1

Experience Implementing

GHS in EU and Japan

Lisam America Inc.

3131 E. 29th Street, Suite E

Bryan, Texas 77802

+1.979.595.1444

andrewn@lisam.com

Andrew Nelson

CEO

Frans Lemaire

Lisam ExESS Regulatory Product Manager

October 25-29, 2010

Process Safety Symposium, Oct 28 2010

2

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.

3

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

4

Worldwide Adoption

• Building blocs

• Europe : CLP classification + SDS Reach

Annex II

• Japan : GHS + JIS

• US : OSHA, EPA, ...

• Other ....

5

Building blocs

6

Building blocs

7

Building blocs

Not in EU

8

Timelines

• Japan : already operational

• Europe :

– December 1, 2010 for substances

– June 2015 for Mixtures

• US : OSHA, EPA, DOT Timing TBD

9

GHS Timelines

10

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

11

Labeling in Practice

Source: MERCK website

12

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

13

Japanese labels in Practice

14

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

15

EU SDS in Practice

16

Japanese SDS in Practice

17

From Questions to Answers

• Own research and

regualtion tracking

• Service Providers

• Software Solutions

18

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/

19

Non IT tools

• Regulator

– Official documents

• Rules

• Conversion tables (regional differences)

• Substance Classification inventories (Annex VI,

Nite, etc)

– Guidelines

20

EU conversion (Annex VII)

Existing to New

21

EU official list (Annex VI)

22

Japanese NITE lists

http://www.safe.nite.go.jp/english/ghs_index.html

23

NITE lists (Excel Series)

24

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

25

Real time demo

26

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 :

27

Questions/Suggestions

Process Safety Symposium, Oct 28 2010

Thank you

28

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

29

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

30

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

andrewn@lisam.com

31

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