International MSDS and Labeling: What Do I Do

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International MSDS and LabelingWhat Do I Do?

• 2003 Management Forum
• April 10 12, 2003
• Dana Point, CA

William H. Starr Manager of Hazard
Communication The Lubrizol Corporation
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Outline

• Regulatory status worldwide
• Universal requirements
• Differences in requirements
• Dilemmas facing global companies
• Options for compliance
• Future direction

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Regulatory status

• Existing MSDS requirements.
• Australia
• Brazil
• Canada
• Chile
• China
• Czech Republic
• European Union

• Hungary
• Japan
• Korea
• Malaysia
• Mexico
• Russia
• United States

Most industrialized countries have MSDS
requirements
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Universal requirements

• Consistencies
• 16 Section MSDS
• Name of the product or hazardous chemical
• Name and address of manufacturer
• Preparation date or revision date
• Emergency telephone number
• Ingredients contributing to the hazards
• Physical and health hazards

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Challenges

• Differences
• Language requirement
• Different hazard evaluation criteria
• Different required hazard classification
• Some require environmental hazards
• Different rules for untested mixtures
• Different regulations covering CBI
• Different exposure limits

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Language requirements

• Generally local language required
• Occasionally two languages required

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Different hazard criteria

• Oral Toxicity (LD50 in mg/kg)

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Different hazard criteria

• Flammable liquids (Flash point, C)

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Different required classification

• Annex I to the EU Dangerous Substance Directive

R 10 Xn R 20/21 Xi R38

Xn
R 10, 20/21, 38
S 25
Xn R 20/21-38
C 20
12,5 C lt 20
Xn R 20/21
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Environmental hazard determination

• European Union
• Acute aquatic toxicity
• Long-term adverse effects
• Dangerous for the ozone layer
• Dangerous for the terrestrial environment

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Different mixture rules

• Annex I to the EU Dangerous Substance Directive

R 10 Xn R 20/21 Xi R38

Xn
R 10, 20/21, 38
S 25
Xn R 20/21-38
C 20
12,5 C lt 20
Xn R 20/21
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Rules for untested mixtures

• European Union Dangerous Preparations Directive

Additivity applies
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Rules for untested mixtures

• Korea

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Main Differences between US and EU
US
EU

• Freestyle description of hazards
• Simple Mixture rule (1 and 0.1 )
• Performance standard on description of hazards
  for all chemicals
• Customer acceptance

• Hazard descriptions must conform to R phrase
• Complex mixture (percentages, calculations and
  additivity)
• Mandatory hazard classification of Annex 1 listed
  chemicals
• Customer compulsiveness

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Regulations covering CBI

• United States
• No claim procedure
• Canada
• Fee based application with MSDS review
• European Union
• More strict under Directive 1999/45/EC
• Application procedure
• Exclusion of certain hazards

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Different Exposure Limits

• OSHA PELs
• ACGIH TLVs
• Most European countries have own OELs
• German MAK
• French OEL
• Denmark OEL
• European Union (2000/39/EC)

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Regulations Governing MSDS

• United States
• 29CFR1910.1200 (OSHA Hazard Comm.)
• ANSI Standard Z400.1 and Z129.1
• Europe
• 1999/45/EC Dangerous Preparations
• 2000/32/EC Dangerous Substances
• 2001/58/EC MSDS

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Regulations Governing MSDS

• Japan
• Industrial Safety Health Law
• Fire Service Law
• Poisonous and Deleterious Substances Control Law
• Ships Safety Act
• Ordinance on Prevention of Lead Poisoning
• High Pressure Gas Control Law
• Ordinance on Prevention of Organic Solvent
  Poisoning

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MSDS Requirements
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Options for compliance

• Sophisticated computerized MSDS system
• Basic computerized MSDS system
• Individual MSDS translation
• MSDS Service Provider
• Dont sell products in the country

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Ideal MSDS system

• Computerized MSDS system
• Composition based
• Allows for multiple hazard evaluation
• Expert system logic
• Encoded output
• Ability to handle double-byte characters

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Computerized MSDS system

• Integrated with formula databases
• Integrated with order processing system
• Integrated with label creation
• Ability to handle regulatory lists
• Ability to update MSDSs
• Use of standard phrases translations

