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Transcript of Green - Global Product Stewardship
Delivering sustainable solutions in a more competitive world
Global Product Stewardship
Environmental InitiativeBusiness & Environment SeriesProduct StewardshipOctober 25, 2011
Delivering sustainable solutions in a more competitive world 2© COPYRIGHT 2009 ERM
Objective and Overview
Objective Today:
Product Stewardship Fundamentals
Business Impacts/Applicability
Regulatory Drivers
Approaches and Actions
Delivering sustainable solutions in a more competitive world 3© COPYRIGHT 2009 ERM
What is Product Stewardship?
1. Product Safety Support
• Is the product safe and sustainable as used for humans and the environment at all stages of product lifecycle from raw material sourcing, manufacturing, to marketing/use and disposal/recycle?
– Toxicology, ecotoxicology, physical/chemical property assessment to identify hazards (ex. PBT), fate & transport and impact assessment, and assistance in selection of “Greener Alternatives”
– This is quantitatively managed via Risk Assessment and Life Cycle Assessment tailored to the appropriate audience whether workers, customers, regulators, the public, or NGOs.
– Chemical Product Hazard Classification, MSDSs, and Labeling is a key issue that impacts global business (i.e., GHS/CLP).
Delivering sustainable solutions in a more competitive world 4© COPYRIGHT 2009 ERM
2. Global Product Regulatory Compliance
• Strategic and technical support to meet current and emerging regulatory compliance requirements
• New and existing chemical product registration at federal, state, and international levels:– Chemicals, Pesticides, Drugs, Feed Additives, Consumer
Products and durable goods across US, Canada, EU, China, South Korea, Japan
– Improved speed to market via ability to replicate regulators decision making schemes to gain government approvals of new products ASAP
• EU REACH legislation is a gigantic product re-registration issue with global business impacts and it is expanding globally
• Hazard classification, labeling, MSDS, product defense, Nanotechnologies, customs certification and supply chain issues like Walmart/Kmart registration
What is Product Stewardship?
Delivering sustainable solutions in a more competitive world 5© COPYRIGHT 2009 ERM
The squeeze
Sources Sources &&
SuppliersSuppliers
End of End of LifeLife
Products&Products&ServicesServices
OperationsOperations Your CustomersYour CustomersTheir CustomersTheir Customers(Consumers)(Consumers)
SupplierResistance
Market and RegulatoryExpectations
Delivering sustainable solutions in a more competitive world 6© COPYRIGHT 2009 ERM
Three business questions
1. What is in your products? What is the chemical composition? If you have these data, are they in a smart-searchable and automatable
database system?
2. What matters? What product performance claims are you making? What obligations or restrictions do you need to be concerned about in
the markets where you ship them?
3. What can you do about it? Can you comply, substitute, or reduce? Can you educate regulators or customers? Are there other business options to consider?
