1. No category

Challenges in Global Product
Safety and Stewardship
Compliance
Alex Ortiz and Julia Tsvetkova
March 17th, 2015
©2015, 3E Company, All Rights Reserved
Agenda
• 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
©2015, 3E Company, All Rights Reserved
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/
Classification
Registration
Labeling
• EU REACH SVHCs
• Japan CSCL (PAC)
• Korea “REACH”
• GHS/CLP
• Classification
• Labeling
• Packaging
©2015, 3E Company, All Rights Reserved
Environment
• Emissions
• GHGs
• Waste – ELV, WEEE
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
©2015, 3E Company, All Rights Reserved
Regulatory Content – The Pieces
1. Accurate, up-to-date substance data
Regulatory
Scientific
2. Accurate, up-to-date product data
SDS
Compliance Documents
3. Dynamic and Global Rules, SDS Templates and Multilingual Phrases
Country Specific
Industry Requirements
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
Ariel WebInsight (WI)
• Subscription based online reference tool with easyto-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
©2015, 3E Company, All Rights Reserved
WebInsight – New & Amended Lists
1200
1000
800
712
600
400
911
607
200
269
0
112
95
2012
2013
©2015, 3E Company, All Rights Reserved
2014
4 Topics of Interest Recently Expanded
• Chemical Weapons Convention (CWC)
• Controlled Drugs and Precursors
• Dual Use Lists and Explosives lists
• PIC lists
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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 Nalkylphenethylamine, alpha-methylphenethylamine, an N-alkyl-αmethylphenethylamine, α-ethylphenethylamine, or an N-alkyl-αethylphenethylamine 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.
©2015, 3E Company, All Rights Reserved
PCTEC Plus for
Scientific Data
Physical Chemical,
Toxicological and
Eco-Toxicological data
©2015, 3E Company, All Rights Reserved
NLM, ECHA,
EPA, HSDB…
Full Text
Documents
NTP, NIOSH,
ATSDR …
PCTEC Plus
Structured
Data
PCTEC Plus
PCTEC
PCTEC Plus Scientific Data
Full Text
Web
resources
IRIS, ITER,
TOXLINE,
PubMed …
200,000+ CAS RN
120+ Sources (DB + FT)
1M+ Records
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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
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
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
PCTEC Plus – Additional Uses
Evaluate toxicological and physicochemical properties
of alternatives – 3E ‘CAAS’
– Green chemistry
– Sustainable alternatives
– Improved compliance
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
3E Chemical Alternatives Assessment System
Chemical Alternatives Assessment System
• Comprehensive method of comparing toxicological and ecotoxicological 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
©2015, 3E Company, All Rights Reserved
Demonstration
©2015, 3E Company, All Rights Reserved
Ariel WebInsight Mobile
• Perform a chemical or database search from your
tablet or smart phone
• http://mobile.arielresearch.com
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
Accurate Up-to-date ‘Integrated’
Substance Data
• Substance Data
– Regulatory
– Scientific
• Best Practices
– SDS System Compliance Integration
a.
b.
c.
Understand and load data applicable to your business
Run Impact Analysis to find impacted substances and products
Automated Update process
©2015, 3E Company, All Rights Reserved
Understanding Your Data
Regulatory Data
• Classifications
• Health Data
• Restricted
Substances
PCTEC
Dangerous
Goods
• Physical &
Chemical
• Toxicity
• Eco-Tox
• International
Data
• Country
Specific Lists
©2015, 3E Company, All Rights Reserved
Supplier Data
• VSDS
• Manual Entry
The Data Load Process
EHS Compliance
System
©2015, 3E Company, All Rights Reserved
ADM EHSAP Impact Analysis
• Analyze
• Select
• “Generics”
Decision
Support
Impact
Analysis
• Real_Sub impact
report
• List_Sub impact
report
•
•
•
•
Configure
Map
Save
Schedule
Load
Detailed RegImpact Reports
©2015, 3E Company, All Rights Reserved
+ Usability and Technical
Enhancements
Regulatory Content – The Pieces
1. Accurate, up-to-date substance data
Regulatory
