Food Contact Notification (FCN) - Obtaining New Regulations from FDA on Your Terms

Why Should You Attend:

Federal regulation of food contact materials has evolved extensively over the past 20 years. Founded on the Federal Food Drug and Cosmetic Act, Food and Drug Administration Modernization Act, and enumerated in 21 CFR 170-186 and numerous Guidance documents, the regulations are complex.

This webinar on the regulation of common materials used in food packaging will feature relevant elements of 21 CFR as well as USFDA Guidance documents pertaining to Food Contact Substances (FCS). Determining the regulatory status of polymers and paper used in food contact is a stepwise process taking advantage of principles of chemistry, toxicology, engineering and risk assessment. This session will highlight the FCN process and show how to obtain a new regulation from FDA if a substance that does not have suitable regulatory status.

Areas Covered in the Webinar:

• Overview of enabling legislation and guidance documents
• Defining, claiming and specifying the Food Contact Substance (FCS)
• Estimating the Daily Intake (EDI) of the FCS
• What toxicology data are associated with the FCS?
• Migration testing
• Form 3480
• What toxicological concerns are associated with a particular level of exposure?
• Interacting with FDA

Who Will Benefit:

Packaging manufacturers as well as food manufacturers and facilities responsible for packaging/labeling food products will benefit from this training. Specifically, those who will benefit include resin manufacturers, formulation developers, companies in the pulp and paper business, specialty chemical manufacturers, food companies, drug, cosmetic, device and veterinary medical companies.

The following titles will benefit:

• Regulatory affairs
• R&D
• Marketing
• Food safety consultants
• Packaging QA/QC

Instructor Profile:

Dr. Jeffrey Scott Eberhard, 19 year career has been spent supporting clients in their efforts to bring heavily regulated products to market. At Morton International (now part of Rohm & Haas) and Covance, he was responsible for directing and performing studies designed to generate data in support of Food Contact Notifications (FCN), Threshold of Regulation opinions (TOR), Food Additive Petitions (FAP) and Color Additive Petitions. With many of these products, he worked closely with client Regulatory and Marketing personnel, as well as client customers, to make sure that marketing’s proposed product claims were supportable and client requirements were met.

In Washington, DC working as a Staff Scientist for Keller and Heckman, Dr. Eberhard developed a high level of expertise in the regulation of Direct, Secondary Direct and Indirect Food Additives by FDA and many of their international counterparts (EU, Canada, MERCOSUR, Japan, China, and South Korea). Later, at Exponent, Nerac and ERM, he brought experience gained at Keller and Heckman and developed new competencies. In addition to the food additive, food contact, pesticide and chemical work, Dr. Eberhard prepared Generally Recognized as Safe petitions for self-certification and submission to FDA.

Follow us :