CHESAR MANUAL. Chesar 3 for sector associations. Creating use maps Including SPERCs, SWEDs, and SCEDs

Transcription

1 CHESAR MANUAL Chesar 3 fr sectr assciatins Creating use maps Including SPERCs, SWEDs, and SCEDs

2 2 Chesar 3 fr sectr assciatins Versin Date Changes 1.0 Nvember December 2016 Sme wrk arunds which had been explained related t the skin surface expsed have been remved as the issue has been fixed in Chesar Additinal explanatins n the pssibility t create nly ne Chesar SPERC with several sub-spercs t cver substances with different technical functins (and different ERCs) has been added. Als advise n hw t reprt cntributing activities fr the envirnment when substances with different technical functins and different ERCs are relevant fr the use has been added. All infrmatin related t uses in rigrusly cntained cnditins have been gruped in a single sectin. 1.2 June 2017 Adaptatin t Chesar 3.2 new functinalities: - New rle fr use map develpers in Bx 7 - Use map management frm Bx 1 - Editability f phrases fr cmmunicatin in the SPERCs and SWEDs Advice n hw t check the use map befre publicatin, is als available in the manual. Disclaimer The infrmatin cntained in this manual des nt cnstitute legal advice. The Eurpean Chemicals Agency des nt accept any liability with regard t the cntents f this dcument. The Eurpean Chemicals Agency is entitled t mdify r revise the dcument at any time with r withut ntice and with r withut cause. Chesar 3 fr sectrs assciatins: Creating use maps - including SPERCs, SCEDs and SWEDs Reference: ECHA-17-R-14-EN ISBN: Cat. Number: ED EN-N DOI: /57660 Date: June 2017 Language: EN Eurpean Chemicals Agency, 2017 Cver page Eurpean Chemicals Agency If yu have questins r cmments in relatin t this dcument please send them (qute the reference and issue date) using the infrmatin request frm. The infrmatin request frm can be accessed via the Cntact ECHA page at: Eurpean Chemicals Agency Mailing address: P.O. Bx 400, FI Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland

3 Chesar 3 fr sectr assciatins 3 Table f Cntent 1. INTRODUCTION Data elements relevant fr use maps in Chesar GETTING STARTED WITH CHESAR Imprt a legal entity cntaining yur sectr assciatin name Assign a Use map develper rle t yur prfile Imprt standard phrase catalgue ESCm USE MAP CREATION STEPS Creating a cnditin f use template in Chesar Creating a SPERC in Chesar frmat Creating a SCED in Chesar frmat Creating a SWED in a Chesar frmat Creating a use map in Chesar frmat Exprt the use map CHECKING OF THE USE MAP BEFORE PUBLICATION Pre-requisite t check the cntent f yur use map Checking that n critical infrmatin is missing Checking that the cntent f yur use map prvides the expected utcme UPDATING A USE MAP OR USE MAP ELEMENTS(SCEDS, SPERCS, SWEDS) Hw t update a SPERC, SCED, SWED Hw t exprt updated SPERCs, SCEDs, SWEDs Hw t update a use map Hw t exprt an updated use map USES IN RIGOROUSLY CONTAINED CONDITIONS Backgrund Specificities in Chesar related t uses in rigrusly cntained cnditins Rigrusly cntained system with minimisatin f release t the envirnment Rigrusly cntained system with strict cntrl fr manual interventins... 30

4 4 Chesar 3 fr sectr assciatins 1. Intrductin This manual is meant t supprt sectrs wishing t make their use maps, including cntributing scenaris with links t the relevant SPERCs, SCEDs and SWEDs, available in a Chesar frmat, s that registrants can directly uplad the Chesar files as a starting pint fr their assessment. See sectin 1.1 f the Chesar 3 user manual fr mre infrmatin n the purpse f Chesar, and hw it supprts registrants in their chemical safety assessment. A glssary is als available at the end f that manual. Chesar cntains a library, which is persnal t each user f the tl. This library serves tw purpses: Fr sectr assciatins creating use maps, the Chesar library is used t generate the SPERC, SCED and SWED infrmatin in a Chesar readable frmat (XML) Fr registrants, the library enables t stre CSA elements that can be used in varius assessments. 1.1 Data elements relevant fr use maps in Chesar In rder t build a cmplete use map, several types f elements need t be created in Chesar. A use map cnsists f a number f uses. Each use cnsists f a number f cntributing activities defined frm the envirnmental perspective, and cntributing activities fr wrkers r cnsumers respectively. Fr each cntributing activity a relevant SPERC (fr the envirnment), SWED (fr wrkers) r SCED (fr cnsumers) can be linked. Thse SPERCs, SCEDs and SWEDs need first t be defined in Chesar befre they can be linked t a cntributing activity. SPERCs and SWEDs cntain cnditins f use. Sme are pre-defined in Chesar (the s-called built-in cnditins f use), ther nt. This fr example cncerns cnditins f use, which are sectr-specific fr the envirnment (justifying the release factrs reprted), r cnditins f use relevant fr expsure estimatin tls ther than the ECETOC TRA fr wrkers, fr example substance use rate r surface area treated, as relevant fr the Advanced REACH Tl (ART). Thse cnditins f use need first t be defined in Chesar befre they can be included in a SPERC r a SWED. The varius data elements f the use map as described abve are illustrated in Figure 1. SPERCs, SCEDs, SWEDs and specific cnditins f use are generated in the Library f Chesar (Bx 6). Mre infrmatin n Chesar library can be fund in sectin 8 f the Chesar 3 user manual fr registrants.

