challenges in global product safety & stewardship...

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Challenges in Global Product Safety & Stewardship

Compliance

Karen Lanka

March 2015


83 days

12 weeks

1992 hours

119,520 minutes

7,171,200 seconds

Until June 1, 2015!

EU and US Countdown


SDS Authoring Challenges

Although harmonization of criteria has been successful, there are differences in Authorities for the two core parts of GHS:

3

Classification

Labeling


SDS Authoring Challenges

• Different versions of the UN GHS adopted

– Provisions for certain variances in adaptation, which results in unharmonized classification

– Sometimes parts of multiple versions were incorporated

– Results in differences in H&P statements, symbols, etc.

4


Versions of UN GHS Adopted

UN GHS Revision Approximate No. of Countries / Regions Adopted

1st 1

2nd 2

3rd 12

4th 11

5th 2* * Regulation Proposed

Up-to-date GHS Country Comparison Chart developed by 3E experts is available on Ariel WebInsight


Why Classifications May Differ

• Decisions on some criteria left to Authorities

– Authority defined hazards

• US – Combustible dust, Simple asphyxiants, Static accumulating flammable liquids

– Conversions from other classification systems

• EU R phrase translation

• NTP carcinogens

• OSHA carcinogens

– Building blocks adopted

• Authorities are free to decide what to adopt

• Some allow the use of a hazard without officially adopting it

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Flammable Liquids

Acute toxicity

Skin corrosion/irritation

Aspiration hazard

Aquatic Acute

Aquatic Long-term

Ozone Hazard

Cat 1A

Cat 1

Building Block Comparison EU/US

Cat 1A

Cat 1

Cat 1B

Cat 2

Cat 2

Cat 1C

Cat 3

Cat 2

Cat 3

Cat 4

Cat 3

Cat 5*

Cat 2

Cat 4

Not adopted by EU

Not adopted by EU or US

Not adopted by EU or US

Cat 1

Cat 1

Cat 1*

Not adopted by US * US allows

Cat 2*

Cat 3*

Cat 2*

Cat 3*

Cat 4*


Why Classifications May Differ

• Concentration limits that differ from UN

– Results in differences in classification of mixtures

• Some differences are beyond the scope of GHS

– More open to expert judgment

– (Un)harmonized classification lists

• One of most common causes of differences

• Some lists are binding, others are advisory

• One country may have several published lists

• Ultimately it is a matter of judgment which list(s) to use for what Authorities

8

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Substance Classifications

Hazard Class

EU

Annex VI

Flammable Liquid 2

Acute Tox Oral 3*

Acute Tox Dermal 3*

Acute Tox Inhal 3*

Eye damage/irritation

Respiratory Sensitization

Reproductive toxicity

STOT SE 1

STOT RE

Methanol CAS 67-56-1 Classifications



Hazard Class

EU

Annex VI

Korea

MOE

Flammable Liquid 2 2

Acute Tox Oral 3* 3

Acute Tox Dermal 3* 3

Acute Tox Inhal 3* 3


2



STOT SE 1 1

STOT RE




Hazard Class

EU

Annex VI

Korea

MOE

Korea KOSHA

Flammable Liquid 2 2 2

Acute Tox Oral 3* 3




2 2



1B

STOT SE 1 1 1,3(Resp &

Narc)

STOT RE 1




Hazard Class

EU

Annex VI

Korea

MOE

Korea KOSHA

Korea

NEMA

Flammable Liquid 2 2 2 2

Acute Tox Oral 3* 3




2 2



1B


Narc)

STOT RE 1




Hazard Class

EU

Annex VI

Korea

MOE

Korea KOSHA

Korea

NEMA

Japan

NITE

Flammable Liquid 2 2 2 2 2

Acute Tox Oral 3* 3 4




2 2 2


1


1B 1B


Narc) 1,3 (Narc)

STOT RE 1 1




Hazard Class

EU

Annex VI

Korea

MOE

Korea KOSHA

Korea

NEMA

Japan

NITE

Taiwan

CLA

Flammable Liquid 2 2 2 2 2 2

Acute Tox Oral 3* 3 4




2 2 2 2A


1


1B 1B 2


Narc) 1,3 (Narc)

