Chemical Safety Assessment under REACH: how Chesar can help registrants Chemical watch 25.04.2017 Roberta Bernasconi, Conny Hoekzema, Hélène Magaud European Chemicals Agency Computational Assessment and Dissemination Unit
Overview Background on Chemical Safety Assessment Tools to help communication in the supply chain Approaches and tools for support DNEL Calculator in IUCLID Use maps and ESCom ECHA s Chemical Safety Assessment and Reporting tool (Chesar) 2
Chemical Safety Assessment under REACH What is it? Who is involved? 3
Chemical Safety Assessment The Chemical Safety Assessment (CSA) aims to characterise the intrinsic properties of a substance Classification No-effect levels Vapour pressure, water solubility, degradability,. to determine the conditions under which the substance can be used safely during its entire life cycle to communicate these conditions with safety data sheet (SDS) to all the commercial users of the substance (as such, in mixture) It is to be documented in the Chemical Safety Report (CSR) as part of the registration For own documentation (product safety) Part of the registration dossier 4
When full safety assessment needed? You manufacture or import substances in 10 or more tonnes per year (excludes intermediates under strictly controlled conditions) Where the substance meets the criteria to be classified hazardous or PBT Duty of each registrant, however lead registrant may perform CSA on behalf of co-registrants (joint CSR) Safety report needs to cover all uses of the substance you are aware of For imported mixtures: for substances present above the concentration levels defined in Article 14(2)
Typical assessment questions Which types of exposure controls are needed at work places to handle the substance safely? Activities at industrial work places Activities at non-industrial workplaces How much of a substance can be used per day at an industrial site without onsite pre-treatment of wastewater? Is the substance in general suitable to be widely used by untrained workers in small business and by consumers? How to ensure the inherent safety of consumer products containing the substance: Maximum concentration; amount per package/use? 6
How to assess? Substance properties: Hazard assessment Substance properties: Distribution and fate assessment Uses and condition of use Risk controlled? Exposure estimates Chemical safety report authorities own documentation Yes No Iterate Exposure scenarios (conditions for safe use) annexed to SDS Use advised against communicated in safety data sheet
What is needed? Safety assessment requires information on substance properties and conditions of use Manufacturer Downstream user Knows the properties of the substance Knows how the substance is used Communication in the supply chain is key 8
Life cycle of a substance M/I of substance as such DU (1) produces a mixture M/I sells substance in mixture DU (2) produces a mixture End-use of mixture by consumer End-use of mixture by DU (3) industrial site End-use of mixture by DU (3) professional Substance in article service life 9
Information flow Registration Dossier Public ECHA and Member States Registrants What are the existing uses? Under which conditions do they take place? Exposure Scenarios (ES): describing the conditions for safe use for individual DU Formulators End users Downstream users
Experience so far The derivation of the no-effect-level for the substance is intransparent or wrong (=> inappropriate risk management) Registrants have included all potential uses into their registration; lack of use-specific volumes (=> real uses and their extent remain unclear) Advice on safe use is often too generic or too unrealistic to be helpful to users of chemicals Registrants have copied/pasted the exposure scenarios from the CSR into the safety data sheets (=> very long SDS) Multiple manual transfer of data from one document to another (=> inefficient and high likelihood of mistakes) Registrants have not planned CSR updates (=> no contractual arrangements; CSA not in database format) 11
Potential consequence for business Customers complain about wrong or unhelpful safety data sheets Authorities pick the substance for further regulatory action for the wrong reasons The registration dossier is incompliant due to inconsistencies between IUCLID, the CSR and the safety data sheet Maintenance and update of the registration dossier is burdensome/costly Solutions available to reduce these business risks 12
Tools to help communication in the supply chain 13
DNEL/PNEC calculator in IUCLID DNELs and PNECs are no effect thresholds : used as basis for the CSA. IUCLID can now calculate DNELs and (soon) PNECs DNEL calculator helps you derive long term systemic DNELs for your substance and report it for your registration dossier Available in IUCLID 6.1.2 Explanations available in Registration manual section 9.7.6.1 https://echa.europa.eu/documents/10162/22308542/manual_regis_and_ppord_en.pdf PNEC calculator will be available in IUCLID 6.1.3 (to be released in April 2017) 14
Tools to help Registration Dossier Public ECHA and Member States Use maps developed by DU associations: What are the uses relevant in one sector? Under which conditions do they take place? Registrants Exposure Scenarios: describing the conditions for safe use for individual DU ESCom XML and phrase catalogue Harmonised format Formulators End users Downstream users
Use maps Use maps: a useful tool for realistic description of uses and conditions of use! More information: https://echa.europa.eu/csr-es-roadmap/use-maps/concept SWED Workers: Sector-specific Worker Exposure Description (SWED) Workers Use description SCED Consumers: Specific Consumer Exposure Determinant (SCED) Consumers SpERC Environment Environment: Specific Environmental Release Category (SPERC) 16
Use map concept Downstream user sector organisations map out the common uses among their membership and document in harmonised format describe the existing conditions of use in a way that they can be fed into the registrant s exposure assessment for workers, consumers, environment; phrase the conditions so that downstream users will understand when they receive the information with the ES Registrants select uses relevant for their substances and upload the information package into their assessment Use maps can be found in https://echa.europa.eu/csr-esroadmap/use-maps/use-maps-library
Chesar: Chemical Safety Assessment and Reporting Tool