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Composition based

• Assist in hazard evaluation
• Regulatory list comparison
• Toluene, for example
• OSHA PEL
• ACGIH TLV
• RCRA
• EU ANNEX I
• TSCA 8a, 8e
• SARA 313

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Multiple hazard evaluation

• Xylene

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Expert system

• Why an expert system?
• Hazard determination based on complex rules
• Gives consistent evaluation
• Speed to handle volume of MSDS

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Encoded Output

• Why encoded output?
• Required for multi-language system
• Enables faster transmission to remote sites
• Enables use of EDI for distribution

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Double-byte characters

• Why double-byte language characters?
• MSDS requirements
• China
• Japan
• Korea
• Represents a large potential market

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Now what do I do?

• Evaluate international business
• Is it sufficient to justify a system?
• Will individual translations work?
• Determine the approach
• Build a computerized system
• Select an MSDS Service Provider
• Sell your products elsewhere

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Whats the future?

• Globally Harmonized System (GHS)
• Classification Criteria
• Health and Environmental Hazards
• Physical Hazards
• Mixtures
• Hazard Communication
• Labels
• Safety Data Sheets

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GHS will bring changes

• Common hazard classification criteria
• Change in MSDS section order
• Hazard pictograms
• Standard hazard statements

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Hazard Pictograms
!
!!
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GHS Status in the US

• US agencies responsible for MSDS and labeling
  have been involved
• Changes could be adopted by
• Congressional Legislation
• Regulation from affected agencies
• Estimates put adoption in 2008

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International MSDS and Labeling

• Questions?

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Regulations in force

• Australia
• Approved Criteria for Classifying Hazardous
  Substances NOHSC 1008 (1999)
• National Code of Practice for the Preparation of
  Material Safety Data Sheets NOHSC 2011 (1994)
• National Code of Practice for the Labelling of
  Workplace Substances NOHSC 2012 (1994)
• List of Designated Hazardous Substances NOHSC
  10005(1999)
• Canada
• Hazardous Products Act R.S.C. 1985. c.H.-3)
• Controlled Products Regulations SOR/88-66
• Ingredient Disclosure List SOR/88-64
• Hazardous Materials Information Review
  Regulations SOR/88-456
• China
• General Rules for the Preparation of Chemical
  Safety Data Sheets GB16483-2000
• General Rules for the Preparation of
  Precautionary Labels GB15258-1999
• European Union
• Dangerous Substances Directive 92/32/EC

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Regulations in force

• Japan
• Fire Service Law Law No. 186 (1948)
• Explosives Control Act Law No. 149 (1950)
• Poisonous and Deleterious Substances Control
  Law Law No. 303 (1950)
• High Pressure Gas Control Law Law No. 204
  (1951)
• Ordinance on Prevention of Organic Solvent
  Poisoning Law No. 36 (1972)
• Ordinance on Prevention of Lead Poisoning Law
  No. 37 (1972)
• Ordinance on Prevention of Tetraethyl Lead
  Poisoning Law No. 38 (1972)
• Ordinance on Prevention of Hazards Due to
  Specific Chemical Substances Law No. 39 (1972
• Industrial Safety and Health Law Law No. 318
  (1972)
• Ship Safety Act
• Korea
• Industrial Safety and Health Act Article
  41 January 5, 1995
• Presidential Decree of the Act, Article
  32 October 19, 1995
• MOL Decree of the Act, Article
  92-2,5 November 23, 1995
• Malaysia
• Occupational Safety and Health
  Regulations P.U. (A) 143 - 1997

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Regulations in force

• Mexico
• Fundamental Health Criteria of the Material
  Safety Data Sheet for Chemical Substances NOM-055-
  SSA1-1993
• System for Identifying and Communicating
  Chemical Hazards in Work Centers NOM-114-STPS-1994
  
• United States
• OSHA Hazard Communication Standard 29CFR
  1910.1200
• Consensus Standards
• United States
• American National Standard for Hazardous
  Industrial Chemicals
• Precautionary Labeling ANSI Z129.1-2000
• American National Standard for Hazardous
  Industrial Chemicals
• Material Safety Data Sheets Preparation
  ANSI Z400.1-1998
• International
• Safety Data Sheet for Chemical Products Part
  1 Content and order of sections ISO 11014-11994

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