REACH ES and CSA process

REACH ES and CSA process M. Viñas

Agenda • Introduction to CSA under REACH • Exposure Assessment • Exposure Scenarios • Cefic proposed processes for ES development • Libraries • ECHA CSA IT tool for CSR and ES development (Chesar) • Safety Data Sheets

Guidance on information requirements and chemical safety assessment, Guidance for downstream users 29 documents!> 2000 pages! 3

Registration dossier - content Technical Dossier • Identify of the manufacturer/importer • Identity of substance • Info- manufacture and use of the substance • Classification and labelling • Guidance on safe use of the substance • Study summaries – substance properties • Test proposals (if relevant) • Exposure information Substance to be registered > 10 tonne/year Chemical Safety Report • Hazard and PBT Assessment Also Chemical Safety Report • Hazard and PBT Assessment • Exposure Assessment • Exposure Scenarios • Exposure Estimation • Risk Characterisation Substance dangerous or PBT/vPvB Also

CSA Process • Identify the conditions ensuring control of risks arising from manufacture and use(s) of a substance. • Prepare a set of corresponding information on operational conditions and risk management measures to be communicated to the users (for dangerous and PBT, vPvB substances) = Exposure Scenario (to be annexed to extended SDSs) • Document the assessment (including how the Exposure Scenarios were derived) in a CSR for the companies’ own documentation. • Submit the CSR to the authorities as part of the registration.

Information: available required/needed • substance intrinsic properties • manufacture, use, tonnage, exposure, risk management Hazard Assessment (HA) • Hazard Classification and PBT conclusion • Dose/Concentration-Response Characterisation Exposure Assessment (EA)* • Build Exposure Scenarios (RMM and OC) • Estimate Exposure Level Dangerous or PBT ? n y Risk Characterization (RC)* Stop Risk controlled? Iteration y n Document in CSR Communicate ES via eSDS Required if substance is dangerous or PBT/vPvB, or exposure based waiving according to annex XI Required for all CSAs *

Content of Exposure Scenarios • Description of conditions suitable to ensure control of risks related to the uses of a substance during the entire life cycle. Environment, workers and consumers to be covered. One ES can cover one or more use: • Operational conditions (OC) determining the exposure (e.g. duration of task) • Practical Risk Management Measures (RMM) suitable / needed to prevent, reduce or limit risks (e.g. exhaust ventilation) • Explanation how the exposure estimates related to these conditions and RMM have been derived • Title of exposure scenario indicating for which uses it can be applied • Boundaries within which the exposure scenario is applicable.

What is an Exposure Scenario ? • A description of safe use including • Conditions of use • Risk management measures • EScovers all activities and processes within the value chain • Production: chemical synthesis of the substance and use as intermediate • Formulation: mixing and blending into a preparation • Industrial, professional use • Consumer exposure and private use • Service life • Waste Life stage

When are Exposure Scenarios needed? Exposure Scenarios and CSAs need to be included in the CSR if • The substance is classified as dangerous or • The substance is a PBT or vPvB and • Produced or imported in excess of 10 t/a • In a preparation in a concentration above limits indicated in article 14 DU can choose to do his own CSA/CSR unless • No SDS needs to be provided • The supplier is not required to develop a CSA • The tonnage limit is < 1 t/a • The downstream uses should also be taken into account • Exposure scenarios need to be developed for all identified uses

ES Development & Communication model M/I and/or M/I-DU Associations => determine strategy Systematic assessment of safe uses (use of Tier1 tool) Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain Determine strategy & collect info for safe uses only Use Alignment DU Wait for final ES DU Use covered? Yes M/I and DU partnership via trade associations Generic ES Development • Input of DU Associations • Development GES library M/I and selected DU’s Specific ES development • Input of selected customers • Use of Cefic ES template No or ES development DU • Prepare CSA/CSR • Inform Agency DU • Complete feedback form • Await decision M/I Communication to direct DU Distribution of e-SDS Final Exposure Scenario (M/I) ES communication Legend M/I = Manufacturer / Importer DU = Downstream User For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.

Cefic workflow on ES development and communication • Development of Exposure Scenarios, using two processes: • Generic Exposure Scenario process • Specific Exposure Scenario process

ES Development & Communication model M/I and/or M/I-DU Associations => determine strategy Systematic assessment of safe uses (use of Tier1 tool) Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors for safe uses only M/I and DU partnership via trade associations Generic ES Development • Input of DU Associations • Development GES library M/I and selected DU’s Specific ES development • Input of selected customers • Use of Cefic ES template Final Exposure Scenario (M/I) Legend M/I = Manufacturer / Importer DU = Downstream User For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted. M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain DU Wait for final ES DU Use covered? Yes No or DU • Prepare CSA/CSR • Inform Agency DU • Complete feedback form • Await decision M/I Communication to direct DU Distribution of e-SDS 15

