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Chesar 2 User manual

Part 3 - Exposure assessment

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Disclaimer The information contained in this manual does not constitute legal advice. The European Chemicals Agency does not accept any liability with regard to the contents of this document. The European Chemicals Agency is entitled to modify or revise the document at any time with or without notice and with or without cause.

Chesar 2 User manual Part 3 - Exposure assessment

Reference: ECHA-12-G-08-EN Publ.date: 6 March 2013 Language: EN

© European Chemicals Agency, 2012 - 2013

Cover page © European Chemicals Agency

Reproduction is authorised provided the source is fully acknowledged in the form “Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written notification is given to the ECHA Communication Unit ([email protected]).

ECHA invites interested parties to submit comments on this document which may be incorporated in future updates. These can be submitted via the Contact ECHA page at: http://echa.europa.eu/about/contact_en.asp

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Document History

Version Comment Version 3.0 06/03/2013

• Adaptation to Chesar 2.2 • Update on the import procedures for external exposure

estimation tool (section 6.5) • Small editorial changes

Version 2.0 24/10/2012 • Possibility to add several determinants in one go (Section 3.4.4) • Release to waste (Section 5.2.2) • Update on the default conditions of use, including the new

determinant “particular considerations on the waste treatment operations” (Section 5.2.4)

• Possibility to report measured data for man via the environment (Section 5.5)

• ECETOC TRA consumers (Section 6.3) • Deepening of the “explanation on exposure value” text for

measured data (Section 6.4.2) Version 1.0 20/06/2012, First version

Table of Contents

1 INTRODUCTION ....................................................................................... 1

1.1 Aim of the document ....................................................................................... 1 1.2 Purpose of exposure assessment under REACH ............................................... 1

2 KEY PRINCIPLES BUILT INTO CHESAR .................................................... 2

2.1 Environmental assessment .............................................................................. 2 2.2 Assessment for human health ......................................................................... 3 2.3 Description of the conditions of use ................................................................ 4

3 OVERVIEW OF CHESAR BOX 3 ................................................................. 5

3.1 Key terms ........................................................................................................ 5 3.2 Main differences with Chesar 1 ....................................................................... 5 3.3 Window organisation ...................................................................................... 6 3.4 Overview of Box 3 functionalities .................................................................... 7

3.4.1 Adding and editing an exposure assessment ........................................................ 7 3.4.2 Deleting an assessment .................................................................................... 8 3.4.3 Copying and pasting an exposure assessment ..................................................... 8 3.4.4 Managing conditions of use ............................................................................... 8 3.4.5 Risk characterisation ratios ............................................................................... 9

3.5 Main steps ....................................................................................................... 9

4 DEFAULT EXPOSURE ASSESSMENT CREATION ....................................... 13

5 EXPOSURE ASSESSMENT FOR THE ENVIRONMENT ................................. 15

5.1 Add environmental exposure assessment ..................................................... 15 5.2 EUSES assessment ........................................................................................ 15

5.2.1 Selection of release estimation method ............................................................. 16 5.2.2 Releases pane ............................................................................................... 19 5.2.3 Exposure and risk characterisation ratio for the environment and man via the environment ........................................................................................................... 20 5.2.4 Default conditions of use ................................................................................. 21 5.2.5 Modifying tonnage information ......................................................................... 22 5.2.6 Adding other conditions of use ......................................................................... 23

5.3 “EUSES assessment” for PBT substances ...................................................... 24 5.4 Environmental measured data ....................................................................... 25 5.5 Combined exposure assessment .................................................................... 26

6 EXPOSURE ASSESSMENT FOR HUMAN HEALTH ...................................... 30

6.1 Introduction .................................................................................................. 30 6.2 ECETOC TRA Workers .................................................................................... 31

6.2.1 Add or edit a TRA workers exposure assessment ................................................ 31 6.2.2 Exposure estimation ....................................................................................... 32 6.2.3 Conditions of use ........................................................................................... 32

6.3 ECETOC TRA Consumers ................................................................................ 34

6.3.1 Add or edit a TRA Consumers exposure assessment ........................................... 34 6.3.2 Exposure estimation ....................................................................................... 35 6.3.3 Conditions of use ........................................................................................... 36

6.4 Measured data assessment (Worker/consumers) ......................................... 38

6.4.1 Add or edit a measured data assessment .......................................................... 38

6.4.2 Exposure estimation ....................................................................................... 38 6.4.3 Conditions of use ........................................................................................... 39

6.5 External exposure estimation tool assessment (worker/consumers) ............ 39

6.5.1 Manually add or edit an external exposure estimation tool assessment ................. 39 6.5.2 Import external exposure assessment .............................................................. 41

Table of Tables Table 1: Main steps for exposure assessment ....................................................................... 10 Table 2: Release factor when release estimation method is ERC .............................................. 44

Table of Figures

Figure 1: Environment assessment workflow .......................................................................... 3 Figure 2: Box 3 general view ................................................................................................ 6 Figure 3: Contextual menu when selecting an assessment in Box 3 ........................................... 7 Figure 4: Empty conditions of use pane for measured data for a workers’ contributing scenario .... 9 Figure 5: Create default exposure assessment ...................................................................... 13 Figure 6: Create environment assessment ........................................................................... 15 Figure 7: EUSES assessment .............................................................................................. 16 Figure 8: Creation/edition of EUSES assessment- selection of release estimation method ........... 16 Figure 9: Various release estimation method selected for different release route ....................... 17 Figure 10: Selection of SpERC for EUSES assessment ............................................................ 18 Figure 11: Release pane when selecting a EUSES assessment ................................................ 20 Figure 12: Exposure and RCR for the environment and man via the environment ...................... 21 Figure 13: Modifying annual use amount at a site ................................................................. 23 Figure 14: Example of conditions of use for a EUSES assessment based on release factor .......... 24 Figure 15: Exposure pane for a PBT substance ..................................................................... 25 Figure 16: Create/Edit environment measured data assessment ............................................. 25 Figure 17: Exposure for measured data assessment .............................................................. 26 Figure 18: Combined environmental assessment ................................................................... 27 Figure 19: Regional exposure ............................................................................................. 27 Figure 20: Editing measured regional concentration .............................................................. 28 Figure 21: Exposure from combined widespread uses ............................................................ 29 Figure 22: Adding an exposure assessment for a workers’ contributing scenario ....................... 30 Figure 23: Exposure assessment details for a human health exposure assessment .................... 31 Figure 24: Exposure routes covered by TRA workers assessment ............................................ 31 Figure 25: TRA workers exposure pane ................................................................................ 32 Figure 26: Example of TRA workers conditions of use ............................................................ 33 Figure 27: Edition of vapour pressure at elevated temperature ............................................... 34 Figure 28: Exposure routes covered by TRA Consumers assessment ....................................... 35 Figure 29: TRA Consumers exposure pane ........................................................................... 36 Figure 30: Example of TRA Consumers conditions of use ........................................................ 37 Figure 31: Create measured data assessment for human health ............................................. 38 Figure 32: Edit exposure value for human health measured data assessment ........................... 39 Figure 33: Create/Edit External exposure tool assessment ..................................................... 40 Figure 34: External exposure tool exposure value ................................................................. 40

Table of Annexes

Annex 1 - Default settings of the release module .................................................................. 42 Annex 2 – ERC based release factors ................................................................................... 44

Chesar 2 User Manual Part 3 – Exposure assessment 1

1 INTRODUCTION

1.1 Aim of the document The aim of this document is to guide the user to:

• Understand the purpose of the exposure assessment under REACH

• Familiarise with the exposure assessment part of the application

• Carry out the quantitative exposure estimates for the contributing scenarios defined in Box 2

• Understand how the exposure assessment is completed in Box 4.

1.2 Purpose of exposure assessment under REACH The purpose of exposure assessment under REACH is the description of use conditions ensuring control of risk (and hence safe use) and to make a quantitative or qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed.

Exposure assessment under REACH includes two elements: i) characterising the operational conditions and risk management measures for the identified uses and ii) predicting the exposure to humans and to the environment occurring under these conditions. If the predicted exposure is lower than the derived/predicted no-effect-levels (DNEL/PNEC), control of risk is demonstrated.