Delivering sustainable solutions in a more competitive world 7© COPYRIGHT 2009 ERM
Three business approaches
1. Put technical issues into business terms Understand business impacts Use business language
2. Look for both risk and opportunities Risks of product deselection and operating disruption are real Dealing with risks faster and better than the competition creates
opportunities
3. Build collaborative solutions Inside your company- probably not your traditional network Beyond your company, starting with business partners up- and down-
stream
Delivering sustainable solutions in a more competitive world 8© COPYRIGHT 2009 ERM
Value Chain in the Product Development Lifecycle
Product Stewardship Services
4 Current / Pending International Regulatory Understanding and Compliance
4 Global Regulatory Inventory Status
4 Sustainability Assessment
4 Risk Screening, Ranking and Prioritization Tools
4 Designing Waste/Risk out from Processes
4 Current / Pending International Regulatory Understanding and Compliance
4 Global Regulatory Inventory Status
4 Sustainability Assessment
4 Risk Screening, Ranking and Prioritization Tools
4 Designing Waste/Risk out from Processes
4 Litigation
4 HPV / VCCEP / ICCA
4 Monitoring and Compliance Reporting to Government Agencies
4 Regulatory Influencing
4 Trade Association Task Force Management
4 Public Relations Issue Management
4 REACH and REACH-Like Regs
4 Litigation
4 HPV / VCCEP / ICCA
4 Monitoring and Compliance Reporting to Government Agencies
4 Regulatory Influencing
4 Trade Association Task Force Management
4 Public Relations Issue Management
4 REACH and REACH-Like Regs
4 Safety Reassurance
4 Literature Searching
4 QSAR Application
4 GLP Product Testing
4Phys/Chem
4Environmental
4Human Health
4Efficacy
4 Global Hazard Classification and Labeling
4 Safety Reassurance
4 Literature Searching
4 QSAR Application
4 GLP Product Testing
4Phys/Chem
4Environmental
4Human Health
4Efficacy
4 Global Hazard Classification and Labeling
4 Customized for Regulator or Client Needs
4 Use of Regulator’s computer models/tools for exposure & risk assessment
4 Site Specific4 Nationally Marketed
4 Product Life Cycle and Risk/Benefit Assessment
4 Customized for Regulator or Client Needs
4 Use of Regulator’s computer models/tools for exposure & risk assessment
4 Site Specific4 Nationally Marketed
4 Product Life Cycle and Risk/Benefit Assessment
4 Assembly of Dossier for regulatory submission
4 Managing interface with regulators
4 Poison Control Center Registration
4 Technical Claim Support
4 Public Relations Risk Management
4Crisis4Proactive
4 Assembly of Dossier for regulatory submission
4 Managing interface with regulators
4 Poison Control Center Registration
4 Technical Claim Support
4 Public Relations Risk Management
4Crisis4Proactive
4 Industrial Hygiene
4 Training
4 Occupational Exposure Guidelines
4 Plant and Field Auditing and Monitoring and Permitting
4 Waste Characterization and Management
4 Industrial Hygiene
4 Training
4 Occupational Exposure Guidelines
4 Plant and Field Auditing and Monitoring and Permitting
4 Waste Characterization and Management
Post-Market Product Support
Post-Market Product Support
Manufacturing Optimization
Manufacturing Optimization
Registration Dossier Prep.Registration Dossier Prep.
Risk Assessment
Risk Assessment
Product Testing
Product Testing
Technology / Product Optimization
Technology / Product Optimization
Delivering sustainable solutions in a more competitive world 9© COPYRIGHT 2009 ERM
Emerging strategic product issues
Proliferating regulations in developed and emerging markets
Innovation, global competition and “speed to market”
Nanotechnology
Energy consumption and related products
Supply chain “Greening”
Step changes in analytical measurement and hazard assessment methodology Personal Care/Pharmaceuticals in Environment
Endocrine Disruption
Cumulative and aggregate risk assessment
Delivering sustainable solutions in a more competitive world 10© COPYRIGHT 2009 ERM
DSL
HPV/IUR/ TSCA/FQPAFDA/CPSC
HPV/VCCEP
EPR and Reverse Logistics
REACH ELV
WEEE/ROHS
New Laws and Amendments in
Emerging Markets
METI
POPs/PBTs/CMRs
Global Climate Change
Sustainability
Transparency
NICNAS
Globally Harmonized
System & MSDSs
Green House Gases
TCCL
Product Global Regulatory Compliance Challenges
Delivering sustainable solutions in a more competitive world 11© COPYRIGHT 2009 ERM
Product Global Regulatory Compliance Challenges
The global proliferation of chemical control and downstream product regulations and restrictions is a major challenge facing Multi-National Corporations (MNCs)
In business terms this represents a strategic barrier to innovation and a major source of enterprise risk that MNCs are not all suitably positioned to control
As these regulations have evolved……. No two are alike They tend to have global supply chain impacts beyond the specific national
jurisdiction
Net, the cost of international business is increasing, and product & supply chain compliance and stewardship is becoming a critical business function
A significant burden, but also a potential source of opportunity and competitive advantage
Delivering sustainable solutions in a more competitive world 12© COPYRIGHT 2009 ERM
Key Points:• Nearly 10-fold increase in number of
emerging environmental regulations globally within the last 8-yrs!
