GHS Implementation Update Presented by Paula Laux Senior Regulatory Specialist Wercs Professional Services

Presentation Format Short GHS Review Update status of rulemaking in major countries Short Demo Questions

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

What is GHS? Globally Harmonized System of Classification and Labeling Defines health, physical and environmental hazards Establishes a 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

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

Important Implementation Points GHS: Voluntary international document-not binding treaty Only when countries adopt GHS into their systems, will there be binding regulatory changes for industry No international implementation schedule Different systems/sectors require different time frames for GHS implementation

Asia-Pacific-Australia GHS MSDS format effective April 2006 GHS classification proposal encompassed 4 standards and code of practices, but addressed only workplace Intend to address a revised GHS hazardous substances list Intent to consolidate the requirements for workplace hazardous and dangerous goods in a single framework

Asia-Pacific-Australia Intent to use the GHS as a classification tool for substances within the scope of the proposed framework March 2007 ended public consultation period issued Issued “Summary of public submission” Comparison EU to Australian draft proposals

Asia-Pacific-Australia Proposed implementation in 2008 per UN- Declaration of new GHS-based framework for the control of workplace hazardous chemicals Transitional periods for implementation Substances –date of entry until 2012 Mixtures- date of entry until 2015

Asia- China AQSIQ (General Admin. Of Quality Supervision, Inspection and Quarantine) is taking lead. AQSIQ finalized 25/26 Standard (same hazards as GHS) Germ cell Mutagenicity is outstanding Technically went into force on Jan. 1, 2008 for materials in production Technically will be in force for materials in distribution Dec. 31, 2008.

Asia- China Standards used GHS First Edition (2003) for test methods and GHS classification Standards also compile precautionary statements and selectively adopted them Biggest differences between GHS (2005) Chinese standards Chinese GHS standard groups “unstable explosives” with Division 1.1. Chinese GHS standards do not include Aspiration Hazard No Chinese standard to incorporation MSDS preparation…(GB )

Asia- Japan Publication of National Standards JIS Z7251:2006 (Labelling of chemicals based on GHS) Entry into force of the amended Industrial Safety and Health Laws (ISHL) -December 2006 Implementation only for product containing > 1% of 99 selected ISHL-regulated chemicals

Asia- Japan All classification for substances under the ISHL released on the National Institute of Technology and Evaluation (NITE) website Government classification are NOT mandatory Expansion to included all ISHL regulated chemicals at varying concentrations (December 2008) Provide and On-line tool for the classification mixtures (2008) English??

Asia- Korea GHS classification and labelling project for 2500 regulated substances Ministry of Labor issued Standards for the Classification and Preparation of Labeling, and SDSs (January 10, 2008 (MoL Public No ) For Korean EPA (Toxic Chemicals Control Law) – Application will be in stages -July 2008 for newly examined products. Single existing chemical July, 2010 Mixtures: July, 2015

Asia- Korea Major differents between UN and Korean MoL Flammable gases –Only Recognizes Category 1 Flammable Liquids- No Category 4 Acute Toxicity- No Category 5 Skin Corrosion- No Category 3 Serious Eye Damage/Eye Irritation – No Category 2B Aquatic Toxicity- No Category 2 or 3 Major difference between Korean MoL and Draft Korean EPA regulations Flammable Gases- Same as UN Recognizes Category 2 Serious Eye Damage/Eye Irritation- All are Category 2

Asia- Korea 2008-Launching of the government official GHS-dedicated website (English?) 2008 Launching of a GHS classification and labelling project for mixtures

Asia-Pacific-New Zeland Implemented GHS through the Hazardous Substances and New Organisms Act (HSNO) and its related regulation. For something to be nonhazardous, it must be in the lowest boundary of the least hazardous GHS category for each class. Code of practices issued in 2006 Preparation of Safety Data Sheets (HSNOCOP 8-1) Consistent with Annex 4 of GHS. HSNO Chemical Classification Information Database (CCID)-5500 chemicals classified according to GHS

Asia-Pacific-New Zeland In force since July 2001 for new hazardous substances For existing substances, transitional period of five years (ended July 2006) Applicable to all (new and existing) substance since July 2006) Labeling being handled separately in order to align with major trading partner (2010)

Canada Taking a Tripartite Approach Implementation plans are based on the first revised edition of the GHS (GHS- Rev.1, 2005 Health Canada charged with lead

Canada Completed Situational Analysis (2003) Multi-stakeholder technical consultations(Pest control, workplace chemical, consumer products) ( ) “Comparison of Sector Interim Recommendations or Preferred Options” (2006) Technical consultations and further development of final recommendations (2007)

Canada Economic analysis expected in mid-2008(?) Target implementation 2009

EU June 1, 2007 REACH enter into force June 27, 2007 Adoption of proposal for GHS regulation (Amends Directive 67/548//EEC and Regulation (EC) No 1907/2006) October 2007 Adoption of proposals implementing the GHS for seven pieces of EU downstream legislation (COM (2007) 611 final; COM (2007) 613 final

EU GHS is primarily a self-classification system for enterprise Use general principles of GHS- Building block approach + adaptations to meet EU needs (ozone depletion.) Scope of regulation includes Biocides just like current system. Takes over the current Annex I of Council Directive 67/568/EEC Takes over the Title XI (Classification and Labelling inventory from REACH Regulation)

EU Consistent with transport Gases under pressure Self-reactive substances and mixture (Types C to G) Self-heating substances and mixtures Oxidizing liquids (Category 3) Oxidizing solids (Category 3) Corrosive to metals Removes hazard categories Flammable liquids (Category 4) Acute Toxicity (Category 5) Skin Corrosion/Irritation (Category 3) Aspiration hazard (category 2) Acute Aquatic toxicity (Categories 2 and 3 )

EU Transitional period is defined which leaves both current legislation and new Regulation in force Entry into force for substance reclassification Nov 30, 2010 Entry into force for mixture reclassification May 31, 2015 Current Directives on classification, labelling and packaging (Council Directive 67/48/EEC and Directive 1999/45/EC) repealed on June 1, 2015

US Last year- “Final Rule anticipated at the end of 2008” Multi-agency discussion underway with OSHA taking lead. DOT/IMDG/ICAO have adopted GHS class 3 and 6 criteria for transport and plan to adopt GHS class 9 for aquatic toxicity in 2009

US OSHA has a detailed comparison of the provision of the GHS to the OSHA Hazard Communication Standard Published a guide to GHS Published advance notice of proposed rulemaking (ANPR) – September 12, 2006 Notice of proposed rule-making based on the comments received Economic analysis has been drafted Proposed rule is under draft for public comment

US EPA updated it’s website and has documents available Materials/Presentations from October 2006 Public Meeting on GHS White Paper: GHS Implementation Planning Issues (PDF) White Paper: GHS Implementation Planning Issues (PDF) (17pp, 88K, about PDF)about PDF Comparison of Current EPA Requirements and the GHS (PDF) Comparison of Current EPA Requirements and the GHS (PDF) (22 pp, 157K, about PDF)about PDF Sample GHS Labels (PDF)Sample GHS Labels (PDF) (1 p, 155K, about PDF)about PDF Benefits of GHS: PowerPoint

US CPSC is just beginning to investigate GHS for consumer product. US implementation will be staggered across all 4 agencies ranging from now until No detailed implementation plan has been developed

Summary Difficult to follow because all countries have different processes for making laws Very clear that countries are implementing using parts and pieces of the building blocks Many countries, don’t have agreement between separate regulatory bodies within the same country Most concise source of information:

WERCS GHS Demo