What has to be done to get to GPS implementation in practice when you have no REACH registration dossier?

1. What has to be done to get to GPS implementation in practice when you have no REACH registration dossier? Dr. Stefan Berg, BASF SE, Ludwigshafen, Germany From REACH to Global Product Strategy (GPS) and Product Stewardship (PS) Workshop 03 – 04 Dec 2009 Zagreb, Croatia

2. Outline of the presentation • How to prioritize chemicals under GPS • GPS tiered risk characterization • How to conduct the risk characterization • GPS safety summary

3. Chemicals under GPS and regulatory systems • GPS (Global Product Strategy): „Chemicals“ = Substances • Products can be (pure) substances or mixtures of substances • First you need an inventory of all substances in your products • Many developed and some developing countries resp. regions (US, CA, EU, CH, JP, KR, CN, PH, AU, NZ) have a regulatory substance inventory. Substances in products must be listed on these substance inventories before you can place your products on the market. • TR (Turkey) presently is setting up a substance inventory (by 2010) • TW (Taiwan) plans to set up a substance inventory by 2010/2011 AU = Australia CN = (Peoples Republic of) China NZ = New Zealand CA = Canada EU = European Union PH = Philippines CH = Switzerland JP = Japan US = United States of America KR = (South) Korea

4. Prioritization Process under GPS –Factors / criteria to be considered • Do you already have prioritization processes in your company? For instance due to • own company Product Stewardship programs or • national or regional regulations (e. g. REACH, ChAMP)  No need to change these prioritization processes • In case no prioritization process exists: Use the factors offered by the GPS Guidance document to categorize chemicals into • “High priority” • “Medium priority” • “Low priority” for completing risk characterizations

5. GPS Guidance document(„ICCA GPS Guidance on Risk Assessment“) The Guidance document will be published on the GPS website http://www.icca-chem.org/Home/ ICCA-initiatives/Global-product-strategy/ • Preface • Legal Notice • Background • ICCA Global Product Strategy (GPS) Approach • Prioritization of Substances for GPS Risk Assessment • General Guidance to Tiered Risk Characterization • GPS Risk Characterization Process • Gathering Hazard and Exposure Information • How to Conduct the Risk Characterization • Applying Appropriate Risk Management • Annex 1 (GPS „Base set of information“, Sorting Criteria, Hazard identification, Dose-response assessment, Exposure assessment, Risk characterization, Trigger for additional data requirements, Examples of possible risk management actions to consider, Process for setting priorities for CSA, Frequently asked questions (GPS))

6. = Yes = No Y N Process of Setting Priorities under GPS –Just follow the flow chart Substance in commerce / transported? N Y To start the evaluation based on the „base set of information“ Verifiable low hazard and/or low exposure profile? Low priority Properties known? N Y Y N Substance has tox / ecotox relevance? N Y Substance under public discussion? Y Limited industrial / professional use? Well-known, controlled conditions of use? Y Y N N N Medium priority Substance on candidate list(s)? Y Wide & dispersive industrial / pro- fessional use or end-consumer use? N N N Substance covered by specific regulation? Y Y High priority Follow legal requirements

7. Generic Example – Substance ABC • Substance in commerce , production volume > 20.000 t/a • Phys / Chem properties known • Substance has tox / ecotox relevance • Wide and dispersive use / application as plasticizer, printing inks, adhesives, sealants/grouting agents, nitrocellulose paints, film coatings and glass fibres, including wide usage in cosmetics, lubricant for aerosol valves, an antifoamer, a skin emollient , etc. Guess……..

8. Generic Example – Substance ABC • Substance in commerce , production volume > 20.000 t/a • Phys / Chem properties known • Substance has tox / ecotox relevance • Wide and dispersive use / application as plasticizer, printing inks, adhesives, sealants/grouting agents, nitrocellulose paints, film coatings and glass fibres, including wide usage in cosmetics, lubricant for aerosol valves, an antifoamer, a skin emollient , etc. ……it’s “High Priority”

9. Outline of the presentation • How to prioritize chemicals under GPS • GPS tiered risk characterization process • How to conduct the risk characterization • GPS safety summary

10. GPS tiered risk characterization process - Standard parameters + Tier 1, 2, 3, or 4 parameters • Standard Parameters • Identity • Phys-Chem • Tox / Ecotoxicity (accidental exposure) • Biodegradability Tier 1 (e.g minimal exposure or no hazard potential) Tier 2 (e.g low exposure or low hazard potential) Tier 3 (e.g medium exposure or hazard potential) Tier 1 - 4 Tier 4 (e.g high exposure or high hazard potential)

11. 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 aquatic toxicity (most sensitive species: fish, daphnia or algae) • Biodegradability Base set of Information – Standard parameters for all substances Substance Identity • CAS Number(s) • Name(s) • Structural Formula • Composition being assessed • Use Pattern (categories types) • Sources of Exposure

12. GPS Risk Assessment Process –How to gather hazard and exposure information Sources can be, but are not limited to (accessible via web): • Information collected / generated for regulatory purposes (e.g. REACH), OECD Chem Portal • (Material) Safety Data Sheets, Chemical Safety Reports (CSRs) • EU Risk Assessment Dossiers, etc. • Dialogue with suppliers of raw materials; • Governmental regulatory/sources e.g. OECD/SIDS dossiers, ORATS (Online European Risk Assessment Tracking System); • Public or company internal databases e.g. IRIS, ESIS (European Chemical Substance Information System); • US EPA sources, Australian and Japanese,

13. Standard Parameters for Substance ABC Substance identity • CAS Number(s) 1234-56-7 • Name(s) ABC • Structural FormulaX(X)3-X(XX)4 • Composition being assessed 99% pure • Use / Exposure application as plasticizer, printing inks, Pattern adhesives, sealants/grouting agents, nitrocellulose paints, film coatings etc.