In the absence of a no-effect-level the exposure estimates cannot be compared with a threshold, and thus no risk characterisation ratio (RCR) can be calculated. In such case the exposure scenarios are to be built (or finalised) with reference to a qualitative exposure assessment and risk characterisation.

In Chesar, the exposure assessment workflow takes partly place in Box 3 and partly in Box 4:

• In Box 3 the quantitative exposure estimates are generated, including identification of operational conditions and risk management measures driving the exposure (quantitative exposure assessment

• Based on this, the final exposure scenarios are built in Box 4. This includes the integration of conditions and measures needed to control risks from hazards for which no DNEL or PNEC is available (qualitative exposure assessment). Finally the assessment is concluded with the risk characterisation. For qualitative risk characterisation exposure estimates from Box 3 can be used as supporting information.


2 KEY PRINCIPLES BUILT INTO CHESAR

2.1 Environmental assessment The environmental protection targets to be taken into account are: water and sediment organisms (freshwater and marine), predators in the aquatic food chain (freshwater and marine), sewage treatment plant organism, agricultural soil organisms, predators in the terrestrial food chain, and air.

In addition exposure estimates are to be generated for intakes by human via the environment. This includes concentration of substance in air, drinking water and different food item (e.g. root cops, diary products, meat and fish).

Exposure concentrations in the different environmental compartments are estimated by the EUSES 2.1 fate model, based on the release rates to water, air and soil. Detailed explanations of environmental exposure assessment are available in the Guidance on Information Requirements and Chemical Safety Assessment Chapter R16: Environmental Exposure estimation.

The releases are estimated in Chesar as described in section 5.2.1 and 5.2.2 based on:

• Information from use reporting such as tonnage

• Information on operational conditions and risk management measures

In the use description (Box 2), uses at industrial sites and wide disperse uses are systematically differentiated. The exposure assessment for these two types of uses differs from each other:

• Uses at industrial sites, are assessed for one generic, representative site per use. It is assumed that a certain tonnage is used at this one single generic site and that a certain fraction of the use tonnage at this site is released (depending on the conditions of use). The release factor depends on the operational conditions and risk management assumed for the generic site. As there may be very large and very small industrial sites for one use, two contributing scenarios (or even the definition of two different uses) may be needed to reflect the difference in conditions and tonnage. By default it is assumed that the discharge from the site is treated in a municipal sewage treatment plant (STP) and the STP-sludge is applied to agricultural soil. However the assessor can change these assumptions. In addition it is assumed that the tonnage released from the site is diluted in 2000 m3 of water in the sewage system and by an additional factor of 10 in the receiving river water. Again the assessor can overwrite these assumptions.

• For wide disperse uses it is assumed that the market tonnage is evenly distributed in space and time. The assessment is carried out for a standard town with 10000 inhabitants and a corresponding use tonnage (fraction of the market tonnage). Thus wide disperse uses are those uses that correspond to consumer activities, services in a municipality or housing. Depending on the conditions of use a certain fraction of this tonnage is assumed to be released to the sewage system. It is also assumed that the tonnage released from the 10000 inhabitants is diluted in 2000 m3 of water in the sewage system and by an additional factor of 10 in the receiving river water. By default it is assumed that the STP-sludge is applied to agricultural soil. Usually the assessor will define one contributing scenario per use, and he will not overwrite the default assumptions on the local conditions for a substance marketed across Europe. The releases from all uses into the municipal sewage system are aggregated to derive an exposure estimate (see section 5.5).

The Predicted Environmental Concentrations (PECs) for the generic site or generic town are estimated taking into account the so-called “local concentrations” (Clocal) and “regional concentrations”. The regional concentration results from all the uses of a


substance and is calculated by EUSES in the background. The regional concentration is added to the local concentration for deriving the local PEC, in order to take into account that a single site or a single town do not discharge into a virgin environment but just add to emissions released by other site or towns.

For substances considered to be PBT or vPvB (see section 5.3) no estimates for the regional exposure are derived, only local concentrations for water are provided. This is due to the large uncertainties in predicting the fate, distribution and long-term effects of such substance in the environment, in particular regarding accumulation in the food chain.

The following scheme summarises the main steps of exposure assessment for the environment. A default assessment can be carried out, if an Environmental Release Category (ERC) and a tonnage has been assigned to the use in Box 2.

Figure 1: Environment assessment workflow

Unless the substance is considered to be a PBT or vPvB, EUSES plugged into Chesar generates exposure estimates (PECs) for all compartments by default. However, exposure assessment and risk characterisation may not be required for all the compartments, if no hazards had been identified in the hazard assessment. The choice which assessments from Box 3 are carried forward to exposure scenario building and risk characterisation is to be made in Box 4.

2.2 Assessment for human health The registrant under REACH is required to provide information on various toxicological endpoints in his registration. This includes local effects (irritation, corrosion, sensitisation) and systemic effects (mutagenicity, carcinogenicity, reproductive toxicity, or toxic effects to other organs). Such effects may occur after short single exposure or after long-term repeated exposure. The exposure triggering such effects may take place via inhalation, dermal contact or oral intake. Oral intake is only considered for consumers/general population.

Where a hazard has been identified, exposure assessment and risk characterisation is required for the corresponding route(s) of exposure, types of effect and target groups.

Minimum data on use - Environmental Release Category (ERC) - Tonnage for that use ► daily use at site ► annual use at site ► daily wide dispersive use

Release estimate • Water • Air • Soil

Conditions of use: OC/RMM

Exposure estimates for all protection targets: Water ► fresh water + sediments ► marine water + sediments ► STP ► food chain Soil ► agricultural soil ► food chain Air

Chesar Release Module

Municipal STP Dilution in receiving water

EUSES Fate Module


The exposure estimation tools plugged in to Chesar generate exposure estimates for long-term (repeated) inhalation, dermal and oral exposure (oral exposure only for ECETOC TRA Consumers). In addition the TRA worker generates exposure estimates for short-term peak exposure. However, exposure assessment and risk characterisation may not be required for all these routes or types of effect, if no hazards had been identified in the hazard assessment. The choice which assessments from Box 3 are carried forward to exposure scenario building and risk characterisation is to be made in Box 4.

2.3 Description of the conditions of use The generated exposure estimates must be referenced to the conditions under which such exposure occurs. In Chesar, a single condition that can be described with a structured set of information is called “determinant”. Such determinant may correspond

• To input parameters of a plugged-in or external exposure estimation tool

• To a set of measured releases or exposure concentrations

• To risk management measures with a certain effectiveness that can be applied to reduce an estimated release or exposure

Determinants can be either:

• Imported if they have been created by other assessors using Chesar. For example, sector organisations may wish to describe common conditions of use in that sector in a standardised way and share this information with the registrants. Also, different assessors at a single company level potentially want to share the results of their work with each other or

• Created by the assessor himself.

Determinants that do not correspond to an exposure estimate under REACH are included into the exposure assessment in Box 4. This applies e.g. to measures minimising exposure in the context of qualitative risk characterisation, or to good practice advice outside the exposure scenarios.

The determinants are stored in the internal library of the tool and can be used for any assessment, when relevant. Standard phrases can be associated to determinants for facilitating the generation of the ES for communication.

User manual 6 provides more information on creation and management of the determinants.


3 OVERVIEW OF CHESAR BOX 3

3.1 Key terms The following terms with a particular meaning within Chesar are used within this manual.

Type of effect: In the context of hazard assessment for human health the term refers to both, duration of exposure (acute/short term and long-term) and local or systemic effects. The hazard has to be assessed for all exposure routes and type of effects, and if some hazard is identified an exposure assessment and risk characterisation are to be carried out.

Exposure estimation method: Exposure can be estimated by different exposure estimation tools (plugged in to Chesar or not) or based on measured exposure data.

Release estimation method: The release to the environment can be estimated by different release estimation models (SpERCs, ERC based release factors or other release factors) or based on measured releases.

Release factor: The release factor is expressed in % and represents the fraction of substance released to a given release route.

• Initial release factor: This is the release factor usually provided by the release estimation model.

