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

Global Status of GHSPresented by Paula Laux

Senior Regulatory SpecialistWercs Professional Services

*Summary of Slide Provide by Michelle Sullivan

Why was GHS developed?

So that a system exists where hazards are identically communicated to all those exposed



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


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


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.


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


Japan Implementation GHS labeling of ISHL (Industrial Safety and Health Law) 1-Dec-

2006

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)


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


Other Asia-Pacific CountriesNew 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)


Other Asia-Pacific CountriesAustralia

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 SDSNo intent to use GHS mixtures ruleWant to address a revised GHS hazardous substances

list

Intent to make draft for labeling of Workplace Chemicals and Preparation of SDSs as well


USA ImplementationDOT

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


USA ImplementationOSHA 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


USA ImplementationOther 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

www.unece.org/trans/danger/publi/ghs/implementation_e.html


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

GHS Hazard OSHA EPA DOT EU WHMIS Canada

PCP Canada

CCCR Canada

Australia

Skin Corrosion: Cat 1A, 1B, 1C

Cat 1A, 1B, 1C

Cat 1A, 1B, 1C

Cat 1A, 1B, 1C

Cat 1A, 1B, 1C

Cat 1 Cat. 1 Cat 1A, 1B, 1C Cat 1A, 1B, 1C

Skin Irritation: Cat 2, Cat 3

Cat 2, Cat 3

Cat 2, Cat 3

Cat 2 Cat 2, Cat 3 Cat 2, 3 Cat 2, Cat 3 pending

Cat 2, Cat 3 (only if EU excepts Cat 3)

Serious eye damage/Irritations: Cat 1, 2A, 2B

Cat 1, 2A, 2B

Cat 1, 2A, 2B

Cat 1, 2A,

Cat 1, 2A, 2B Cat 1, 2A, 2B

Cat 1, 2A, 2B Cat 1, 2A, 2B

Skin Sensitization: Cat 1

Cat 1 Cat 1 Cat 1 Cat 1 Cat 1 Pending Cat 1

Respiratory Sensitization: Cat 1

Cat 1 No Cat 1 Cat 1 Under discussion

Pending Cat 1

Germ Cell Mutagenicity: Cat 1A, 1B, 2

Cat 1A, 1B, 2

Does NOT require hazard labeling

Cat 1A, 1B, 2

Cat 1, 2 Cat 1A, 1B, 2 (only adopting for SDS purposes; risked based labeling)

Pending Cat 1A, 1B, 2

Cacinogencity: Cat 1A, 1B, 2

Cat 1A, 1B, 2

Does NOT require hazard

Cat 1A, 1B, 2

Cat 1, 2 Cat 1A, 1B, 2 (only adopting for SDS



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

GHS Hazard OSHA EPA DOT EU WHMIS

Canada PCP

Canada CCCR Canada

Australia

Reproductive Toxicity-Effects on lactation: Cat 1

Cat 1 Does NOT require hazard labeling

Cat 1 Cat 1 Cat 1 (only adopting for SDS purposes; risked based labeling)

Pending Cat 1

Reproductive Toxicity: Cat 1A, 1B, 2

Cat 1A, 1B, 2

Does NOT require hazard labeling

Cat 1A, 1B, 2

Cat 1, 2 Cat 1A, 1B, 2 (only adopting for SDS purposes; risked based labeling)


Specific target organ-Single Cat 1, 2, 3

Cat 1, 2, 3

Methanol, Others?

Cat 1, 2, 3

Cat 1, 2, 3 Cat 1, 2 (only adopting for SDS purposes; risked based labeling); Cat 3 (under discussion)

Cat, Cat 2/3 Pending

Cat 1, 2, 3

Aspiration Toxicity: Cat 1,2

Cat 1,2 ? Cat 1 Under discussion

Under discussion

Cat 1,2 Pending Cat 1,2



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 GHSContact Information:

Paula LauxSenior Regulatory SpecialistWercs Professional Services

518 [email protected]

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