• Focus on substance related regulations in the coming years (REACH, GHS/CLP, TSCA, Safe Chemicals Act etc)
Delivering sustainable solutions in a more competitive world 13© COPYRIGHT 2009 ERM
Key Point:• General increasing trend of the number of
environmental regulations on a global-scale• Dynamic switch in recent year from EU & AP
to US and Canada• Technical progress and milestones for
implementation of regulations entered into force in previous years are becoming increasingly important to follow.
Delivering sustainable solutions in a more competitive world 14© COPYRIGHT 2009 ERM
Delivering sustainable solutions in a more competitive world 15© COPYRIGHT 2009 ERM
GE notes critical nature of product stewardship
GE Citizenship – 2009 Global Focus on RegulationsReleased July 20, 2010
“Examples include the release of a Product
Stewardship toolkit as an interactive, user-friendly
and relevant framework in support of R&D, Product
Design/Re-design and launch to market.”
Delivering sustainable solutions in a more competitive world 16© COPYRIGHT 2009 ERM
Enterprise Risk?
Strategic Risk that can affect Brand and demand for your products
Risks that can impact Speed to Market and Intellectual Property
Change in Customer Critical Requirements (Black List Effects)
Operational Disruption of supply chain or site operations (i.e. materials stuck in Customs or no longer available)
Risks that can damage your credibility in the marketplace (i.e. – Producer Responsibility / Product Take back)
Financial Risk to shareholder and marketplace acceptance
Risks to Raw Material pricing and availability (i.e. chemicals under pressure in the market place)
Legal & Compliance Risk of action by regulatory agencies, courts, individuals, customers, suppliers/partners, supply chain
SOME EXAMPLES
Global Product Stewardship/Compliance KEY in supporting ability to sustain: global product development; global market access; global company reputation
Product Global Regulatory Compliance Challenges
Delivering sustainable solutions in a more competitive world 17© COPYRIGHT 2009 ERM
Product Global Regulatory Compliance Challenges
How Did We get Here?
North American and EU Chemical and Product Safety Reassurance and “Right to Know” initiatives been the foundational driver for these regulations
>50,000 chemicals in commerce pre-1970’s were “Grandfathered” and accepted as already on the markets without government review and transparent safety reassurance
Hazard versus Risk based approaches had been a key variable
Early regulations sought to control chemical products with an eye towards: Worker/Public/Consumer Safety, and eventually Worker, Community, & Public Right to Know (i.e. Transparency)
Latest trends have focused on Sustainability and Transparency with a “Reversal of the Burden of Proof of Safety” from Government to Industry
Importantly, EU regulators have been leading the way in evolving and globally exporting their regulatory initiatives for the past 20 years
The Globally Harmonized system for Hazard Classification & Labeling (GHS), REACH, and Extended Producer Responsibility initiatives are key examples
These are spreading around the world and no two are identical!
Delivering sustainable solutions in a more competitive world 18© COPYRIGHT 2009 ERM
GHS (Globally Harmonized System for Classification and Labeling of Chemical Substances)
What is GHS? Why is there a GHS?• Classification and Labeling globally inconsistent:
Disparate “Hazard Communication”
Dissimilar Labeling
Compromised SDS content
• Enhance safety to human health & environment, including the workplace
• Global Market: “Level the Field”
Help standardize existing national regulatory regimes (mature countries)
Simplify development and deployment of new chemical regulatory regimes (developing countries)
• Standardizes and classifies chemical substances by “hazard”
• Provides comprehensive communication criteria for packaging (labels) and SDS’s
• Non-regulatory as such, but countries encouraged to adopt in to their ownRegulatory programsby 2008. Adoption isramping up nowacross the globe (e.g. REACH/CLP, China)
The so-called “Purple Book”
Third Revised Version
Global Implementation is NOT harmonized!
