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William G. Machin Manager; Classification and Hazard Communication Cefic

William G. Machin Manager; Classification and Hazard Communication Cefic European Chemical Industry Council Brussels. GHS Implementation & Issues Arising. Module 6 – Contents 6.1 General Issues 6.2 Chemical Categories 6.3 REACH Interface 6.4 SME’s and Mixtures

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William G. Machin Manager; Classification and Hazard Communication Cefic

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  1. William G. Machin Manager; Classification and Hazard Communication Cefic European Chemical Industry Council Brussels

  2. GHS Implementation & Issues Arising

  3. Module 6 – Contents 6.1 General Issues 6.2 Chemical Categories 6.3 REACH Interface 6.4 SME’s and Mixtures 6.5 International Inventories 6.6 CAS Numbers

  4. 6.1 Implementation General Issues

  5. Issues • GHS is political compromise between existing systems • Substances • Health and Environment Criteria • Lot of commonality with EU supply scheme • Less robust in some areas e.g. C & R • Some more severe criteria e.g. STOT • Physical Hazards Criteria • Existing UN Transport system • Mixtures (Preparations) • Generally more severe than existing EU supply system • Safety Data Sheets – basically same as existing EU system • Downstream legislation – Seveso Directive, Waste

  6. GHS & Substance Classifications • GHS Aim; One Substance, One Global Classification • GHS Intended to be a Self-Classification System • No Global Inventory of Substance Classifications • Therefore no Forum for agreeing Classifications • GHS Annex VI/C&L Inventory could become a de facto Global Inventory

  7. Workability of Implementing REACH/GHS • GHS Implementation restricted to equivalent to current EU system • Avoid duplication of work • REACH Registration should begin with GHS classification • Phased Implementation of GHS is proposed • Classify substances first – 3 years is being proposed • Classify mixtures after – further 4½ years is being proposed • De minimis levels for REACH Title XI are required • Downstream legislation needs to be addressed in the interim • * Resource will be an issue if EC wants REACH and GHS together

  8. 6.2 Chemical Categories

  9. Chemical Categories • The properties of a compound are likely to be similar or follow a regular pattern as a result of structural similarity • Exploit structure-activity relations • - for either structural alerts or non-alerts • - use information for waiving of studies

  10. SAR/Read-across Interpolation Extrapolation SAR/Read-across Interpolation Extrapolation ●Existing data point ○Missing data point Chemical 1 Chemical 2 Chemical 3 Chemical 4 Structure xxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxxxxx Property 1 ● ○ ● ○ Property 2 ● ○ ○ ● Property 3 ○ ● ● ○ Activity 1 ● ○ ● ○ Activity 2 ● ○ ○ ● Activity 3 ○ ● ● ○ Chemical Categories

  11. Chemical Categories • Advantages • - identifying data gaps and structural alerts • - filling data needs • > by read-across, trend analysis, (Q)SAR,… • > interpolation or extrapolation to other chemicals, reducing need to test for every endpoint for every chemical • - better consideration of the biological plausibility of grouping the chemicals within a category

  12. Chemical Categories • Limitations • - Problems to identify/define category • > Endpoint-related subcategories may emerge • > You need sufficient evidence for a common mode of action • - Any hypothesis needs to be debated and needs to • be open to experimental validation

  13. Chemical Categories • C&L • > Some members of the category meet the criteria for one hazard classification for the particular endpoint, whereas other members of the category meet the criteria for another.

  14. 6.3 REACH Interface

  15. European Commission view on the GHS • Explanatory memorandum to the amendment to • Directive 67/548/EC, 29-10-2003; 2003/0257(COD): • “it is the intention of the Commission to propose the introduction of the internationally agreed GHS into Community law as soon as possible” • “the Commission will come forward with the necessary proposals for having it adopted at the same time as the final adoption of the REACH legislation” European Commission will coordinate activities across services i.e. Supply and Transport European Commission GHS web site http://europa.eu.int/comm/enterprise/reach/ghs_en.htm

  16. REACH and the GHS – Scope comparison REACHGHS R,E,A,Ch Classification, Labelling, SDS Risk Hazard Substances Produced Substances/Mixtures Hazardous and Non-Hazardous Hazardous > 1 Tonne per Manufacturer Any volumes Harmonised Classifications Self Classification CMRs at EU Level Other Endpoints - Industry European Union Global Supply Supply and Transport