• Local release factor: This is the release factor calculated from the initial release factor after all on-site risk management measures have been applied (this excludes the effectiveness of the Municipal STP calculated by EUSES). It corresponds to the overall release factor from the site.

Release rate: The release rate is expressed in kg/day and corresponds to the amount of substance release over the day. When a release factor is provided the release rate is equal to the release factor multiplied by the daily tonnage.

Risk characterisation ratio (RCR): A RCR value can be calculated for each compartment (of the environment) or route/type of effect (for human health). It corresponds to the ratio between the estimated exposure value for the given compartment or route/type of effect and the corresponding hazard threshold (PNEC or DNEL) value.

3.2 Main differences with Chesar 1 In Box 3 exposure assessments will be created and edited. An exposure assessment consists of release/exposure estimates as well as related conditions of use. Conditions of use required to control risk, e.g. under qualitative assessment will be dealt within Box 4.

Therefore in Chesar 2 it is possible to create an “exposure assessment” regardless of the scope of the exposure assessment, i.e. whether exposure estimates are “required” or not, or whether the exposure estimates will be used for quantitative risk characterisation or in support to qualitative risk characterisation.

For plugged-in tools, an exposure assessment is systematically created even if some mandatory data (for example, physicochemical parameters) are not available in the IUCLID data set. In such case the assessment will be created but no exposure estimate will be available. For example, if the molecular weight is missing, no exposure estimates is provided by ECETOC TRA workers for inhalation. Such feature will ensure that the exposure estimates can be simply recalculated if the substance properties are modified in IUCLID (e.g. new data available on physicochemical properties or on hazard conclusions). In the “information on calculation” field Chesar informs the assessor how the exposure estimates have been obtained (including any particularity such as properties outside boundaries), or why no exposure estimates are provided.


For worker, ECETOC TRA v3 is plugged in to Chesar 2 and not TRA v2. It is not anymore possible to add other determinants for TRA worker.

For the environment, more than one contributing scenario per use can be defined now. When several contributing scenarios exist for one use, the highest release per route is taken into account for the estimation of the regional exposure estimation. Consequently, overestimation may occur in such cases for the regional exposure estimates.

It is also possible to make use of measured regional exposure concentration and overwrite the concentrations calculated by EUSES for freshwater, marine water, air and soil.

The display of the information is quite different between Chesar 1 and Chesar 2: All information on the exposure assessments are displayed on the right hand pane when selecting an element in the tree (displayed on the left). Also, the conditions of use are displayed under a simplified format.

3.3 Window organisation Once you have created the life cycle tree of the substance, click the 3rd icon to open the “manage assessment” window. As shown in the figure below, the life cycle tree is available on the left hand side.

Figure 2: Box 3 general view

On the top of the life cycle tree a node called Combined Environment Assessment is available. This contains information on releases and exposure which relates to the full life cycle of the substance (see section 5.5).

All the uses and contributing scenarios are displayed in the tree. In addition, for each contributing scenario all created exposure assessments are displayed

• When clicking on a use, the use description from Box 2 is displayed on the right hand pane.

• When clicking on a contributing scenario, you see on the right pane all the available assessment that have been carried for this contributing scenario, grouped by compartment for the environment and route/type of effect for human health. For each assessment the exposure value and related RCR is reported. This enables ad a quick glance to see all available quantitative exposure information per compartment or route of exposure.

• When clicking on an exposure assessment, all the information related to this assessment are displayed on the right pane


3.4 Overview of Box 3 functionalities The tool bar, above the life cycle tree, contains 11 buttons

with the following functions:

• Expand the full life cycle tree

• Collapse the full life cycle tree

• Create default assessment (see section 2)

• Add assessment

• Delete assessment

• Edit assessment

• Copy assessment

• Paste assessment

• Move up an assessment

• Move down an assessment

• Import external tool assessment

The functionalities related to assessment are also available by selecting an exposure assessment and right clicking it

Figure 3: Contextual menu when selecting an assessment in Box 3

3.4.1 Adding and editing an exposure assessment Exposure assessment can be created in Box 3 for the full life cycle by “default” (see section 4) or for a single contributing scenario.

For creating a single exposure assessment, select a contributing scenario in the life

cycle tree and press the button. For more details on creating an assessment see the sections specifically addressing the different exposure assessment types.


If an assessment has been created (e.g. by default), it is visible in the tree on the left hand pane.

Once the assessment is created it can always be edited by selecting it and pressing the button. Editing an assessment enables changing the information that had been

provided during the creation step.

3.4.2 Deleting an assessment At any time, you can delete an assessment.

If you delete a EUSES assessment, recalculation takes place for all other EUSES assessments as the regional concentrations may be modified.

3.4.3 Copying and pasting an exposure assessment Exposure assessment can be copied in Chesar 2.

For plugged-in exposure estimation tools, recalculation is done based on the characteristics of the contributing scenario to which the exposure assessment is copied.

When an external exposure estimation tool is used for creating several exposure assessments for different contributing scenarios, the copying/pasting functionality may be particularly useful. It avoids multiple re-selection of all determinants related to that exposure estimation tool. However, the exposure estimates are not recalculated. Thus, be careful not to forget adapting exposure estimates when appropriate in each pasted assessment.

3.4.4 Managing conditions of use For all exposure assessment a pane Conditions of use can be seen on the right side of the screen.

The conditions of use are displayed under the different subheadings of the Exposure Scenario format relevant for the type of use assessed (see user manual 6, annex 1). The term “Conditions of use” corresponds to determinants in Chesar terminology. More information can be found in user manual 6.

• For exposure assessment based on external tool (see section 6.5) there is no determinant when the exposure assessment is created (see Figure 4). The same sets of determinant types can be reused across different assessment for a given tool.

• For exposure assessment based on measured data for human health (see section 6.3) there is no determinant when the exposure assessment is created (see Figure 4). Specific set of determinants may have to be created to describe the conditions of use related to the measured concentrations.

• For EUSES assessment (see section 5.2) some determinants are displayed by default and cannot be removed. Additional determinants can be added.

• For TRA Workers assessment (see section 6.2) a set of determinants is displayed and no additional ones can be added.

• For TRA Consumers assessment (see section 6.3) a set of determinants is displayed and no additional ones can be added.

• For measured data for the local environment, no determinants can be reported. The reason is that the conditions of use leading to a particular environmental concentration can usually not be established. In addition, the concentrations in the various compartments of the environment are related to each other. However, usually a complete set of measured data for all compartments is not available. Therefore measured data can only be used as supportive information, but not as the exposure estimates for risk characterisation.


Figure 4: Empty conditions of use pane for measured data for a workers’ contributing scenario

When relevant you have to add determinants in order to report the conditions of use related to the exposure estimates. These will then be transferred to the exposure scenario. For measured data for human health, those determinants can be very specific to the use situation. The appropriate determinants have to be available in the Chesar determinant type library (see user manual 6).

You can add determinants (condition of use) by clicking on icon. A popup window will appear allowing the search for the determinant types available in the Chesar library. If you select one determinant type you can immediately select the appropriate value. If you select several determinant types by pressing the Ctrl key all of them will be included with their default value. To select the appropriate value you have to edit them by clicking the icon. When selecting a value, you can provide (when relevant) a justification or explanation in the field Explanation for CSR. All determinants added in an exposure assessment can be deleted at any time by the user.

3.4.5 Risk characterisation ratios For all exposure assessment a pane reporting exposure estimates is available on the right side. A risk characterisation ratio (RCR) is calculated, being the ratio of the exposure estimates and the related PNECs or DNELs. The following icons appear showing the status of the RCR:

• A green icon appears if RCR <1

• A red icon appears if RCR ≥1

• The following icon appears if the RCR is not calculated. This happens if the hazard conclusion is not quantitative, or if the value or the unit for the PNEC or DNEL is not properly set.

3.5 Main steps The following scheme describes the main steps to take in Box 3. For each step, reference to the user manual sections is provided. In order to provide a simple scheme, only the “standard” actions are included. Alternatives and case-specific situations are described in the user manual.