Delivering sustainable solutions in a more competitive world 19© COPYRIGHT 2009 ERM
EU Harmful (St. Andrew’s Cross)
US Toxic
CAN Toxic
Australia Harmful
India Non-toxic
Japan Toxic
Malaysia Harmful
Thailand Harmful
New Zealand Hazardous
China Not Dangerous
Korea Toxic
Historically, there has been global disharmony in chemical Classification and Labeling.
ex. Different risk phrases were used for a substance with an Acute Oral Toxicity LD50 ~257 mg/kg/day.
Illustration of why is GHS necessary?
GHSGHS Toxic (Danger + Skull & Cross Bones)Toxic (Danger + Skull & Cross Bones)
Delivering sustainable solutions in a more competitive world 20© COPYRIGHT 2009 ERM
ExplosivesSelf-Reactive Substances and MixturesOrganic Peroxides
Oxidizing GasesOxidizing LiquidsOxidizing Solids
Gases under pressureRefrigerated Liquefied gas
Corrosive to Metals
Flammable GasesFlammable AerosolsFlammable LiquidsFlammable SolidsOrganic PeroxidesSelf-Reactive Substances and MixturesPyrophoric SolidsSelf-Heating Substances and MixturesContact with Water, Emit Flammable Gas
Physical-Chemical Hazards
GHS Pictograms
Delivering sustainable solutions in a more competitive world 21© COPYRIGHT 2009 ERM
Acute Toxicity: Danger
Acute Toxicity: WarningSkin Corrosion/Irritation: Warning (irritation)Eye Damage/Irritation: Warning (irritation)Skin Sensitization: WarningSTOT* Single: Warning (Category 3)* Specific Target Organ Toxicity
Skin Corrosion/Irritation: Danger (Corrosion)Eye Damage/Irritation: Danger (Corrosion)
Germ Cell Mutagenicity: Danger, WarningRespiratory Sensitization: DangerGerm Cell Mutagenicity: Danger, WarningCarcinogenicity: Danger, WarningToxic to Reproduction: Danger, WarningSTOT Single : Danger (Cat 1), Warning (Cat 2)STOT Repeated: Danger, WarningAspiration Toxicity: Danger, Warning
Hazardous to the Aquatic Environment, Warning
Human Health and Environmental Hazards
GHS Pictograms
Delivering sustainable solutions in a more competitive world 22© COPYRIGHT 2009 ERM
Alignment of the OSHA Hazard Communication Standard to the GHS
• Final Rule pending Expected in August, 2011, then September, 2011 – still waiting….. Phase-in period of 2-3 years anticipated once final
• Major proposed changes to the HCS Hazard classification (substances and mixtures) Labels (includes harmonized signal word, pictogram and hazard
statement + precautionary statements) Safety Data Sheets (specified 16-section format) Information and training (require workers are trained within 2 years of the
publication of final rule)
• Over 40 million workers and 5 million workplaces will be impacted Significant costs associated with classifying chemicals and revising
SDSs and labels (OSHA estimates $11 MM/year for ~90,000 establishments)
OSHA estimates worker training costs of ~44 MM/year for affected workplaces
Delivering sustainable solutions in a more competitive world 23© COPYRIGHT 2009 ERM
REACHRegistration
Evaluation
Authorization/Restriction
……………….of Chemical Substances
In some respects true, but it really means…….
new European Union Chemicals Legislation Implemented from 2007 through 2018, but this regulatory framework and approach to chemical control is now “spreading” globally!
