Supply chain communication, GPS safety summaries, (e)SDS and use of harmonised IT tools Workshop on Implementation of REACH and CLP INT MARKT – 28 June 2013, Moscow L. Heezen

Content Purpose of supply chain communication GPS safety summary Extended Safety Data Sheet (eSDS) Harmonised IT tools 2

Purpose of Supply Chain Communication  To inform Downstream Users on hazards of the substance  Human health hazards  PhysChem Hazards  Environmental Hazards  To inform Downstream Users on risks of the substances  For identified uses, the recommended Risk Management Measures (RMM) to use it safely 3

Purpose of supply chain communication Chemical Producers have initiated voluntary programs and have legal obligations to communicate:  Voluntary initiatives Product Stewardship Responsible care Global Product Strategy – Safety Summaries  Obligatory: Classification and labeling Safety Datasheet Extended Safety Datasheet 4

GPS Safety Summaries ICCA has develop a GPS specific format that can be used to communicate the essential information in a transparent way with interested stakeholders (GPS Safety Summary). To provide the general public with a short easy to understand overview of relevant information for the chemical To help and inform users of the substance on hazards and risks with it recommended RMM Does not replace technical materials such as the (M)SDS 5

GPS Communication- Safety Summary The summary should be fairly basic and understood by a layman Compilation of relevant risk characterization and risk management information in an easily understandable format To be communicated to employees, downstream customers, the public and other interested parties Regional flexibility will apply in the content of the GPS Safety Summary, it is up to the company to define the relevant information and layout but should include some basic elements Currently more than 1800 GPS Safety Summaries are already available via ICCA IT Portal Safety Summaries can be downloaded from ICCA IT Portal 6

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) 7

Safety Data Sheet under REACH SDS are mandatory when: –Substance/mixture is classified as hazardous –Substance is PBT/vPvB –Substance is in candidate list (SVHC) (ECHA website) On request of recipient: SDS also for preparations not classified as dangerous but containing: –Classified substance > 1% –PBT/vPvB > 0.1% –SVHC > 0.1% –substances limited on workplace SDS not obligatory for: –general public (but sufficient info on safe use) –Articles (but if SVHC > 0.1 %, communication on safe use to be provided) 8

Who prepares the SDS? SDS are prepared by competent persons: Competent Persons are persons – or a coordinator of a group of people - who have, as a result of their training and continued education, sufficient knowledge for the elaboration of the respective sections of the SDS or of the entire SDS. It is not necessary that the expert knowledge is provided in full by one person. These duties can be delegated to own staff or to third parties. Competent persons should be trained regularly 9

How are SDS provided? SDS must be provided free of charge In an official languages of the recipient’s MS Electronically by Posted on website + notification to downstream user to download under discussion (MS opinion is that it needs pro-active action) 10

Consistency with registration dossier Identified uses Supplier Exposure control Personal protection Phys-chem properties Etc… Safety Data Sheet 11

SDS with at least one exposure scenario (ES) included in the annex. The term ‘extended’ is not meant to indicate only that the content of the main body of the SDS is extended REACH does not define the format nor the content of the ES attached to the SDS. The ECHA guidance on IR/CSA “Exposure Scenario Format” lists examples 12 What is an extended SDS (eSDS)?

What is an Exposure Scenario ? A description of safe use by describing Conditions of use Risk management measures “Algorithm” to be used by DU for validating safe use ES covers 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

Format of an ES 1.Title section Use descriptor ES description Contributing scenarios 2.Conditions of use affecting exposure Product characteristics Operational conditions Risk Management measures 3.Exposure Estimate and reference to its source Release rates and RCR Exposure assessment toll used 4.Guidance for Downstream Users Scaling information Reference to websites Not obligatory, but recommended by ECHA and used in IT tools

Exposure scenario development Exposure scenarios need to be developed for: Manufacturing process Identified uses Life cycle stages from manufacturing to identified uses till waste stages.

There are several valid reasons why an exposure scenario might not be included as an annex to your supplier’s SDS: The substance is not classified hazardous substances registered in quantities lower than 10 tonnes/year substances registered as a transported isolated intermediate substance that does not meet the criteria for classification as hazardous and not assessed to be a PBT or vPvB 16 Not all SDS will be ‘extended’

17 ES Development & Communication model DU Wait for final ES M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain DU Use covered? DU Company feedback form Await decision M/I DU Prepare CSA/CSR Inform Agency No Yes Distribution of eSDS Check if use is covered 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) M/I and/or M/I-DU Associations => determine strategy Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors Systematic assessment of safe uses for safe uses only 17

