety

assessment and risk management. This leads to the following conclusions:

a) Use descriptors / Short Titles: These briefly describe a use in general terms in thecontext of i) Annex VI in the registration dossier, ii) use-identification from DU tosupplier and iii) in giving an exposure scenario a name. This brief, general descriptionshould be based on the standard descriptor system as described in part D.3.3.

b) Conditions of use in an ES (not part of the short title): The conditions of use (i.e.the operational conditions and risk management measures) shall be described at alevel of detail appropriate to carry out the safety assessment, to ensure control of risksand to communicate the conditions of use in the supply chain in a way that they can

be implemented by the (downstream) user.Consequently the elements of a) are aimed to facilitate communication, transparency,traceability of substances in the market, application of standard exposure scenarios forvarious uses and processing in the REACH IT system, while the elements of b) havedirect consequences regarding REACH obligations for the actors in the chain.

Also note that there is not necessarily a 'one-to-one' link between a) and b). There maybe several ES for the same 'brief general description of use' as it, for example, may be possible to control the risks from a process by implementation of different RiskManagement Measures. Moreover, different substances may have the same type ofuse that can be covered by the same brief description of use, but may require

different Risk Management Measures due to different hazardous properties. Likewise,a generic exposure scenario may cover several uses/processes and several briefdescriptions of uses may therefore be used to name the same ES. In such a case it canalso be considered to have more generic titles for the ES to cover several briefdescriptions of identified uses.

A.2.4.1.3 Standard Descriptor for Uses

The legal text of REACH does not define in which form the brief general descriptionof use has to be given. However, communication in the supply chain and effectiveimplementation of the exposure scenario concept depend on harmonised languageacross the European market. Consequently, a standard descriptor system for uses has

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412413414

415

416417418419420421422423424425426427428

429

430431432433434

435436437438439440441

442443

444445

446

447

448449450

451452

been developed. The system has been incorporated in the REACH registrationsoftware (IUCLID 5) for registration purposes and is foreseen to be the backbone forassigning short titles to ES in the IT support tools under development.

It consists of four descriptors, each one allowing to select the appropriate level of

detail to briefly characterise the use: Sector of use. This is used to describe in which sector of trade and industry a

substance is used on its own or in preparations. This descriptor also covers the usein private households and the public domain.

Chemical product category. This describes the type of preparation in which thesubstance is used.

Process category. This describes the type of technical process categories oroperation units in which the substance on its own or in preparations is used. Theyhave an impact on the exposure to be expected and hence on the risk managementmeasures needed.

Article categories. This describes the type of article into which the substance isincorporated (if relevant).

The use descriptor system is further explained in part D.3.3.

A.2.4.2 Determinants of release and exposure and exposure assessment

Determinants of release and exposure represent the main information that needs to becollected for making an exposure scenario. Determinants of exposure can relate to (i)substance characteristics (ii) the operational conditions and risk managementmeasures and (iii) the surroundings where the substance is used or into which thesubstance is emitted.

In principal, these so-called determinants of exposure may differ from use to use,however based on current experience it is possible to define a set of key determinantsof exposure which are relevant in most cases (see list of key information/determinantsin table D-1). These include for example the volatility, water solubility and dustinessof the substance, the amounts used, the duration and frequency of use, the amount ofenergy applied while using the substance, and the different kinds of risk managementmeasures.

Based on the list of key determinants, the registrant can target his informationcollection

i) to develop one or more initial Exposure Scenarios andii) to carry out first estimate of exposure by use of standard tools (see part D).

A.2.4.3 Function and content of exposure scenarios

A.2.4.3.1 Function and content of the initial and final ES

The Exposure Scenario or use and exposure category for an identified use (or a groupof uses) describes the conditions under which a dangerous substance/PBT/vPvB (or agroup of substances) can be used whilst controlling risks.

The ES is an instrument for communicating operational conditions and riskmanagement measures that are suitable to ensure control of risk throughout the supply

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453454455456457

458

459

460461462463464

chain. Different ESs will probably be needed to cover identified uses at different stepsin a supply chain. At the same time the ES describes the key determinants driving the

pattern and level of emissions and exposure as a basis for exposure assessment andrisk characterisation in the CSA. This includes the suitable measures to controlexposure of the environmental compartments (air, water, soil) and exposure of certain

target groups, like consumers and workers.