Table 1: Main steps for exposure assessment

Actions Icon/tab/button/link to be activated

Notes Section of user manual 3

1) Start assessment

Activate Box 3 from Chesar tool bar

Chesar displays life cycle area with the life cycle of the selected substance available

Perform default assessment for full life cycle tree based on Box 1 and Box 2 information

The default plugged-in exposure assessment tools (ERC/EUSES and ECETOC TRA v 3 workers and consumers) generate default assessments for environment and workers

4

2) Iterate and finalise the assessment for the environment

Decide which release method you want to select for the environment by editing the EUSES assessment

Possible choices: - ERC for water, air and soil - Release factor for water, air and soil - Measured releases for water and air - SpERC available in the library

5.2.1

Identify for which use and for which protection target the RCR is ≥1 Check also for man via the environment

The flag system helps you identifying if the RCR is ≥1

3.4.5

Iterate the estimation of the releases based on additional on-site risk management measures and/or modification of the conditions of use Provide more accurate information on tonnage

Add determinants (RMM) in the condition of use pane (determinants should be available in the library)

3.4.4, 5.2.5 and 5.2.6


Report measured exposure concentration when relevant, creating a new “Environmental measured data” and selecting the appropriate compartments

The measured exposure estimates may be used as supportive information in the risk characterisation (Box 4)

5.5

3) (Start) iterate and finalise the assessment for Workers

For existing exposure assessment (e.g. TRA workers) identify for which route/type of effect RCR is ≥ 1 or not assessed (if exposure assessment is required)

The flag system helps you to identify further assessment needs Check with the scope of assessment in Box 1

6.2

Iterate exposure assessment with ECETOC TRA workers in the “Conditions of use” pane

No determinant can be added to ECETOC TRA plugged-in assessment

6.2.3

Create other exposure assessments using external exposure estimation tools or measured data, selecting the relevant route/type of effects Report exposure and related conditions of use (determinants)

Determinants have to be available in the Library

6.4 and 6.5

4) Start, complete and iterate the assessment for Consumers

For existing TRA Consumers exposure assessment select a product/article subcategory in the “Conditions of use” pane to get exposure and RCR. Identify for which route/type of effect RCR is ≥ 1 or not assessed (if exposure assessment is required)

The flag system helps you to identify further assessment needs Check with the scope of assessment in Box 1

6.3


Create other exposure assessments using external exposure estimation tools or measured data, selecting the relevant route/type of effects Report exposure and related conditions of use (determinants)

Determinants have to be available in the Library

6.4 and 6.5


4 DEFAULT EXPOSURE ASSESSMENT CREATION

A “default assessment” can be carried out for the full life cycle tree by clicking on the Create default assessments button on the top bar. Such “default assessment” consists of:

• An exposure assessment for all environmental contributing scenarios based on the ERC release factors and EUSES v 2.1 with default setting for the embedded conditions of use (e.g. site tonnage, use of STP or river flow rate)

• An exposure assessment for all workers’ contributing scenarios (for manufacture, formulation, end use or service life “by workers”) performed with the ECETOC TRA v3 workers with default use conditions.

• An exposure assessment for all consumers’ contributing scenarios (for consumer use and service life “by consumers”) performed with the ECETOC TRA v3 Consumers. Please note that in this case the assessment needs to be activated for the different contributing scenarios by selecting an appropriate value of the product/article subcategory determinant, as indicated in section 6.3.3 of this manual.

•

Figure 5: Create default exposure assessment

Those default exposure assessments can be iterated one by one (see section 5.2 for environment, 6.2 for TRA worker and 6.3 for TRA Consumers).

Although an ECETOC TRA assessment is created for all workers/consumers contributing scenario, in some situations no exposure estimate is provided for certain contributing scenarios. This is the case when the TRA does not cover the assessment for the contributing scenario (for example if PROC 26 is assigned to a worker’s contributing scenario, such contributing scenario cannot be assessed by the TRA workers; the same happens also for consumer’s contributing scenarios as the TRA Consumers does not provide exposure estimates for all PC/AC ) or the relevant substance properties or use description are missing.

If the “default assessment” is deleted, or if new uses are included in the life cycle tree at a later stage in Box 2, it is still possible to create one for those non-assessed contributing scenarios by clicking again on Create default assessment as described


above. The “default assessment” will only be created for those contributing scenarios which have not yet been assessed. The existing exposure assessments will not be modified, i.e. the conditions of use, the exposure estimates and the release estimation will remain unchanged.

For the environment, any new exposure assessment has an impact on the exposure estimates for the already existing assessments because the contribution of the additionally assessed uses is taken into account for the regional concentration.


5 EXPOSURE ASSESSMENT FOR THE ENVIRONMENT

For each environmental contributing scenario an exposure assessment can be carried out with EUSES, using one of several methods to estimate the release (see section 5.2.1). In addition measured data can be reported to be used as supportive information for the risk characterisation (see section 5.4).

5.1 Add environmental exposure assessment To add an exposure assessment, select a contributing scenario and click on the Add button as shown in Figure 6:

Figure 6: Create environment assessment

Only one EUSES assessment can be created for a given contributing scenario.

When creating a “EUSES assessment” the release method has to be selected (see section 5.2.1).

When creating a “measured data assessment” a name is to be reported (reference that will be reported in the CSR), and the relevant compartments for which measured data are available have to be selected (see section 5.4).

5.2 EUSES assessment The fate and transport model in EUSES 2.1 is used by Chesar for the environmental exposure estimation following the estimation of the release (see section 5.2.1 and 5.2.2). In addition to the release data, also data on substance properties are needed to calculate exposure concentrations. The basic substance properties needed to run the fate and transport models of EUSES are:

• Molecular weight

• Vapour pressure

• Water solubility

• Octanol/water partition coefficient (Kow) (or adsorption-desorption coefficient (Koc) and measured BCF value)

• Results of screening test on biodegradability

In addition, other substance parameters, if available, are used by EUSES to perform a refined assessment (see R16 Guidance). Those parameters are displayed in Box 1 as “optional parameters for EUSES”.


When selecting a EUSES assessment in the life cycle tree, the following information can be seen in the right pane:

• Releases

• Exposure and risk characterisation ratios for the environment and man via environment

• Conditions of use

You can see a collapsed view of the three panes in Figure 7.

Figure 7: EUSES assessment

5.2.1 Selection of release estimation method When creating a EUSES assessment, you have to select the release estimation method for the 3 release routes as shown on Figure 8. You may select:

• ERC based for any of the release route: water, air and soil. This is the release method selected by default, as it corresponds to a worst case estimate of release under the assumption that no specific risk management measures have been put in place.

• Release factor for any of the release route : water, air and soil

• Measured release for water and air1

• SpERC based covering all release routes

If you have already created your EUSES assessments by default, you will have to edit each of those for which the ERC based release estimation is not appropriate. For that select the EUSES assessment and press the Edit button.

Figure 8: Creation/edition of EUSES assessment- selection of release estimation method

1 Only for site assessment (not for widespread uses)


If the release estimation is ERC based, the initial release factor is set by the ERC (see Annex 2).

If the release estimation is Release factor, you have to input the initial release factor in % (of daily tonnage) for the related release route (see Figure 9). In addition to the release factor you should report the following information (which will be reported in the CSR):

• A name/reference for the release estimation

• An explanation and justification to explain the source of such release factor

If the release estimation is Measured release, you have to input the local release rate (kg/day) for the related release route. In addition to the release rate you should report the following information (which will be reported in the CSR)

• A name/reference for the release estimation

• An explanation and justification to explain the source for such measured release.

Figure 9: Various release estimation method selected for different release route

Finally you can base the release on a SpERC. In this case all the information related to the SpERC should be available in the Chesar SpERC library (see user manual 6).

After having clicked on the SpERC based checkbox, you should select a SpERC from those available in the library (see Figure 10). When pressing the Select SpERC button, a list of all available SpERCs corresponding to the ERC selected for the use are proposed in a pop up window. When selecting the relevant SpERC, a list of sub-SpERC is proposed in the lower part of the pop up menu.

To select the relevant SpERC and sub-SpERC the following information is displayed:


• (sub-) SpERC title

• (sub-) SpERC code

• Scope of the (sub-) SpERC. This field provides information on activities or process covered by the (sub-) SpERC and is only used by the assessor to search for suitable SpERC in the library (see user manual 6).