Introduction Chesar is a web application developed by ECHA to support registrants in consistently carrying out their Chemical Safety Assessment generating their Chemical Safety Report (CSR) as part of their registration generating the Exposure Scenario for communicating conditions for safe use (annex to extended Safety Data Sheet) It is released as a Desktop and Server version It is free-of-charge and easy to install https://chesar.echa.europa.eu/home
Information flows ECHA and MS Registrant s IUCLID instance ECHA s database Public Substance properties CSR Use description + exposure assessment Industry associations Use maps ECHA Webpage Chesar XML Exposure estimation tools ES for esds ESComXML DU s or Registrant own IT system
Chesar 3 workflow: the Chesar boxes 1. Substances 2. Uses 3. Exposure assessment 4. Chemical Safety Report 5. Exposure scenario for extended safety data sheet 6. Library 7. Users 21
Characterise the substance: understanding composition, form of the substance during its life cycle (D.2) Assessment workflow Guidance D Physico chemical/fate properties (D.4.1) Use characterisation Use description (Guidance R.12) Conditions of use (OCs/RMMs) for exposure scenario building (D.3) Hazard assessment (Guidance Part B, R.7b/c and R.10 for environment and R.7a and R.8 for HH ) Release /exposure estimation (D.4, Guidance R14, R15, R16) Risk characterisation (quantitative/qualitative) (D.5, Guidance Part E) Scope of the assessment (D.2.3, Guidance Part B) Chemical Safety Report (D.6) Exposure scenario for communication (D.7) Yes Risk controlled? No Use advised Against? No Iteration: refine use conditions, hazard, exposure.. Yes Inform ECHA and downstream users 22
Terminology Life Cycle: Use Exposure Assessment per Use Use name Exposure Scenario (ES) name Exposure to Environment (all compartm.) Contributing Activity (CA) name Environment + ERC Contributing scenario (CS): Conditions of use from environmental perspective Release to Environment Exposure of Man via Environment Contributing Activity (CA) name by workers + PROC Contributing scenarios (CS) C C o o n n d t i r ti b o u n t s in o g f u s s c e en fr a o ri m os: C w o o n r d k i e t r io p n e s rs o p f e u c s t e iv f e rom occupational perspective Exposure of workers for each CS 23
Physico chemical properties Results of hazard assessment Environment Human health PBT status Import substance data from IUCLID Chesar3 workflow Import use maps Select uses, complement information: tonnage, TF Conditions of use are already included from SPERCs, SCEDs, SWED linked in use map Carry out quantitative exposure assessments (exposure tools) and quantitative and/or qualitative risk characterisation Conditions of use SPERC, SCEDs, SWEDs Standard phrases Import updates Generate CSR Section 9 and 10 Generate full CSR Export of uses and exposure data Extract ES for extended SDS Export to companies EHS systems (ESComXML) 24
Chesar provides opportunities for Consistency Within the CSA: substance properties, uses reported in IUCLID and the chemical safety report Information for the authorities (CSR) and for the supply chain (exposure scenario for communication) Standardisation (efficiency gains for all actors) Systematic workflow Import/export/printed format of Use maps, Chemical safety report, Exposure scenarios for communication (Standard phrases: ESCom) Efficiency in single assessment Integrated exposure estimation tools Re-use of information across substances Automated generation of documents Facilitated updates 25
More information 1 Chesar user manual https://chesar.echa.europa.eu/support/manuals-tutorials Helptext within the application : the magic button Webinars have been recorded Training: ECHA has been organising some trainings. Next one planned for 14-15 June 2017 26
More information 2 https://chesar.echa.europa.eu/ will be updated at release time. Subscribe to be kept informed! 27
Chesar DEMO
Chesar: assessment of complex cases In some situations several sets of information on substance properties may play a role for conducting the exposure and risk assessment of a registered substance, e.g.: Different forms/compositions with different hazard profile Substance transforming into another substance Substance composed of many constituents (including UVCB) Creation of Assessment Entities (AE) in IUCLID Assessment for (groups of) assessment entities in Chesar More information: Chapter D2 of Guidance part D: https://echa.europa.eu/documents/10162/13632/information_requirements_part_d_en.pdf Manual How to prepare registration and PPORD dossiers : https://echa.europa.eu/manuals Chesar 3 manual, chapter 9: https://chesar.echa.europa.eu/support/manuals-tutorials Helptext in Chesar (visible when AE have been imported)
Chesar: the future
Chesar 3.2 Next release by June 2017 Editability of substance properties used by plugged-in tools Improved support for use maps Editable chemical safety report preview Support for translated ES for communication
Editability of substance properties Phys-chem and fate properties used by plugged-in tools can be edited directly in Chesar (without going back to IUCLID and reimport) Exposure estimates for plugged-in tools automatically recalculated Possibility to revert to original value Note: Keep in mind that eventually IUCLID and Chesar will need to be synchronised! Hazard conclusions not editable Change in log Kow not reflected in PNECsediment / soil when based on equilibrium partitioning
Editability of substance properties
Editability of substance properties
Editable CSR preview Preview directly in Chesar of the CSR as it will be printed Possibility to edit (explanation) fields Additional fields not completed in earlier boxes (e.g. 9.0) Fields completed during assessment Visual indication of fields that have no explanation
Editable CSR preview
Improved support for use maps Separate role for use map developers enables creation and update of use maps Assessor can import use maps in Box 2 (as in Chesar 3.1.1) Possibility to import updated use map Changes compared to current use map in Chesar visible
Support for translated ES for communication Framework of SDS ES is translated in all EU languages Possibility to import translations for standard phrases Choice in which language to generate SDS ES Phrases for which no translations are available are in English
Support for translated ES for communication
Chesar future. Potential future developments: Update of embedded exposure tools Integration of other exposure tools More support for assessment of article service life
Thank you! chesar@echa.europa.eu roberta.bernasconi@echa.europa.eu Subscribe to our news at echa.europa.eu/subscribe Follow us on Twitter @EU_ECHA Follow us on Facebook Facebook.com/EUECHA