The Exposure Scenario must cover both:

the operational conditions of use (exposure determinants such as amount used,application process, duration and frequency of use, conditions of the receivingenvironment),

the risk management measures (emission or exposure determinants such as wastewater treatment or local exhaust ventilation).

The initial exposure scenario describes the typical conditions of use as existing in themarket of a substance, based on readily available standard information. If it can be

demonstrated that these conditions of use control the risks, the initial ExposureScenario will become the final

465466

467Exposure Scenario. The Final ES will be:468

469470471

472473474

475

476477478479480481482483

484485

486487

488489490491492493

494

documented as a subchapter in chapter 9 of the CSR format and communicated as an annex to the extended Safety Data Sheets to the

customers.

If it turns out that control of risks cannot be demonstrated for current practice or basedon available information, or that other than the standard determinants play asignificant role, iterations have to be made (see A.3.1 and part D).

A.2.4.3.2 Use and Exposure categories

The level of detail required in describing an exposure scenario will vary substantiallyfrom case to case, depending on the use of a substance, its hazardous properties andthe amount of information available to the manufacturer or importer. Exposurescenarios may describe the appropriate risk management measures for severalindividual processes or uses of a substance. An exposure scenario may thereby covera large range of processes or uses. Under REACH such an exposure scenario can becalled use and exposure category (UEC) (Definition in Article 3) or simply broadexposure scenario.

It is important to note that this categorisation-option in the legal text is based onactivities with a substance (see use definition Article 3 (24)) or processes.

Other possible criteria like exposure routes, exposure patterns (time), sectors of use orproduct types are not mentioned.

M/I would group those activities/processes under one UEC for which the risk can becontrolled by the same set of risk management measures. How broad such a categoryis defined, and whether other categorisation-criteria are applied in addition, is thechoice of the registrant. However, the UEC must still correspond to the structure andthe content of the exposure assessment in the CSR. The possible broadness may bealso limited in that respect that a too broad grouping may negatively impact on the

usefulness of the UEC for the downstream user.

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495496497498499

500

501502503504

505506507

508509

510511512513514515516517

518

519

520521522523524525

526527528

529530531532533534

535

536537

The use descriptor system suggested in section D-3.3 of the TGD is built oncategories of processes/activities (descriptor 3) and product categories (descriptor 2and 4). It can be used to support exposure related categorisation of

processes/activities/products relevant in the market of a substance. The resultingcategories can be directly linked to available tools for tier 1 exposure assessment.

A.2.4.3.3 Generic versus specific exposure scenarios

Exposure scenarios can cover a specific use (specific ES) or cover a broader range ofuses. Independent of the scope of the ES (narrow or broad), M/Is ES will describe ina more or less generic way the operational conditions of the covered uses and thecorresponding measures to control the risk.

There may be situations where M/Is exposure scenario is quite specific: Uses of veryhazardous substances and/or particular complexity of exposure determinants (e.gvapour pressure of a substance and reaction rate on use control the exposure) Also

the immediate downstream user may wish to narrow down the generic exposurescenario in order to be able to offer specific advice for his customers.

If the exposure scenario covers a broad range of uses, the M/I will usually not reflectthe details of a use in a specific product or at a specific local site in his exposurescenarios (including UEC) for a substance. In these cases, the ES will be mostly basedon generic assumptions or recommendations related to the uses covered in the ES.This can be for example assumptions on amounts applied, concentrations in a

preparation, effectiveness of LEV or the duration of exposure. It will be task of thedownstream user to evaluate whether the specific conditions of use at his site and theconditions of use including RMMs further downstream are covered by the M/Is

generic ES.

A.2.4.4 Exposure Scenarios for substances in preparations

Where a substance is being used in a preparation, an ES might need to be developedfor this use of the substance. Depending on the situation, either the M/I or the DU cantake the initiative to develop the initial ES that includes the identified use of thesubstance in a preparation (see chapter A-4). The risks associated with this use need to

be covered in the exposure assessment, as part of the life-cycle of the substance thatincludes the downstream uses.