Generic Exposure Scenarios (GES)‏ • GESs describe ESs for (groups of) substances for an area of operation within industry and are developed by M/Is in partnership with DU Associations (surrogate for individual DU)‏ • The (composite) GES is aggregated from the ESs for individual tasks/activities and incorporated into a library of GESs for access by relevant stakeholders • describes Risk Management Measures & Operational Conditions relevant for safe use of a group of substances with a similar risk profile • M/I selects relevant GES to support their substance registration • GES and supporting documentation is refined as necessary to form the substance-specific ES for demonstration of safe use and inclusion within their CSR • ES is transferred to the e-SDS for communication to customers

Key Characteristics of GESs • Determine simple titles (and descriptions) that describe the areas of use and that are understandable across DUs within and across supply chains • Involve the collaboration of M/I (and/or formulator) associations and DU associations • Represent a mapping of all (or key parts of) the supply chain for a substance (or groups of substances)‏ • Follow a process that aligns with the requirements of the TGD and delivers documentation sufficient to meet these for a CSR and/or eSDS (subject to confirmation on the part of the registrant)‏ • Communicate all relevant OCs and RMMs for the identified scenarios • Describe the ES according to a library of standard phrases

How is GES developed?

Cefic workflow on ES development and communication • Development of Exposure Scenarios, using two processes: • Generic Exposure Scenario process • Specific Exposure Scenario process

ES Development & Communication model M/I and/or M/I-DU Associations => determine strategy Systematic assessment of safe uses (use of Tier1 tool) Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors for safe uses only M/I and DU partnership via trade associations Generic ES Development • Input of DU Associations • Development GES library M/I and selected DU’s Specific ES development • Input of selected customers • Use of Cefic ES template Final Exposure Scenario (M/I) Legend M/I = Manufacturer / Importer DU = Downstream User For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted. M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain DU Wait for final ES DU Use covered? Yes No or DU • Prepare CSA/CSR • Inform Agency DU • Complete feedback form • Await decision M/I Communication to direct DU Distribution of e-SDS 21

What are Specific Exposure Scenarios ? • Specific Exposure Scenarios (SES) describe Exposure Scenarios (ES) for individual substances in both specific and general uses • SESs are developed by the M/I in dialogue with DU selected representative customers • SESs can cover one task or a set of tasks related to an application • The SES process is particularly useful to develop ESs for substances in relatively short supply chains or supply chains lacking well structured sector organizations

Cefic SES template dialogue Available on Cefic website. Please consult regularly for updates:

CEFIC dialogue template for SES building • Enables M/I to develop initial ESs, using a harmonised industry format • Enables DU to give feedback on uses and use conditions to M/I in a standardized way • Enables DU to enter new ES, if he finds his use not covered (art. 37-2)‏ • Structured according to ES format in Technical Guidance Document • Each section contains the basic information for description of the ES and exposure assessment using the ECETOC TRA tool • Template in line with the final version of the ECETOC TRA tool

How are SESs developed? SES process: stepwise approach, initiated by M/I in dialogue with DU 1. Inhouse collection of information on uses and use conditions 5. Evaluation of draft SESs in the CSA Aggregation into final SESs 2. Development of initial SESs (use of SES dialogue template)‏ 6. Documentation of SESs in Chemical Safety Report 3. Dialogue with selected customers (feedback, using SES dialogue template)‏ 7. Transformation of SES for substance to ES for product (annex SDS)‏ 4. Development of draft SESs (based on input by customers)‏ 8. Communication of ES to direct DU customers

Final remarks on ES development • Dialogue template for SES building is aimed at two way communication in an effective and efficient way; it is NOT a questionnaire! • SES and GES development processes are complementary; both processes on their own or in combination offer the flexibility needed to develop ESs that suit M/I needs and the needs of DU customers • Cefic strongly supports and recommends the use of both ES development methods and accompanying tools to achieve optimal information exchange on uses in the supply chain

Selecting the Approach Generic ES approach Specific ES approach Main Focus Main Focus M/I and DU Partnership via Trade Associations M/I and Key customer iteration Common Uses, e.g. commodity chemicals Specialised Uses, e.g. fine chemicals Dispersive application Limited supply chain Assumes some knowledge of substance handling by M/I May have limited knowledge of substance handling in the supply chain by M/I Groups of substances with similar applications Single substance with specific or general applications