5 Chesar 3 fr sectr assciatins 5 Figure 1: Data elements f a use map USE MAP Created In Bx 1. The name shuld refer t the sectr, and pssibly als the versin f the use map Use (by wrkers) 1 Cntributing activity envirnment 1 Cntributing activity envirnment i Cntributing activity wrkers 1 Cntributing activity wrkers 2 Cntributing activity wrkers j SPERC 1 Built-in cnditin f use (by default in Chesar) Created in Bx 6 Cnditin f use nt in Chesar by default: created by assciatin in Bx 6 SPERC i SWED 1 Created in Bx 6 SWED 2 Built-in cnditin f use (by default in Chesar) Cnditin f use nt in Chesar by default: created by assciatin in Bx 6 Use (by wrkers) 2 Use (by wrkers) n Use (by cnsumers) 1 Cntributing activity envirnment 1 Cntributing activity cnsumers 1 Cntributing activity cnsumers 2 Cntributing activity cnsumers n SCED 1 Created in Bx 6 SCED 2 Built-in cnditin f use (by default in Chesar) Use (by cnsumers) n SPERCs, SCEDs, SWEDs and cnditins f use, nce created, have a unique identifier and have a clear Authr. They can be imprted as such (r as part f a use map) by assessrs int their wn library, fr assessing cntributing scenaris. Hwever the single assessr cannt mdify them. Chesar includes a versining management system fr thse elements (see sectin 5). Use maps created in Chesar 3.2 nward als have a unique identifier, which allws a tracking f the use map versins. In practice, it means that each use map is unique, and that all versins f the same use map have the same identifier. When sectrs decide t update their use map, they shuld simply mdify its cntent as needed in Chesar, and exprt a new versin. If a registrant had already made use f the use map fr his assessment, when he imprts the updated versin f the use map, the system will nly mdify the parts f the use map which have been mdified.

6 6 Chesar 3 fr sectr assciatins 2. Getting started with Chesar Yu can find infrmatin n hw t install and start Chesar 3 in the Installatin manuals available in The bxes referred t in this dcument crrespnd t the majr grups f functinalities listed belw. An icn is assciated with each Bx. All the icns frm the main tlbar: Figure 2: Chesar main tl bar Bx 1: Substances Bx 2: Uses Bx 3 : Expsure assessment Bx 4: CSR Bx 5: ES fr extended SDS Bx 6: Library Bx 7: Users Chesar 3 needs t be set up in rder t be ready t be fully functinal fr yu. Fr that yu need t: Imprt a legal entity that cntains the name f yur sectr assciatin, and assign it t yur user prfile Assign a Use map develper rle t yur prfile Imprt the ESCm phrase catalgue 2.1 Imprt a legal entity cntaining yur sectr assciatin name The assignment f a legal entity in Chesar is required t create Chesar library items (cnditin f use templates, SPERCs, SCEDs and SWEDs) t trace the authr f thse elements. When a legal entity is available (and assigned t yur username) all items created by yu will have that specific legal entity as the authr. The authr f a library item (nce finalised) cannt be mdified, s the wner f a specific library item is always knwn. If yu d nt have yur legal entity yet, yu can create ne directly in IUCLID 6. The name f yur legal entity will be the authr f the Chesar library elements yu will create.

7 Chesar 3 fr sectr assciatins 7 Steps fr imprting and assigning a legal entity t yur username: 1. Click the Legal entity management tab in Bx 7 2. Click the imprt buttn: the imprt legal entity dialgue bx appears 3. Select yur legal entity and imprt it 4. Click the User management tab in Bx 7 5. Select yur username (by default it will be admin ): the Edit user page appears 6. G t the legal entity drpdwn bx and select yur legal entity 7. Click the Save buttn 2.2 Assign a Use map develper rle t yur prfile In rder t be able t create a use map, and have access t the Use map management functinalities in Bx 1, yu need t assign a specific rle called Use map develper t yur prfile. Assigning rles t yur prfile is very easy: 1. Click the User management tab in Bx 7 2. Click n yur username (by default it will be admin ): the Edit user page appears 3. G t the rles and select Use map develper. Check that the Library manager rle is als assigned. In rder t be able t check the cntent f yur use map befre publicatin, yu will als need the assessr rle. Therefre yu are advised t set all the rles t yur prfile. 4. Click the Save buttn 2.3 Imprt standard phrase catalgue ESCm It is recmmended t uplad the standard phrase catalgue, ESCm. ESCm is a catalgue f standard phrases develped by the Eurpean chemical industry and which is available in Chesar frmat n Steps fr imprting ESCm phrase catalgue nce dwnladed frm Cefic webpage: 1. Click the Standard phrases tab in Bx 6

8 8 Chesar 3 fr sectr assciatins 2. Click the imprt buttn and uplad the Chesar file fr ESCm Phrase Catalgue (ending with.chr3). Nte the specific explanatins available n Cefic website if yu dwnlad the file with internet explrer. 3. Use map creatin steps Yu can create the varius elements f yur use maps in any rder by saving parts f them and then cmpleting with ther elements. Nevertheless it is imprtant t understand that in rder t link an element t anther ne (e.g. a cnditin f use in a SPERC r a SPERC t a cntributing activity), it has t be created in the Library first. Therefre, we advise yu t create the varius elements f a use map in the fllwing rder: Create cnditin f use templates if needed fr any SPERC r SWED in Bx 6. (D nt frget t check befrehand if a cnditin f use des nt already exist in the library.) Create SPERCs, SCEDs, SWEDs in Bx 6, including, as relevant, the cnditin f use templates created in the previus step Create and name the use map in Bx 1 Describe all the uses, and their cntributing activities under the use map in Bx 2 Assciate SPERCs, SCEDs, SWEDs t the relevant cntributing activities in Bx 3 Frm Bx 1, yu can then exprt the use map. It will include all the SPERCs, SCEDs, SWEDs.