Delivering sustainable solutions in a more competitive world 24© COPYRIGHT 2009 ERM
Really
Eliminate
All
Chemicals
REACH =
Delivering sustainable solutions in a more competitive world 25© COPYRIGHT 2009 ERM
REACH Covers:• Chemical substances – as such
• Preparations – Mixtures of Chemical Substances
- Including Alloys
• Articles
• Articles designed to release• An ink cartridge is an article that contains a substance/preparation (ink)
REACH IS NOT a PRODUCT REGULATION [like WEEE (waste electrical and electronic equipment) and RoHS (restriction of the use of certain hazardous
substances in electrical and electronic equipment)]. IT IS A CHEMICAL SUBSTANCE REGULATION with direct impact on Products and
Global Supply Chains.
SiO2 Powders
Organic Polymer+ Pigments
Metal Alloy formed to give it a functional part
Article with embeddedPerfume designed to release
Delivering sustainable solutions in a more competitive world 26© COPYRIGHT 2009 ERM
II. No Data/No Info…..No Market in the EU
• Manufactures, Importers and downstream users all have obligations
• Management of Change systems needed to stay in compliance
Principle REACH Concepts:I. “Safe Use” of Chemicals Across Supply Chains +
Elimination of the “Hazardous” Ones
• Global Supply Chain Impacts
• Requires Industry Collaboration and Alignment
• Introduces “Substances of Very High Concern” (SVHCs) which also impact articles (e.g., automobiles, furniture, packaging, etc.)
Delivering sustainable solutions in a more competitive world 27© COPYRIGHT 2009 ERM
New CLP (including GHS Classification & Labeling System)
Substances & Mixtures Transition (3 yrs)
Current EU System (DSD/DPD): Obligatory CLP/GHS System for substances and mixtures: Voluntary
*Deadline for reclassification of substances according to CLP (GHS) — 12/01/10
*Obligation to confirm supply chain alignment with Art. 36 record keeping
EU CLP IMPLEMENTATION
MILESTONES
Mixtures Transition (+ 4.5 yrs)
DPD System mixtures: Obligatory CLP/GHS System Obligatory
(substances); Voluntary (mixtures)*Deadline for reclassification of Mixtures according to CLP (GHS)
— 06/01/15
Current EU Directives 67/48/EEC
& 1999/45/EC repealed 06/01/15
GHS System: Obligatory
CLP Regulation(EC) 1272/2008EIF 1/20/2009
GHS Proposal adopted by EU Commission 06/27/07
In 2009 Companies Implement CLP• Check and Align on Annex VI for
Classifications made by EU Authorities, 30th & 31st ATP
• Align and Classify according to the EU CLP criteria and SIEFs where self-classification is necessary
• Understand the implication of new CLP classifications to REACH substance registration timing and possible Candidate Listing
Pre-CLP EU classification & labeling System (DSD/DPD)
SDS format under REACH
Mixture Deadline06/01/15
Substances Deadline 12/01/10AND
C&L Notification Deadline 1/3/11
KEY: ECHA = EU Chemical Agency; CLP = Classification and Labeling and Packaging Regulation; EIF = Enters in Force; GHS = Globally Harmonized System of Classification and Labeling;
DSD/DPD = Dangerous Substances and Preparations Directives and 67/48/EEC & 1994/45/EC; SVHC = Substance of Very High Concern
EU REACH and CLP Implementation Timelines 2007 2008 2009 2010 2013 // 2018
Companies Prepare for REACH in 2009• Update Chemical Substances Inventories• Define legal entity structure in EU• Register phase-in substances• Track REACH strategy, by substance:
• What is the Registration deadline?• Is there an Authorization risk?• Suppliers registrations?• Locate (internal) data, ID data gaps• Participate in SIEFs
ECHA Operational
REACHEIF
06/01/07
Pre-Registration06/01/08 - 12/01/08
Phase-In Registration > 1000 tpa; CMR 1&2 > 1 tpa; R50-53 > 100 tpa Deadline 11/30/10
Phase-In Registration > 1 tpa; Deadline 05/31/18
Registration of New Substances with Chemicals Agency
Phase-In Registration > 100 tpa; Deadline 05/31/13
Pre-Registration SIEFs Operational until 1 June 2018Pre-SIEF Discussions
> 1000 tpa/ CMR/R50/R53 Phase-In 11/30/10
> 100 tpa Phase-In 05/31/13
> 1 tpa Phase-In 05/31/18
Rec. Authorization List Annex XIV
06/01/09
Initial Candidate List Release 10/9/08
First 7 substances prioritized forAnnex XIV 1/14/09
Second Group for Candidate List Proposed 9/1/09; Added to CL 1/13/10
EU REACH IMPLEMENTATION
MILESTONES
8/3/2010 Public Consultation on 8 new Potential Candidate List Substances; 30/3/10 Acrylamide added to the CLS
Delivering sustainable solutions in a more competitive world 28© COPYRIGHT 2009 ERM
GHS and “REACH-Like” Chemical Control Programs are Spreading Globally, but No Two are Alike!
