Agenda

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  1. Coffee and registration

  2. Welcome

    Moderator

    Nhat Nguyen Nhat Nguyen
    Chief Analyst, Enhesa Product Intelligence, USA
  3. Session one: Food Contact Regulations in North America
  4. An update on OFAS (Office of Food Additive Safety)

    Kristi Muldoon Jacobs Kristi Muldoon Jacobs
    Director (Acting), Office of Food Additive Safety, FDA
  5. Changing Landscape: State Challenges re Chemicals of Concern, FDA Post-Market Reviews

    • Increase in activities on chemicals and plastics used in food packaging at the state (and sometimes, local) level;
    • State developments related to Per- and Polyfluoroalkyl Substances (PFAS) and possible future candidates; and
    • FDA post-market review of food packaging materials – examples of FDA reviews of FCS which are the subject of FCNs and food additive regulations.
    George Misko George Misko
    Partner, Keller and Heckman LLP
  6. Q&A

  7. Break and Refreshments

  8. Generally recognised as safe (GRAS) substances: still under attack? A bit of history and a policy update

    • Why is the GRAS exemption under scrutiny?;
    • What are the recent developments regarding GRAS substances?; and
    • What is the policy outlook for GRAS substances?
    Joe Dages Joe Dages
    Attorney, Steptoe & Johnson LLP, US
  9. Food Contact and Proposition 65

    • History and overview of requirements;
    • Exceptions to warning; and
    • Enforcement and examples of listed chemicals found in food-contact materials
    Mitzi Clark Mitzi Clark
    Partner, Keller and Heckman LLP, US
  10. Q&A

  11. Session two: Substance-specific issues
  12. Printing inks for food packaging and accompanied communication down the packaging chain

    • Packaging safety and its utmost importance for sensitive applications;
    • How self-commitments can help to harmonise a globally non-harmonised regulatory landscape; and
    • Statement of composition (SoC) as tool for transparent communication down the packaging chain
    Evert Delbanco Evert Delbanco
    Director Food Safety & Toxicology, Siegwerk Druckfarben AG & Co. KGaA
  13. Printing inks and the food packaging materials supply chain

    • Establishing FDA food contact regulatory compliance of printing inks requires detailed information exchange;
    • Raw material suppliers are required to disclose sufficient chemical composition to facilitate compliance assessments of the inks; and
    • Knowledge of the packaging structure from printers and intended use by brand owners allows for post-market acceptability determinations
    Gregory V. Pace PhD, MS Gregory V. Pace PhD, MS
    Consultant, Regulatory and Product Stewardship, Gregory V. Pace Ph.D. LLC
  14. Q&A

  15. Lunch and networking

  16. Unlock the full value of your compliance and product stewardship with Chemical Watch

    Discover the full range of Chemical Watch solutions and get your questions answered at this service presentation and platform demo.

    Greg Harrop-Griffiths Greg Harrop-Griffiths
    International Business Development Manager, Chemical Watch
  17. Welcome back

    Moderator

    Nhat Nguyen Nhat Nguyen
    Chief Analyst, Enhesa Product Intelligence, USA
  18. Paper-based packaging regulations in the US

    Food safety, clean packaging, transparency, and challenges:

    • what is clean packaging and why is product transparency important;
    • what needs to be done regarding compliance and safety;
    • discuss the main strategy and the process
    Wolfgang Urhahn Wolfgang Urhahn
    Director, Global Compliance, HAVI, US
  19. Food contact evaluation for coatings and adhesives

    • Food contact evaluation for coatings and adhesives;
    • Applicable regulations for raw materials used for coatings and adhesives; and
    • Comparison of EU and NA risk assessments for complex substances.
    Bethany Woods Bethany Woods
    Senior Food Contact Compliance Manager, BASF Corporation, US
  20. Q&A

  21. Break and Refreshments

  22. Session three: Risk assessment
  23. Welcome back

    Moderator

    Melanie Rybar Melanie Rybar
    Regulatory and Compliance Analyst, Enhesa Product Intelligence, USA
  24. Risk assessment of FCMs: FDA perspective

    • Provide an overview of the risk assessment framework for food contact substances;
    • Discuss how the risk assessment framework is used in FDA’s safety reviews of food contact substances; and
    • Review recommended safety testing for food contact substances based on the exposure tiers  in FDA Guidance.
    Laura C. Markley, Ph.D Laura C. Markley, Ph.D
    Toxicologist, US FDA/CFSAN/Office of Food Additive Safety
  25. Risk assessment of non-intentionally added substances (NIAS)

    • Regulatory framework underlying risk assessment of NIAS (EU versus US);
    • Risk assessment steps in food contact substances (intentionally and un-intentionally added); and
    • Guidance documents to be considered in the evaluation of risk.
    Matthew Savidge Matthew Savidge
    Group Leader, Toxicology, knoell USA
  26. NIAS regulations from an industry perspective

    • Industry example of applying the NIAS regulation
      • Translating the regulation to requirements;
      • Outline of our approach; and
      • Challenges we faced during our assessment.
    Krys Bronk Krys Bronk
    Manager, Product Stewardship, W. R. Grace
  27. Food substances in contact with infant formula and/or human milk

    • the key changes from the ‘regular’ FDA guidance such as the normalised exposure-based testing tiers and outline the minimum testing recommendations and modified protocols; and
    • discuss the age dependent cancer risk analysis of carcinogenic constituents and provide useful examples
    Guillaume Letellier, M.S., E.R.T Guillaume Letellier, M.S., E.R.T
    Senior Manager, Toxicology, Intertek Assuris
  28. Q&A

  29. Close of day one and drinks reception

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