Global Status of GHS Presented by Paula Laux Senior Regulatory Specialist Wercs Professional Services

Why was GHS developed? So that a system exists where hazards are identically communicated to all those exposed

Why was GHS developed?  Today same product requires multiple MSDSs and labels in international trade  Today there are different classification schemes between Environmental, Industrial, Transportation, and Consumer sector - even in same country  Today the same substance/preparation requires different warnings based on jurisdiction

Who is the target audience?  Governments  Companies  Workers  Emergency Responders  Member of the Public  Consumers

What types of Chemicals are Regulated? Hazardous Chemicals  Substances  Products  Mixtures  Pesticides  Consumers Products

What is GHS? Globally Harmonized System of Classification and Labeling  Defines health, physical and environmental hazards  Establishes classification scheme using available data  Establishes a common hazard communication method  Explains how to apply the system  Supplies building blocks for countries to develop own laws

Published Guidance documents  Published by the United Nation Economic Commission for Europe (UNECE)  First publication in 2003  Revision 1 edition published in 2005  Referred to as “UN Purple Book”

What GHS Isn’t? A regulation or a standard…  Not mandated until it becomes law in a given region  May require various regulatory authorities within region to pass laws

*Summary of Slide Provide by Michelle Sullivan General Implementation Guidelines  GHS: Voluntary international document- not binding treaty  When countries adopt GHS into their systems, there will be binding regulatory changes for industry  No international implementation schedule  Different systems/sectors require different time frames for GHS implementation

*Summary of Slide Provide by Michelle Sullivan Canada Implementation  Looking for harmonization between NAFTA countries  Sectors WHMIS, Consumer Chemical, Pesticide control, and Transportation  Published, “Comparison of Sector Interim Recommendations or Preferred Options” (Feb, 2006)  Next steps: Consultation with trading partners; Economic analysis, Development of final recommendations, Decision making, Draft regulations, Regulatory process, Phasing in implementation  May revisit based on US and Mexican work.

*Summary of Slide Provide by Michelle Sullivan EU Implementation  As per REACH, GHS SDS formats required already June 1, 2007  Sections 2/3 should be inverted  Transition period for GHS implementation 3 years for substances, 7-8 years for mixtures  Will require extended SDS for certain material with varying phase-in period

*Summary of Slide Provide by Michelle Sullivan Japan Implementation  GHS labeling of ISHL (Industrial Safety and Health Law) 1-Dec  GHS labeling technically applies to only 99 of the denoted ISHL materials  GHS classification manual does exist in English  1500 GHS classification of chemicals regulated in Japan  Industrial labeling and SDS system based on GHS  Have approved risk based labeling for consumer products (Not consistent with GHS)

*Summary of Slide Provide by Michelle Sullivan Other Asia-Pacific Countries  Australia, Bahrain, Bangladesh, Brunei Darussalam, China, Cambodia, Fiji, India, Indonesia, Islamic Republic of Iran, Japan, LAO, Malaysia, Maldives, Mongolia, Myanmar, Oman Philippines, QATAR, Republic of Korea, Sri Lanka, Thailand, Vietnam, Yemen  20/23 Countries have plans to implement GHS  Several (New Zealand, Bahrain, & Mauritius) countries have already adopted GHS

*Summary of Slide Provide by Michelle Sullivan Other Asia-Pacific Countries New Zealand  GHS has been adopted in a legislative sense (GHS 2003)  Revisions based on 2005 GHS (rev 1) expected in 2007  Implementation not planned before 2008  List of GHS classified chemicals  Labeling being handled separately in order to align with major trading partner. (2010)

*Summary of Slide Provide by Michelle Sullivan Other Asia-Pacific Countries Australia  GHS MSDS format was effective April 2006  GHS classification proposal- Addresses only workplace  Draft National Standard for the Control of Workplace Hazardous chemicals Transition period: 5 years for SDS No intent to use GHS mixtures rule Want to address a revised GHS hazardous substances list  Intent to make draft for labeling of Workplace Chemicals and Preparation of SDSs as well

*Summary of Slide Provide by Michelle Sullivan USA Implementation DOT  For harmonization of transportation (US DOT) voluntary compliance is now authorized, the provisions become mandatory on 1-Jan-2008  Exception to above for Division 3 and 6.1- old packing groups can be used until 1-Jan-2012  Environmentally hazardous substances will be considered for change in a separate rulemaking proceeding

*Summary of Slide Provide by Michelle Sullivan USA Implementation OSHA  Under a Notice of Proposed Rulemaking (12-Sept-2006) OSHA considered modifying HCS to include: Changing criteria for classifying health & physical hazards Adopting standardized labeling requirements Requiring a standardized order of information for MSDS  Final Rule anticipated at the end of 2008

*Summary of Slide Provide by Michelle Sullivan USA Implementation Other Agencies  EPA/FIFRA: Federal Register 25-Aug-2004 (situational analysis and white paper) Stakeholder meeting 19-Oct-2006  CPSC: Beginning work on situation analysis Current regulation includes consideration of risk, but not environmental endpoints.

Best Source Of Implementation Information

Comparison of various regulations and pieces of GHS classification accepted *Compiled from multiple slides prepared by Michelle Sullivan, Ph.D

Why was GHS developed? So that a system exists where hazards are identically communicated to all those exposed

Other Challenges  Ingredient Disclosure (Purple book leaves it Competent Authority)  Additional Country Specific information that is outside classification  Labeling (especially for Consumer Products that have been historically risk based)

Global Status of GHS Questions/Comments?

Global Status of GHS Contact Information: Paula Laux Senior Regulatory Specialist Wercs Professional Services