The formulators usually have the necessary knowledge on operational conditions andRMMs appropriate for formulating and using the preparation. Initial ESs couldtherefore also be made by the formulator.

It would facilitate the formulator's task of consolidating ES for single substances intoan SDS for the preparation, if the registrants would tune the ES for the individualsubstances to the needs of the formulators. If a formulator makes his preparation outof other preparations, the ESs for the individual substances in the preparationssupplied to him might simply be passed on to the final formulator. This could simplifythe communication in case a preparation is made out of other preparations.

In most cases, a preparation containing classified substances in a concentration greater

than the limits in REACH Article 14 will lead to the classification of the wholepreparation as dangerous.

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538539

540541

542543544545546547

548549550551552553554555556

557558559560561562563564565566567

568

569570

571572

573574

575576577578579

580581

This corresponds to the current requirements under the EU Dangerous PreparationsDirective (1999/45/EC).

The formulator has to provide appropriate information on safe use to his professionalor industrial customers. In some cases, an ES for one of the substances in the

preparation may cover the whole preparation. In such case, the relevant exposurescenario can simply be passed on if considered appropriate. In other cases, it couldoccur that the single exposure scenarios for the different dangerous components in the

preparation sold to the customers may lead to conflicting advice related to safe use ofthe whole preparation. Then, the formulator may need to consolidate the differentexposure scenarios into one ES or Safety Data Sheet for the preparation (see Part G).

REACH does not require that the ESs for the individual substances in a preparationhave to be merged when a formulator prepares a SDS. However, any DU shallidentify and where suitable recommend appropriate measures to control risksidentified in a SDS for the entire preparation. This implies that the different pieces ofinformation are taken into account when developing a SDS for the preparation. TheSDS for the preparation should offer consistent advice on operational conditions andrisk management measures in the main body of a SDS and in ES(s) annexed to theSDS. The relevant methods can be looked up in the guidance on preparations of theDU-TGD, section 14.

If a preparation supplied to the customer is not classified as dangerous but contains adangerous substance (with ES(s) received by the formulator) in concentrationexceeding any of the thresholds laid down in Article 31(3) of REACH, additionalcommunication obligations may exist from the DU to the end-user, for instancecommunicating specific conditions of use (including use conditions or uses advisedagainst), the identity and the hazard identification of the relevant component(s) of the

preparation. However, it may be that it is not always relevant to attach a certain ES toa SDS for a non-dangerous preparation, for instance, if the ES for that substancedefines that the substance can be used in the preparation below a definedconcentration level without further RMMs or OCs, and the substance is present in the

preparation below that concentration.A.2.4.5 Exposure Scenarios for substances in articles

According to REACH article 3(3), an article is an object which during production isgiven a special shape, surface or design which determines its function to a greater

degree than does its chemical composition. Typical articles are textiles, paper sheets,plastic or glass bottles and tyres.

A substance incorporated onto or into an article matrix becomes part of that, e.g. dyestuffs in textile-articles, pigments in plastic articles or stabilisers in tyres.

The substance then enters into the service-life-stage of the article. A registrant of adangerous substance has to cover all identified uses and resulting life cycle stages inhis CSA/CSR. If the incorporation of the substance into an article is an identified use,he therefore has to include the service-life stage and final waste stage into hisCSA/CSR.

If a DU incorporates a dangerous substance (on its own or as part of a preparation)into an article, the SDS received from the supplier may or may not contain an

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Improving the hazard information - if a limited toxicity data set is available to derivePNECs or DNELs, it is common to use relatively large assessment factors (see Part B)In such cases, collecting additional information may lead to the use of less stringentassessment factors that account for the increased confidence in the data (cf. section onDNEL and PNEC derivation, B-8). However, the risk characterisation may also point

out that certain risks are not controlled and that additional data needs to be collected.This may occur for instance if the CSA points to significant emissions to the soilcompartments. In such a case, additional soil toxicity data may need to be collected.

