How to Manage Regulation as a Global Business Chemical Watch Regulatory Summit December 2013 Christina Widodo 3E Company ©2013, 3E Company, All Rights Reserved Agenda • Trading with South America, Asia and the EU; • State level regulation; • The horizon - what US companies need to look out for ©2013, 3E Company, All Rights Reserved Regulations Affect Businesses Everywhere … affecting the entire supply chain… … targeting substances and products … Data Exchange and Collaboration § SIEFS and Consortia Customers Regulatory Authority Substa Registrati nce ons Document Data s Sales ICCA … affecting product/ substance substitutions R&D SAIC M Suppliers Purchasing Materials Management Production Core Business Processes Ever more complex regulations … … to secure your business ©2013, 3E Company, All Rights Reserved Vast And Complex Regulatory Landscape Chemical Workplace Transportation GHS: Global Harmonization System European Chemicals Agency Registration, Evaluation, Authorization and Restriction of Chemicals Environmental Health & Safety Commission: UK Security Local Criminal TSCA (1) 4 ©2013, 3E Company, All Rights Reserved Vast and Complex Regulatory Landscape • Content/ Regulatory Information Management – Identify, understand relevant and applicable regulatory requirements – Track and manage complex global regulatory data/ information and process – Content dissemination ©2013, 3E Company, All Rights Reserved Managing Regulatory Challenges 1970’s Major EHS rules and regulations published 1980’s 1990’s Check-list dependent BAT and precautionary principle Green chemistry (EU) Authority Control based approach Responsible care & local community relations Hazard label regulations MSDS/SDS regulations ISO and EMAS certifications Quality management End user influence  Proliferation of regulations  Regulations becoming stricter over time  Compliance v. innovation ©2013, 3E Company, All Rights Reserved 2000’s Next EU REACH Future Regulatory Drivers GHS REACH GHS Nanomaterials Managing Regulatory Challenges (Impacting all teams) Sample of recently changed, or new regulations: Restricted Substances • RoHS • Phthalates • BPA Authorization/ Classification Registration Labeling • EU REACH • Japan CSCL (PAC) • K-REACH • China REACH • GHS/CLP • Classification • Labeling • Packaging Environment • Carbon Reporting • Emissions • GHGs • Waste – ELV, WEEE Corporate Social Responsibility • US Dodd Frank for conflict materials  Increase in frequency and volume of regulatory changes  Burden of assessing and complying with changes has increased  Fewer resources and smaller budgets = Pool resources , share burden and yield significant benefits ©2013, 3E Company, All Rights Reserved 7 Trading with South America, Asia, Europe • Challenges – Lack of visibility – Lack of clarity – Local compliance issue • Consequences – Non-conformance – Mismanagement of regulations ©2013, 3E Company, All Rights Reserved Global Marketplace • Uncertainty of regulations in emerging markets – Regulatory interpretation – Compliance/ Enforcement ? – Visibility into future regulatory requirements ? • EU – Regulatory interpretation – Mitigating risk (Regulatory compliance v. Industry ‘Best practices’) ©2013, 3E Company, All Rights Reserved State Level Regulations • General Facts: – Regulations may exist in print, but not updated frequently – State Regulations mostly incorporates the Federal Regulations by reference – Not enforced as well as Federal • Challenges: – Identify differences between State and Federal regulatory requirements – Tracking when States revise their regulations ©2013, 3E Company, All Rights Reserved Knowledge Management Supply Chain R&D EHS/HSE Product Stewardship Sustainability ….Yes, share our data! But how, across so many teams? ©2013, 3E Company, All Rights Reserved Central Repository One “single version of the truth” - One reference point Sharing data and documents ©2013, 3E Company, All Rights Reserved Knowledge Management Process (Take a deep breath…!) Initiate collaboration Identify common regulatory needs: Evaluate data delivery mediums • Bring teams together to identify common challenges • Evaluate resources (people and budget) • SDS • Material Declarations • Hazard classification of raw materials….. • Existing • Future ©2013, 3E Company, All Rights Reserved Knowledge Management  Dedicated FTE  Regulatory expertise  Technical expertise “Global Mind. Local Response” ©2013, 3E Company, All Rights Reserved Knowledge Management Information dissemination Knowledge sharing Cross-training In-house v. 3rd party vendor ©2013, 3E Company, All Rights Reserved What US companies need to look out for • GHS in South America (e.g. Chile, Ecuador, etc.) • GHS implementation in Asia – Adopting different UN editions, building blocks – SDS and labeling requirements vary – Governmental vs. industrial practice  Key: Understanding each country regulatory requirements  Concern: GHS implementation can be costly/ resource intensive ©2013, 3E Company, All Rights Reserved What US companies need to look out for • REACH adoption in Asia: various shapes and types – – – – K-REACH; China “REACH” (new chemical notification); Taiwan REACH; Japan “REACH” (CSCL), etc.  Only Representative (“OR”) principle  Chemicals Substitution  Key: EU REACH v. “Other” REACH Concern: Compliance & Innovation ©2013, 3E Company, All Rights Reserved Thank You ©2013, 3E Company, All Rights Reserved