Food Contact Regulations USA 2022

Moderator

Nhat Nguyen

Chief Analyst, Enhesa Product, USA

• 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

Partner, Keller and Heckman LLP

• 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

Attorney, Steptoe & Johnson LLP, US

• History and overview of requirements;
• Exceptions to warning; and
• Enforcement and examples of listed chemicals found in food-contact materials

Mitzi Clark

Partner, Keller and Heckman LLP, US

• 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

Director Food Safety & Toxicology, Siegwerk Druckfarben AG & Co. KGaA

• 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

Consultant, Regulatory and Product Stewardship, Gregory V. Pace Ph.D. LLC

Moderator

Nhat Nguyen

Chief Analyst, Enhesa Product, USA

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

Director, Global Compliance, HAVI, US

• 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

Senior Food Contact Compliance Manager, BASF Corporation, US

Moderator

Melanie Rybar

Regulatory and Compliance Analyst, Enhesa Product, USA

• 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

Toxicologist, US FDA/CFSAN/Office of Food Additive Safety

• 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

Group Leader, Toxicology, knoell USA

• 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

Sr. Regulatory Advisor, W. R. Grace & Co.

• 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

Senior Manager, Toxicology, Intertek Assuris