624625626627628

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652

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Improving the exposure information Iterations on exposure data or on assumptionsmay be necessary by adapting or improving any default input values for which this isconsidered necessary: refinement of data on substance properties, emission data,exposure assumptions, model definition or complexity (e.g., go to less conservativeassumptions), or replace model predictions by measured data.

Improving information on operational conditions - The description of the operationalconditions can be refined to get closer to reality, for example duration or frequency ofactivities can be adapted, (e.g. a default 8 hr/day shift is assumed while in practice it isonly 4 hr/day). If further refinement is needed, recommended operational conditionscould be tightened or changed.

Improving information on risk management- The initial exposure scenario is based onavailable information on implemented and recommended RMMs. Therefore, when theresidual exposure still suggests the potential for risks, stricter RMMs can lower theexposure. Several options can be explored to improve the information on RMMs. Thiscould be demonstrating and documenting a higher efficiency of the implementedRMMs than the default assumptions. Another option is to add RMMs that were notyet present such as on-site waste water treatment, changing to a closed system orimproved recirculation of processing chemicals. In general, safer alternatives or

process and technical controls have priority over RMMs based on personal protectionequipment.

A.2.7 Iteration strategy

Due to the flexibility of the CSA under REACH, the most efficient strategy to achievecontrol of risks differs from assessment to assessment. In general, the quickest and

possibly most cost-effective approach is to improve the realism of the exposure andrisk management assumptions of the assessment. If it can be demonstrated that initial

hazard and or exposure information can be replaced by improved and more realisticinformation, further testing or additional RMMs may not be needed. It may be best tofirst exhaust the iteration possibilities with the available data or consider collectingadditional exposure information or measurements. If enough exposure information isavailable, more complicated exposure models ('higher tier' models) may be employedto get a more precise exposure estimate. Running such models would normally requirecollection of additional information related to the use and use conditions of thesubstance. The trade-off between additional time and information requirements and animproved exposure assessment depends on many factors and varies from case to case.In some cases the safety assessment may lead to the conclusion that certain types ofuses can no longer be supported and thus can not be covered by the ES.

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668669670671672

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Uncertainties are present in all steps of the CSA. Practical guidance has beendeveloped to help the registrant to determine the influence of uncertainties on the riskcharacterisation at any stage during iterations of the CSA (see Chapter R.19).Uncertainty analysis can be used in the CSA iterations to test the robustness of therisk characterisation, identify the most uncertain inputs to the entire CSA (whether

hazard or exposure related) that influence the risk characterisation, and to decide onthe most effective way to collect additional information on these elements to improvethe CSA and risk management.

A.2.8 Updating the CSA

New information which becomes available after registration may trigger theobligation to update the exposure scenarios, the CSA and the CSR. Then theregistration also needs to be updated. Such information is for example:

A new identified use of the substance promoted by the substance M/I which leads

to an update of exposure scenarios. A new identified use made known by downstream users in response to the

extended safety data sheet and supported by the M/I. This applies if the use cannotbe covered by the use conditions in one of the already existing exposure scenarios.

A new use advised against Additional information on the conditions of use for an already identified use,

becoming available after the registration that require changing operationalconditions or RMMs

New information on the physicochemical properties or adverse effects of asubstance has been identified or results of tests proposed to the Agency have

become available. Change in classification. If changes of production volume and/or import volume result in a change of

tonnage band requiring additional hazard information. The exposure scenario or other information needs to be changed due to decisions

by the Authorities under REACH procedures (information requested underevaluation(s), granted or refused authorisation or new restrictions, harmonisedclassification and labelling).

A.2.9 Chemical safety report

The final or updated CSA, including the final exposure scenarios and the associatedexposure estimation needs to be documented in the chemical safety report (see part F)and submitted to the Agency with the technical dossier.

A.2.10 Exposure Scenario annexed to the Safety Data Sheet

The final exposure scenarios can be extracted from the CSR and converted into theannex(es) for the extended safety data sheet. Different options exist for the way theES information is translated to the SDS, as explained in part G.