9 Chesar 3 fr sectr assciatins 9 Figure 3: Steps t create a use map Bx 7 Imprt Legal Entity and assign it t user Assign the «Use map develper» rle t user Bx 6 Imprt standard phrase catalgue (ESCm) Bx 1 Create specific cnditins f use if needed fr SPERCs/SWEDs Create SPERCs (activate) Create SWEDs (activate) Create SCEDs (activate) Create and name a use map Bx 2 Describe all uses and related cntributing activities under the use map Bx 3 Assign SPERCs t cntributing activities envirnment Assign SWEDs t cntributing activities wrkers Assign SCEDs t cntributing activities cnsumers Bx 1 Exprt Use map

10 10 Chesar 3 fr sectr assciatins 3.1 Creating a cnditin f use template in Chesar Select the cnditin f use templates tab in Bx 6 and select the create buttn. Read the help text in the applicatin t understand the infrmatin t be reprted in the varius fields. Once yu have finalised yur cnditin f use template, Activate it. Yu can then use it when creating SPERCs r SWEDs. 3.2 Creating a SPERC in Chesar frmat Select the SPERCs tab in Bx 6 and select the create buttn. Read the help text in the applicatin t understand the infrmatin t be reprted in the varius fields. A SPERC describes the cnditins f use fr a cntributing activity, and the related release factrs. In mst end-uses, mixtures are used rather than substances. In that case the cnditins f use apply t all substances in the mixture, but the related release factrs may differ frm substance t substance, depending n the technical functin and

11 Chesar 3 fr sectr assciatins 11 the fate prperties f each substance. Therefre, sub-spercs can be defined t prvide differentiated sets f release factrs fr different types f substances. Sub-SPERCS are created in the Releases tab in Chesar. Nte the fllwing when transferring the infrmatin frm a SPERC t Chesar: Making use f the pssibility t create several sub-spercs within a SPERC in Chesar has the advantage f ensuring that the set f cnditins f use described in the SPERC is cnsistent fr all ingredients f the mixture. It als limits the number f SPERCs in the Chesar library. The selectin f the apprpriate sub- SPERC fr the assessr is autmatically made by Chesar n the basis f the ERC selected and the substance prperties when relevant. There is supprt fr versining in Chesar. See sectin 5. The entry screens differ depending whether the SPERC is meant fr a use being widespread r at a site. The infrmatin n the peratinal cnditins is t be reprted in the fllwing way: The Place f use, whether there is Water cntact during use and whether the site is expected t be cnnected t a standard municipal bilgical STP can be selected frm existing (built-in) cnditins f use in the Cnditins f use tab Whether the cntributing activity takes place in a Rigrusly cntained system with minimisatin f release t the envirnment is t be reprted in the tab SPERC Identifiers. Fr all Further peratinal cnditins impacting n releases t the envirnment a cnditin f use template shuld have been created and the cnditins f use added in the Cnditins f use tab. When prviding an explanatin fr the CSR fr a cnditin f use using the, d nt repeat the infrmatin already specified in the cnditin f use itself. Prvide in this field additinal infrmatin fr readers f the CSR when relevant nly. The Waste handling and dispsal is als predefined in the cnditin f use sectin. Fr all the bligatry RMM n site a cnditin f use template shuld be created in the library (Bx 6) and the cnditins f use added in the Cnditins f use tab f the SPERC. T reprt the infrmatin frm the sectin 3 expsure assessment inputs f the SPERC template: T reprt the Fractin f EU tnnage used in regin, yu shuld add the cnditin f use Percentage f EU tnnage used at reginal scale. It is nly useful t d s if the value deviates frm the defaults (100% fr uses at industrial sites and 10% fr widespread uses). The amunt f substance used per day is t be reprted in the Daily use amunt at site field in the cnditin f use tab. Fr widespread uses, in Chesar a field enables t reprt the Lcal daily fractin f reginal tnnage fr the use (widespread) used t estimate the lcal daily tnnage frm the annual use tnnage. By default it is set t as described in the guidance n envirnmental assessment R16. If infrmatin is prvided in the SPERC factsheet fr mdifying this value (in the Fractin f Reginal tnnage used lcally), then the Lcal fractin f tnnage fr the use (widespread) is t be mdified accrdingly in Chesar.

