esds What works for users? webinar, 30 January 2013, 2pm GMT

esds What works for users? webinar, 30 January 2013, 2pm GMT

Today s webinar - aims What downstream users need to do once they receive an esds and their role in ensuring safe use in the supply chain; Hear from a member state regulatory authority on its activities relating to what should go into an exposure scenario, including data models and assessments; Look at how companies should approach implementation of both CAD and REACH by incorporating new information generated by REACH into their risk management activities.

Q&A session If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar. http://forum.chemicalwatch.com

Speakers Andrew Murray, Senior Scientific Officer, Directorate for Risk Management on chemical safety assessment and exposure scenarios, ECHA Gudrun Walendzik, Unit 4.1 "Exposure Scenarios", Federal Institute for Occupational Safety & Health, BAUA Dr Charles Alarcon, Industrial Hygienist, CEHTRA Chair: Emma Chynoweth, Deputy & News Editor, Chemical Watch

Information in the supply chain: Safety Data Sheets and Exposure Scenarios Webinar: esdss what works for users? Andrew Murray Senior Scientific Officer Directorate for Risk Management 30 January, 2013 14:00-15:30 (London, GMT)

Information in the supply chain: Safety Data Sheet and Exposure Scenario Information and supply chain communication The new Safety Data Sheet The Exposure Scenario Sections of Exposure Scenario What to do when you receive an SDS What further actions to take, depending on the outcome Typical examples of how to check an Exposure Scenario 2

Information and Communication in the supply chain INFORMATION ON Uses Conditions of use Chemical Safety Assessment Safety Data Sheet (+ES) Substance Properties Registered Uses Operational Conditions RMM End User.. DU X.. DU 1 DU 1 DU X.. End User.. Before registration After Registration Downstream Users Registrants Manufacturers /Importers Downstream Users Good communication is vital for good information on safe use! 3

Valid reasons for receiving SDS without exposure scenarios Substance is exempted from registration Substance not registered yet Substance is not hazardous Substance registered as an intermediate Substance registered below 10 tonnes/year SDS provided on a voluntary basis http://echa.europa.eu/downstream

The new SDS Safety Data Sheet + Exposure Scenario Main body Classification and labelling information Registered Uses Threshold values for exposure (DNELs PNEC) Physicochemical data Toxicological and ecotoxicological data Exposure scenarios Use-specific operational conditions Use-specific risk management measures 5

The Exposure Scenario What is it? a control strategy providing operational conditions for manufacture and/or identified use(s) of a substance. describes appropriate risk management measures (RMMs) for ensuring adequate control of risk (information on safe use) When is it required? When a Chemical Safety Report need to be prepared (volume > 10t/year) And If the substance meets the criteria to be classified or identified as PBT vpvb (Persistent, Bioaccumulative and Toxic; very Persistent, very Bioaccumulative) ESs must cover all identified uses at all life cycle stages! Relevant ES are attached to the SDS (so called extended SDS) 6

The Exposure Scenario Sections Title Section Short title Use and Conditions of use (Use descriptors) Contributing scenarios Environment Workers Consumers Exposure estimate Method used for exposure estimation (modelling tool or measured data..) Exposure estimates Risk Characterisation Ratio Other information Scaling options (advice on how to determine if your conditions of use are within the boundaries of the ES) 7

When you receive an extended SDS Check if use is covered (section 1.2 of SDS and ES) Check if conditions of use are covered (ES) Focus on your own use (uses at your sites) design of your products foreseen uses of your mixtures by your customers (if you produce mixtures which are used further down the supply chain) 8

Check of Exposure Scenario : outcomes Use and conditions of use are clearly covered You ve done! Document your use. Use and conditions of use clearly not covered See next slide Not clear if use and conditions of use are covered Further checks are needed. Communication with your supplier might help 9