General Chemical Control Laws (Registrations, Inventories, GHS/SDS/LabelRestrictions, Notifications, Bans, Lists, etc.)
Countries Comment CommentChina (REACH Like amendments ) Effective Date
10/15/2010GHS 2/2/2009, Classification, Labeling Hazard Communication of Chemicals 5/1/2010 (one year transition period for labels of substances and mixtures).
India 2000 Amended HCR (List based - 685), no Inventory.
GHS compatible CLP Q2-2011
Korea TCCA Amended 10/2009 (blend of TSCA & REACH)New REACH like amendments announced week January 24, 2011
Final classifications est. 12/17/2010 - mandatory C&L substances 7/ 2011 / for mixtures July 2013. GHS implemented July 1, 2011-substances / July 1, 2013-mixtures. Manufacturers/importers to supply GHS compliant SDSs by July 2011.
Malaysia Notification and registration scheme (Volume based / REACH-like) expected mandatory in 2011.
Final GHS requirements expected late 2010 or in 2011, implementation is expected between 2010-2012 timeframe
Taiwan Inventory built by Ind Noms thru 12/2010. NSN scheme expected 7/2011. Existing chemicals nominations required 12/30/2010. Publication of Existing Substances Inventory 6/30/2011.
List based since 2006, 6/30/2010, 12/31/2014
SingaporeRestrictions / Licenses required 11/08-12/10 | 11/09-12/12Japan First phase in 2010 - harmonize with international
practice. Second phase in 2011 - achieve the WSSD 2020 goal efficiency.Chemicals will be designated by end of FY2010, exempted for certain chemicals.
List based since 2006. All mixtures/subs by 12/2010.
Indonesia TBD GHS MSDS and labels mandatory - single substances and voluntary for mixtures (Q2)-2010.
Russia TBD Chemical product safety passport, labeling 1/1/2009. Test methods-planned effective date: end of 2010 to end of 2011. Classification of mixtures of environmental hazards-planned effective date end of 2012.
Philippines
A pre-manufacturing & pre-import notification required for chemicals placed on the market >1000 kg/yr.
Implemented 6/2009 (1-2 yr implementation)Adoption of GHS elements for labels and MSDSs (2007)-3 year window).
Thailand 1600 substances on Hazardous List Registration required; Permit required.
7/2008 / 7/2012
Vietnam New CL 2008 (new Agency 1/2009) - Registration New Chemical Law as of 7/2008.
Effective now - was adopted as part of new C&L by 2011.