12 12 Chesar 3 fr sectr assciatins The Justificatin and infrmatin surces shuld be reprted in the explanatin fr CSR field accessed by the. The number f emitting days may be reprted in the Extraplatin factr fr annual use amunt fr uses at site 1 in case it crrespnds t the number f use days. If the number f emitting days des nt crrespnd t the number f use days, Chesar 3.2 des nt supprt the release estimatin. T reprt the Release factrs yu have t g t the Releases tab and create a sub-sperc (even if yu nly need ne). Nte that in Chesar, in case yu have several sub-spercs with similar justificatin yu can reprt sme Explanatins fr the release factrs valid fr all the Sub-SPERCs. Fr the cmmunicatin f the cnditins f use: If the expsure assessment is SPERC-based, then it is the cnditins f use prvided in the SPERC that will be cmmunicated in the expsure scenari. By default each cnditin f use is cmmunicated as defined in the cnditin f use template in the Library. Nevertheless it is pssible t adapt the default setting fr cmmunicatin within each SPERC. T d s, click n the Edit SDS ES (paperclip icn). Yu can then see whether the cnditin f use will be cmmunicated (this is the case when the bx is ticked) and the default phrase/text fr cmmunicatin is shwn. Yu can mdify bth the cmmunicatin setting and the default phrase if needed. Befre activating yur SPERC, Save it and Create SPERC reprt frm the main tab t check that yur cntent is fine. Once yu have finalised yur SPERC, Activate it s that yu can link it t a cntributing activity in yur use map (see sectin 3.5). 1 fr widespread uses it cannt be mdified. If the use is seasnal this infrmatin has t be taken int accunt fr the Lcal daily fractin f reginal tnnage fr the use (widespread)

13 Chesar 3 fr sectr assciatins Creating a SCED in Chesar frmat Select the SCEDs tab in Bx 6 and select the create buttn. Read the help text in the applicatin t understand the infrmatin t be reprted in the varius fields. Nte the fllwing when transferring the infrmatin frm a SCED t Chesar: In the Cmmn parameters/frequency f use ver the year, the picklist item Occasinal and Very infrequent cannt be selected anymre, as Chesar has been adapted t the update f guidance R15 n cnsumer expsure assessment. Infrequent in Chesar means less than 15 days f expsure per year. T summarise, this means that: Frequent and Occasinal in SCED are equivalent t Frequent in Chesar; Infrequent and Very infrequent in SCED are equivalent t Infrequent in Chesar. In the Dermal parameters/skin Cntact Area: 2 hands selected in SCED is equivalent t Hands selected in Chesar; Inside f 2 hands/palm f 2 hands/ ne hand in SCED is equivalent t Inside f hands/ ne hand /palm 2 hands in Chesar In Inhalatin parameters/expsure via inhalatin rute, if Inhalatin expsure estimated t be negligible had been selected, it crrespnds t Cnsidered nt t be relevant in Chesar. An explanatin has t be prvided. In Oral parameters/expsure via ral rute, if Oral expsure nt freseen had been selected it crrespnds t Cnsidered nt t be relevant in Chesar. An explanatin has t be prvided. Once yu have finalised yur SCED, Activate it s that yu can link it t a cntributing activity in yur use map (see sectin 3.5).

14 14 Chesar 3 fr sectr assciatins 3.4 Creating a SWED in a Chesar frmat Select the SWEDs tab in Bx 6 and select the create buttn. Read the help text in the applicatin t understand the infrmatin t be reprted in the varius fields. Nte the fllwing when transferring the infrmatin frm a SWED t Chesar: Althugh pssible, it is nt useful t use a standard phrase fr the SWED name (it is nt freseen t be cmmunicated dwnstream). What will be cmmunicated is the cntributing scenari name (which may be the same as the SWED name). The cnditins f use are nt prvided in the same rder in the SWED template and in Chesar, as in Chesar they fllw the ES sub-heading rder. If values (quantitative r qualitative input) are missing, which are required t run the TRA wrkers, it will nt be pssible fr registrants t get an expsure estimate using the TRA in Chesar. All the cnditins f use required t run the TRA are by default present in a SWED when created in Chesar, therefre it is advised that n values are left empty. Fr sme cnditins f use where picklists are prvided in the SWED template, the ptin ther is usually nt cvered in the built-in cnditins f use in Chesar. In this case yu need t create a specific cnditin f use template. If the place f use selected is Indr r utdr, select Indr and utdr in Chesar. Nte that the TRA wrkers cannt run with such a value, as tw separate assessments with different resulting expsure estimates wuld be needed. The picklist items fr the Physical frm f the used prduct are expressed slightly differently fr slids between the SWED template and Chesar but they mean the same fr the TRA calculatins:

15 Chesar 3 fr sectr assciatins 15 Value in SWED Slid (high dusty) Slid (medium dusty) Slid (lw dusty) Value in Chesar Slid (very dusty frm) Slid (medium dusty frm) Slid (nn r lw dusty frm) The perating temperature can nly be reprted as a numerical value in Chesar. This is because this numerical value is used fr recalculating a vapur pressure r cmparing t the melting pint fr slids. The standard default temperature assumed in Chesar (wrst case ambient temperature fr summer suthern Eurpe) is 40 C. The picklist items fr the General ventilatin are expressed slightly differently between the SWED template and Chesar but they mean the same fr the TRA calculatins: Value in SWED Basic (natural) Gd (natural and/r mechanical) Enhanced (engineered mechanical) Value in Chesar Basic general ventilatin (1-3 air changes per hur) Gd general ventilatin (3-5 air changes per hur) Enhanced general ventilatin (5-10 air changes per hur) Fr the Lcal exhaust ventilatin, if yu expect the registrant t use the effectiveness prvided by the ECETOC TRA (TRA default value selected in the SWED) leave the field empty. When the SWED is used, Chesar will autmatically ppulate the effectiveness with the TRA value. In case yur SWED cntains an effectiveness fr the LEV different than the ne f the TRA, it will nt be pssible fr registrants t estimate expsure using the TRA. Fr the respiratry prtectin, if yu had selected an effectiveness f 90% yu shuld pick in Chesar Yes (Respiratr with APF f 10). If yu had selected an effectiveness f 95% yu shuld pick in Chesar Yes (Respiratr with APF f 20). Fr the dermal prtectin, the values prpsed are accrding t the ECETOC TRA wrkers: Effectiveness selected 80% 90% 95% Value in Chesar Yes (Chemically resistant glves cnfrming t EN374 Yes (Chemically resistant glves cnfrming t EN374 with basic Yes (Chemically resistant glves cnfrming t EN374 with specific If in yur SWED the rigrusly cntained system in rw 4.1 f the template is set t Yes yu shuld check the bx at the tp f the cnditins f use tab (see sectin 6 fr mre infrmatin). When a SWED is expected t cver assessments made with ther tls than ECETOC TRA, use the field Advice t assessr (template 1.4.1) t prvide infrmatin n hw t select the input parameters which are nt part f the cnditins f use. e.g. yu culd specify here the activity class t select in ART r values fr cnditins f use nt specified in the SWED. In the cnditin f use descriptin, there is n need t repeat in the field Default explanatin fr CSR the infrmatin already specified in the cnditin f use itself. Prvide in this field additinal infrmatin fr readers f the CSR when