STOT RE 1 1 1



Why Label Elements May Differ

• Hazard statement deviations – Combined/Alternate hazard statements

– Redundant hazard statement suppression

– Uniquely defined by authority

• Precautionary statement deviations – Different versions of UN in a single authority

– Uniquely defined by authority

• Different symbol precedences – Some require all physical hazard symbols

– US – Exclamation mark criteria differs from all others

• Other elements – EUH/AUH statements

– Allowable reduction of P statements

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Class & Labeling Nuances

BR CH EU MX RU RS ZA TR UY US

Published

Classification List *

R Phrase Translation

H Statement

Variations

Alternate Repro Tox/

Cancer H Statements

EUH Statements

P Statement

Variations

Reduced P

Statement Allowance

Symbol Precedence

Deviations

* Uses EU CLP Annex VI


Class & Labeling Nuances

AU CN ID JP KR MY NZ PH SG TH TW VN

Published

Classification List

R Phrase Translation *

H Statement

Variations

Alternate Repro Tox/

Cancer H Statements

EUH Statements *

P Statement

Variations

Reduced P

Statement Allowance

Symbol Precedence

Deviations

* Similar but not identical to EU


Why SDS/Labels May Differ

• Address/emergency contact requirements

• Cut-off limits other than those presented in UN

– Results in different ingredients being disclosed in Section 3

• National/regional regulatory specifics

– OELs, Biological limits, skin designation limits, sensitizer limits, DG agencies, other regulatory lists

• Language requirements

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No single SDS or label can be used globally!

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The nature of the (un)harmonized beast!

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Authoring Software & Services

• 3E Authoring Services and MSDgen Software – Growing group of over 100 professionals

• 50+ on the Software team

• 60+ on the Services team

– Software team provides IT, Project Management support

– Largest, most expert team of Authors in the world

– 3E Authors use MSDgen for all Out-sourced Authoring

– 3E Authoring helps many MSDgen clients with Co-sourced Authoring projects

• Joint Software and Service Projects – Base Chemical Classifications

– Exposure Scenario Enhancements

– Authoring Automation

– Authoring Training

– Co-Authoring


Maintaining our Leadership

• Global Chemical Regulatory Content and Logic – MSDgen remains core software product and our focus remains

on this core • Compel clients to remain as standard as possible

– Two MSDgen releases per year • January • July

– Each release provides updates to keep customers current – Global GHS Updates are first priority – Document Templates – GHS Algorithms – Glossary Assignment Rules – Translations in 45+ Languages – Supporting Data Structures and GUI Updates – Quarterly updates of Ariel Regulatory Data



• Technology – Utilize the latest tools and methods

• .Net and database (Oracle and SQL Server) development

– Automatic Calculations and Rules Generation

• Unique methodology that processes all GHS Authorities at once

• Optimizations are part of each release

• Batch Processing for mass and routine updates

– Integration with the Enterprise and ERP systems including SAP

• Formulation

• Sales Order

• Label Production

• Distribution

• Quality – Continue to follow strict release processes

– Continue expanding scope to include more aspects of system



• Authoring, Training, and Consulting – Authoring

• Largest diverse team of Authors in the world, coming from all facets of industry

• Experience with all popular Authoring systems

• PhDs, Masters; Biology, Chemistry, Environmental Engineering, Toxicology

• Languages: Armenian, Chinese, Danish, English, French, German, Italian, Japanese, Kazakh, Norwegian, Polish, Portuguese, Russian, Swedish, Uzbek

– Training • MSDgen

• GHS

• DG

– Regulatory Consulting • Collection of data

• Late Pre-registration

• Product Registration

• Interpretation of toxicity data

• Identification of missing data (tox, eco-tox, phys-chem)

• Notification of classification and labeling on behalf of customers


Software Development

MSDgen Template Experts

3E Central Rules & Template Experts

MSDgen Quality Assurance

MSDgen Release (Software Updates

with Rules/Templates/Phrases)

