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Global Chemical Management: GHS, Registration and Evaluation

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As the Globally Harmonized System for Classification and Labeling (GHS) expands internationally, there continues to be major differences between countries in the way that GHS is being implemented. The primary focus of this presentation is the status of GHS implementation, chemical inventories and new chemical notification requirements.

This webinar explores:
• A quick overview of the types of chemical substances that might be excluded from notifications
• Potential exemptions from full notification requirements
• Testing requirements for various government agencies

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Global Chemical Management: GHS, Registration and Evaluation

  1. 1. Presented By: Brussels · Washington, DC · Tokyo · www.enhesa.com GLOBAL CHEMICAL MANAGEMENT GHS, REGISTRATION AND EVALUATION ©2016 Enhesa. All rights reserved. CONFIDENTIALITY STATEMENT This document is confidential. All rights reserved. No part of this presentation may be reproduced or transmitted in any form or by any means, electronic or mechanical, without permission in writing from Enhesa.
  2. 2. Presented By: Brussels · Washington, DC · Tokyo · www.enhesa.com GLOBAL CHEMICAL MANAGEMENT GHS, REGISTRATION AND EVALUATION Jillian Bernstein, Senior Audit and EHS Regulatory Consultant, Enhesa Riaz Zaman, Senior EHS Regulatory Consultant, Enhesa ©2016 Enhesa. All rights reserved.
  3. 3. COMPLIANCE IS OUR BUSINESS. Enhesa is the Market Leader in Global Environmental, Health and Safety Assurance Providing Support to Businesses Worldwide. GLOBAL COVERAGE. EXPERT ANALYSIS. ©2016 Enhesa. All rights reserved.
  4. 4. 4 Enhesa Webinar Series An Overview Held on a bi-monthly basis Download webinars on Enhesa’s website. Our library of past webinars include: • Slide decks • Recordings Share your feedback on the post-webinar survey! Complimentary webinars on topics covering: • Environmental, health & safety • Product stewardship • EHS auditing Not on our mailing list? Send an email to: webinars@enhesa.com to have your name added to our distribution list. Do you have topic suggestions for our future webinars? • Note them on the post-webinar survey • Email us ©2016 Enhesa. All rights reserved.
  5. 5. 5 Practical Details Today’s Moderator Muting And Sound Quality Question And Answer • Tjeerd Hendel-Blackford Business Development Manager EMEA at Enhesa • Due to the number of participants, we have muted everyone to ensure good sound quality. • If you experience sound quality problems, please make sure you are using a wired connection with adequate bandwidth. If the problem continues, please call into the teleconference. • Please submit your questions to the presenters using the question box. • We will try and answer as many questions as possible at the end of the presentation. ©2016 Enhesa. All rights reserved.
  6. 6. 6 Today’s Presenters Jillian Bernstein Senior Audit and EHS Regulatory Consultant Enhesa Riaz Zaman Senior EHS Regulatory Consultant Enhesa ©2016 Enhesa. All rights reserved.
  7. 7. 7 Today’s Webinar: Global Chemical Management Today We Will Cover: ©2016 Enhesa. All rights reserved. Q & A U.S. TSCA Reform SAICM Regional Cooperation in Asia Evaluation & Registration Requirements in Asia GHS Implementation Worldwide Components of GHS GHS Basics
  8. 8. 8 And The Results Are In… Chemical classification Chemical labeling SDS Notification requirements Testing requirements Other (please specify) What Part Of Chemical Management Are You Most Concerned With? ©2016 Enhesa. All rights reserved.
  9. 9. Global Management System Changes Extended SDS for Mixtures Change between GHS and NFPA Implementation of GHS Requirements Compliance with Regulation Social Risks GHS labelling GHS Chemical Disposal Employee Culture and Engagement Risk Assessment Climate Change Zero Waste to LandfillManagement System TSCA Reform ISO 45001 Certification EHS Standards in third world countries Updating Old MSDS Reduce Carbon Footprint And the Results Are In… When Asked What The Biggest EHS Issues Or Challenges Your Company Will Face In 2016, You Said: ©2016 Enhesa. All rights reserved.
  10. 10. GHS Around The Globe: Flexibility In Implementation Presented By: Jillian Bernstein, Senior Audit and EHS Regulatory Consultant, Enhesa ©2016 Enhesa. All rights reserved.
  11. 11. GHS Basics 1) Why Is It Necessary? 2) How It Came About 3) What It Does 11©2016 Enhesa. All rights reserved.