16 16 Chesar 3 fr sectr assciatins relevant nly. Fr the cmmunicatin f the cnditins f use: If the expsure assessment is SWED-based, then it is the cnditins f use prvided in the SWED that will be cmmunicated in the expsure scenari. By default each cnditin f use is cmmunicated as defined in the cnditin f use template in the Library. Nevertheless it is pssible t adapt the default setting fr cmmunicatin within each SWED. T d s, click n the Edit SDS ES (paperclip icn). Yu can then see whether the cnditin f use will be cmmunicated (this is the case when the bx is ticked) and the default phrase/text fr cmmunicatin is shwn. Yu can mdify bth the cmmunicatin setting and the default phrase if needed. Befre activating yur SWED, Save it and Create SWED reprt frm the main tab t check that yur cntent is fine. Once yu have finalised yur SWED, Activate it s that yu can link it t a cntributing activity in yur use map (see sectin 3.5). 3.5 Creating a use map in Chesar frmat T create yur use map, fllw the step by step instructins belw: Dwnlad the use map substance frm the Chesar website library ( G t Bx 1, in the Substance management menu item, select t imprt the Use map substance in yur Chesar.

17 Chesar 3 fr sectr assciatins 17 Nte that in case yu have already imprted the use map substance befre, yu shuld select it using the icn n its right. G t the Use map management tab 2 and click n the +Create buttn. Prvide a name fr the use map. The name f the use map culd include fr example the sectr name, pssibly a versin date r number. Yu als have the pssibility t prvide additinal infrmatin t the assessr. The internal remarks field will nt be visible t the assessr, but culd be used by yu t recrd sme infrmatin regarding the versin histry f the use map fr example. Save the infrmatin yu have specified. In Bx 2, yu can nw create the backbne f the use map, i.e. yu can describe under the use map name all the uses, and their cntributing activities. Fr mre infrmatin n hw t create/add uses and cntributing activities, read the help text in Chesar. 2 Remember that such tab is nly visible if yu have the Use map develper rle.

18 18 Chesar 3 fr sectr assciatins Specific ntes when transferring use infrmatin frm the use map template (excel files) t Chesar: The use cde and the link t entry in previus use maps d nt have crrespnding fields in Chesar. This infrmatin shuld be reprted in the field Additinal infrmatin frm use map. Fr an envirnmental cntributing activity, several ERCs may be applicable depending n the technical functin f a substance in that activity and its fate during the use. In that situatin, several cntributing activities with the same name shuld be created (under ne use) in Chesar, but with different ERCs assigned (Nte: in Chesar nly ne ERC can be assigned per cntributing activity). The assessr will have t select the relevant cntributing activities based n the relevant ERC (depending n the technical functin f his substance). In this case, the same SPERC (cntaining several sub-spercs fr the releases f substance with different technical functins) can still be assciated t all the cntributing activities created as described abve. The relevant sub-sperc will autmatically be selected fr assessrs based n the ERC. When service life is part f the use map, it will be up t the assessr t keep r delete the related uses depending whether they are relevant fr the substance (i.e. if the technical functin f the substance implies that the substance will remain in the article). It may be useful t draw the attentin f the assessr t the fact that he needs t select the apprpriate ERC by adding explanatin either at the use map level in the field Advice t assessr r at the level f the use in the field Additinal infrmatin frm use map. In Bx 3, yu can then fr each cntributing activity assciate a relevant active SPERC, SCED r SWED, which yu shuld have first created in yur library. T d s: Fr an envirnmental cntributing activity, in the Cnditins f use sectin, select Cnditins based n SPERC and Select yur SPERC.