Figure 10: Selection of SpERC for EUSES assessment

If some sub-SpERCs are only valid for a range of water solubility and vapour pressure, then only those corresponding to the substance properties are proposed. Consequently it could be that no sub-SpERC is proposed, if none is available for the assessed substance properties.

Once you have selected the appropriate sub-SpERC, Chesar will use all information coming from the SpERC/sub-SpERC for the release estimation, i.e.:

• The default daily use at site and annual use at a site are overwritten by the values from the sub-SpERC if available;

• The initial release factors from the sub-SpERC are used for the 3 release routes;

• The explanations on each release factor from the sub-SPERC are reported;

• All conditions of use (determinants) related (linked) to the initial release factor and potential additional risk management measures are reported in the conditions of use section.

When the release is based on a SpERC you cannot change the initial release factors nor the determinants related to them. Nevertheless it may still be possible to modify the tonnage information as well as any determinant related to additional RMM.


5.2.2 Releases pane When clicking on an EUSES assessment in the life cycle tree (left pane) in the Releases pane the information on the selected release estimation methods is available, together with release estimates and explanations on those when available. At any time, clicking on the Edit button you may change the release method initially chosen.

In the Releases pane the following information is displayed:

• Release estimation method

• Release estimation name. Not available when the release is based on ERC

• Initial release factor: set by the ERC or by a SpERC, or manually entered when selecting a release estimation method based on “release factor”

• Local release factor:

o When the release is based on the ERC, on a release factor or on a SpERC, the local release factor takes into account the effectiveness of the risk management measures reported in the conditions of use. In this case: local release factor = initial release factor * (1- effectiveness RMM(%)/100)

o When the release is based on a measured release rate, the local release factor is calculated based on the measured release rate and the site tonnage (local release factor (%) = measured release(kg/day) *1000/ daily site tonnage (tonnes/day)).

• Local release rate: quantity emitted per day, calculated from the local release factor when the release method is based on ERC, SpERC or any other release factor (local release rate (kg/day) = local release factor(%)*daily use at site (tonne/day)/1000*100). When the release estimation method is based on measured release the value is entered by the assessor.

Releases to soil for any use and releases to air for wide dispersive uses are only taken into account at regional scale. Consequently no local release rate applies.

In addition Releases to waste can be reported. The percentage of the substance use tonnage ending up in wastes during the use is differentiated between:

• the fraction released from the process itself (including the fraction left in a packaging when relevant) and

• the fraction moved to waste by the on-site risk management measures (applied to waste water or exhaust air).

When a SpERC is used for assessment, the fraction of waste generated during the process is assumed to be reported and explained in the SpERC itself. Consequently the information in first field is automatically filled by the SpERC information, and cannot be edited.

If particular considerations have to be made regarding the treatment of the substance in waste, this is to be included in the conditions of use pane. A default determinant is available (see section 5.2.4).


Figure 11: Release pane when selecting a EUSES assessment

5.2.3 Exposure and risk characterisation ratio for the environment and man via the environment

When selecting an exposure assessment, all local exposure estimates and related RCR are reported in the section “Exposure and risk characterisation ratios for the environment and man via the environment” for all compartments and for man via the environment.

In addition, the local concentration and doses in food related to the exposure of man via the environment via the oral route are displayed (see Figure 12).


Figure 12: Exposure and RCR for the environment and man via the environment

If you click the information on calculation button a popup opens in which you get a message indicating if one or more parameter is missing or outside EUSES boundaries. If all parameters are available and within the EUSES boundaries, then the message is simply “The exposure estimates for the environment and man via the environment have been estimated with EUSES 2.1”.

In the exposure part on the left side of the compartments the icons related to the calculation of the RCR are displayed as described in section 3.4.5.

5.2.4 Default conditions of use In the condition of use pane, the list of determinants used by the release calculation and EUSES are displayed. The following determinants appear by default in all EUSES assessments and cannot be deleted:

• Amount related determinants (reported under sub heading Amounts used):

o Daily use at a site (for uses in industrial settings) or daily wide dispersive use (for wide dispersive uses). Their values are calculated by default from the tonnage assigned to the use (see Annex 1).

o Annual use at a site (only for uses at industrial settings). The value by default is the tonnage for that use.

o Percentage of tonnage used at regional scale (for uses in industrial settings). For industrial sites, the value is by default 100% of the tonnage for that use, and for wide disperse uses it is 10%.

• Municipal sewage treatment plant (STP) related determinants (reported under sub heading Conditions and measures related to sewage treatment plant):

o Municipal STP: The presence of the municipal STP is assumed by default (= Yes).

o Discharge rate of STP: 2000 m3/day by default as in EUSES.

o Effluent discharge rate: 2000 m3/day by default as in EUSES. It is displayed when the Municipal STP is set to No (no municipal STP assumed and thus the waste water system of the industrial site directly discharges into the river).


o Application of the STP sludge on agricultural soil: it is assumed by default leading to soil exposure. This determinant is not available when Municipal STP is set to No.

The Discharge rate of STP is used for the calculation of the concentration of the substance in the sewage system in order to determine the exposure of microorganisms in biological waste water treatment. The discharge rates are used for the calculation of the dilution in the receiving water.

• Dilution related determinant (reported under the sub heading Other conditions affecting environment exposure ):

o Receiving surface water flow rate: set by default to 18 000 m3/day as in EUSES

• Waste treatment related determinant (reported under the sub heading Conditions and measures related to treatment of waste (including article waste)):

o Particular considerations on the waste treatment operations:

o set by default to “No (low risk)” corresponding to “ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.”

o For all other cases (ERC based releases but with modified conditions of use or non ERC-based releases), the assessor has to select the specific value corresponding to his case and, when relevant, provide additional Explanations for the CSR while selecting the relevant value.

When the assessment is based on a SpERC and if the SpERC already contains a determinant under the sub-heading Conditions and measures related to treatment of waste (including article waste), then the default Chesar waste treatment determinant is not displayed.

The values of all these determinants can be modified based on available site/sector specific data.

For wide dispersive uses some of the determinants listed above cannot be modified, as it would be hardly possible to provide an appropriate justification covering the use all across Europe. This concerns the “Percentage of tonnage used at regional scale”, the “Receiving surface water flow rate” and the setting and availability of “municipal STP”, i.e. “Discharge rate of STP”, “Application of the STP sludge on agricultural soil”.

5.2.5 Modifying tonnage information The release estimation can also be refined by providing more accurate information on the tonnage:

• If site-specific information such as the actual daily amount at the manufacture site, on the actual amount used by the largest downstream user, specific information on market data, or on the release of the substance is available, then you may change the value for the “daily use at a site” and the “annual use at a site” for uses in industrial settings. Explanations on the source of the information can be provided in the Explanation for CSR field when editing the determinant.

When modifying the daily and annual use amounts, be aware that the ratio between the two should not exceed 365.

• For wide dispersive uses it is also possible to modify the value for the “daily wide dispersive use”, which corresponds to the amount used in a standard town (with


10000 inhabitants). However, it may be difficult for an assessor to modify the default assumptions used for deriving these values, unless statistics are available to support the statement that the time and geographic distribution of the uses could lead to different assumptions.

All determinants can be edited by clicking on the icon, as indicated in Figure 14. Each time a determinant is modified, added or removed, the release and exposure estimates are recalculated.

When the tonnage for a use is modified in Box 2, the site tonnage and wide dispersive tonnage used for the exposure assessment in Box 3 are not adapted automatically. It is however possible to reset these values to a new default calculated from the modified use tonnage: Edit the determinants from Box 3 and remove the previous value (see Figure 13).

Figure 13: Modifying annual use amount at a site

5.2.6 Adding other conditions of use You can add other determinants by clicking on the Add icon (see section 3.4.4). This may be useful when, for example, additional risk management measures have to be ensured on site to limit releases. When adding a determinant being a RMM with effectiveness the local release is calculated as described in section 5.2.2.


All determinants added by the assessor can be deleted at any time if they turn out not being relevant.

