‘Supply chain communication under REACH: current issues and potential solutions’ Workshop on REACH & supply chain on April Mercedes Viñas

Topics Introduction Identified issues Potential solutions Conclusions 2

3 REACH in a nutshell A producer/importer registers a substance and pays registration fee and letter of access (no data, na market) For specific uses (covering the supply chain) These uses are covered by the chemical safety assessment (if substance > 10 ton per year) If substance is dangerous exposure scenarios (ES) must be worked out These ES will be added to the extended safety data sheet The Agency and Member States can evaluate a substance Substances of very high concern can lead to an authorisation process and to substitution Substances with unacceptable risk to human health and environment can go into restriction of their allowed uses

Communication down the supply chain Manufacturers and Importers of a substance/preparation shall communicate how their substances/preparations can be used in a safe way Safety Data Sheet (SDS) including Exposure Scenarios (ES): Operational Conditions (OC) and Risk Management Measures (RMM) under which the substances/preparations can be used in a safe way If a SDS is not required, the M/I shall communicate key risk information to enable appropriate risk management (article 32) Distributors to pass on information on safe use to their customers

Communication up the supply chain DU has the right to make their use known to their supplier DU has the duty to inform his supplier about: inappropriateness of the received RMM new information on the hazardous properties of the substance/preparation Distributors shall pass on the information received from DU to the next actor up in the supply chain

Topics Introduction Identified issues: market vs registration driven communication Potential solutions Conclusions 6

Market vs registration driven communication  A well organised communication was and will be a key issue again Key questions for Downstream Users: related to registration: Will my substance be registered? Will my use be covered by my supplier? related to authorisation: Will my supplier go for authorisation and will the authorisation be granted?  Very closely related the communication on Substances of Very High Concern (SVHC) in the supply chain 7

Market driven: Reassuring the supply chain Suppliers could issue generic statements to express their intentions regarding status of substances/products. There is no fixed way to make this information available. In our case [Indeed, we will inform you on the uses we intend to cover in our registration via this link/website/…][we plan to cover the uses identified to the sector associations in their use mappings] Downstream users consult the available sources of information Each level of the SC can then confirm status to the customers as appropriate. Downstream users can include verification of these systems in their Quality Management Systems actions on suppliers, and/or commercial contracts 8

Unless you have a particular use, there is no need to pro-actively communicate common uses up the supply chain. Common uses, such as those covered in the existing SDS, will normally be covered; therefore there is no need to communicate those. Particular uses should be communicated as soon as possible. In doing so, Downstream users should provide sufficient information to the suppliers. Common uses are those included in e.g. the DU Associations use mapping websites, already registered uses, and /or previous SDS 9 Market driven: Reassuring the supply chain

M/I should inform proactively and as soon as possible if there is an intention to stop production/import Companies should be encouraged to share these intentions in the SC because: -this may give the opportunity to DU to assess whether they can give support to the supplier for the registration process; -it gives the confirmation to the supplier if there is a real business case for this substance in the SC. -having this information would allow the SC to anticipate problems and find solutions. The wording of this communication should be carefully prepared by companies 10

Reassurance of supply chain will also apply – even more importantly – to the intention not to apply for an authorisation for a certain substance /use. Some sectors like the automotive, have their own databases (e.g. declarable substances, IMDS, etc.). However it has taken long time for such systems to be developed, implemented and accepted/used by the relevant parties in the SC There is a need to keep authorities informed in case of some critical situations Any system will at the end based on trust to a large extent 11 Market driven: Reassuring the supply chain

Preventing issues  Supply chain aspects should be taken into consideration since the early stages of the process of registration  Tools and guidance developed by industry to support preparation of CSA/CSR/ES SpERCs SCEDs ESCom package … 12

To support use and CSA/CSR/ES Inform the supply chain and collection of use information: -Model letter on use communication to inform the SC: -UsER template with basic information to describe a use -Library of use mappings: to consult use information prepared by sectors: 13

Generic Exposure Scenarios (GESs) describe ESs for (groups of) substances for an area of operation/type of application within industry and are developed by M/Is in partnership with DU Associations Substances clustered by hazard (DNEL band) and volatility and grouped by type of application (i.e. have a similar risk profile) Each GES consolidates related tasks/activities involving potential for exposure (Contributing Scenarios) which are mapped to relevant use descriptor codes (Worker – PROC codes; Consumer – PC codes 1)M/I (Consortia) select relevant GES to support their substance registration 2)GES and supporting documentation is refined as necessary to form the substance-specific ES for demonstration of safe use and inclusion within their CSR 3)ES is transferred to the e-SDS for communication to customers To support use and CSA/CSR/ES: GES

GES Example: Mapping Use and Typical Use Conditions – Human Health Worker

16 First level Environment Assessment under REACH based on ERC’s (R16) Release defaults set for ERC based emission estimates are worst case assumptions This may lead to overly conservative results with corresponding difficulties for DUs An approach applying more realistic values while keeping standardization appears reasonable  Specific Environmental Categories (spERCs) To support use and CSA/CSR/ES: spERCs

17 To carry out more realistic CSA by using information on realistic environmental values: Refinements of the ERC-based emission estimation. Define realistic default values (based on good practice information supplied by sector groups, trade associations). Are documented in SPERC fact sheets, deposited in ES library. More than 170 SPERCs are available for the time being SPERCs have been extensively used for generating the dossiers of the 2010 REACH registrations Further development ongoing All published on the Cefic web site To support use and CSA/CSR/ES: spERCs