  12. 12. 12 Why Is It Necessary? Production and use of chemicals is essential to the economy Provide consistency across jurisdictions ©2016 Enhesa. All rights reserved.
  13. 13. 13 Why Is It Necessary? Source: www.discoverysafety.com Canadian Pictograms ©2016 Enhesa. All rights reserved.
  14. 14. 14 Why Is It Necessary? EU Pictograms Source :www.basichealthandsafetytraining.co.uk ©2016 Enhesa. All rights reserved.
  15. 15. 15 How It Came About 1992 Earth Summit Four regimes influenced harmonized system United Nations transport recommendations European Union dangerous substance & preparations directive U.S. requirements for workplace, consumer & pesticides Canadian requirements for workplace, consumers & pesticides ©2016 Enhesa. All rights reserved.
  16. 16. 16 What It Does • Defines Hazards of chemicals • Creates A classification process • Communicates Hazard information ©2016 Enhesa. All rights reserved.
  17. 17. Components of GHS 17 1) Hazard Classification 2) Label Requirements 3) Safety Data Sheets ©2016 Enhesa. All rights reserved.
  18. 18. 18 Hazard Classification: Three Types Environmental Health Physical ©2016 Enhesa. All rights reserved.
  19. 19. 19 Hazard Classification: Physical Hazards Examples: • Explosives • Gases under pressure • Flammable solids • Self-reactive substances ©2016 Enhesa. All rights reserved.
  20. 20. 20 Hazard Classification: Health Hazards • Skin corrosion/irritation • Serious eye damage/irritation • Respiratory or skin sensitization • Germ cell mutagenicity • Carcinogenicity • Reproductive toxicology ©2016 Enhesa. All rights reserved.
  21. 21. 21 Hazard Classification: Environmental Hazards Hazardous to the aquatic environment ©2016 Enhesa. All rights reserved.
  22. 22. 22 Hazard Communication Labels Safety Data Sheets ©2016 Enhesa. All rights reserved.
  23. 23. 23 Hazard Communication: Labels Labels must include:  Symbols (hazard pictograms)  Signal words  Hazard statements  Precautionary statements  Product identifier  Supplier identification  Any necessary supplemental information ©2016 Enhesa. All rights reserved.
  24. 24. 24 Hazard Communication: Safety Data Sheets (SDS) Identification of: • Substance or mixture • Supplier • Hazards Composition / Info on ingredients Exposure controls / Personal protection Measures for: • First aid • Firefighting • Accidental release Physical & chemical properties Stability & reactivity Handling & storage Disposal considerations Information on: • Toxicology • Ecology • Transport • Regulations & Other ©2016 Enhesa. All rights reserved.
  25. 25. 25 EU: Extended SDS To Include Exposure Scenarios Exposure scenarios include: • Uses including known uses of by downstream companies • Technical function of the substance • Threshold values of exposure levels • Physicochemical data • Conditions of safe use (based on one or more exposure scenarios) ©2016 Enhesa. All rights reserved.
  26. 26. 26 Extended SDS In The EU If your conditions of use are not covered, you have several options: • Ask your supplier to include your uses in his chemical safety report. • Adapt your activity to the conditions of use described in the exposure scenarios. • Look for another supplier who provides an exposure scenario covering your use or one who is ready to do so. • Carry out your own chemical safety assessment and prepare your own chemical safety report for your uses and conditions of safe use.
  27. 27. GHS Implementation 27 1) United States 2) Canada 3) Mexico 4) European Union 5) China ©2016 Enhesa. All rights reserved.
  28. 28. 28 Revisions Implemented China 4th Revision U.S. 3rd Revision Canada 5th Revision Mexico 5th Revision EU Classification and Labelling 4th Revision EU SDS 5th Revision Differences between revisions: • New hazard classes & sub-categories • New samples for labelling • New provisions for the allocation of hazard statements • Further rationalization & further clarification to avoid differences in their interpretation • New test methods ©2016 Enhesa. All rights reserved.
  29. 29. 29 Classification Differences During Implementation Physical, Health & Environmental Subcategories Classification Inventory Additional Hazard Classes ©2016 Enhesa. All rights reserved.
  30. 30. 30 Hazard Communication Differences During Implementation • Language • Emergency contact number • Concentration Label Requirements
  31. 31. 31 Timeline For Implementation Implementation Lengthy transition By chemical By role Single effective date ©2016 Enhesa. All rights reserved.