If a use/conditions of use are not covered 1. Adapt conditions of use to the received ES: Implement ES regarding own use Adapt the composition/design of the product to be supplied further down the chain Recommend to customers the conditions of use specified in the received ES 2. Communicate to the supplier so that he would include the identified use in his CSR and provide an ES: sufficient information on the conditions of use should be made available to the supplier to enable assessment! 3. Look for another supplier who will include the use in his CSR and provide an appropriate ES 4. Prepare own CSR and annex corresponding ES to the own SDS; report (limited) information according to article 38 to ECHA within 6 months 10

Federal Institute for Occupational Safety and Health Division 4: Assessment Unit for Occupational Safety and Health Webinar: esdss what works for users Exposure Scenarios under REACH Impact for occupational safety and health Dr. Gudrun Walendzik

Overview Benefit of the extended safety data sheets (esds) Determinants of exposure assessment Structure of exposure scenarios Examination of exposure scenarios submitted during the first registration period Conclusion/Outlook 31.01.2013 2 Dr. Gudrun Walendzik

Benefit of exposure scenarios for the supply chain Task in the chemical safety report Creation of a transparent connection between use conditions and exposure assessment to enable risk characterisation Task in the annex of the extended safety data sheet (esds) support of the communication on the safe use conditions within the supply chain 31.01.2013 3 Dr. Gudrun Walendzik

Determinants of exposure Technicalmeasures Organisational measures Risk management measures: Substance properties: Volatility Dustiness Personal protective equipment Exposure Scenario Working conditions: Temperature 31.01.2013 Quantity Duration and Frequency Process 4 Dr. Gudrun Walendzik

Common tools for exposure assessment Deterministic Models (mathematical models) Control banding Tools EMKG [Einfaches Maßnahmenkonzept Gefahrstoffe] Expo Tool (DE) Tier 1 Tools recommended in REACH-GD R 14 EASE => [Estimation and Assessment of Substance Exposure] (UK) COSHH [Control of Substances Hazardous to Health] Essentials (UK) ECETOC-TRA [European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment Tool] (Industry) Stoffenmanager (NL) Probabilistic Models Art [Advanced REACH Tool] (NL) BEAT [Bayesian Exposure Assessment Toolkit] Higher Tier Tools recommended in REACH-GD R 14 31.01.2013 RISKOFDERM 5 Dr. Gudrun Walendzik

Exposure models pros and cons Complementary to measurement data there are available several tools for occupational exposure estimation Critical use means: Estimation results should be cross checked by comparison with other tools our measurement data A general tool for all types of exposure estimation doesn t exist 31.01.2013 Validity of the tools is partly inadequately proved (yet) 6 Dr. Gudrun Walendzik

Documentation of an exposure scenario One standard often used for exposure scenario documentation consists of 4 parts: Part 1 Part 2 Part 3 Part 4 Title, identified uses Use conditions Exposure assessment Guidance for the downstream user (DU) whether or not his use is covered by the exposure scenario 31.01.2013 This structure is just as standard not a legal obligation! 7 Dr. Gudrun Walendzik

Exposure scenario - structure Title The title of an exposure scenario should include information which uses are covered By application of the - use descriptor system, the process categories (PROC) should appear If multiple uses are covered by the ES they should be clearly arranged 31.01.2013 8 Dr. Gudrun Walendzik

Exposure scenario - structure (2) 31.01.2013 Title Conditions of use Conditions of use have the purpose to describe the circumstances and the substance properties, which influence the exposure: Concentration Amount Ambient conditions Temperature Duration of use Frequency of use Emission into environment No substance intrinsic properties 9 Dr. Gudrun Walendzik

Use descriptors (1) Use descriptors are specified and systematically described conditions of use, which characterise the use They support the harmonized and structured description of uses Based on the short title, the downstream user can quickly determine whether a received exposure scenario covers his uses Conversely, the use descriptors help the downstream users to describe a use if he needs to inform the supplier in accordance to Article 37 (2) Only uses within the EU are recorded in the CSR under REACH 31.01.2013 In many cases the registrant will need additional information to the use descriptors to generate suitable exposure scenarios 10 Dr. Gudrun Walendzik

