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©2015, 3E Company, All Rights Reserved
Challenges in Global Product Safety and Stewardship
Compliance
Alex Ortiz and Julia Tsvetkova
March 17th, 2015
©2015, 3E Company, All Rights Reserved
• The Complexity and Challenges of Regulatory Compliance
• Benefits and Best Practices for:
1. Substance-Level Data Management (Regulatory & Scientific)
• Reference Content
• Integrated into your EHS Compliance System
2. Product-Level Data Management
• Integrated into your EHS Compliance System
3. Rules, Phrases & Templates
4. Regulatory Updates
Agenda
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The Complexity – A Regulatory Perspective
• Companies struggle under the burden of spiraling global EH&S regulations – Ever more demanding regulators and clients
Restricted Substances
• RoHS
• Phthalates
• BPA
• Drug precursors
• Conflict Minerals
• US CA Prop 65
Authorization/
Registration
• EU REACH SVHCs
• Japan CSCL (PAC)
• Korea “REACH”
Classification
Labeling
• GHS/CLP
• Classification
• Labeling
• Packaging
Environment
• Emissions
• GHGs
• Waste – ELV, WEEE
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The Complexity – A Company Perspective
• Product Stewardship teams are under pressure to produce accurate and extensive SDS documentation with: – Fewer resources
– Outsourced IT departments
– Methodologies to collect critical product compliance data within the organization are often inefficient and error prone
– Difficulties getting product data from numerous suppliers
– Consumer green buying patterns and sustainability
– Transparency and corporate responsibility
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3. Dynamic and Global Rules, SDS Templates and Multilingual Phrases
Country Specific Industry Requirements
2. Accurate, up-to-date product data
SDS Compliance Documents
1. Accurate, up-to-date substance data
Regulatory Scientific
Regulatory Content – The Pieces
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1. Accurate Up-to-date Substance Data
• Substance Data – Regulatory
– Scientific
• Best Practices – Proactive alerts
– Global monitoring and compliance with numerous regulatory topics
– Business impact analysis and risk mitigation
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Expert International Staff
• Regulatory attorneys and researchers
• PhDs, chemists, toxicologists, industrial hygienists and chemical engineers
• Software systems and data experts
• Business and strategy consulting professionals
• SDS Authors
• 25+ languages spoken
• Fully dedicated employees
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• Subscription based online reference tool with easy-to-use, intuitive interface with robust search, query, reporting and analysis features
• Search through regulations issued by 90+ countries around the globe
• Instantly access close to 1,500 regulatory lists containing thousands of data elements
• Access to Full Text, “Generics” data, GHS classification tools, multilingual phrases and more
• Continuously Changing and Expanding data set
Ariel WebInsight (WI)
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WebInsight – New & Amended Lists
95 269
112
607
712 911
0
200
400
600
800
1000
1200
2012 2013 2014
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4 Topics of Interest Recently Expanded
• Chemical Weapons Convention (CWC)
• Controlled Drugs and Precursors
• Dual Use Lists and Explosives lists
• PIC lists
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Regions Covered
• North America – Canada, US Federal, and some US states
• Latin America – Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, and Venezuela
• Asian Pacific – Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Philippines,
Singapore, Taiwan, Thailand, and Vietnam
• Middle East / Africa – Algeria, Bahrain, South Africa, and Dubai
• International – UN Convention for Narcotics and Psychotropics – Chemical Weapons Convention – Wassenaar Agreement – Rotterdam Convention – Nuclear Suppliers Group
• Western Europe – EU, Norway, Portugal, Switzerland, Germany
• Eastern Europe – Kazakhstan, Russian Federation, Georgia
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Generic Analysis
• We have 196 lists total in the following topics Chemical Weapons Convention (CWC) - 26 lists Controlled Drugs and Precursors – 124 lists Dual Use Lists and Explosives lists – 36 lists PIC lists – 10 lists
• In these 196 lists, we have 8,843 entries Only 2,939 entries have CAS# listed Many of these CAS# are assigned by 3E i.e., the regulation does not
assign the CAS
The remaining entries either lack a CAS number or are groupings of chemicals
3E chemists have added total of 15,719 generic children to these regulations. i.e., exploded the specificity of these lists > 5x
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Generic Analysis Example
Hong Kong. Narcotics and Psychotropic Substances
• Entry names are typically general descriptions – Any compound (not being methoxyphenamine or a compound for the time being
specified in subparagraph (a)) structurally derived from phenethylamine, an N-alkylphenethylamine, alpha-methylphenethylamine, an N-alkyl-α-methylphenethylamine, α-ethylphenethylamine, or an N-alkyl-α-ethylphenethylamine by substitution in the ring to any extent with alkyl, alkoxy, alkyl-enedioxy or halide substituents, whether or not further substituted in the ring by one or more other univalent substituents
• After structural analysis, we found a total of 210 children • For example: MMDA hydrochloride, Levmetamfetamine,
Etilamfetamine, etc.