One or more different exposure scenario annexes are needed to communicate theinformation relevant to the respective customers, depending on the diversity of the

conditions under which the substance is used by different downstream user groups.Several identified uses can be addressed in one exposure scenario, if the operational

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711712713714715

716

conditions and the risk management measures (leading to comparable levels andpatterns of exposure) are the same. Also, the same ES annex may be used for varioussafety data sheets for different substances, provided it has been demonstrated in theCSRs that control of risks can be ensured. Thus, the exposure scenarios and safetydata sheets in the portfolio of the supplier may be combined with each other as

appropriate. Further guidance is provided in part G.

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A.3 COMMUNICATION IN THE SUPPLY CHAIN717

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A.3.1 Shared responsibility and communication in the market

Once a substance is classified as dangerous or is found to be a PBT/vPvB, exposureassessment is required to demonstrate control of risks for the entire life cycle of asubstance. This is a shared responsibility for all actors in the supply chain, exceptthose i) transporting chemicals, ii) treating waste for recycling2 or final disposal andiii) using chemicals in private households. Companies using substances on their ownor in preparations are defined as downstream users under REACH. Consumer use ofsubstances and preparations is not a downstream use, but may be an identified use.

Downstream Users incorporating substances into articles are at the same time article producers. Article producers and importers of articles are subject to specificrequirements under REACH (see section A.3.3 and RIP 3.8).

Companies or consumers that are only using articles (into which substances have beenincorporated) are not downstream users according to REACH, but will be referred toas 'article users'. These may also be subject to specific requirements (see section A.3.3and RIP 3.8).

A.3.2 Organise dialogues in the supply chain

The identification of uses of a substance is the first step in building exposurescenarios and carrying out a CSA for these scenarios. To carry out the CSA, themanufacturer or importer of a substance needs to possess or to collect sufficient

information on how the substance is being used by the various actors in the supplychain. REACH does not require the M/I to collect all the details on uses. However theM/I is obliged to make himself aware of all the conditions which determine exposure,wherever his substance is used throughout his markets. This includes his immediatecustomers as well as the markets of his customers further down the chain. The level ofdetail required depends on the hazard profile of the substance, the principal exposure

potential connected to the use, and the principal means of risk management thedifferent user groups have at their disposal.

Two mechanisms are foreseen in REACH to increase the knowledge of M/I:

Interaction before registration:

The downstream user has the right to make known his use(s), including supportinginformation on the conditions of use (or information on measured exposure levels) inwriting one year before the corresponding registration deadline by the latest(December 1, 2009 for the first registration phase)3.

Also the manufacturers and importers may start a dialogue with representativecustomers to get more knowledge on the general or specific conditions of usedownstream. There are various ways to start the dialogue. M/I may for example

2 Companies re-introducing recovered substances (on its own or in preparations) as products into the

market must however check whether or not they have to register these recovered substances.3 Legal reference article 37(2), 37(3)

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754755756

757

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develop initial exposure scenarios based on in-house knowledge, and send these forfeedback to selected/all customers before registration. Also visits to selected customersites may be a useful way to promote the dialogue.

Interaction after registration:

The downstream user can make his use known (including supporting information) fora registered substance at any time after registration. The M/I is obliged to process thereceived information in order to decide whether i) he can include the use in one of thealready existing exposure scenarios or ii) the registration needs to be updated with anew exposure scenario or iii) whether he is unable to support the use based on healthand environment concerns.

M/IfinalDUsDU formulators

associations

DU formulators

Making uses known to M/I

Informing about conditions of use Giving feedback on ES

Identification of uses

ES building Conducting CSA

M/I - DU

dialogue

DU - DU

dialogue

Overall Dialogue process


associations

DU formulators





M/I - DU

dialogue

DU - DU

dialogue


associations

DU formulators





M/I - DU

dialogue

DU - DU

dialogue


associations

DU formulators





M/I - DU

dialogue

DU - DU

dialogue

Overall Dialogue process

764

765

766767

FigureA- 3: Overview of dialogues in the supply chain.