Scientific
2. Accurate, up-to-date product data
SDS Documents
Other Certificates and Rules
3. Dynamic and Global Rules, SDS Templates and Multilingual Phrases
Country Specific
Industry Requirements
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
ADM-Supplier Process
Initial Load
Request a list of products in SAP EHSM
SAP Material
Master
Response with MSDSs and metadata for storage in SAP
Material
Inventory
SAP EHSM
ADMVMSDS
Application
Internet
Web Service
Request a list of impacted products
SAP SD
(Document
Distribution)
Response with MSDS and metadata for storage in SAP
Data Updates
©2015, 3E Company, All Rights Reserved
3E Central Repository
•
Real Sub/MM ID
•
MSDS/Supplier Cert
•
Language
3E Catalog
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
3E’s Cloud – New Rules
• 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
ADM VSDS
ADM
EHSAP
ADM
MM
Product Level Data
©2015, 3E Company, All Rights Reserved
Demonstration
©2015, 3E Company, All Rights Reserved
Regulatory Content – The Pieces
1. Accurate, up-to-date substance data
Regulatory
Scientific
2. Accurate, up-to-date product data
SDS
Other Certificates and Rules
3. Dynamic and Global Rules, SDS Templates and Multilingual Phrases
Global Scope
Country Specific Requirements
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
Global Scope
Americas
• US Federal
and State
• Canada
• Mexico
• Brazil
• Uruguay
EU
• CLP
• DPD
• DPD to CLP
Conversion
• Country
specific
Asia Pacific
Non-regional
Transport
• Australia
• China
• Japan
• Korea
• Malaysia
• Singapore
• Taiwan
• Thailand
• New Zealand
• Inventory
Status
• Formulation
• HNOC
• Global
Conventions
• Generic GHS
• Classes 2, 3,
4, 5, 6.1, 8
and 9
©2015, 3E Company, All Rights Reserved
Expert Rule Types
Classifications
Section 2
Label elements
Hazardous ingredients
Section 3
Reportable composition
Occupational Exposure limits
Section 8
Country specific local
regulations/Inventories
Section 15
Ariel Rules Builder
©2015, 3E Company, All Rights Reserved
Soft Sec. (4. 5, 6,
7, 8, 9, 10, 11)
Rules Builder: A User Friendly Tool to
Author/Create Rules
Property Tree
Phrases
Rules
Builder GUI
SAP EHSM
-Value
Assignments
-Inheritance
.mdb files
.rul files
Rules
Generator
Rules
Generat
Phrase
orAssignment
Content
EHS
Expert
©2015, 3E Company, All Rights Reserved
Benefits
• Easy to use
interface
• Prepackaged
content
• Allows extended
automation
‘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
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
SDS Multilingual Phrases
Ara bi c
Bra zi l Portugues e
Bul ga ri a n
Ca na di a n French
Chi nes e
Chi nes e tra d.
Croa ti a n
Czech
Da ni s h
Dutch
Engl i s h
Engl i s h UK
Es toni a n
Fi nni s h
AR
1P
BG
3F
ZH
ZF
HR
CS
DA
NL
EN
6N
ET
FI
French
Germa n
Greek
Hebrew
Hunga ri a n
Icel a ndi c
Indones i a n
Ita l i a n
Ja pa nes e
Korea n
La tvi a n
Li thua ni a n
Ma l a ys i a n
Mexi ca n Spa ni s h
Hi ndi
©2015, 3E Company, All Rights Reserved
FR
DE
EL
HE
HU
IS
ID
IT
JA
KO
LV
LT
MS
1X
HI
Norwegi a n
Pol i s h
Portugues e
Roma ni a n
Rus s i a n
Serbi a n
Sl ova ki a n
Sl oveni a n
Spa ni s h
Swedi s h
Tha i
Turki s h
Ukra i ni a n
Vi etna mes e
NO
PL
PT
RO
RU
SR
SK
SL
ES
SV
TH
TR
UK
VI
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
Generic GHS
Australia
China
Japan
Korea
Malaysia
Singapore
Taiwan
Thailand
New
Zealand
• Arabic
• Non Arabic
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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)
©2015, 3E Company, All Rights Reserved
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
©2015, 3E Company, All Rights Reserved
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)
©2015, 3E Company, All Rights Reserved
Demonstration
©2015, 3E Company, All Rights Reserved
Update Process for your System’s
Content
3E Releases
Quarterly
update
notifications
Run Rules and
Generate
templates
Attend
Quarterly
Update webinar
and Review
Release Notes
Perform Impact
Analysis in ADM
&
Load Data
Test Technical
Update
Install Technical
Update
Data Sync via
ADM
©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!
©2015, 3E Company, All Rights Reserved