Volker J. Soballa, Evonik Industries AG Introduction and Overview of ICCA GPS Risk Assessment Guidance Copyright© 2012 ICCA All Rights Reserved Responsible Care Metrics and GPS Workshop Dubai 24 and 25 September 2012

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Promote knowledge and skills transfer Improve the availability of information Increase awareness on chemical management Research on existing and emerging issues Training Workshops Guidance materials GPS Network of experts Base Set of information GPS Safety Summary Web-based IT-Portal ICCA Principles for Chemical Management Systems ICCA Long Range Research Initiative (LRI) Global Product Strategy - Contribution to SAICM 2

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG GPS Risk Assessment Guidance Pilot – Feedback The Guidance is a valuable tool and will help companies to meet their commitments to GPS as well as regulatory requirements but there is opportunity for improvement. » Simplify language, add examples to illustrate processes and harmonized the guidance with the GHS classification After technical revision the document was revised by a professional communicator. Rollout of first version in July 2010, North America (Dow, ExxonMobil) Asia Pacific (Sumitomo, Mitsubishi) South America (Braskem) Europe (BASF, Evonik) Africa & Saudi Arabia (Sasol, Sabic) 3

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG The target audience are emerging economies and small and medium sized companies (SMEs) with no or very limited experience in risk assessment and related methodologies. Our goal was to come up with an easy to use step wise process as a first step to bridge gaps in current performance. Based on the comments from the pilot project we’ve decreased the level of details to keep it simple and straightforward. The guidance has its limitations, it will be a living document to be updated / improved in the years to come. Improve performance – Risk Assessment Guidance 4

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Status GPS Risk Assessment Guidance SMEs in Focus: First Step to Perform a Risk Assessment Revised by OECD, ICAPO, ACI Additions / New Chapters  Industry perspective on Assessment factors  Evaluation of preparation (Mixtures)  Occupational Health Assessment Actual version since July 2011

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Improve performance – Risk Assessment Guidance “College Level” Little to no experience “Bachelor Level” Advanced knowledge “PhD Level” Expert knowledge OECD / REACH Guidance ICCA GPS Guidance The GPS guidance is intended to be simple and pragmatic: a first step for beginners in risk assessment. More detailed guidance can be obtained from other sources 6

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Improve Industry Performance – GPS Guidance Section One: Preparation Step 1: Select chemicals for assessment Step 2: Gather information Step 3: Prioritize chemicals into Tiers Step 4: Develop “Base Set of Information” Section Two: Implementation Step 5: Characterize Hazard Step 6: Assess Exposure Step 7: Conduct Risk Characterization Step 8: Document Safety Summary SMEs in Focus: First Step to Perform a Risk Assessment

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 1: Select substances for assessment GPS risk assessments should be performed for industrial chemicals: » Sold (“in commerce”) or transported world-wide in quantities of more than 1 metric ton per year by company and those that » Pose a major threat to human health and/or the environment (e.g. known carcinogens, etc.) even if they are sold or transported in smaller amounts than 1 metric ton per year The inventory should be kept strictly company internal due to antitrust / competition law compliance 8

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 2: Gather information How to obtain the information: sources to access information on GHS information, Phys/Chem, Hazard and Exposure Information Evaluate the quality of the Information: Reliability, Relevance and Adequacy of data for assessment Close data gaps: As long as the information is considered reliable, alternative sources are accepted e.g » Route-to-route extrapolation / Read-across from related substances » In vitro methods / (Quantitative) Structure Activity Relationships » Animal tests should always be the "last resort" 9

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 3: Prioritize substances into Tiers Under GPS the prioritization of chemicals into “Tiers” is based on an initial evaluation of their hazard and / or exposure potential. 1.Identify if your chemical has intrinsic hazard. 2.Identify use, dissemination and exposure control of chemical 3.Allocate chemicals into Tiers Each Tier is associated with a specific set of information. Chemicals with higher hazard and / or exposure potential require more information and are assessed first. Just because a chemical is identified as high priority for RA does not mean that the RA outcome will show the chemical is of highest risk. Even a hazardous substance can be safely used in accepted applications. 10