  17. REACH Classification Provisions REACH Classification Related Objectives Classification & Labelling Inventory Title XI, Articles 112-116 Harmonised Substance Classifications Title XI, Article 115 REACH Classification Related Provisions Pre-Registration Title III, Article 28 Classification not required Registration Title II, Article 10 Classification required Classification & Labelling Inventory Title XI, Articles 114 Classification of Marketed Substances notified for Inventory

  18. European Commission GHS Draft Proposal • Interface with REACH • SDS to remain in REACH • Title XI of REACH will move to the GHS Regulation • Harmonised Substance Classifications will go into Annex VI of GHS • Transitional period for substances 3 years, but this expires 30/11/2010 (REACH Tier 1 Registration deadline) • Transitional period for mixtures 4½ years starting 1/12/2010 • Estimated 30,000 Marketed substances subject to REACH to enter into the Inventory + • Other substances to enter into the Inventory

  19. EU implementation of the GHS - Timing REACH Timing Provisions REACH Entry Into Force Date is 1/06/2007

  20. 6.4 Implementation Mixtures & SMEs

  21. Mixtures Issues EU Chemical Industry Structure (2004) • NOTE: - 1 The above figures exclude Pharmaceuticals • 2 Only 6317 SMEs (24%) produce substances • 96% of Enterprises are SMEs • > 75% of SMEs are formulators only • > 55% of SMEs are not members of a Trade Association

  22. Impact on Mixtures of GHS Implementation • Mixtures are not just Mixtures of Substances • Most mixtures contain Intermediate Mixtures • Mixtures can contain multiple layers of Intermediate Mixtures • Substances may be common to Final Mixture & Intermediates • Example; Paint • (i) Paint can contain Colour Dispersion, Resin, Solvent (Driers) • (ii) Colour Dispersion can contain Resin, Solvent • (iii) Resin can contain Solvent, Driers • (iv) Driers can contain Solvent and Substances • In many cases substances in intermediates are speciality chemicals • Speciality chemicals may not be manufactured on a regular basis • It could take a long time for a change in classification of a substance at the lowest level to feed through to the final mixture

  23. Substance A (Solvent) Manufacturer (a) > 1000 t/a Importer (b) > 1 t/a Importer (c) > 0.1 t/a Substance P (Co Comp.) Manufacturer (a) > 100 t/a Manufacturer (g) > 1 t/a Importer (k) > 0.1 t/a Drier Substance A F S P Resin Drier Substances A C M X Resin Substances P Q U X Z Colour dispersion Resin Substances B P K L N M O Y Paint Colour Dispersion Resin Substances A B C D SUBSTANCE composition of Paint A, C, D, P, N, O, S, manufacturer (a) manufacturer (g) Importer (b) Importer (c) Importer (k) Some substances are considered to be below cut-off concentration due to dilution in the manufacturing process

  24. Impact on Mixtures Importance of knowing Substance Chemical Identities Using the previous Paint Example Drier contains 0.1% of a substance classified as a CMR Cat.2 (EU) Therefore Drier classified as a CMR Cat.2 Resin contains > 0.1% Drier (> 0.0001 CMR Substance) Therefore Resin classified as a CMR Cat.2 Colour Disp. contains > 0.1% Resin (> 0.0000001 CMR Substance) Therefore Colour Dispersion classified as a CMR Cat.2 Paint contains > 0.1% Colour Disp. (> 0.0000000001 CMR Sub.) Therefore Paint classified as a CMR Cat.2

  25. Mixtures Classification GHS 1.3.2.3 Hierarchy of data for mixtures classification (a) Where test data are available for the complete mixture, the classification of the mixture will always be based on that data; (b) Where test data are not available for the mixture itself, then bridging principles included and explained in each specific chapter should be considered to see whether they permit classification of the mixture; In addition, for the health and environmental classes, (c) If (i) test data are not available for the mixture itself, and (ii) the available information is not sufficient to allow application of the above mentioned bridging principles, then the agreed method(s) described in each chapter for estimating the hazards based on the information known will be applied to classify the mixture.