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Physical Chemical, Toxicological and
Eco-Toxicological data
PCTEC Plus for Scientific Data
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PCTEC Plus Scientific Data
200,000+ CAS RN 120+ Sources (DB + FT) 1M+ Records
PC
TEC
Structured Data
NLM, ECHA, EPA, HSDB… P
CTE
C P
lus Full Text
Documents
NTP, NIOSH, ATSDR … P
CTE
C P
lus Full Text
Web resources
IRIS, ITER, TOXLINE, PubMed …
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PCTEC Plus Database Scope
60+ Physical-Chemical End Points
• Acid Dissociation Constant
• Boiling Point
• Characteristic Odor
• Color
• Density
• Flammable Limit, Lower and Upper
• Octanol-water partition coefficient
• pH
• Solubility, Water
• Surface Tension
• … and many more
45+ Toxicity End Points
• Acute toxicity
• Carcinogenicity
• Chronic/ Repeated dose toxicity
• Genetic Toxicity: In Vitro / In Vivo
• Eye Irritation
• Skin Irritation
• Skin sensitization
• Neurotoxicity
• Reproductive tox
• Developmental tox
• DNELs
• … and many more
15+ Eco-Toxicity End Points
• Bioaccumulation
• Biodegradation
• Fish, Acute toxicity
• Fish, Chronic toxicity
• Invertebrates (Aquatic) toxicity
• Invertebrates (Aquatic) toxicity, Short term
• PNECs
• … and many more
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Applicability
• SDS Creation
• Hazard Classification (GHS, CLP, etc.)
• Hazard Risk Assessments
• Anticipate Regulatory trends – a lot of PCTEC is ahead of regulatory activity
• R&D formulation screening
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How WI and PCTEC Works?
• Single click search of both regulatory and chemical hazard, toxicity and eco-toxicity data
• Search over 120 end points in database mode
– Combine your search with full text resources from over 100 sources
• Extensive collection of original study reports as well as integration of web services from NLM’s ToxNet
• Searchable full text by various criteria, including CAS, chemical name and text pattern/keywords
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PCTEC Plus – Additional Uses
Evaluate toxicological and physicochemical properties of alternatives – 3E ‘CAAS’
– Green chemistry
– Sustainable alternatives
– Improved compliance
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Chemical Alternatives Assessment
CHEMICAL ALTERNATIVES
– Regulatory pressure (e.g. ECHA)
– Manufacturers want “greener” products
SCREENING: 3E GREEN CAS SCORE services
FULL ASSESSMENT:
3E Chemical Alternatives Assessment System
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3E Chemical Alternatives Assessment System
Chemical Alternatives Assessment System • Comprehensive method of comparing toxicological and eco-
toxicological effects (and more) of alternative chemicals/mixtures
• Simplified numerical scoring/screening system to compare chemical alternatives
• Scores based on actual toxicology data values -- not imputed from prejudged criteria (e.g. lists or GHS scores) i.e. continuous scale data analytics
• Avoids pitfallof categorical systems: discontinuity
• QSAR/ Read-across available
• Service: expert judgment included
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Demonstration
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Ariel WebInsight Mobile
• Perform a chemical or database search from your tablet or smart phone
• http://mobile.arielresearch.com
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1. Accurate Up-to-date Substance Data
• Best Practices – Proactive alerts
– Global monitoring and compliance with numerous regulatory topics
– Business impact analysis and risk mitigation
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Proactive Alerts
• Understand how up and coming regulations impact your substances and products
• Get proactive alerts when: – New chemicals are added on a banned or an SVHC list
– New reporting requirements
Enable Proactive Compliance
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Global Monitoring and Compliance
• Make sure SDSs and labels are compliant for the markets in which the products are sold
• Make sure products are compliant for the markets in which products are sold
• Complete incoming customer inquiries, regulatory disclosures
• Quickly identify: – chemical release and spill reporting regulations
– export/import notification and reporting compliance requirements
• Read thousands of regulations and regulatory overviews in English
Enable Global Compliance
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Business Impact Analysis
• New Product/New Market Introduction:
– What country specific regulatory requirements are applicable?
• Supplier Selection:
– Do my suppliers use substances that are compliant, properly labeled and classified?
– Do my suppliers use substances that might need registration or are on a list of concern?
• Supplier Responsiveness:
– Respond to supplier compliance questionnaires
• New Manufacturing Facility Selection:
– What are the exposure limits for workers?