Delivering sustainable solutions in a more competitive world 29© COPYRIGHT 2009 ERM
Chemicals Regulation & GHS Components
General Chemical Control Laws•MAJOR Regulatory Amendment 1/2010 (REACH Like) •Six Supplementary Documents 9/2010
1) Guidance for New Chemical Substance Notification and Registration2) Codes for Supervision, Management and Check on new Chemical Substances3) General Notification Form for New Chemical Substance and Instructions4) Simple Notification Form for New Chemical Substance and Instructions5) Scientific Research Filing Table for New Chemical Substance and Instructions6) First Activity Reporting Form and Instructions
•Effective Date 10/15/2010
GHS/SDS/Label•Incorporates (as provisions) 28 existing standards covering Material Safety Data Sheets, 26 GHS endpoints, GLP and the International Program on Chemical Safety/Environmental Health Criteria No. 225•Mandatory GHS Implementation 5/1/2010, one year transition period for substances and mixtures
China
Delivering sustainable solutions in a more competitive world 30© COPYRIGHT 2009 ERM
Brazil Product & Chemical Programs
Topic Legislation Effective Date Effect Status
WEEE type Article 33 of Law # 12.305 (Brazil New Waste Law)
08/02/2010 Supersedes all existing federal level waste laws
Mandatory
RoHS type ABNT NBR IECQ 080000-2010 01/01/2011 Aligns with EU RoHS Directive
Non-mandatory (for now)
DfE / Eco Design type ABNT NBR IECQ 62430-2010 02/01/2011 Aligns with EU EuP / ErP Directives
Non-mandatory (for now)
Chemical Control Laws No Federal level Inventory program. All sectoral specific
Legacy Driven in sectoral and state level programs
Mandatory / Non-mandatory …No view toward a REACH-like program (yet)
GHS NBR 14725 : 2009 02/27/2011 Substances 06/01/2011 Mixtures
Authoring and Receiving SDS’s from Suppliers
Mandatory NOW for substances
Delivering sustainable solutions in a more competitive world 31© COPYRIGHT 2009 ERM
GHS in Brazil
• There currently is no banned/controlled substances lists or chemical inventory or registration scheme
• But, GHS has been implemented in Brazil (NBR 14725:2009)– currently based on UN GHS Rev. 1 (with only 2 very minor differences)– Brazil currently working toward alignment with UN GHS Rev. 3
• The NBR implements GHS in 4 Sections:– 14725:2009-1 Terminology– 14725:2009-2 Classification – 14275:2009-3 Labeling– 14275:2009-4 SDS
includes unique CBI clause option (to mask identity so long as hazards presented) requires in Section 15 reference to any applicable Brazil legislations (I.e. Mercosul Agreement on bilateral trade) / International Conventions (I.e. Montreal Protocol)
• Mandatory Implementation– for substances as of February 27, 2011– for mixtures as of June 1, 2015 (can use NBR 2005 or NBR 14725:2009 until mandatory deadline)
Everything in Portuguese-When “receiving” (including Imports) or placing on Brazil Market-When exporting to other country, destination country language typically required
Delivering sustainable solutions in a more competitive world 32© COPYRIGHT 2009 ERM
Brazil National Waste Law (12.305/2010) and Implementing Regulation (Decree 7.404/2010)
• Solid / Hazardous Waste Provisions• Reverse Logistics on certain waste
“products” and their “packagings”
Consumer Merchants/Distributors (M/D)
Manufacturer / Importer (M/I)
AdequateEnvironmentalTreatment by M/I
AdequateEnvironmentalDisposal (refuse)by M/I
No Reporting (yet)--------------------GeneralRecordkeepingExpectation onM/D’s AND M/I’sto demonstratecomplianceupon inspection
$ $
$Product Categories cited in Scope:• Agrochemicals (includes pesticides & their packagings)• Batteries• Tires• Oil lubricants & their packagings• Fluorescent lamps, sodium & mercury vapor lamps and mixed lamps• Electro-electronic products and their components
Implementation details / other definitions remain unclearPotential impact on MNCs is large
Reverse Logistics Concept (applicable product and/or packaging)
Law contains 57 legislative “Articles”Article 33 is that of the “Reverse Logistics” program