Exposure scenario - structure (3) Title Conditions of use Risk Management Measures (RMM) Risk Management Measures are such measures which lead to a reduction of exposure: Technical measures Organisational measures Personal protective equipment (PPE) 31.01.2013 the efficiency of the applied measures should be itemized 11 Dr. Gudrun Walendzik

Exposure scenario - structure (4) Title Conditions of use Scaling is the variation of the influencing parameters without changing the target value. If scaling is allowed, the target valuein response to the influencing parameters should be specified. 31.01.2013 Risk Management Measures (RMM) Scaling advice Risk characterisation ratios are helpful at this point. Environment: RCR = PEC/PNEC Human health: RCR = Exposure value/dnel 12 Dr. Gudrun Walendzik

Evaluation of the exposure scenario by the downstream user Step 1: Analysis of the extended safety data sheet corresponding ES should be in the annex of the SDS Step 2: Check whether the conditions of use at least comply with the conditions of an ES. Control of use (application) conditions and risk management measures regarding the comparability to the information in the ES Ë if necessary additional steps when this is not the case. 31.01.2013 Reason: Legal consequences for the DU, if the conditions of save use are not met. 13 Dr. Gudrun Walendzik

Observations on exposure scenarios from the first registration wave 31.01.2013 14 Dr. Gudrun Walendzik

Observations on the use description Often very generic, does not support understanding of what is practically done with the substance Includes often nearly all use descriptors (regardless of whether this is plausible, consistent or relevant for the substance) Registrants try to cover everything i) just to be on the safe side or ii) to include everything they have received from downstream 31.01.2013 Registrants have copied their use descriptions from lead registrant or even from a generic CSR generated on sector level 15 Dr. Gudrun Walendzik

Exposure Scenarios What should be improved? (1) Often for high tonnage substances, registered by large consortia, highly schematic generic exposure scenarios are incorporated: 31.01.2013 often very generic difficult to understand defective therefore unsuitable for risk communication in the supply chain and thus of limited use Not all life cycle stages covered by exposure scenarios Titles do not support easy recognition by downstream users whether or not an ES applies to him Operational conditions and risk management measures are unrealistic and over-stringent 16 Dr. Gudrun Walendzik

Exposure Scenarios What should be improved? (2) 31.01.2013 Incompliance of proposed risk mitigation measures with Directive 98/24/EG Art.6(2) which requires application of technical and organisational measures to reduce exposure. It is regularly ignored that PPE should be used as a last resort ; justification arguments why technical and organisational measures can not be proposed are missing. Results of exposure assessments related to models are not clear - retraceability of the exposure assessment is not given - e.g. by incomplete documentation of determinants Exposure scenarios with inhalation exposure at elevated temperature calculated with models, which don t give the possibility for an assessment at variable temperatures Ë leading to underestimation 17 Dr. Gudrun Walendzik

Conclusion and outlook 31.01.2013 A significant number of the reviewed registration dossiers showed relevant shortcomings in the description of occupational exposure. Industry and authorities are in a learning process (new roles; mass generation of assessments). Dossier evaluation under REACH should address more often exposure aspects because risk is defined by comparison of hazard AND exposure. The main tools for CSA/CSR have to be continuously improved to support a more systematic, consistent and structured assessment. Practical guides and illustrative examples are needed The use of PPE should be deemphasized because of the low compliance especially in the frame of professional uses. Dermal exposure assessment should be improved Validation activities for exposure assessment tools are essential for the transparancy and quality of exposure estimates by models ( e.g. ETEAM project, www.eteam.eu) 18 Dr. Gudrun Walendzik

Thank you for your attention Dr. Gudrun Walendzik Federal Institute for Occupational Safety and Health Friedrich-Henkel-Wag 1-25 44149 Dortmund, Germany www.baua.de 31.01.2013 19 Dr. Gudrun Walendzik