If releases are estimated based on a SpERC the determinants justifying the initial release factors of the SpERC cannot be deleted.

Figure 14: Example of conditions of use for a EUSES assessment based on release factor

5.3 “EUSES assessment” for PBT substances For substances considered as being PBT, releases have to be minimised and therefore appropriate conditions of use have to be reported to ensure minimisation of emissions. The release estimation is done as for non PBT substances (see sections 5.2.1 and 5.2.2)

Exposure cannot be estimated with sufficient reliability in a regional environment, either for predators or man via the environment.

Consequently in the combined environment assessment pane (see section 5.5) no regional concentrations are reported. It is nevertheless possible to report measured regional concentrations if available.

For each environmental contributing scenario only the local concentrations (Clocal) for water, air and agricultural soil are estimated. For sediments, EUSES does not return a local concentration (without regional contribution) and thus no estimate is available. The ratio between CLocal and PNECs is also displayed for information (see Figure 15). Although a RCR icon (see section 3.4.5) is displayed on the left side of the table, it does not mean that the risk is controlled. This icon only signals whether the Clocal/PNEC is below or above 1. Risk characterisation takes place in Box 4.


Figure 15: Exposure pane for a PBT substance

5.4 Environmental measured data Chesar 2 supports reporting of exposure estimates based on measured concentrations in a local environment (for measured concentration in a regional environment see section 5.5).

You can create an Environmental measured data assessment as described in section 5.1. When an Environmental measured data assessment is created, the popup window appears as shown in Figure 16.

Figure 16: Create/Edit environment measured data assessment


Indicate the exposure assessment name (e.g. name of data set) in the related field and select the relevant compartments covered by your set of measured data.

By default all possible compartments are selected. To select only one or a subset of them, click Ctrl + click on the desired compartments.

Once the exposure assessment is created you have to click the Edit button for each compartment to report the exposure value (and unit) as well as explanations on such exposure value. For example explanations on the source of information, the number of data points, the representativity and reliability of the information can be reported.

Figure 17: Exposure for measured data assessment

An indicative RCR is calculated for each compartment for which exposure estimates are reported and a related icon is shown.

This RCR will not be used for risk quantification in Box 4 (for reasoning see section 3.4.4). But the measured data can be used as supportive information during the risk characterisation.

5.5 Combined exposure assessment Selecting the node Combined Environment Assessment in the tree the following information is displayed:

• Total direct releases into the environment

• Regional exposure (environment and man via environment)

• Combined widespread uses

The total direct releases correspond to the sum of the regional and continental2 releases from all assessed uses over one year. When several contributing scenario exist for one use, the maximum of the release for each route is taken into account.

2 The continental release corresponds, as in EUSES, to the releases from the use related to the full EU tonnage minus the tonnage within one region. It is not displayed in Chesar.


Figure 18: Combined environmental assessment

The regional exposure displays the PEC regional estimated by EUSES for the environment and for man via the environment. A RCR is calculated and the related icon is shown on the left of the table (see Figure 19).

Figure 19: Regional exposure

It is possible to report measured regional concentrations for one or several compartments. When measured concentrations are reported they are automatically used as regional concentrations (overwriting the EUSES estimates), and thus also impact on


the local PECs for each contributing scenario. Consequently only very reliable regional concentrations should be reported here.

For sediments the regional concentration is always calculated in EUSES based on the regional water concentration. Thus measured regional sediment concentrations can be reported, but do not directly impact on the local exposure estimates. For man via the environment, note that the concentration used for inhalation is the same as the concentration in air for the environment. Consequently, if measured data are reported they should be similar for those two fields. In addition, the measured data for man via the environment in the region will only be used for the regional RCR and will not impact the local RCR.

To report a measured regional concentration you should Edit the information for the relevant compartment. Explanations on the source of information, the number of data points, the representativity and reliability of the information should be reported in the justification and explanation field (see Figure 20). If measured data for regional concentration are available, but if their representativity is not very good you may report them in the text field “Remark on risk characterisation” below. This text-field also enables to explain any observation you may have related to the regional contribution to the risk. This information will be reported in section 10.2.1 of the CSR.

Figure 20: Editing measured regional concentration

The table on Combined widespread uses displays the PEC local and RCRs estimated based on the sum of the releases to water from all the widespread uses (see Figure 21). Indeed, as the tonnage of the substance may be split into several uses which occur in a same “town”, all the releases have to be summed up to estimate the local concentration linked to these uses. Two free-text fields are available to report any remark on the RCR for the combined widespread uses. All this information will be reported in section 10.2.2 of the CSR as soon as there are two or more widespread uses in the life cycle tree.


Figure 21: Exposure from combined widespread uses


6 EXPOSURE ASSESSMENT FOR HUMAN HEALTH

6.1 Introduction For workers the following exposure assessment methods are available:

• ECETOC TRA Workers v3 (see section 6.2)

• Measured data (see section 6.4)

• External exposure estimation tools (see section 6.5)

For consumers the following exposure assessment methods are available:

• ECETOC TRA Consumers v3 (see section 6.3)

• Measured data see (section 6.3)

• External exposure estimation tools (see section 6.5).

It may be useful to create several exposure assessments:

• When it is not possible to demonstrate control of risks with one of the already created exposure assessments, e.g. if the exposure estimates obtained with a Tier 1 exposure estimation tool are too conservative

• To provide additional supportive evidence for an RCR <1

• To provide exposure estimates for various routes of exposure and type of effect.

As explained in section 3.4.1, to create an exposure assessment you first have to select the worker (or consumer) contributing scenario to assess. When selected, the Add button becomes available as indicated in the following screenshot. Select the relevant exposure assessment method.

Figure 22: Adding an exposure assessment for a workers’ contributing scenario

The information to be reported when creating an exposure assessment is explained in the following sections.

Once an assessment has been created, if you click on it in the life cycle tree you will see 2 panes on the right side (see Figure 23 for a collapsed view of the two panes):

• Exposure and risk characterisation ratios

• Conditions of use


Figure 23: Exposure assessment details for a human health exposure assessment

6.2 ECETOC TRA Workers The user can select the ECETOC TRA method to perform an exposure assessment. The workers exposure estimations provided by Chesar are calculated using the workers ECETOC TRA tool v3 (available on ECETOC website http://www.ecetoc.org/tra).

A TRA workers exposure assessment can also be created “by default” as described in Section 3 of this manual.

6.2.1 Add or edit a TRA workers exposure assessment When selecting TRA workers as the method for exposure estimation, the different routes of exposure and type of effects covered by the plugged-in tool are displayed: inhalation and dermal long term exposure, as well as acute exposure for inhalation. It is possible to change the selection of the routes to be covered by clicking on them using the Ctrl key as indicated in Figure 24. It is not possible to select more routes than the ones for which the TRA provides exposure estimates.

Figure 24: Exposure routes covered by TRA workers assessment

When building the exposure scenario and performing the risk characterisation in Box 4 you will have to select from the exposure assessments carried out in Box 3 which route of exposure and type of effect you want to use the TRA workers exposure estimates. If you de-select some of the routes already in Box 3, there will be no exposure estimates for those routes.

In order to run the ECETOC TRA tool some substance properties are needed to calculate exposure concentrations:


• Physical state of the substance (solid or liquid)

• Vapour pressure if liquid

Also a PROC has to be assigned to the selected contributing scenario.


The default exposure assessment with ECETOC TRA workers is based on the conditions of use representing worst case assumptions.

6.2.2 Exposure estimation In the Exposure and risk characterisation ratios pane, the exposure estimates are displayed for each selected route of exposure and type of effect, together with the RCR calculated by Chesar. On the very left hand side the icons related to the calculation of the RCR are displayed, as described in section 3.4.5.

Figure 25: TRA workers exposure pane

The information on calculation button opens a popup in which the assessor gets a message indicating whether some specific considerations have been made for the exposure estimation within the TRA v3., or why no exposure estimates are provided (e.g. if input data are missing or if the TRA does not provide exposure estimate). In standard cases the message is simply “The exposure estimates are calculated according to the TRA workers version 3 (developed by ECETOC. For more information see http://www.ecetoc.org/tra)”.