  32. 32. 32 Important Upcoming Deadlines 1 June 2016 U.S. employers required to update workplace labelling & HazCom program 31 May 2017 EU deadline for downstream users to communicate to suppliers information on the uses of chemicals under REACH for substances to be registered by 30 May 2018 1 June 2017 Canadian chemical manufacturers & importers must comply with HPR 9 Oct. 2018 All companies must comply with Mexican standard NOM-018-STPS 2015 ©2016 Enhesa. All rights reserved.
  33. 33. 33 Number Of Countries That Adopt Modifications To The U.N. GHS In National Law Regions No Modification Modification Asia 3 (countries) 6 (countries) Middle East 1 North America 2 Pacific 2 South America 5 3 Total 6 13 ©2016 Enhesa. All rights reserved.
  34. 34. 34 Number Of Countries Adopting Each GHS Revision Region No Version Specified Rev. 1 (2005) Rev. 2 (2007) Rev. 3 (2009) Rev. 4 (2011) Rev. 5 (2013) Rev. 6 (2015) Asia 3 1 2 3 CIS 1 Europe 2 31 International 1 Middle East 1 North America 1 1 Pacific 1 1 South America 1 1 1 1 2 2 Grand Total 5 2 1 7 36 3 3 ©2016 Enhesa. All rights reserved.
  35. 35. 35 In Other Words… • Complex system • Flexibility in implementing GHS • Different revisions • Different classifications • Different implementation deadlines ©2016 Enhesa. All rights reserved.
  36. 36. Exploring Chemicals Management & Hazard Communication: Chemical Evaluation Requirements & Restrictions Presented By: Riaz Zaman, Senior EHS Regulatory Consultant, Enhesa ©2016 Enhesa. All rights reserved.
  37. 37. 37 Next, We’ll Be Discussing… Q & A U.S. TSCA Reform SAICM Regional Cooperation in Asia Evaluation & Registration Requirements in Asia ©2016 Enhesa. All rights reserved.
  38. 38. 38 Overview: Japan Law Regulated Hazards Chemical substances control law Biodegradability, long-term toxicity & bioaccumulation Poisonous deleterious substances control act Acute toxicity to human health (Not GHS criteria) Fire services act Physical hazards (Not GHS criteria) Industrial safety and health act Health and physical hazards ©2016 Enhesa. All rights reserved.
  39. 39. 39 What Is A New Chemical in Japan? 1. Chemical Substances Control Law (Existing and notified chemicals – METI’s List) • Existing chemicals (about 20,600 as of 1973) • Notified chemicals (about 6,800 since 1973) • Class I and Class II designated substances (about 40) • Priority assessment chemical substances (about.164) • Monitoring chemical substances (about 40) 2. Industrial Safety And Health Act (ISHL List) ©2016 Enhesa. All rights reserved.
  40. 40. 40 New Chemicals Registration Process: Japan Chemical substances control law Notification / Biogradation tests Class 1 Priority assessment Class 2 ©2016 Enhesa. All rights reserved.
  41. 41. 41 What Is A New Chemical In China? Existing chemical substances: 45,612 chemicals in the Inventory of Existing Chemical Substances (2013 version) •Regular new chemical substance •Hazardous new chemical substance •Hazardous new chemical substances of key environmental concern Measures On Management Of New Chemical Substances (2010) ©2016 Enhesa. All rights reserved.
  42. 42. 42 Notifications: China Notification types • Regular notification: ≥ 1 tonne per year • Simplified notification: < 1 tonne per year • Scientific notification: R&D + < 100 kilograms per year Who can submit the notification? • Native companies • Non-Chinese companies through an “only representative” ©2016 Enhesa. All rights reserved.
  43. 43. 43 Three Aspects Of Chemicals Management In: South Korea South Korea: K-REACH went into effect on 1 January 2015. 1) Reporting of manufacture, import and sale 2) Existing chemicals 3) Registration of chemicals ©2016 Enhesa. All rights reserved.
  44. 44. 44 Three Aspects Of Chemicals Management In: South Korea South Korea: K-REACH went into effect on 1 January 2015. 1) Reporting of manufacture, import and sale • New chemicals • ≥1 tonne/year of existing chemicals ©2016 Enhesa. All rights reserved.
  45. 45. 45 Three Aspects Of Chemicals Management In: South Korea South Korea: K-REACH went into effect on 1 January 2015. 2) Existing chemicals • Industrial chemicals in circulation before 2 Feb. 1991 and published by the ministry of environment, the ministry of employment and labor as such; and • Chemicals assessed on or after 2 Feb. 1991 published by MOE • Can be searched on the chemicals information system ©2016 Enhesa. All rights reserved.