In order to avoid significant updating of registration dossiers, a high number ofdownstream user CSAs after registration, and high efforts in communication up anddown the chain in single supplier-customer dialogues, coordinated interaction beforeregistration should take place. It is therefore recommended that M/I and DU seek co-operation and dialogues through their associations (see overall mechanisms in figureA-3). This may include:

768769770771

772773774775776777778779

Reaching agreement on the format and the core content of exposure scenariosamong the manufacturers/importers of substances with similar markets

Reaching agreement among downstream users on the standard conditions of useexisting in certain sectors/branches. This may include dialogues betweenformulators / distributors and the industrial/professional end-users of substancesas such or in preparations (see second dialogue circle in Figure A3)

Reaching agreement between M/Is and DUs. on a number of generic exposurescenarios reflecting the conditions of use in a certain market.

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Figure A-3 illustrates the basic mechanism to increase the knowledge of M/I on theconditions of use in his supply chain (arrows pumping information upstream).During its life cycle the substance passes various stages in the supply chain (arrowsindicating the substance flow down the chain). Often M/I does not supply thesubstance directly to the final downstream users, but various DUs mixing chemicals

may sit in between. M/I will receive the information on uses and conditions of usethrough his immediate customers. In all these activities, the associations at differentlevels of the supply chain may take an active role in setting up efficientcommunication systems.

Guidance on how to run the process of exposure scenario building is provided in partD. This includes a number of suggestions how to organise the dialogues in an efficientway, suitable to manage the registration process under REACH.

A.3.3 Key tasks in the supply chain

Box A-1 provides an overview on the key tasks to be implemented along the supplychain. The key tasks are assigned to the roles defined in REACH. The downstreamuser role is split into various roles, of which the most important ones are: Formulators(F) of preparations from substances or preparations, and industrial or professionalend-users of substances or preparations (E). Industrial end-users of preparations areoften at the same time producers of articles. Although consumers are end-users, theyare not considered downstream users according to REACH. Some actors may haveseveral roles, e.g. a manufacturer can also be a downstream user, or a formulator canalso be an end-user of e.g. a processing aid. For more details on identifying DU roles,see section 2 of the DU TGD.

For each of 14 key tasks identified, Box A-1 gives a reference to the correspondingsections in the TGD, or makes a cross reference to the TGD for downstream users(DU-TGD). The tasks are summarised in Figure A-4.

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RIP 3.2-2 PART A

806

807808

809

810811812813814815816817818819820821822823824825826827828829830

831832833834835836837838839840841

842843844845846847848849850851852

BOX A-1: Key tasks related to the CSA, for manufacturers (M), importers (I)

and downstream users (DUs). DUs can be formulators (F) or end users.

1. M/I: identify if a CSA is needed (substances manufactured or imported on

their own or in preparation 10tpa or articles produced or imported andcontaining substances 10tpa that are intended to be released). Check theexemptions for this requirement (REACH art. 14).

2. M/I: Conduct Hazard Assessment: determine the classification and labelling ofthe substances (if any) and establish the relevant Derived no-effect levels(DNELs) and Predicted no-effect Levels (PNECs) (see part B).

3. M/I: Determine if substance is considered to be persistent, bioaccumulativeand toxic (PBT) or very persistent and very bioacccumulative (vPvB), and ifso, characterise all emissions throughout the lifecycle of the substance thatresult from manufacture and identified uses (see part C)

4. M/I: Identification of uses, including as a minimum, a brief general descriptionof identified uses (see Section D.3.3). If the substance does not meet thecriteria for classification as dangerous and does not meet the criteria forPBT/vPvB, go to step 7.

5. M/I: For substances classified as dangerous, and/or being PBTs/vPvBs:conduct an exposure assessment and risk characterisation (see part D and E).Develop one or more initial exposure scenarios. Describe the conditions of usein the initial ES(s) based on current practice and readily available information(see part D), with emphasis on

o Technical description of process and/or activities carried out with thesubstance

o Operational conditions of use that are relevant for controlling riskso Risk management measureso For PBT/vPvB substances: Emission and exposure shall be minimised.

Assess whether risks are controlled (see part E).

