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GRAS Conclusions: An Uncompromising Approach to Facilitate Market Access for Safe Food Ingredients from Industrial Biotechnology

Drawing from industry and US FDA expertise, this discussion panel, organized by the Enzyme Technical Association (ETA), will provide a general overview of the GRAS process for Industrial Biotechnology (IB) products and will review essential elements of a voluntary GRAS Notification to FDA. The panel will also discuss how microbial enzymes used as food/feed ingredients are uniquely suited to this process. Finally, recent developments in FDA’s implementation of the GRAS Final Rule will be discussed, including FDA’s draft Guidance on GRAS scientific panels and it new Guidance on the GRAS Regulatory Framework; both are expected to be helpful in preparing successful GRAS Notifications for IB products.

  • Date:Tuesday, July 17
  • Time:10:15 AM - 11:30 AM
  • Location:201 A
  • Session Type:Breakout Session
  • BIO Track:Specialty Food Ingredients, Flavors, and Fragrances
Vincent Sewalt
DuPont Industrial Biosciences
Diane Shanahan
BASF Enzymes LLC
James LaMarta
DSM Nutritional Products
Lauren VieBrock
US Food and Drug Administration