Available tools on Cefic web • Newsletter: guidance on Use and ES development and Supply Chain Communication VCI Practical guide CSR eSDS • DUCC UseR template: • Use and ES communication • IT tool requirements Strictly Controlled |Intermediates M/I and/or M/I-DU Associations => determine strategy Systematic assessment of safe uses (use of Tier1 tool) Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors • Preparation phase • Use communication holding letter for safe uses only DU Wait for final ES DU Use covered? Yes • Guidance on SES process + templates • Guidance on GES process + templates M/I and DU partnership via trade associations Generic ES Development • Input of DU Associations • Development GES library M/I and selected DU’s Specific ES development • Input of selected customers • Use of Cefic ES template No or DU • Prepare CSA/CSR • Inform Agency DU • Complete feedback form • Await decision M/I ES for preparations, DPD+ Communication to direct DU Distribution of e-SDS Final Exposure Scenario (M/I)‏

Cefic libraries TF What? • Generic Exposure Scenarios • Standard Phrases for SDS/ES • RMM and associated efficiencies • Use Mapping including Use Descriptors. • Reference latest guidance material When? • Q1 2010 Where? http://cefic.be/en/reach-for-industries-libraries.html 30

ECHA CSA Tool for ES development • Name of tool has changed: Chesar (Chemical Safety assessment and reporting tool) • IUCLID 5 plug in • Basic goals • Support registrant's CSA process • CSR/ES authoring for a substance • Included • Supports exposure scenario building based on Tier 1 exposure estimates (based on TRA and ERC)‏ • Allows to report exposure scenarios built with other exposure assessment tools or based on measured data • Supports starting from existing (partial) (Generic) Exposure Scenarios • Provides some flexibility in structure of information sent to customers based on what is documented in the CSR • CSA extraction tool + CSA tool should result in complete drafting of CSR

ECHA CSA tool for ES development • Included library for ‘templates’ • Full or partial exposure scenarios + corresponding exposure estimates (by different assessment methods) • Single determinants of exposure (= OC and RMM)‏ • Target group templates (sets of determinants related to workers, consumers or environment)‏ • Exposure scenario templates • The Chesar input XML can accept: • GES tables 1 and 2 • SES template • DUCC UseR

General purpose of the CSA Tool • What does the Chesar not do? • Support information gathering from Dus • Hazard assessment • PBT assessment • Enable running other exposure models • Can be done outside Chesar and results entered in the tool

Timing CSA tool • Successive Chesar releases: • Version 0.5 : early 2009, some basic functionalities • Version 1.0: April 2010, complete version for CSR preparation • Version 1.x: Q4 2010, ES for eSDS included • The Chesar will be developed as a IUCLID plug-in • Stand alone and distributed version • You need IUCLID 5.2 installed to run! • Cefic sees main use of tool after first registration deadline

Safety Data Sheet (SDS) • The purpose of the SDS is to provide the user with: • necessary measures relating to protection of human health and environment • information to convey down the supply chain when they are not final user (i.e. to compile the SDS for their own mixtures) • Format of the SDS: • The SDS follows a 16 section format which is internationally agreed. • The SDS must be in the language of the country in which it is placed on the market.

Safety Data Sheet (SDS) • When is a SDS required? • Article 31: suppliers need to provide SDS for substances and mixtures if: • Classified • PBT or vPvB • Candidate list • On request of recipient: SDS also for mixtures not classified as dangerous but containing SVHC or substances limited on workplace

Safety Data Sheet (SDS) • When is a SDS not required? • For general public, but sufficient info to be provided on safe use • For articles, but if SVHC > 0.1 %, communication on safe use to be provided if requested • It is common practice in industry to provide SDS for non-classified products on voluntary basis.

Safety Data Sheet (SDS) • Communication down the supply chain when no SDS is required: • If a SDS is not required, the M/I shall communicate key risk information to enable appropriate risk management: • If Substance is subject to Authorisation/restriction: • Registration number • Details of granted authorisation or appropriate info if authorisation is denied • Details of restriction • Other available and relevant info on safe use • If Substance is not subject to Authorisation/Restriction: • Registration number • Available and relevant info to assure appropriate RMM

Safety Data Sheet (SDS) • What is new in REACH? • Inversion chapters 2 & 3 • Email of competent person • Information consistent with registration dossier • Registration number • Exposure Scenarios (e-SDS)

Safety Data Sheet (SDS) • What is new in CLP/GHS? • More, and more precise information in SDS. • Format: new sub-headings! • Transitional periods • « Old EU » classification in SDS until 1 June 2015 • CLP classification can be included on voluntary basis for mixtures • Labeling information in section 2 • Guidance on SDS under development (foreseen publication in summer 2010)

Useful links Cefic website: http://cefic.org/templates/shwPublications.asp?HID=750 DUCC UseR template: http://www.aise.eu/reach/documents/DUCC_Use_and_ES_MappingTemplate_revisedFinal15072009.xls Ecetoc TRA: https://www.ecetoc-tra.org/public/login/index.asp ECHA: http://echa.europa.eu/reach/software_en.asp Thank you for your attention! mvi@cefic.be

REACH ES and CSA process