Specific Consumer Exposure Determinants: can be seen as the consumer equivalent of SpERCs Several sector associations known to have described/ justified Habits &Practoces information for relevant consumer uses (AISE, ESIG, FEICA, CONCAWE, etc.) ECETOC is now finalising a template to facilitate the efficient and consistent collection and display of relevant information across PCs/sectors Vision is for managing and sharing/posting as part of Cefic/DUCC libraries activities Helps focus trade association activities on critical consumer determinants for their uses Final vision is for incorporation of the library into the TRA (and Chesar) in a manner similar to the SpERCs The development of SCEDs is still at an early stage To support use and CSA/CSR/ES: SCEDs

Exposure Descriptor or Determinant ValueJustification Use description Consumer re-fuelling of cars and similar vehicles Product/Article Use Category PC13 PC/AC Subcategory NoneAutomobile refuelling Product Ingredient Fraction100% Frequency of Use0.14Once per week Relevant Route(s) of Exposure dermal / inhalationOral exposure not considered relevant for this use Dermal Specific Parameters Skin Contact Area (cm 2 )210Palm of only one hand holds fuel nozzle Skin Transfer Factor 0,05 Assumed value of no greater than 5% of material transferred from contaminated pump handle/item to skin. Long standing contamination eliminated through evaporation. Contact invariably is indirect with contaminated surfaces rather than virgin product. Inhalation Specific Parameters Amount of Product used per application (g) Based on 50 litres and density of 750 g/l Exposure Time (hr) minutes. 97 th % value from Vainiotalo et al, 1999 Is product used outdoors ? Outdoor use Room Volume (m 3 ) n/a 100m 3 used as default volume (consistent with Stoffenmanager) Ventilation specified or likely due to properties n/a Outdoor air exchange rate considered to equivalent to value cited by RIVM for garages (0.6x) Inhalation factor (fraction of total amount handles lost to air) 0.2% loss Evaporative losses during refueling expected to be <<1% based on mass balances Oral Specific Parameters Volume Ingested (cm3)n/a Oral Transfer Factorn/a Responsible organisation CONCAWEArlean Rohde To support use and CSA/CSR/ES: SCEDs

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 -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 20 To support use and CSA/CSR/ES: ESCom

Information in the supply chain with ESCom XML EHS System ESCom XML Supplier‘s system Customer‘s system

ESCom shall be applicable for the DU communication over the whole supply chain of the (ext-)SDS Made available for free in the English 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 22 To support use and CSA/CSR/ES: ESCom

ESCom XML status of implementation: Significant demand: > 1,000 downloads Data Model: dependencies to be reviewed / revised Mapping ES (printed) format to ESCom XML Need for more extended examples, also for Mixtures Validation tool needed (‘Is our XML file correct ?’) Testing of ESComXML: send / receive with other companies No possibility to exchange free text, but 160 ‘standard’ fields foreseen 23 To support use and CSA/CSR/ES: ESCom

ESCom ES Phrases status: > 1900 ES Phrases Adding Metadata has started Inconsistencies / fine-tuning in ES Phrase data (e.g. spelling, dots, capitals) Duplicate Phrases (approx. 80) to be resolved Missing Phrases, Metadata not complete yet How apply / implement ES Phrases metadata in IT systems 24 To support use and CSA/CSR/ES: ESCom

ECHA – Industry Cooperation Make industry Developments/Tools available in / for CHESAR: ongoing GES SPERCs ESCOM phrases ESCOM XML – aligning with CHESAR XML ECETOC TRA CEFIC-DUCC Coordination 25

Our 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 26

Timeline Q1Q2Q3Q4Q1 Chesar 2.0 GES SpERCs ESCom Phrases ESCom XML Data standards ES for mixtures Scaling EHS IT systems Continuous update The given timelines are indicative and depend on voluntary contributions of company experts 27

Conclusions There are major contributions from industry to set up the ES development and communication process We are not there yet -Harmonisation and standardisation is key -Exposure Scenario information for mixtures -Scaling tools -Further development of ESCom and harmonisation with assessment tools like Chesar -Define standards for industry tools to apply them in IT systems 28

Conclusions The Safety Data Sheets (extended or not) remain the core element for supply chain communication on substances and mixtures IT solutions and industry proposed standards are key to achieve efficient communication:  Standard will only work if all players in the supply chain apply XML and phrase standards  Will take some time to implement in the supply chain and to have all IT systems upgraded 29

Conclusions – open issues There are some other open issues: Different parts of the supply chain = different information needs, the format and ‘language’ can therefore be adapted as it goes down the SC e.g. are use descriptors understood and ‘fit for purpose’ at the end of the SC?, do DUs buying mixtures need ES? Mixtures into articles: ‘broken link’? big information gap appears when the mixtures are transformed into articles. Companies buying articles do not receive safety data sheets and therefore not much information is available on presence of substances, etc. 30

Where to find information 31

Conclusions REACH was ‘born’ end 2006 This young child is discovering the complexity of the world of chemicals and its uses from the cradle to the grave Tools are developed in function of the encountered difficulties but there is still room for progress (quality of dossiers) REACH is expected to be ‘adult’ in 2018 REACH is not a single shot, getting the registration number is not the end, it is the beginning of a journey 32

33