User requests & feedback User requests & feedback

MSDgen User Community

Ariel Data Experts

Regional Regulatory Research Experts

Translations Experts

MSDgen Rules/Phrase Experts

3E Authoring Experts

MSDgen Developers

MSDgen

Regulatory Experts

MSDgen Regulatory Experts

Development Workflow

Language Experts

Regional Regulatory Experts

DGSA (Dangerous Goods Safety Advisors)


Regulatory Body

Version of UN Adopted / Implementation Deadline

Original Update

Australia 3rd Rev 1-Jan-2017 None

Brazil 2nd Rev Substances: 26-Feb-2011, Mixtures: 1-Jun-2015 4th Rev Substances: 10-Dec-2012, Mixtures: 1-June-20152

China 2nd Rev 1-Feb-2009 4th Rev 1-Nov-2014

European Union 2nd Rev Substances: 1-Dec-2010, Mixtures: 1-Jun-2015 4th Rev Substances: 1-Dec-2014, Mixtures: 1-Jun-2015

Indonesia 2nd Rev 15-Nov-2009 4th Rev Substances: 12-July-2013, Mixtures: 31-Dec-2016

Japan 2nd Rev Dec-2006 4th Rev 1-Jan-2017

Korea 2nd /3rd Rev Substances: 1-Jul-2010, Mixtures: 1-Jul-2013 None

Malaysia 3rd Rev 17-Apr-2015 None

Mexico 3rd Rev 4-Jun-20112 None

New Zealand 2nd Rev 1-Jul-20062 None

Philippines 4th Rev Mid-Mar-2015 None

Russia 2nd Rev 1-Jan-2009 4th Rev 1-Aug-2014

Singapore 2nd Rev Substances: Feb-2012, Mixtures: mid 2015 4th Rev Substances: 4-Feb-2014, Mixtures: Mid-2015

South Africa 3rd Rev Substances: 2012, Mixtures: 2016 None

Switzerland 3rd Rev Substances: 1-Dec-2012, Mixtures: 1-Jun-2015

Taiwan 3rd Rev 31-Dec-2008 4th Rev 24-Jan-20151

Thailand 3rd Rev Substances: 2013, Mixtures: 2017 None

United States 3rd Rev 1-Jun-2015 None

Uruguay 4th Rev Substances: 31-Dec-2012, Mixtures: 31-Dec-2017 None

Vietnam 3rd Rev Substances: 30-Mar-2014, Mixtures: 30-Mar-2016 None

Canada 3rd/5th Rev 1-Jun-20161 None

Serbia 3rd Rev Substances: 1-Oct-2012, Mixtures: 1-Jun-20151 None

Turkey 3rd Rev Substances: 1-Jun-2015, Mixtures: 1-Jun-20161 None

1Planned for MSDgen 6.56 2Additional Update Planned for MSDgen 6.56 Pending Final Publication

MSDgen GHS Support Status


MSDgen

Demonstration

26


MSDgen 2015 Regulatory Roadmap

• 5th Revised Edition of UN GHS

• Canada GHS Rollout

– “WHMIS 2015” Hazardous Products Regulations

• Turkey and Serbia GHS Rollout

– Implementation similar to 2nd ATP to CLP

• Taiwan GHS Update

– Updating to 4th Revision of UN

• Mexico and New Zealand GHS Updates

– Authorities working on draft regulations to incorporate 5th Revision of UN

• Ukraine, Kazakhstan and Uzbekistan GHS Rollouts

– Implementation similar to Russia’s

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Conclusions

• Identify products and services that you can utilize to ease your compliance burden

• Determine your approach to “global” classification

‐ Country specific or worst-case

• Be aware of variations in GHS adaptations

‐ Critical in order to comply with multiple authorities

• Select appropriate SDS and label templates to suit each country

‐ Ensure your software/service option provides compliancy expansion opportunities that meet your business needs

• Take account of timelines for transition to GHS

‐ Updates in advance of required implementation dates


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challenges in global product safety & stewardship...

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