6. M/I: If risks are not controlled, the hazard and/or exposure assessment has to be refined. The hazard assessment, exposure scenario or the estimation ofexposure needs to be iterated until control of risks can be demonstrated (see

part E). This may includeo modification of risk management measures (RMM) or operational

conditions (OC) and/or

o limiting the uses of a substance covered by the CSA and/oro collecting further information on substance properties and refining the

hazard assessmento refining the estimation of exposure to better reflect the situation where

the ES(s) are implementedAfter iteration(s), assess whether risks are controlled ( see part E).

7. M/I: Document the CSA in the Chemical Safety Report (CSR). If an exposureassessment was done, document control of risks based on exposure scenariosand the related exposure estimation (see part F)

8. M/I: Integration of information relevant for the DU into the extended safetydata sheet (see part G)

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RIP 3.2-2 PART A

853854855856857

858859860861862863864865866867868

869870871872873874875876877878879880881882883884885886887888889

890891892893894895

9. F: Comparison of the exposure scenario received from supplier with the usesand the actual conditions of use at formulators level and further downstream;in case the conditions of use are not covered in the exposure scenario, theformulator may take the following action (see DU-TGD)

o adapt his own conditions of useo approach the supplier with the aim of identifying his own as well as

downstream use and operational conditions and suggest respectivemodification of the exposure scenario or

o conduct an own CSA and, where required, report to the Agency oro replace the substance by a non dangerous alternative or an alternative

with a more suitable ES10.F: If relevant, communicate to the supplier new information on hazardous

properties of the substance not mentioned in the safety data sheet orinformation that calls into question the appropriateness of risk managementmeasures suggested by the supplier (see DU-TGD)

11.F: Forward the exposure scenario information for the different dangerous

substances in a preparation to the DU, in an appropriate manner. This isfurther detailed in Section G and the TGD for downstream users.

12.Professional/industrial end-user of the substance: Comparison of the exposurescenario received from supplier with i) the uses and the actual conditions ofuse at the level of substance/preparation end-user and ii) the conditions of usein the life cycle stages resulting from the use (service life in articles and wastelife stage); in case the conditions of use are not covered in the exposurescenario, the downstream user may take the following action (see DU TGD):

o adapt his conditions of use and/or the conditions of use in the life cyclestages resulting from his use

o approach the supplier with the aim of identifying his own use as wellas downstream use and operational conditions and suggest respectivemodification of the ES or

o conduct an own CSA and, where required, report to the Agency oro replace the substance by a non dangerous alternative or an alternative

with a more suitable exposure scenario.13.Professional/industrial end-user of the substance: At any time, communicate

to the supplier new information on hazardous properties of the substance thatis not mentioned in the safety data sheet or information calling into questionthe appropriateness of OCs or RMMs suggested by the supplier (see DU-TGD).

14.Professional/industrial end-user of the substance: Industrial end-users are oftenarticle producers. For substances of very high concern on the candidate list,that are contained in articles > 0.1%, supply information to the professional,industrial recipient of the article in order to allow control or risks of the article.On request, also supply this info to consumer (see guidance on articles[RIP3.8])

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RIP 3.2-2 PART A

Figure A-4: Overview of key tasks to be implemented along the supply

chain.

896897

898899900

901

902

MI = manufacturer/importer, downstream users are divided in F = Formulator

and E = end user (professional or industrial) of a substance on its own or in a

preparation. Each task delivers an output in the form of information exchange

or documentation of the results of the CSA in the ES, the CSR or the SDS

1. Is CSAneeded?

No

Finalise registrationwithout CSR

2. Conduct HazardAssessment

Yes

DNELs and PNECs

C&L

Hazard part of CSROutput

3. Conduct PBT/vPvBAssessment

DocumentPBT/vPvB

assessmentOutput

5. Conduct ExposureAssessment.

Develop ES(s)

Initial ESs,including OCs andRMMs. See pt. DOutput

6. Refine Exposure/hazard information

and ES.

