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Experience Implementing
GHS in EU and Japan
Lisam America Inc.
3131 E. 29th Street, Suite E
Bryan, Texas 77802
+1.979.595.1444
Andrew Nelson
CEO
Frans Lemaire
Lisam ExESS Regulatory Product Manager
October 25-29, 2010
Process Safety Symposium, Oct 28 2010
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Who is Lisam America, Inc.?
Lisam America Inc. is a joint venture between Lisam Systems
and the Texas A&M University System created to provide global
EH&S software solutions, including GHS management in the US.
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GHS Challenges
• Worldwide adoption– GHS regional differences (building blocs)
• Timelines– Different entry dates for EU, Asia, US, CAN, etc
• Labeling and SDS – Regional differences. Many phrases. Many pictograms. Variety in
SDS formats (SDS EU Annex II, Japanese JIS, USA OSHA, etc)
• IT support and solutions– New rules and complex algorithms
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Worldwide Adoption
• Building blocs
• Europe : CLP classification + SDS Reach
Annex II
• Japan : GHS + JIS
• US : OSHA, EPA, ...
• Other ....
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Building blocs
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Building blocs
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Building blocs
Not in EU
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Timelines
• Japan : already operational
• Europe :
– December 1, 2010 for substances
– June 2015 for Mixtures
• US : OSHA, EPA, DOT Timing TBD
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GHS Timelines
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Labeling in Practice
• Labeling
– New data items
– New Pictograms (6 possible per chemical)
– Many P statements (precedence rules)
– Extra phrases per region (EU = EUH statements)
– Number of languages on one label
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Labeling in Practice
Source: MERCK website
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EU Labeling in Practice
http://www.altec.nl/lassie-2-printen-van-ghs-labels.html
http://www.nl.bradyeurope.com/bradyeurope/catalog/searchResultsView.do?searchTerms=GHS
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Japanese labels in Practice
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SDS in Practice
• SDS
– New format for GHS has different regional
translations
– New sections and subtitles
– Additional translations for SDS ww distribution
– Different regional timelines to respect
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EU SDS in Practice
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Japanese SDS in Practice
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From Questions to Answers
• Own research and
regualtion tracking
• Service Providers
• Software Solutions
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Non IT tools
• Industry
– Consultancy
– Training
– Associations, Federations, Agencies
• Regulators
UNECE : http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html
ECHA : http://echa.europa.eu/clp_en.asp
EUROPA : http://ec.europa.eu/enterprise/sectors/chemicals/
NITE : http://www.safe.nite.go.jp/english/
JCDB : http://www.jcdb.co.jp/en/
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Non IT tools
• Regulator
– Official documents
• Rules
• Conversion tables (regional differences)
• Substance Classification inventories (Annex VI,
Nite, etc)
– Guidelines
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EU conversion (Annex VII)
Existing to New
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EU official list (Annex VI)
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Japanese NITE lists
http://www.safe.nite.go.jp/english/ghs_index.html
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NITE lists (Excel Series)
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Operational IT tools
• Options
– Regulatory databases
• Qualisys, LOLI, ARIEL, Atrion, ...
– Product databases
• Many web-based “almost ready” labels and SDS’s
– Chemicals Management tools (Lisam ExESS)
• IT tool to author and manage GHS documents
• Classification calculation modules
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Real time demo
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Conclusion
• Complexity– New rules, interpretation games, need guidelines
• Timelines– Regional differences Your organization should watch dates!
• Application domain– Impact on labeling, SDS and related regulations as transport etc...
• Stability – Continous upgrades + dependency on REACH, IUR, CSCL, etc
• Role of IT tools and Support– Many IT suppliers are ready to help you :
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Questions/Suggestions
Process Safety Symposium, Oct 28 2010
Thank you
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Glossary
CLP Classification, labeling & packaging
CMR Carcinogenic, Mutagenic and
Reprotoxic substances
CPSC Consumer Product Safety Commission
CSA Chemical Safety Assessment
CSR Chemical Safety Report
DNEL Derived No-Effect Level
ECHA European Chemical Agency
Einecs European Inventory of Existing
Commercial Chemical Substances
Elincs European List of Notified Chemical
Substances
EA Exposure Assessment
eSDS Extended Safety Data Sheet
ES Exposure scenario
EU EER en IJsland, Lichtenstein,
Noorwegen
EuPhraC European Phrase Catalogue
GHS Globally Harmonised System
HA Hazard Assessment
HCS Hazard Communication Standard
IUCLID International Uniform Chemical
Information Database
NITE National Institute of Technology and
Evaluation
NIOSH National Institute for Occupational
Safety and Health
OC Operational Conditions
OR Only Representative
OSHA Occupational Safety & Health
Administration
PBT Persistent, Bioaccumulative and Toxic
substances
PNEC Predicted No-Effect Level
PPORD Process & Product Oriented R&D
REACH-IT Online IT systeem van het ECHA
RL Richtlijn
RMM Risk Management Measures
SDS Safety Data Sheet
SVHC Substances of Very High Concern
vPvB very Persistent and very
Bioaccumulative substances
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Links & documentation
Official Publications :
CLP regulation : http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF
CLP Annex VI : http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:235:0001:0439:en:PDF
ECHA CLP Guidance : http://guidance.echa.europa.eu/docs/guidance_document/clp_introductory_en.pdf
Individual CLP files : http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification/
Comparison between EU SDS and CLP SDS Annex II
http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/anii-rev-sds-comparison_en.pdf
Original GHS UNECE pictograms & documentation
http://www.unece.org/trans/danger/publi/ghs/pictograms.html
Draft Guidance Manual for CLP labeling
http://guidance.echa.europa.eu/docs/draft_documents/draft_clp_labelling_guidance_for_peg.pdf
ECHA Guidance on CLP
http://echa.europa.eu/clp/clp_help_en.asp
Software for Worldwide Chemicals Management
www.hemmis.be
www.lisam.com
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For more information on GHS
US or global software solutions:
Andrew Nelson, CEO
Lisam America Inc.
3131 E. 29th Street, Suite E
Bryan, Texas 77802
(979) 595-1444
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Although the information in this presentation is presented in good faith and believed to be correct at the
time of compilation, neither Lisam Systems, Lisam America Inc., nor any Lisam affiliates will accept
responsibility of any kind for the completeness or accuracy of the information in this presentation.
Process Safety Symposium, Oct 28 2010