6.2.3 Conditions of use The different determinants driving the exposure in ECETOC TRA v3 are displayed in the Condition of use pane. The determinants that are displayed depend on several factors such as:

• The interaction between the different determinants (for example LEV cannot be applied outdoor)

• The assigned PROC.

The exposure estimates (and Risk Characterisation Ratios) can be iterated by modifying the values of one or several “determinants” of the TRA by clicking the Edit icon on the


very right of the determinant as indicated in Figure 26. This may be needed when the RCR is > 1.

Figure 26: Example of TRA workers conditions of use

Please note the following “specificities” of the TRA in Chesar compared to the Excel version of the TRA Workers:

• In Chesar the determinant corresponding to the industrial or professional setting is called “Occupational Health and Safety Management System”. An “Advanced System” corresponds to “industrial setting” conditions in TRA v3 and a “Basic System corresponds to the “professional setting”. The value is fixed depending on the life cycle stage except for Formulation where the value can be changed by the assessor (by default it is set to “advanced”);

• For liquid substances, if the process takes place at elevated temperature, the exposure estimation has to take into account the value of the vapour pressure at that temperature. By default, as soon as the “Process Temperature (for liquid)” is set to a value higher than the default (40 C), a new determinant appears in the conditions of use called “Vapour pressure at elevated temperature”. The default value for the vapour pressure is 10001Pa as this will trigger the highest exposure estimates based on the TRA. If this assumption leads to an over estimation of exposure, you have to edit the determinant and report the value of the vapour pressure at the process temperature. In such situation you may modify the explanation for CSR provided by default as shown in Figure 27;


• A determinant “containment” making explicit the assumptions made by the TRA based on the PROC value is reported and cannot be modified by the user. This determinant is reported under the subheading “Technical conditions and measures at process level (source) to prevent release”;

• A determinant called “solid in solid mixture” appears with a fixed value “yes” as soon as the substance is solid and the concentration of the substance in the product is less than 100%. The purpose is to remind the user (and communicate the information in the ES for the supply chain) that the TRA does not predict exposure for solids in liquid mixture (e.g. solid pigment in a paint).

Figure 27: Edition of vapour pressure at elevated temperature

•

ECETOC TRA v3 Workers determinant appearing in Chesar cannot be deleted. No determinant can be added to the default ones.

6.3 ECETOC TRA Consumers The user can select the ECETOC TRA method to perform an exposure assessment. The estimation of exposure to consumers provided by Chesar is calculated according to the standalone version of the ECETOC TRA tool v3 (available on ECETOC website http://www.ecetoc.org/tra).

A TRA Consumers exposure assessment can also be created “by default” as described in Section 3 of this manual.

6.3.1 Add or edit a TRA Consumers exposure assessment When selecting TRA Consumers as the method for exposure estimation, the different routes of exposure and type of effects covered by the plugged-in tool are displayed: inhalation, dermal and oral long term exposure. Please note: The TRA provides estimates per exposure event, and it is assumed by default for all product types that there is at least one event per day. This daily repeated event exposure is treated in Chesar as representing a long term exposure.

If you want to deselect a route, you have to click on the corresponding tick box as indicated in Figure 28. It is not possible to select more routes than the ones for which the TRA provides exposure estimates.


Figure 28: Exposure routes covered by TRA Consumers assessment

When building the exposure scenario and performing the risk characterisation in Box 4 you will have to select from the exposure assessments (carried out in Box 3) which route of exposure and type of effect you want to use for the TRA Consumers exposure estimates. If you de-select some of the routes already in Box 3, there will be no exposure estimates for those routes.

In order to run the ECETOC TRA tool some substance properties are needed to calculate exposure concentrations:


• Vapour pressure

Also a PC (respectively AC) has to be assigned to the selected contributing scenario for consumer use (respectively service life by consumers). The first step to get exposure estimates is to select a product/article sub category in the conditions of use pane (see section 6.3.3).

6.3.2 Exposure estimation In the Exposure and risk characterisation ratios pane, the exposure estimates are displayed for each selected route of exposure and type of effect, together with the RCR calculated by Chesar. On the very left hand side the icons related to the calculation of the RCR are displayed, as described in section 3.4.5.


Figure 29: TRA Consumers exposure pane

The information on calculation button opens a popup in which the assessor gets a message indicating whether some specific considerations have been made for the exposure estimation within the TRA v3, or why no exposure estimates are provided (e.g. if input data are missing or if the TRA does not provide exposure estimate). In standard cases the message is simply “The exposure estimates are calculated according to the TRA Consumers version 3 (developed by ECETOC. For more information see http://www.ecetoc.org/tra)”.

6.3.3 Conditions of use • The first step to launch the ECETOC TRA Consumers exposure estimation is to

activate the assessment by selecting a product/article subcategory. The product/article subcategory available depends on the PC/AC selected for the contributing scenario in Box 2. For some PC/AC no subcategory are available when the TRA Consumers does not support exposure estimation for those PC/AC. In this case other exposure estimation methods have to be used.

• Once a product/article subcategory is selected a list of determinants driving the exposure in ECETOC TRA v3 are displayed in the Conditions of use pane. Default values are provided for each of them, depending on the product/article subcategory.


Figure 30: Example of TRA Consumers conditions of use

• Some of those conditions can be modified by the assessor by clicking the Edit icon on the very right of the determinant. Nevertheless, when doing so, it is recommended to provide a justification for the change of the default in the field Explanation for CSR. The exposure estimates and RCR are then automatically recalculated. Such explanation should include the source of information based on which the default has been changed, and whether the modification applies to all products falling under the selected sub-category.

• Some of the determinants cannot be edited by the assessor, for example “Frequency of use” or “Exposure time”.

Please note the following “specificities” of the TRA in Chesar compared to the Excel version of the TRA Consumers:

• In Chesar each relevant product/article subcategory is assessed on its own. A “sentinel” assessment for all subcategories within a product category as in the TRA excel version is not supported.

• Chesar does not support yet the definition of new product subcategories with a related set of default conditions.

• For some product subcategories, the TRA flags one or more routes of exposure as being not relevant. In Chesar the reasoning for the “non-relevance” is made explicit in the description of the determinant type, as far as it was possible on the basis of the documentation of ECETOC TRA Consumers v3 (ECETOC TR 107 - Addendum to ECETOC Targeted Risk Assessment Technical Report No. 93)

ECETOC TRA v3 Consumers determinant appearing in Chesar cannot be deleted. No determinant can be added to the default ones.

http://www.ecetoc.org/technical-reports

http://www.ecetoc.org/technical-reports


6.4 Measured data assessment (Worker/consumers) 6.4.1 Add or edit a measured data assessment

When selecting Measured data as the method for exposure estimation, a popup window appears a shown in Figure 31.

Figure 31: Create measured data assessment for human health

You have to provide a name for the assessment (e.g. reference of data set) and select the exposure routes you want to cover by pressing the Ctrl key.

6.4.2 Exposure estimation In the Exposure and risk characterisation ratios pane the list of selected routes is available for editing. All exposure estimation data (exposure value and unit as well as explanations) have to be manually entered for each route, as indicated in Figure 32. When measured data are to be used for the risk characterisation it is important to explain the source and the representativity of those values. Chesar does not provide yet a detailed structure for reporting such information. Only the number of measured data points can be reported in a separate field. In the freetext field Explanation on exposure value all relevant other information should be reported. This includes for example:

• information whether the measurements took place on the substance itself or on an analogous substance (and if so which one)

• when relevant, some explanations on the conditions of use under which the measurement took place, that are reported in the exposure scenario

• the sampling strategy (e.g task based or shift based) and information whether the measurement have been taken inside or outside of protective equipment

• information on the sampling methods and analytical methods (with limit of detection), etc.

• a number of statistical descriptors of the sample such as the measure of the central tendency, minimum and maximum of the measured exposure within the sample, the measure of the variation, the percentile in the distribution to which the selected exposure value corresponds


Figure 32: Edit exposure value for human health measured data assessment

If in the hazard conclusion a DNEL value is available (in IUCLID), Chesar calculates the related RCR. On the left side of the target routes the icons related to the calculation of the RCR are displayed as described in section 3.4.5.