Adaptations toassumptions and input

to CSAOutput

7. Final Exposure

Scenario(s)

Document final ES(s)and expo assessment

in CSROutput

9. Conditionsof use covered

in ES?No

Adapt conditions orES [MI/-F dialogue]

or make DU-CSA

Communicate to MIReceive updated ES

or make DU-CSAYes

Yes

Consistent ESinformation for

preparationOutput

Adapt conditions orES [F-DU dialogue]

or make DU-CSANo

Communicate to FReceive updated ESYes

No

8. Final ExposureScenario in SDS

Final ESsDocumentation in SDSOutput

10. Additional

information onhazard, RMM etc?

12. Conditionsof use covered

in ES?

11. Forward ESs tothe DU

13. Additionalinformation on

hazard, RMM etc?

Yes

No

M/I

M/I

M/I

M/I

M/I

M/I

M/I

M/I

F

F

F

E

E

E

4. Identify usesin supply chain

Identified Uses

Grouping of UsesOutput

14. For articles,does it containSVHC > 0.1%?

Supplier responsible

for information oncontrol of risks

Yes

No

No additonalrequirements for

supplier

903

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RIP 3.2-2 PART A

A.4 CSA FOR DIFFERENT ACTORS904

905 A.4.1 CSA for a so-far unsupported use by a Downstream User

906907908909910911912

913914915

916917

918919920921

922923924

925926927

AimA downstream user may find that the exposure scenarios and the conditions of use contained in it,as received from the upstream supplier, do not cover his actual conditions of use or uses furtherdown the supply chain. The first action a DU can take is to inform this supplier of his use andsupporting information to allow his use to become an identified use. In some cases, the duty to carryout a CSA for a particular use or for certain conditions of use then shifts from the M/I to adownstream user, for instance in the following situations:

A supplier has already advised against a particular use but a downstream user neverthelesswants to apply the substance for such use. The same applies in a situation where a supplierrefuses to include a newly identified use from the DU upstream into the Safety Data Sheet

(SDS), e.g. based on health and environment considerations. The downstream user considers the use confidential business information.

In such cases, and unless exempted according to Article 37 (4) the DU is obliged to take over theresponsibility for conducting the CSA for that use (see SectionA.3.2) and, where required, reportthis to the Agency. More detail on how the DU can check coverage of the ES can be found in theTGD for downstream users.

In those cases, the DU will need to cover the life-cycle of a substance in the CSA from its receipt bythe downstream user, for his own uses and identified uses further down the supply chain as asubstance, in a preparation or in an article, if this is not covered by an ES supplied to him. When a

DU decides to prepare his own CSA/CSR, the M/I has no additional obligations to this specific DU,other than communicating the relevant SDSs (on further requirements, see TGD for downstreamusers)

928

929930931932

933

934935

936937938

939940

CSA and CSR

The different steps of a downstream user CSA are detailed in Box A-2. The emphasis of the CSR ison developing exposure scenarios for uses that are not within the boundaries of the ES supplied tothe DU by supplier. The exposure and risk assessment of the CSA can be refined, if necessary, inorder to control risks from the use of the substance.

If additional information on hazard (beyond what the DU has received from his supplier) is needed,

the DU should generate or collect this information, if needed supported by a proposal for testingwhen testing on vertebrates is needed.

It is quite likely that the identified uses for which the DU wants to register concerns preparations, possibly containing several classified substances. Developing ESs for preparations by a DU, isexplained in Part G, Appendix 3 and in the TGD for downstream users.

Additional general and specific duties in the supply chain, in relation to substances in preparations,are listed in steps 9-14 of the general duties of actors in the supply chain (Box A-1).

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RIP 3.2-2 PART A

Box A-2: Steps to prepare a downstream user chemical safety assessment941

942

943944

945946947948949950951952953954955956957958959960

961962

963964

965966967968

969970

971

972

973974

1. DU: Consider the need for preparing a DU CSA (see introduction of 3.2).2. DU: If a DU-CSA is needed, start with identification of uses, including brief general description

of identified uses of the substance, starting with the receipt and use of substance by the DU andcovering any identified uses further down the supply chain as well as life-cycle stages resultingfrom own and identified uses, including service life and

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