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 3: Prioritize substances into Tiers 11

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 4: Base Set – Standard Parameters (for all) Substance Identity CAS Number(s) Name(s) Structural Formula Composition being assessed Use Pattern (categories types) Sources of Exposure Phys / Chem Physical state Melting Point Boiling Point Relative Density Vapour Pressure Partition Co-efficient Water Solubility Ignition temperature Explosiveness Tox / Ecotox Acute toxicity data (relevant route of exposure e.g. oral, dermal, inhalation) Acute Toxicity (most sensitive species: fish, daphnia or algae) Biodegradability 12

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 4: Base Set – Tiered Information Tier 4 Irritation Tier 3 Irritation Mutagenicity Sensitization Tier 2 Irritation Mutagenicity Sensitization Repeated Dose Tier 1 Irritation Mutagenicity Sensitization Repeated Dose Repro / Develop Top Priority for RA2 nd Priority for RA3 rd Priority for RA Increased priority for RA = Higher information requirement 13

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Section One: Preparation Step 1: Select chemicals for assessment Step 2: Gather information Step 3: Prioritize chemicals into Tiers Step 4: Develop Tier-relevant information (“Base Set of Information”) Section 2: Implementation Step 5: Characterize Hazard Step 6: Assess Exposure Step 7: Conduct Risk Characterization Step 8: Document outcome (GPS Safety Summary) GPS Guidance on Risk Assessment 14

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 5: Characterize Hazard 15

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 6: Assess Exposure Step-wise process » Collect information on chemical properties » Collect information on the uses and the typical operating conditions and risk management (exposure control) measures applied » Set up an Exposure Scenario for each use » Estimate exposure for each scenario, using estimating tools (e.g. ECETOC TRA) or measured data Perform the respective assessment for: » Human Exposure - Workplace and Consumer scenarios » Environmental Exposure Assessment 16

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 7: Conduct Risk Characterization Risk Characterization Ratio (RCR) Threshold or non-threshold effect » RCR = EXPOSURE / DNEL » RCR = EXPOSURE / DMEL Environmental » RCR = PEC / PNEC Margin of Exposure (MoE) MOE = NOAEL or NOAEC Exposure » If MOS > Overall Assessment Factor → No concern » If MOS < Overall Assessment Factor → Concern RCR ≥ 1 Risk is high Detailed assessment and RMMs required RCR < 1 Risk is controlled No further action required MOE > 100 No concerns MOE < 100 Concern Refine analysis or control exposures MOE < 1 Cause for high concern Direct measures needed 17

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 8: Document outcome After the RA it is important to check the efficiency of the safety measures adopted, document the outcomes of the assessment and reviewing the assessment regularly to keep it updated. As this documentation will contain data of proprietary nature it will stay company internal and does not have to be shared with co- producers or the public (no mandatory exchange of dossiers). 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 » Does not replace technical materials such as the (M)SDS 18

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Step 8: GPS Safety Summary - Template Summary Chemical identity Uses and Benefits Physical/chemical properties Health Effects Environmental Effects Exposure Risk Management Recommendations First‐aid measures Fire‐fighting measures Accidental release measures Handling and storage Disposal consideration State Agency Review Classification and Labeling Conclusion Contact Information within company Date of finalization of the Safety Summary 19

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG GPS versus REACH: Similarities and Differences REACH Information requirement (high) based on production volume Assess Hazard Derive e.g. DNEL Similar Calculate Safe Use Document in CSR Assess Exposure GPS Information requirement equivalent to risk potential Assess Hazard Derive e.g. DNEL Calculate Safe Use Document internally Assess Exposure Communicate relevant information to the public Differences

Chemicals Policy and Health (CP&H) Volker J. Soballa, Evonik Industries AG Thank you very much for your attention!