Eliminate Risk in the Supply Chain
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Accurate Up-to-date ‘Integrated’ Substance Data
• Substance Data – Regulatory
– Scientific
• Best Practices – SDS System Compliance Integration
a. Understand and load data applicable to your business
b. Run Impact Analysis to find impacted substances and products
c. Automated Update process
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Understanding Your Data
Regulatory Data
• Classifications
• Health Data
• Restricted Substances
PCTEC
• Physical & Chemical
• Toxicity
• Eco-Tox
Dangerous Goods
• International Data
• Country Specific Lists
Supplier Data
• VSDS
• Manual Entry
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The Data Load Process
EHS Compliance System
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ADM EHSAP Impact Analysis
• Analyze
• Select
• “Generics”
Decision Support
• Real_Sub impact report
• List_Sub impact report
Impact Analysis • Configure
• Map
• Save
• Schedule
Load
Detailed RegImpact Reports + Usability and Technical Enhancements
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3. Dynamic and Global Rules, SDS Templates and Multilingual Phrases
Country Specific Industry Requirements
2. Accurate, up-to-date product data
SDS Documents Other Certificates and Rules
1. Accurate, up-to-date substance data
Regulatory Scientific
Regulatory Content – The Pieces
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2. Accurate, up-to-date product data
• Product Data – Supplier SDS Documents
– Other Certificates and Rules
• Best Practices – ADM VSDS – Collect supplier compliance documentation
– Apply changes regularly
– Make supplier data available for use in downstream compliance processes:
• Classification
• Substance Volume Tracking (SVT) for REACH and other compliance activities
• Regulatory Reporting
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Material Inventory
SAP EHSM ADM-
VMSDS Application
Internet Web Service 3E Catalog
SAP Material Master
SAP SD
(Document Distribution)
ADM-Supplier Process
Available Data for Integration
• Material/Product Name
• Manufacturer Name
• Revision Date
• Flash Point, Boiling Point
• Density, pH
• Composition
• Classification - GHS, EU R&S and CLP, NFPA, HMIS, SARA
• VOC
Request a list of products in SAP EHSM
Response with MSDSs and metadata for storage in SAP
Request a list of impacted products
Response with MSDS and metadata for storage in SAP
Initial Load
Data Updates
3E Central Repository
• Real Sub/MM ID
• MSDS/Supplier Cert
• Language
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• Automating certain rules outside your company perimeter with VSDS data
– Supplier GHS Classifications and compositions but also:
• Seveso classifications
• Green score analytics
• Other reporting requirements
3E’s Cloud – New Rules
Product Level Data
ADM MM
ADM VSDS
ADM EHSAP
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Demonstration
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3. Dynamic and Global Rules, SDS Templates and Multilingual Phrases
Global Scope Country Specific Requirements
2. Accurate, up-to-date product data
SDS Other Certificates and Rules
1. Accurate, up-to-date substance data
Regulatory Scientific
Regulatory Content – The Pieces
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3. Up-to-date Expert Rules/Templates/Phrases
• Dynamic SDS Content – Expert Rules
– Document Templates
– Multilingual Phrases
• Best Practices – Rules and Templates – Global scope with country specific variations
– Flexible and proactive application of changes
– User friendly tool to add/change rules
– Easy out-of-the box customizing options/settings
– Update Process
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Global Scope
Americas
• US Federal and State
• Canada
• Mexico
• Brazil
• Uruguay
EU
• CLP
• DPD
• DPD to CLP Conversion
• Country specific
Asia Pacific
• Australia
• China
• Japan
• Korea
• Malaysia
• Singapore
• Taiwan
• Thailand
• New Zealand
Non-regional
• Inventory Status
• Formulation
• HNOC
• Global Conventions
• Generic GHS
Transport
• Classes 2, 3, 4, 5, 6.1, 8 and 9
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Expert Rule Types
Classifications
Label elements
Hazardous ingredients
Reportable composition
Occupational Exposure limits
Country specific local regulations/Inventories
Ariel Rules Builder
Section 2
Section 3
Section 8
Section 15
Soft Sec. (4. 5, 6, 7, 8, 9, 10, 11)
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Rules Builder: A User Friendly Tool to Author/Create Rules
Property Tree
Phrases
Rules Generat
or
.mdb files
.rul files
EHS Expert
SAP EHSM
-Value Assignments
-Inheritance Phrase
Assignment Content
Rules Generator
Rules Builder GUI
Benefits
• Easy to use interface
• Prepackaged content
• Allows extended automation
