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BASF Food Contact Regulatory Governance Implementation Project

BASF Food Contact Regulatory Governance Implementation Project. Update – November 5, 2010. Introduction. “BASF Food Contact Regulatory Governance Implementation Project” Near term (2010-2011) Benchmark the current food contact regulatory clearances

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BASF Food Contact Regulatory Governance Implementation Project

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  1. BASF Food Contact Regulatory Governance Implementation Project Update – November 5, 2010 INTERNAL

  2. Introduction • “BASF Food Contact Regulatory Governance Implementation Project” • Near term (2010-2011) • Benchmark the current food contact regulatory clearances • Establish and maintain a food contact regulatory database in BASIS • Long Term (beyond 2011, feasibility study in progress) • Utilize the template and distribution capabilities in BASIS • Ultimately • Bring the process of communicating the food contact status of applicable BASF products to our customers from a reactive to a proactive state. • Having such a system in place will allow BASF to streamline the regulatory maintenance processes for current products on the market and allow us to focus onnew products for emerging food contact applications, thereby sustaining our global presence in the food contact marketplace. INTERNAL

  3. Introduction • Scope • All BASF products sold on the market for FDA food contact applications • Background • General industry practice • The customer procures food contact regulatory status from its supplier when needed • The problem • Following procurement of Food Contact Declaration, the customer takes the regulatory status for granted and does not check for updates • BASF does not have a system in place to proactively inform the customer of changes to the food contact regulatory status • Potential for customer to use non-sanctioned BASF products for food contact applications INTERNAL

  4. Introduction • Related Issues / Goals • General need for broad review of FDA Summary sheets across all business groups; requested in 2009 • Benchmark methodology of food contact compliance decisions for products • Too many different forms and layouts for food contact declarations within BASF; Provide customers with a “universal” form for these declarations • Readiness for new regulatory jurisdictional requirements in emerging food contact markets (China, Japan, India, South America, etc.) INTERNAL

  5. Introduction INTERNAL

  6. Process and Roles INTERNAL

  7. Process and Roles INTERNAL

  8. Process and Roles INTERNAL

  9. Process and Roles INTERNAL

  10. FDA Review by Business • Major Regulations • 175.105 • 175.300 • 175.320 • 176.170 • 176.180 • 176.210 • 177.1010 • 177.1500 • 177.1520 • 178.1010 • 178.2010 • 178.3297 • 178.3400 INTERNAL

  11. Review Process – Overview • The review process for individual ODs will be based on the following considerations • Priority and Timeline • Differing Chemistries • Degrees/Methods of Regulatory Compliance • Manufacturing/Operational Changes • Supply-chain Positioning • Other Regulatory Needs and Agreements INTERNAL

  12. Review Schedule – Overview INTERNAL

  13. Review Process – ED Dispersions • Products will be assessed according to • Existing FCNs, TORs, FAPs • Listing in 21 CFR (175.105, 175.125, 176.170, 176.180) • Verification of component listings as per 21 CFR • Full review of prior assessments / brochure listings • Supplier statement verification • Compilation of historical data files • Verification of BASIS Composition INTERNAL

  14. Review Schedule – ED Dispersions INTERNAL

  15. Review Process – ED Resins • Products will be assessed according to • Existing FCNs • Listing in 21 CFR (175.105, 175.300, 175.320, 176.170, 176.180) • Full review of prior assessments / brochure listings • Supplier statement verification • FDA Notification of Change in Manufacturing Site • Calibration of Assessment Data with Netherlands INTERNAL

  16. Review Schedule – ED Resins INTERNAL

  17. Review Process – ED Pigments • Pigments will be assessed according to • Existing FCNs, TORs, FAPs • Listing in 21 CFR (majority in 178.3297) • Verification of component listings as per 21 CFR • Full review of prior assessments / brochure listings • Supplier statement verification • Verification of BASIS Composition • Other • Impact of Project CORAL INTERNAL

  18. Review Schedule – ED Pigments INTERNAL

  19. Review Process – EV Pigments • Pigments will be assessed according to • Existing FCNs, TORs, FAPs • Listing in 21 CFR (majority in 178.3297) • Verification of component listings as per 21 CFR • Full review of prior assessments / brochure listings • Supplier statement verification • Verification of BASIS Composition • Other • Impact of Project CORAL INTERNAL

  20. Review Process – EM • Products will be assessed according to • Existing FCNs, TORs, FAPs • Listing in 21 CFR (175.105, 176.170, 176.180, 178.1010, 178.3400) • Verification of component listings as per 21 CFR • Full review of prior assessments / brochure listings • Supplier statement verification • Compilation of historical data files & Drug Master Files • Update of compliance as per ongoing FDA activities • Provide listing for ONEPIE upload INTERNAL

  21. Review Process – EV • Products will be assessed according to • Existing FCNs, TORs, FAPs • Listing in 21 CFR (177.1520, 178.2010) • Verification of component listings as per 21 CFR • Full review of prior assessments / brochure listings • Supplier statement verification • Compilation of historical data files & Master Additive Files INTERNAL

  22. Review Process – KT • Products will be assessed according to • Existing FCNs • Listing in 21 CFR (majority in 177.1500) • Verification of component listings as per 21 CFR • Full review of prior assessments / brochure listings • Supplier statement verification • Compilation of historical data files & Drug Master Files • Update of compliance as per ongoing FDA activities INTERNAL

  23. Review Process – KU • Products will be assessed according to • Listing in 21 CFR (majority in 175.105, 177.1680,177.2600) • Verification of component listings as per 21 CFR • Full review of prior assessments / brochure listings • Supplier statement verification • Verification of BASIS Composition • Compilation of historical data files INTERNAL

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