Full scope of products/product types in this category remains unclear
Delivering sustainable solutions in a more competitive world 33© COPYRIGHT 2009 ERM
Global Product Regulations AcrossChemical Supply Chains & Market Sectors
4Petroleum and Coal Derived materials
4Mined Ores
4Plant and Animal Derived Products and Feedstocks
4Petroleum and Coal Derived materials
4Mined Ores
4Plant and Animal Derived Products and Feedstocks
4Specialty Organic and Inorganic Chemicals
4Polymers4Industrial Products
4 Pesticides/Agricultural Chemicals
4Parts/Articles4Building Materials4Perfumes/Dyes
4Specialty Organic and Inorganic Chemicals
4Polymers4Industrial Products
4 Pesticides/Agricultural Chemicals
4Parts/Articles4Building Materials4Perfumes/Dyes
4Packaged Consumer Goods4Pesticidal, Anti-Microbial4Food Contact/Additives4OTC Healthcare/Medical Devices4Cosmetics, Personal Care4Pharmaceuticals
OEMs:4Transportation (Auto, Rail, Aerospace,
Defense)4Electronics, Batteries4Public Sector4Nanotechnology4Global/Local Regulatory Tracking
4Packaged Consumer Goods4Pesticidal, Anti-Microbial4Food Contact/Additives4OTC Healthcare/Medical Devices4Cosmetics, Personal Care4Pharmaceuticals
OEMs:4Transportation (Auto, Rail, Aerospace,
Defense)4Electronics, Batteries4Public Sector4Nanotechnology4Global/Local Regulatory Tracking
FinishedProductsFinishedProducts
IntermediateProducts
IntermediateProducts
PrimaryChemicalsPrimary
Chemicals
REACH, GHS, RoHS Cut Across These Sectors Globally
• MNCs need a global supply chain approach to addressing their specific obligations
• Downstream product regulations become increasingly specialized and MNCs need to invest in mastery of these regulations to be in these markets
Delivering sustainable solutions in a more competitive world 34© COPYRIGHT 2009 ERM
ERM Perspective:The global proliferation of chemical control and downstream product regulations and restrictions is a major challenge facing MNCs
What it takes to Comply MNCs need to operationalize for product compliance and stewardship Proactive internal and external program elements
Internal – To your Business and Supply Chain
Cross Functional Business Engagement: Management, EHS, Product Quality/Technology, Legal, IT, Purchasing/Sourcing Appropriate use of outside resources for expertise and capacity
Know your products, supply chains, and obligations: Develop Inventory of Chemical Substances, Direct and Indirect, how much do you use and what
used for? Which ones are “Critical” or “At Risk” Understand your suppliers and customers, what are they doing with your products and are they
supporting your uses? Be prepared to demonstrate safe and sustainable use …”Take the Scientific High Ground” and
consider providing proactive leadership and transparency
Delivering sustainable solutions in a more competitive world 35© COPYRIGHT 2009 ERM
ERM Perspective:What it takes to Comply Continued……
External – To your Business and Supply Chain
Understand and Influence the Regulations Mastery in regulatory requirements, especially how new products are reviewed and assessed by authorities, can
be a source of competitive advantage » (i.e. Speed to Market!)
Opportunity to influence new regulations and restrictions if you engage early enough
Know your Industry Peers and Industry Associations Benchmark to identify common shared interests and best practices Industry voice more impactful than single company voice Protect Intellectual Property & Confidential Business Information (CBI)
Steward Critical to Business Technologies Know the current and emerging scientific trends Consider proactive presentations and peer review publications, blue ribbon panels and scientific advisory groups
as appropriate
Delivering sustainable solutions in a more competitive world 36© COPYRIGHT 2009 ERM
THANK YOU!
Dianne Green
Senior Project Manager - ERM9987 Carver Road - Suite 240
Cincinnati, OH 45242513-830-9035 (Office)513-830-9031 (Fax)
513-739-7111 (Mobile)
One Planet. One Company. ERM.