14. Standard Parameters for Substance ABC Phys / Chem Properties • Physical state liquid • (Appearance colourless, faint odor) • Melting Point 31°C • Boiling Point 180°C • Relative Density 1.045 at 20°C • Vapour Pressure < 0.1 hPa at 20°C • O/W Partition Coefficient logPOW = 4.9 • Water Solubility slightly soluble in water • Ignition temperature 390°C • Explosiveness not explosive

15. Standard Parameters for Substance ABC Tox / Ecotox Properties Acute Toxicity: • LD50 rat (oral): 6,300 mg/kg • LC50 rat (by inhalation): > 15 mg/l (4 h) • LC50 rabbit (by inhalation): > 4000 mg/kg Acute aquatic toxicity: • Toxicity to fish: LC50 (96 h) 0.92 mg/l, Pimephales promelas • Aquatic invertebrates: EC50 (48 h) 3.4 mg/l, Daphnia magna Biodegradability: • Biodegradation: Readily biodegradable

16. How do you attribute chemicals based on a certain hazard or exposure to tier 1-4 ? Simplified criteria matrix • Hazard allocation (Hazard Sorting Matrix) - It utilizes basic information about endpoint specific toxicity (e.g. NOEL values, GHS classification, MOE/MOS) to step the user through a matrix-based decision-making process • Exposure allocation (Exposure Sorting Matrix) (Categorization of exposure at current stage with examples expressed in REACH Use Descriptor terminology) - generic descriptions / guidance which cover multiple use or exposure MOE = Margin of Exposure GHS = Globally Harmonized System MOS = Margin of Safety REACH = Registration, Evaluation, Authorisation of Chemicals NOEL = No Observed Effect Level

17. Hazard Sorting Matrix (Toxicological)List of criteria / key principles

18. Hazard Sorting Matrix (Ecotoxicological)List of criteria / key principles

19. Exposure Sorting Matrix – Current REACH Use Descriptor Terminology PPE = Personal Protection Equipment

20. Substance ABC – Base Set Tier according to Hazard / Exposure Profile • Flammability Tier 1 • Reactivity Tier 2 • Acute Toxicity Tier 1 • Irritation Tier 1 • Sensitization Tier 1 • Mutagenicity Tier 1 • Reprotoxicity (GHS Cat 1B) Tier 4 • Acute Aquatic Tox (GHS Cat 1) Tier 4 • Wide and dispersive end consumer use Tier 4 Due to sorting matrix and pre-existing GHS classification allocation to Tier 4

21. Outline of the presentation • How to prioritize chemicals under GPS • GPS tiered risk characterization process • How to conduct the risk characterization • GPS safety summary

22. GPS Risk Assessment Process –How to conduct the risk characterization Hazard Evaluation Design and describe Risk Management Measures*) (if required) Exposure Evaluation Risk Characterization Documentation of the Risk Assessment: GPS Safety Summary Decision Point: Information sufficient? No Yes *) Some examples for Risk Management Measures are given in the presentation „How to transfer a REACH dossier to GPS?“ by L. Heezen in this workshop

23. Risk Assessment Conclusions –Health / Environmental Hazard • Given the exposure pattern and the low toxicity observed in the acute oral, inhalation, and dermal studies it is concluded that substance ABC is of no concern with respect to acute effects • Substance ABC did not show skin or eye irritating properties. According to EC criteria substance ABC needs not to be classified on the basis of the available tests. • Substance ABC can be considered non-genotoxic • Substance ABC has been identified to have reprotoxic effects and is classified accordingly (R61, GHS Cat 1B) • Substance ABC has been identified as aquatic toxicant and is classified accordingly (R50, GHS Cat 1)

24. Do we need risk management measures for Substance ABC ? • Human health • At the anticipated exposure levels of workers / consumers there is at present no need for further information, testing or risk reduction measures beyond those being applied already. • Environment • There is at present no need for further information or testing or risk reduction measures beyond those which are being applied already. This conclusion applies to effects on the aquatic compartment (including sediment), soil and secondary poisoning. On the basis of the risk assessment current applications and uses of substance ABC are safe

25. Outline of the presentation • How to prioritize chemicals under GPS • GPS tiered risk characterization process • How to conduct the risk characterization • GPS safety summary

26. GPS Safety Summary –Company examples http://www2.basf.us/corporate/ehs/product_safety_summaries.htm http://www.dow.com/productsafety/finder/index.htm

27. GPS Safety Summary –Two examples – flexible in content / layout