19 Chesar 3 fr sectr assciatins 19 SPERCs prpsed by Chesar fr selectin fr a given cntributing activity are SPERCs which are relevant fr the same ERC as the ne in the selected cntributing activity. Repeat the actin fr each envirnmental cntributing activity fr which a SPERC is available. The same is t be dne fr each cnsumer cntributing activity where a SCED can be assigned. SCEDs prpsed by Chesar fr selectin fr a given cntributing activity are SCEDs which are relevant fr the same PC r AC as the ne in the selected cntributing activity. The same is t be dne fr each wrkers cntributing activity. SWEDs prpsed by Chesar fr selectin fr a given cntributing activity are SWEDs which are relevant fr the same PROC as the ne in the selected cntributing activity. Nte that, if yu had already started preparing yur use map in a previus versin f Chesar, yu can migrate it by using the Imprt Chesar Use map file buttn available in Bx 1. Fr example, use maps prepared in Chesar 3.1 can be imprted/migrated int Chesar 3.2 with this buttn. It is recmmended t always verify the cntent f yur use map after imprt. 3.6 Exprt the use map Once finalised, yu can exprt yur use map: G t Bx 1, in the Use map management menu item, and select the use map yu have created. Click n the exprt icn Prvide an apprpriate name (use map name, pssibly including a mdificatin date r a versin) fr the exprted file. Yur use map will cntain all relevant infrmatin. When a registrant imprts the use map, the SPERCs, SCEDs and SWEDs linked t it will autmatically be imprted in his library. Nevertheless, if yu have updated sme SPERCs, SCEDs r SWEDs in an updated use map yu shuld als exprt them frm yur library as explained in sectin 5. The use map yu have created can then be made available t all registrants n ECHA webpage We strngly recmmend that yu check/test yur use map befre publicatin in the ECHA use maps library. Yu will find mre infrmatin in the sectin 4 n hw t check (test) yur use map. 4. Checking f the use map befre publicatin Befre making its use map available t assessrs, use maps develpers are encuraged t perfrm the fllwing checks: - Ensure that a TRA assessment can be run based n the infrmatin available (where it is indeed the intentin that TRA culd be used)

20 20 Chesar 3 fr sectr assciatins - Ensure that an EUSES assessment can be run based n the infrmatin available (where it is indeed the intentin that EUSES culd be used) - Check the cntent f the CSR and ES fr cmmunicatin generated based n their use map Chesar can help use maps develpers in identifying: Cntributing activities in their use map where it will nt be pssible fr registrants t run a TRA/EUSES expsure assessment based n the infrmatin prvided. This may be useful t check where it is indeed the intentin that these expsure assessment tls culd be used. Whether sme phrases fr the ES fr cmmunicatin are missing frm a SPERC r a SWED. Chesar can als be used t check the cntent f the CSR and the ESs fr cmmunicatin generated based n use maps. Thse basic checking steps are highly recmmended as they can prevent sme feedback frm users f the use map (therefre preventing a need fr update). In additin t this checking, we als recmmend that yu test yur use map with a registrant and frmulatr frm yur sectr, in rder t fix ptential issues that wuld nt have been highlighted by the basic checking in Chesar. 4.1 Pre-requisite t check the cntent f yur use map In rder t perfrm the checking in Chesar, yu first need t exprt the use map yu have created frm Bx 1. Yu will then run Chesar as an assessr. 4.2 Checking that n critical infrmatin is missing The fllwing step by step instructins enable checking that: Apprpriate infrmatin is included in the use map fr running an expsure estimatin with built-in expsure estimatin tls (TRA wrker and cnsumer and EUSES) and that Infrmatin fr the ES fr cmmunicatin is available in the use map 1. Bx 1 - Imprt dummy substance files: Tw Chesar files fr dummy substances (slid and liquid) are available n Chesar website in the use map sectin f They cntain dummy key phys-chem parameters (needed t run TRA and EUSES), as well as fake PNECs and DNELs fr systemic effects. Fr the purpse f this exercise, we recmmend t use thse substance files. Imprt the substance files in Chesar Nte that if yu had imprted the substance previusly yu just need t select it. Check that the prpsed substance is selected and that a CSA is selected (nt a use map)

21 Chesar 3 fr sectr assciatins Bx 2 - Imprt the use map yu want t check: 3. Checking that an envirnmental assessment can be run with EUSES In rder t check that, fr example, n release factrs were missing in any SPERC linked t the use map, yu may want t run an EUSES assessment fr all the envirnmental cntributing activities using the UseMapValidatin_Liquid substance. Fr that yu first need t prvide a tnnage fr each use in Bx 2 (yu may input a fake value) and then run a EUSES expsure data set fr the full life cycle tree. Thanks t the icns appearing in the life cycle tree in Bx 3 yu will quickly see if infrmatin is missing. a. Bx 2 - Prvide use tnnage fr each use:

22 22 Chesar 3 fr sectr assciatins b. Bx 3 - Add EUSES default expsure datasets c. Bx 3 - Check if EUSES can run In Bx 3, expand the life cycle tree by clicking. All the cntributing scenaris fr the envirnment fr which there is a blue questin mark indicate that the expsure assessment culd nt be calculated. Have a clser lk at thse. In particular check that all release rates are prvided. Yu may ntice that fr a cntributing scenari where a SPERC is assigned in the use map, the SPERC has been replaced by Manual selectin fr the cnditin f use and the release estimatin methd by ERC. This may be the case if there is n sub-sperc in yur SPERC valid fr the substance prperties yu have assigned. 4. Checking that a TRA wrkers can be run If yu expect that a number f registrants will use the TRA t assess their substance n the basis f yur use map, yu may want t quickly check whether all relevant infrmatin is prvided in yur use map. Yu may need t run the check twice: fr the UseMapValidatinLiquid and UseMapValidatinSlid substances. a. Bx 3 - Add TRA wrkers default expsure datasets b. Bx 3 - Check if ECETOC TRA wrkers can run In Bx 3, expand the life cycle tree as shwn in the screensht belw. Yu can easily figure ut if ECETOC TRA can run, thanks t the symbl in frnt f each cntributing activity. The blue questin marks indicate that the expsure assessment culd nt be calculated.