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‘Out of the Box’ Customizing Options
• Rules:
– Ability to apply a regulatory classification for compliance with multiple countries’ GHS requirements
– Specify a threshold or disclosure limit where regulations are grey
– Take advantage of supplier classifications
– Add your own “soft section” content with the Ariel Rules Builder
• Templates:
– Apply logos and customer specific addresses
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Ariel Multilingual Phrases
Thousands of distinct regulatory phrases as well as phrases used for the creation of (M)SDSs, including:
– Header and sub-header phrases
– Phrases for specific (M) SDS sections, e.g. First Aid
– GHS phrases (i.e. H and P statements, hazard classes and categories)
– Risk and safety phrases
– Titles of regulations
– Exposure Scenario (ES) phrases
The library has been used and tested by Ariel’s own in-house authoring experts and is provided in:
- 40+ languages and more than 10,000 phrases
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SDS Multilingual Phrases
Arabic AR French FR Norwegian NO
Brazi l Portuguese 1P German DE Pol ish PL
Bulgarian BG Greek EL Portuguese PT
Canadian French 3F Hebrew HE Romanian RO
Chinese ZH Hungarian HU Russ ian RU
Chinese trad. ZF Icelandic IS Serbian SR
Croatian HR Indones ian ID Slovakian SK
Czech CS Ita l ian IT Slovenian SL
Danish DA Japanese JA Spanish ES
Dutch NL Korean KO Swedish SV
Engl ish EN Latvian LV Thai TH
Engl ish UK 6N Lithuanian LT Turkish TR
Estonian ET Malays ian MS Ukrainian UK
Finnish FI Mexican Spanish 1X Vietnamese VI
Hindi HI
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Ariel SDS Templates
Regulatory Rules, Phrases and Templates
©2015, 3E Company, All Rights Reserved
Current Templates Offering
Americas
• Canada
• Mexico
• Brazil
• Uruguay
• OSHA
EU
• CLP
Asia Pacific
• Australia
• China
• Japan
• Korea
• Malaysia
• Singapore
• Taiwan
• Thailand
• New Zealand
Generic GHS
• Arabic
• Non Arabic
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Americas
• Mexico
– Norma Mexicana NMX-R-019-SCFI-2011 SISTEMA ARMONIZADO DE CLASIFICACION DE PELIGROS DE LOS PRODUCTOS QUIMICOS - GLOBALLY HARMONIZED SYSTEM (GHS)
• Canada
– Workplace Hazardous Materials Information System (WHMIS)
– Optional: OSHA HCS with Canadian additions (OEL, WHMIS, etc)
• Brazil
– ABNT NBR 147325-4: Chemicals - Information about safety, health and environment
• Uruguay
– Decree No. 307/009
– Decree No. 346/011
• OSHA
– OSHA Hazard Communication Standard Final Rule - 29 CFR 1910.1200
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EU and Generic GHS
• CLP
– Annexes I and II to Regulation 453/2010/EU amending Regulation 1907/2006/EC (REACH)
• Generic GHS – UN (4th Revised Edition)
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Asia Pacific
• New Zealand
– Code of Practice for the Preparation of Safety Data Sheets (HSNO CoP 8-1 09-06)
– Hazardous Substances (Classification) Regulations 2001
• Malaysia
– Notice of Industry Code of Practice on Chemical Classification and Hazard Communication (ICOP CHC) 2014 GAZETTE [P.U.(B) 128]
– Industry Code of Practice on Chemical Classification and Hazard Communication 2013 (ICOP)
• Australia
– Australia – Preparation of Safety Data Sheets for Hazardous Chemicals section 274 of Work Health and Safety Act (August 10, 2011)
• China
– GB 30000-2013 for Classification of Chemicals (replacing GB 20576 - GB 20602-2006)
• Korea
– MoEL amendment 2013-37 to the Standards for Classification and Labeling of Chemical Substances and Safety Data Sheets
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Asia Pacific Continued
• Singapore – SS 586: 2008, as amended by 2014 Amendment No. 1, SS586: Part 3: 2008
• Taiwan
– MoL No. 10302007861 ; EPA No. 0980078120
• Japan – JIS Z 7253:2012
• Thailand – Ministry of Industry Notification Re: the Hazard Classification and Communication
System for Hazardous Substances (B.E. 2555)
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Demonstration
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3E Releases Quarterly
update notifications
Attend Quarterly
Update webinar and Review
Release Notes
Install Technical Update
Data Sync via ADM
Test Technical Update
Perform Impact Analysis in ADM
&
Load Data
Run Rules and Generate templates
Update Process for your System’s Content
©2015, 3E Company, All Rights Reserved
Summary
• Regulatory requirements are constantly changing
• Product Stewardship teams are under pressure to produce accurate and extensive SDS documentation
• Applying best practices for:
- Regulatory and Scientific Data, Expert Rules, SDS Templates and Multilingual Phrase Management can help you stay on top of regulatory changes and ever increasing pressure to produce accurate SDSs
©2015, 3E Company, All Rights Reserved
Thank you!