  26. 6.5 International Inventories

  27. Inventories and EU GHS Implementation Inventories EU REACH/GHS proposals will establish an Inventory UN RTDG Chapter 3.2 is an Inventory of Substance classifications Japan has Inventory of 1423 GHS Substance classifications New Zealand has Inventory of 5655 GHS Substance classifications Transport Regulatory Structure United Nations UN Recommendations on the Transport of Dangerous Goods International Conventions (Global & between EU Countries) Sea Transport IMDG Code (Binding Convention) Air Transport ICAO T.I. Rail Transport RID (not global but wider than EU) Road Transport ADR (not global but wider than EU)

  28. Inventories and EU GHS Implementation Classification and Labelling Comparison Supply v Transport 994 Substances Common to TDG & EU Inventories 340 Substances have differing classifications

  29. Inventories and EU GHS Implementation Classification and Labelling Comparison - EU Supply v Transport Phenol UN1671 (Solid), UN2312 (Molten), Division 6.1 Packing Group II 604-001-00-2; R68, R23/24/25, R34, R48/20/21/22 Supply Transport 4,4’-Diaminodiphenylmethane (MDA) UN2651, Division 6.1 Packing Group II 612-051-00-1; R45, R68, R39/23/24/25, R43, R48/20/21/22, R51/53 Supply Transport

  30. GHS & Substance Classifications CMR Substances GHS v EU Categories Comparison EU Category 1 = GHS Category 1A EU Category 2 = GHS Category 1B EU Category 3 = GHS Category 2

  31. GHS & Substance Classifications Example GHS Classification; Phenol EndpointEU Classif.Japan Classif.N.Z. Classif.TDG Classif. Carcinogen (No) (No) (No) Not Applicable Mutagenicity Cat.2 Cat.1BCat.1B Not Applicable Reprotox. (No) Cat.1BCat.2 Not Applicable Corrosive Cat.1 Cat.1 Cat.1 (No) Toxicity Acute Oral Cat.3 Cat.3 or 4 ? Cat.2 ?Cat.2 (Route?) Acute Dermal Cat.3 Cat.3 or 4 ? Cat.2 ?Cat.2 (Route?) Acute Inhal. Cat.3 Cat.3 or 4 ? Cat.2 ? (No) Target Organ Cat.2 Cat.2 ? Cat.1 Not Applicable Environment Water (No) ?? Cat.3 ?? Soil Not Applicable ?? Cat.4 Not Applicable Invertebrates Not Applicable ?? Cat.2 Not Applicable

  32. Concentration Limits Hydrogen Peroxide EU Directive 67/548/EEC Annex I Index Number 008-003-00-9 Classification R5, R8, R20/22, R35 Concentration Limits C > 70% R20/22, R35 50% < C < 70% R20/22, R34 UN RTDG Chapter 3.2 UN2015 C > 60% Class 5.1, Class 8, PGI UN2014 20% < C < 60% Class 5.1, Class 8, PGII

  33. 6.6 Implementation CAS Numbers

  34. Inventories and EU GHS Implementation • CAS Number Issues • The use of CAS Numbers in 2 Inventories/Databases • EU Dangerous substances Directive (DSD) Annex I • A North American web-site database • PHOSPHORUS • Red Phosphorus in North American web-site CAS 29879-37-6 • Red Phosphorus in EU 67/548/EEC Annex I CAS 7723-14-0 • White Phosphorus in North American web-site CAS 7723-14-0 • White Phosphorus in EU 67/548/EEC Annex I CAS 12185-10-3 • TDI (Toluene diisocyanate) • 2,6-TDI in the North American website CAS 91-08-7 • 2,6-TDI in EU 67/548/EEC Annex I CAS 584-84-9 • 2,4-TDI in the North American website CAS 584-84-9 • 2,4-TDI in EU 67/548/EEC Annex I CAS 91-08-7

  35. Challenges • Awareness creation • SMEs – how to reach them and train them • Preparing in companies for the changes the GHS will bring • Implementing REACH and GHS at the same time is a complex operation with significant implications • Resource will be a limiting factor for implementing REACH and GHS at the same time • Training for all involved in using or applying the GHS • GHS Guidance – RIP 3.6 • Timing between jurisdictions is an issue – Catch 22 situation • Other Issues • Packaging • - Transport has a packaging testing and certification regime • - National/Regional supply legislation packaging provisions • Timing of the introduction and updating of the GHS • Downstream Legislation

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