  46. 46. 46 South Korea: K-REACH went into effect on 1 January 2015. 3) Registration of chemicals • Manufacture or import of new chemicals • Manufacture or import of ≥1 tonne/year of existing chemicals subject to registration • Transition period for existing chemicals subject to registration Three Aspects Of Chemicals Management In: South Korea ©2016 Enhesa. All rights reserved.
  47. 47. 47 Data Submission For Risk Assessment >100 Decrease in tonnes per year 2015 2017 2018 2019 2020 >70 >50 >20 >10 ©2016 Enhesa. All rights reserved.
  48. 48. 48 REACH-Like Laws In Asia Pacific ©2016 Enhesa. All rights reserved. Country Major Laws Scope of Notification / Registration requirements Size of Chemical Inventories Last Amended EU Regulation EC/1907/2006 (REACH) “Phase-in” & “non phase-in” industrial chemicals > 44,000 2014 Japan Chemical Substances Control Law (CSCL) “Japanese REACH” Industrial chemicals with long-term toxicity > 28,000 2009 China Measures on the Environmental Management of new Chemical Substances “China REACH” New chemical substances > 45,000 2015 South Korea Act on the Registration and Evaluation of Chemicals “K- REACH” New & existing industrial chemicals > 43,000 540 (Designated existing) 2013 Taiwan Amendments to the Toxic Chemical Substances Control Act New & existing chemical substances 90,000 (Existing) 2014
  49. 49. 49 Harmonization At The ASEAN Level • Asian sustainable chemical safety plan • ASEAN chemical safety database • Memoranda of cooperation • Japan international cooperation agency ©2016 Enhesa. All rights reserved.
  50. 50. 50 ASEAN-Japan Chemical Safety Database http://www.ajcsd.org/top ©2016 Enhesa. All rights reserved.
  51. 51. 51 ASEAN-Japan Chemical Safety Database ©2016 Enhesa. All rights reserved.
  52. 52. Precautions Related To Chemicals Management In Asia 52 Multiple entries for one substance Multiple registration requirements Varying testing requirements Testing by nationally- certified labs Language barriers ©2016 Enhesa. All rights reserved.
  53. 53. 53 Strategic Approach To International Chemicals Management • Risk reduction • Knowledge & information • Governance • Capacity-building & technical cooperation • Illegal international traffic ©2016 Enhesa. All rights reserved.
  54. 54. 54 SAICM And Products Regulation • Colombia’s national chemical profile and lifecycle analysist - Paints - Varnishes - Pesticides • Thailand’s nanotechnology policy - Textiles - Food - Agricultural products - Cosmetics - Health care products
  55. 55. 55 TSCA Reform ©2016 Enhesa. All rights reserved. New proposed safety standard: “No unreasonable risk to health or the environment will result from exposure to a chemical substance under the conditions of use” . . . without taking into consideration costs or other non-risk factors. Consideration must be given to effects on: • The general population • Any potentially exposed or susceptible population that the administrator has identified as relevant to the safety assessment and safety determination for that chemical substance.
  56. 56. 56 TSCA Reform: Confidentiality Confidential • Expires after 10 years • Manufacturing / process information • Marketing and sales • Suppliers / customers • Use, function & application • Production & import volumes • Aggregated volumes Not Protected • Health & safety information • Identity of chemicals after the act • Safety assessments & determinations • Manufacturing volumes & aggregated volumes ©2016 Enhesa. All rights reserved.
  57. 57. 57 Enhesa’s GHS Tracking Service
  58. 58. 58©2016 Enhesa. All rights reserved.
  59. 59. BELGIUM 15 rue du Mail 1050 Brussels, Belgium Tel: +32 2.775.97.97 Fax: +32 2.775.97.99 UNITED STATES 1911 North Fort Myer Drive | Suite 1150 Arlington, VA 22209, USA Tel: +1.202.552.1090 Fax: +1.202.747.2874 JAPAN 4F&5F Yaesu Dori Bldg. 3-4-15 Nihonbashi Cho-Ku, Tokyo 103-0027 Japan Tel: +81.(0)3.6870.3527 Fax: +81.(0)3.4330.6144 Brussels · Washington, DC · Tokyo · www.enhesa.com Jillian Bernstein Senior Audit and EHS Regulatory Consultant, Enhesa Riaz Zaman Senior EHS Regulatory Consultant, Enhesa Thank You For Attending ©2016 Enhesa. All rights reserved.

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