6.4.3 Conditions of use When selecting the newly created exposure assessment, an empty set of conditions of use is displayed in the area below (see section 3.4.4).

You have to report the conditions of use which relate to the measured data set. For that you may have to create determinant types in your library (see user manual 6). This is in particular very important if you want to use the exposure estimates for your risk characterisation, and consequently to ensure that the related conditions of use are part of the exposure scenario. In case you only intend to use the measured exposure as supportive information for your risk characterisation then you may only report the relevant information in the Explanation on exposure value field as shown in Figure 32.

6.5 External exposure estimation tool assessment (worker/consumers)

6.5.1 Manually add or edit an external exposure estimation tool assessment

If exposure estimates have been obtained using an external exposure estimation tool (e.g. Stoffenmanager for workers or Consexpo for consumer uses) an external estimation tool assessment can be created. The popup window appearing at assessment creation allows the user to select among several external assessment tool names. In case you use a different tool, the “other” picklist entry can be selected and the name of the tool indicated in the free text associated.


Figure 33: Create/Edit External exposure tool assessment

You also have to select the exposure routes you want to cover by pressing the Ctrl key.

It is also possible to provide any information in the Internal remark field regarding the assessment. This will not be reported in the CSR.

In the Exposure and risk characterisation ratios pane the list of selected routes are available to be edited. All exposure estimation data (exposure value and unit as well as explanations on the exposure value) have to be manually entered for each route, as indicated in Figure 34. The explanations on the exposure value may for example include the percentile of the value extracted from a distribution (unless this is determined in the exposure estimation tool by default), or any choice that the assessor made when using the exposure estimation tool.

Figure 34: External exposure tool exposure value

If in the hazard conclusion a DNEL value is available (in IUCLID), Chesar calculates the related RCR. On the left side of the target routes the icons related to the calculation of the RCR are displayed as described in section 3.4.5.

When selecting the newly created assessment, an empty set of conditions of use appears below (see section 3.4.4).

You have to add the relevant determinants in order to report the conditions of use that will then be transferred to the exposure scenario. When using external exposure


estimation tools, standard sets of determinants corresponding to the input parameters of the tool can be potentially used. Exposure estimation tool owners may provide sets of determinants in the appropriate Chesar format that could be downloaded from their website.

6.5.2 Import external exposure assessment Chesar 2.2 enables import of exposure assessment carried out with external tools as soon as they are provided in a Chesar compatible format. For that select a contributing scenario and click the Import external tool assessment in the main tool bar or in the

right click menu .

You will then be asked to select the file (.chr format) to import. A comparison of the substance properties that are used in the external tool assessment and of the properties corresponding to substance is provided. It is up to the assessor to decide whether he wants to proceed or not in case the properties are not the same.

When proceeding all relevant information (condition of uses and exposure estimations) will be populated automatically in Chesar.

Stoffenmanager 5.0, to be released in 2013, generates a Stoffenmanager based exposure assessment in a Chesar compatible format that can be imported into Chesar 2.2. The name of the assessment in Stoffenmanger will be reported in the Internal remark field.

It is recommended not to manually change information related to an imported assessment. If any information is not adequate (you want to change a conditions of use), it is advised to carry out a new assessment in the original tool and reimport it in Chesar.

More exposure tool owners may decide to provide the outputs of their assessment in a Chesar compatible format. The Chesar data format is described in the XML schema available on Chesar website.


Annex 1 - Default settings of the release module

The release module of Chesar estimates the local, total regional and total continental releases that are provided as input to EUSES for exposure estimation. These releases are estimated based on tonnage assumptions and release factors to water, air and soil.

Annex 1.1. Default setting of tonnage information At local scale, the tonnage used for estimating the release rate depends on whether the use is taking place in an “industrial site” or as a “wide dispersive use”.

Annex 1.1.1. “Industrial site” scenarios (ERC 1 to 7 and 12)

The tonnage used at local scale to estimate the release to the environment is the daily use at a site. Chesar provides a default ‘daily use at a site’ based on the life cycle stage and the tonnage for that use.

Life cycle stage Tonnage for the use(tonnes per year): T Daily use at a site (tonnes per day)

2. Manufacture

T < 1000 0.05 *T

1000 < T < 10 000 0.01*T

10 000 < T (1/300)*T

4. Formulation

T < 100 0.1 *T

100 < T < 2000 0.01*T

2000 < T (1/300)*T

5. Industrial end-use

T < 1000 0.05 *T

1000 < T < 5000 0.01*T

5000 < T (1/300)*T

The assessor has the possibility to overwrite the value for the “daily use at a site” in the conditions of use (see section 5.2.5).

Regarding the estimation of the exposure of man via the environment and (top) predators, an averaged release per day over the year is necessary. This is based on the “annual use at a site”. By default, it is equal to the registrant’s EU level tonnage for that use.

The assessor has the possibility to overwrite the value for the “annual use at a site” in the conditions of use.

Annex 1.1.2. Wide dispersive uses (ERC 8 to 11)

The daily wide dispersive use in a “standard town of 10000 inhabitants” for the estimation of the release rate is, by default, set to:

daily wide dispersive use [tonnes/day] = tonnage for that life cycle stage [tonnes]* 5.5 10-7

The factor of 5.5 10-7 is based on the use of the default as described in R16 guidance:

Fmain source * Fvol_reg /Temission

• Fmain source = 0.002

• Fvol_reg = 0.1

• Temission = 365 days


Annex 1.2. Regional and Continental releases For uses in “industrial site” (ERC 1 to 7 and 12), the releases to the region are based on 100% of the registrant’s EU level tonnage for that use. There are no continental releases.

For wide dispersive uses (ERC 8 to 11), the releases to the region are based on 10% of the registrant’s EU level tonnage for that use. The continental releases are based on the remaining 90% of the registrant’s EU tonnage for that use.


Annex 2 – ERC based release factors

In the default release estimation, the applied release factor is derived from the corresponding ERC (see guidance on information requirement and chemical safety assessment, R16 Environmental exposure estimation).

Table 2: Release factor when release estimation method is ERC

No ERC Release factors

to air to water to soil

1 Manufacture of chemicals 5% 6% 0.01% 2 Formulation of mixtures 2.5% 2% 0.01% 3 Formulation in materials 30% 0.2% 0.1% 4 Industrial use of processing aids 100% 100% 5% 5 Industrial inclusion into or onto a matrix 50% 50% 1%. 6A Industrial use of intermediates 5% 2% 0.1% 6B Industrial use of reactive processing aids 0.10% 5% 0.025% 6C Industrial use of monomers for polymerisation 5% 5% 0% 6D Industrial use of auxiliaries for polymerisation 35% 0.005% 0.025% 7 Industrial use of substances in closed systems 5% 5% 5% 8A Wide dispersive indoor use of processing aids, open 100% 100% 0% 8B Wide dispersive indoor use of reactive substances , open 0.10% 2% 0% 8C Wide dispersive indoor use, inclusion into or onto a

matrix 15% 1% 0%

8D Wide dispersive outdoor use of processing aids, open 100% 100% 20% 8E Wide dispersive outdoor use of reactive substances,

open 0.10% 2% 1%

8F Wide dispersive outdoor use, inclusion in matrix 15% 1% 0.5% 9A Wide dispersive indoor use in closed systems 5% 5% 0% 9B Wide dispersive outdoor use in closed systems 5% 5% 5% 10A Wide dispersive outdoor use of long-life articles, low

release 0.05% 3.2.% 3.2%

10B Wide dispersive outdoor use of long-life articles, high or intended release

100% 100% 100%

11A Wide dispersive indoor use of long-life articles, low release

0.05% 0.05% 0%

11B Wide dispersive indoor use of long-life articles, high or intended release

100% 100% 0%

12A Industrial processing of articles with abrasive techniques (low release)

2.5% 2.5% 2.5%

12B Industrial processing of articles with abrasive techniques (high release)

20% 20% 20%

EUROPEAN CHEMICALS AGENCY ANNANKATU 18, P.O. BOX 400, FI-00121 HELSINKI, FINLAND ECHA.EUROPA.EU

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