Disclaimer This Information is an interpretation of REACH (Regulation (EC) No 1907/2006). It was assembled with a maximum of care and is based on solid knowledge on chemical regulations. As the construction of REACH is still under development alternative interpretations might be possible in particular cases. Any advice, information and indication is therefore for information only and without legal responsibility. Liability claims of any material or ideal kind toward the Federal Institute for Occupational Safety & Health (BAuA) are excluded. 31.01.2013 20 Dr. Gudrun Walendzik

Interface between ChemicalsAgents Directive and REACH at the workplace. Someexemples fromfrench industries. Charles ALARCON, CEHTRA. charles.alarcon@cehtra.fr Phone: +33(0)6 17 88 69 66 30 january2013

BACKGROUND ON CAD in french industries. In France, CAD 98/24/EC (Chemical agents) and 2004/37/CE (carcinogens and mutagens) have been implemented by transposing Directive into national legislation. Consequences for french industries : Risk assessment on chemical agents is mandatory and must be documented. Measurement is mandatory as first approach for some substances.

BACKGROUND ON CAD in french industries. Is CAD really applied in industries? Most of the french industries applied partially national legislation on chemical agents. Major difficulties to have a relevant way to archieve and to insure traceability of actions.

Comparisonof REACH and CAD approach. Many similarities between REACH and CAD. Scope; Risk assessment; Substitution; Exposure reference levels; Control; Information and training.

Comparisonof REACH and CAD approach. Main objective Optimization of REACH and CAD compliance actions Use CAD risk assessment documents to check esds compliance (Risk Management Measures, Operational Conditions). Use REACH approach (under esds) to initiate and/or to improve CAD risk assessment.

Case 1 -Industrie coatingsand paints Industrie coatingsand paints. CAD risk assessmentdone since 2005 using risk rating tool (INRS, France). more than 100 substances used for formulation. 2012 = 15 esds received (with relevant ES annexes)

Case 1 -Industrie coatingsand paints Actions done. Training of REACH and HSE team. Onsite audit and activity process maping - Links between activity approach under CAD risk assessment and Contributing Scenario from supplier esds. Identification of OC and RMM at workplace onsite check list compliance with OC and RMM from esds supplier.

Case 1 -Industrie coatingsand paints Mean results. 65% of OC and RMM from esds in line with onsite OC and RMM from CAD. 35% of OC and RMM from esds not in line with onsite OC and RMM from CAD: 25% compliance after scaling (meanly on duration and % substance in formulation) 10% not in compliance after scaling measurement data from CAD assessment used to demonstrate that onsite control are acceptable to insure employee health and safety.

Case 2 -Industrie washing and cleaning products Industrie washing and cleaning products. 150 employes no CAD risk assessment done. no measurement data onsite 2012 = 10 esds received (with relevant ES annexes)

Case 2 -Industrie washingand cleaningproducts Actions done. Training HSE team. Activity process mapping and risk assessment in plant using REACH tools (ECETOC TRA, Advanced REACH Tool). onsite check list compliance with OC and RMM from esds supplier.

Case 2 -Industrie washingand cleaningproducts Mean results. As the CAD risk assessment done using REACH tools and approach (Contributing Scenario approach), compliance check of esds (on OC and RMM) less time consuming. In this example, esds has been a good opportunity to initiate a relevant risk assessment on plant. Improvement of general risk management measures (local exhaust ventilation has been implemented in relevant process points).

Lessons learned. Organisation ressources management. Training, instruction. Optimisation of work done. Link with existing data.

Global 2012 results. (based on 25 french industries audited) 35% good CAD risk assessment onsite direct link between CAD risk assessment and esds compliance 45% basic CAD risk assessment onsite, not completed esds = improve CAD risk assessment and RMM in plants 20% no CAD risk assessment onsite esds = good opportunity to initiate a risk assessment onsite.

Q&A session If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar. http://forum.chemicalwatch.com

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