Available tools on Cefic web 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 DU Wait for final ES DU Use covered? DU Complete feedback form Await decision M/I Final Exposure Scenario (M/I)‏ DU Prepare CSA/CSR Inform Agency No Yes or 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 Communication to direct DU Distribution of e-SDS for safe uses only Newsletter: guidance on Use and ES development and Supply Chain Communication VCI Practical Guide on Exposure Assessment and Communication in the Supply Chains Use and ES communication IT tool requirements Guidance on GES process + templates Guidance on SES process + templates Preparation phase Use communication holding letter UseR template ES for preparations, DPD+ ESCom XML Libraries use mappings ESCom phrases 18 SpERCs

Assessment of Exposure: helpful tools Industry sectors have developed tools to help in the assessment: Generic Exposure Scenarios (GES) GESs describe exposure assessments for (groups of) substances for an area of operation within industry and are developed by M/Is in partnership with DU Associations 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 his assessment most advanced for workers exposure Renewed templates for GES liquids and solids have been published May 2013: reach/Guidances-and-Tools1/ reach/Guidances-and-Tools1/

Assessment of Exposure: helpful tools Specific Environmental Release Classes (SPERCs) Developed by different industry sectors to make ERCs more specific. Describe the typical operations in their sectors including (conservative) release factors and efficiencies of RMM/OC. Fact sheets to justify specific factors under preparation Are used in the Ecetoc TRA and Chesar Overview of SPERCs and fact sheets from: - reach/Guidances-and-Tools1/ reach/Guidances-and-Tools1/

Assessment of Exposure: helpful tools Chemical Safety Assessment and Reporting Tool (Chesar) Developed by EU Chemicals Agency -Latest release 2.2 April 2013 Standalone version Helps in the assessment process Generates reporting of CSR and ES for communication

Assessment of Exposure: helpful tools Chemical Safety Assessment and Reporting Tool (Chesar) Imports data from IUCLID XML standard agreed for import and export data Use descriptor system Uses Ecetoc TRA for workers/consumers and EUSES for environment as default -Results of other estimating tools can be processed

Ecetoc TRA European Center for Ecotoxicology and Toxicology of Chemicals – Ecetoc Targeted Risk Assessment Tool, version 3, 2012 Integrated (Workers, Consumers, Environment) or stand alone consumers Tier 1 Exposure Assessment tool Version 3 : Increased flexibility and accuracy Improved sensitivity for dermal exposure prediction Improved consumer exposure algoritms Improved use of SPERCs Incorporated in Chesar V 2.2

Format of ES ECHA ES for communication*: 1.Title section Use descriptor ES description Contributing scenarios 2.Conditions of use affecting exposure Product characteristics Operational conditions Risk Management measures 3.Exposure Estimate and reference to its source Release rates and RCR Exposure assessment toll used 4.Guidance for Downstream Users Scaling information Reference to websit es * ES in CSR chapters 9 and 10 and follow different format, with extended information to report

Assessment of Exposure: helpful tools Standard phrases for communication: ESCom Standard Standard phrase library (ESCom Phrases) available for MSDS and offered by EHS providers Standard phrases for safe use of chemicals are developed by industry and are available in English, free of charge XML standard (ESCom XML) for harmonised communication available also available free of charge Translation into local language via EHS providers Mar 2013 new release of phrases V 1.1: Tools1/

EsCom: Exposure Scenario Communication Package Aim of the EsCom is to have standardised phrases and an harmonised IT standard for ES communication between companies IT systems in the supply chain. The EsCom package products: ESCom XML 1.1 – The Container for ES Info XML Schema-definition ESCom XML guidance document Technical documentation Example of an XML-File ESCom Standard-Phrases - The Content for ES Info Master-File with standard-phrases (incl. phrase-codes) Guidance document for phrase development

Objectives for the ESCom Package ESCom shall be applicable for the downstream communication over the whole supply chain of the SDS. Made available for free in the Enlish language Being aligned with BDI EuPraC phrase system for SDS  Will only work if all players in the supply chain apply XML and phrase standards.  Should be used for the entire ES, no possibility for free text  Will take some time to implement in the supply chain and to have all IT systems upgraded

Industry vision M/I Exposure Assessment Tool DU Scaling Tool Formulator Mixture Assessment Tool GES SpERC EsCom Phrases Data Std ESCom XML Format ESCom XML Format ESCom XML Format Industry standards Chesar TRA ? Tools for Mixture Assessment Under Development Scaling Tools Under Development

Useful links CSA/CSR/ES tools: Tools1/ Tools1/ Use libraries: ESCom package: ECHA guidance’s and tools: ECETOC TRA:

Thank You! Leo Heezen