23 Chesar 3 fr sectr assciatins 23 T understand why expsure assessment culd nt be calculated, click n the cntributing activity with, and press the Expsure estimates infrmatin buttn. There might be varius reasns why an expsure assessment culd nt be calculated, fr example: A cnditin f use is missing which is required t be able t run the ECETOC TRA assessment in Chesar The cntributing activity has been assigned PROC 7 and the Occupatinal Health and Safety Management System has been set t Basic

24 24 Chesar 3 fr sectr assciatins The cntributing activity has been assigned PROC 21 and the substance being assessed is a liquid Nte that in case a SWED is expected t cver assessments made with ther tls (such as ART), is nrmal. In that situatin, yu may want t check that sufficient infrmatin is available in the field Advise t assessr, s an assessr wuld understand why the TRA assessment in Chesar cannt be run. T view this field, click n shw mre/shw less in the cntributing activity 5. Checking that all relevant infrmatin fr cmmunicatin n cnditins f use is part f the use map a. Bx 5 - Generate the ES fr cmmunicatin By clicking Generate SDS ES, yu can already identify if sme phrases are missing in the ES fr cmmunicatin. A warning bx will appear.

25 Chesar 3 fr sectr assciatins 25 When a phrase is mentined as missing a. Yu can check whether the assignment f default text fr SDS ES is part f the cnditin f use template in Bx 6 (g t Bx 6, search fr the cnditin f use and scrll t the SDS ES related infrmatin sectin). If the cnditin f use is expected t be cmmunicated, in mst cases, it is relevant t have a default phrasing fr cmmunicatin. b. If the setting in the cnditin f use template is fine, yu may lk in which SPERC r SWED the cnditin f use is used by selecting the used in sectin in the cnditin f use template definitin in Bx 6. G t thse SPERC/SWED and check that the settings fr the SDS ES are apprpriate fr the mentined cnditin f use. 4.3 Checking that the cntent f yur use map prvides the expected utcme It may be relevant t check a bit further whether yur use map cntains apprpriate infrmatin. In particular, yu may want t check whether: Assessing ne r mre substances relevant fr yur sectr is supprted by yur use map. The CSR and the ES fr cmmunicatin generated n the basis f yur use map cnvey the relevant infrmatin. Thse checks are mre time cnsuming than the previus nes, but may ensure that the infrmatin yu generated is meaningful and crrespnds t what yu expected. 1. Assessing a relevant substance Yu may carry ut the same assessment steps as the nes described in sectin 4.2 using a relevant substance fr yur sectr. This will enable yu t check whether: It is pssible t get RCR <1 fr relevant cncentratins f the substance in standard prducts f yur sectrs. Whether the cnditins f use supprt adequately sme qualitative hazard which

26 26 Chesar 3 fr sectr assciatins may ccur with sme substances. 2. Bx 4 - Generate CSR sectin 9-10 Check the cntent f the CSR sectin 9-10: des it cntain what yu expected t cntain? In particular, pay attentin t the fllwing parts f the dcument: Title sectin fr each ES (crrespnding t yur use descriptin) Cnditins f use (cming frm SPERC/SCED/SWEDs) Generate the ES fr cmmunicatin, and lk at it: des it cntain what yu expected t cntain? In particular, pay attentin t the fllwing parts f the dcument: Table f cntent: are the structured shrt titles clear, can yu differentiate the different uses frm each ther? Cnditins fr safe use in Sectin 2 f the ES: is it cmprehensive enugh fr the sectr? 5. Updating a use map r use map elements(sceds, SPERCS, SWEDs) 5.1 Hw t update a SPERC, SCED, SWED Sme functinalities have been implemented in Chesar t better supprt versining management f SPERCs, SCEDs and SWEDs. Sectrs can specify that a new versin f a SPERC (SCED/SWED) updates (replaces) a previus versin. When this infrmatin reaches the assessr: The previus versin is nt available fr selectin in a new assessment. It is pssible t identify in which previusly carried ut assessment the ld versin SPERC (SCED/SWED) has been used. When an assessment has been carried ut with the ld versin f a SPERC (SCED/SWED) the assessr is warned and has the pssibility t replace the ld SPERC (SCED/SWED) by the new ne. Fr updating a SPERC, SCED, SWED the fllwing steps have t be fllwed: Select the SPERC (SCED/SWED) yu want t update in yur library. Cpy it by pressing. In the Chesar versin infrmatin blck yu are advised t reprt in the Versin

27 Chesar 3 fr sectr assciatins 27 field a new versin number r versin/mdificatin date. This versin is nly relevant fr the management fr the library and is nt part f the cmmunicatin. Then yu have t select (again) the SPERC (SCED/SWED) that yu want t update with this new ne (the ne yu initially selected and cpied fr mdificatin) by pressing the Select SPERC (SCED/SWED) buttn. Mdify the newly created SPERC (SCED/SWED) as needed. Once dne (pssibly after checking the SPERC (r SWED) reprt Pay attentin that if yu generate a saved SPERC reprt, then the SPERC which it updates is remved and yu need t select it again), Activate it. When activating the new versin f the SPERC (SCED/SWED) the SPERC (SCED/SWED) which have been updated are set t bslete by Chesar. 5.2 Hw t exprt updated SPERCs, SCEDs, SWEDs When creating an exprt file cntaining SPERCs (SCEDs/SWEDs) fr assessrs yu shuld include all the versins that yu had previusly made available, t ensure traceability in the recipients libraries. When assessrs imprt the new files in their wn library the fllwing will happen: The SPERCs (SCEDs/SWEDs) fr which an update is imprted will be autmatically set t bslete. This means that they will nt be ffered anymre fr use fr new assessments. They will nevertheless remain in the assessr s library as they may have been used in previusly carried ut assessments. Fr all the assessments carried ut with previus versins f the SPERCs (SCEDs/SWEDs) the assessr will be warned that a new versin exists and he may decide t update his assessment. T exprt all the versins f the SPERCs (SCEDs/SWEDs) g t advanced search and search fr bth active and bslete elements.

