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Agenda
Welcome
Moderator
Nhat Nguyen, Enhesa Product
Session one: Food Contact Regulations in North America
An update on OFAS (Office of Food Additive Safety)
Kristi Muldoon Jacobs, FDA
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, Keller and Heckman LLP
Q&A
Break and Refreshments
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, Steptoe & Johnson LLP, US
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, Keller and Heckman LLP, US
Q&A
Session two: Substance-specific issues
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, Siegwerk Druckfarben AG & Co. KGaA
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 Ph.D. LLC
Q&A
Lunch and networking
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Greg Harrop-Griffiths, Chemical Watch
Welcome back
Moderator
Nhat Nguyen, Enhesa Product
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, HAVI, US
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, BASF Corporation, US
Q&A
Break and Refreshments
Session three: Risk assessment
Melanie Rybar, Enhesa Product
Welcome back
Moderator
Melanie Rybar, Enhesa Product
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, US FDA/CFSAN/Office of Food Additive Safety
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, knoell USA
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, W. R. Grace & Co.
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, Intertek Assuris