28 28 Chesar 3 fr sectr assciatins Then select all the versins f the varius SPERCs yu want t exprt by clicking the check bx n left and create yur exprt file clicking the the page. buttn n the tp f Nte that if yu d nt include all the previus versins (e.g. very ld versins), the assessrs wh had used thse versins and imprt the new files will nt be made aware that their ld versin may need t be replaced by a newer ne. 5.3 Hw t update a use map T update a use map, select it in the Use map management tab in Bx 1 (after having selected the use map substance in the Substance management tab). Then mdify it as yu need and exprt it. Yu are advised t reprt in the internal remarks field infrmatin which will help yu track back when and why yu intrduced sme changes. Yu may als prvide sme advice t the assessr. Nte that the versining management is t be dne utside Chesar. If yu want t g back t an earlier versin f yur use map, yu will have t imprt it again. Nte that such imprt will verwrite all the changes yu may have dne in the meantime. 5.4 Hw t exprt an updated use map Each use map is identified by a UUID (a cde nt visible t the user), which makes it unique. It is imprtant that if a use map develper wants t update his use map, he des this always frm the same use map. S nce a registrant imprts a new versin f the use map, the changes between the versins are recgnised and are flagged t him. Updating a use map culd mean: New use added Use remved Use descriptin updated (new/update/deletin f cntributing activities) Update in the SPERCs, SWEDs, SCEDs

29 Chesar 3 fr sectr assciatins 29 Once the changes have been perfrmed (and checked), the use map develper can exprt the use map, and publish it in the ECHA library (cf sectin 3.6). As a gd practice, it is recmmended, t keep track f the changes perfrmed in the use map, and list them in a release nte that culd be published tgether with the Chesar file f the use map in the ECHA library. This will als help assessrs t determine whether they need t imprt the updated use map r e.g. imprting the imprted SPERCs/SCEDs/SWEDs wuld suffice. It is als recmmended t indicate a versin date r a versin number in the name f the use map. 6. Uses in rigrusly cntained cnditins 6.1 Backgrund There is a pssibility in IUCLID t flag uses that take place under rigrusly cntained cnditins (with a differentiatin between wrkers and the envirnment). This flag can be used by the authrities, in cmbinatin with infrmatin n the hazard f the substance and the tnnage fr the use, t depriritise a substance regarding further regulatry actins. The flag needs t be supprted by adequate infrmatin describing the rigrusly cntained cnditins. Figure 4: screensht f IUCLID in a use (sectin 3.5 f IUCLID) Such infrmatin will be exprted frm Chesar t IUCLID. It is t be set per use (meaning it shuld apply t all the cntributing activities under that use). If the use may take place under bth cnditins, rigrusly cntained r mre pen (e.g. depending n the cmpanies r technlgy applied), yu shuld create tw uses and supprt registrants in estimating the tnnage (e.g. via the use map), which is handled in cntained cnditins. Nte: Withut differentiatin f tnnage, authrities will have difficulties t use the flag n rigrusly cntained cnditins as described abve. 6.2 Specificities in Chesar related t uses in rigrusly cntained cnditins When sme uses in a use map are in rigrusly cntained cnditins with regard t the envirnment and /r human health yu may flag this fr assessrs in Chesar in the Additinal infrmatin field fr the relevant uses. Assessrs will then be able t check related checkbxes in Bx 3 when selecting their use Rigrusly cntained system with minimisatin f release t the envirnment If the use takes place in Rigrusly cntained system with minimisatin f release t the envirnment (fr all the cntributing activities fr the envirnment (if several) f the use) then yu shuld nly assign SPERCs which have the flag Rigrusly cntained system with minimisatin f release t the envirnment t each cntributing activity fr the envirnment fr that use. Nte that in such cases the assessr will als have t

30 30 Chesar 3 fr sectr assciatins prvide a Descriptin f nn-technical means fr rigrus cntainment and strict cntrl fr manual interventin. Such explanatin will als cver the nn- technical means relevant fr the wrkers activities if they take place in Rigrusly cntained system with strict cntrl fr manual interventins (see sectin 6.2.2). Yu may prvide supprt fr such infrmatin in the Additinal infrmatin frm use map fr the use in yur use map Rigrusly cntained system with strict cntrl fr manual interventins If the use takes place in Rigrusly cntained system with strict cntrl fr manual interventins (fr all the cntributing activities fr wrkers f the use) then yu shuld nly assign SWEDs which have the flag Descriptin f nn-technical means fr rigrus cntainment and strict cntrl fr manual interventin t each cntributing activity fr wrkers fr that use. In this case, the assessr will als have t prvide a Descriptin f nn-technical means fr rigrus cntainment and strict cntrl fr manual interventin. Such explanatin will als cver the nn-technical means relevant fr the envirnment if the use takes place in Rigrusly cntained system with minimisatin f release t the envirnment. Yu may prvide supprt fr such infrmatin in the Additinal infrmatin frm use map fr the use in yur use map.

31 Chesar 3 fr sectr assciatins 31

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