Tuesday 8th December 2026 • 16:00 - 18:00 • Vienna, Austria • €349 +VAT
Please note: A main P&P conference ticket must be purchased alongside a workshop ticket.
Following the U.S. Food and Drug Administration’s (FDA) release of its Proposed Rule on Generally Recognized as Safe (GRAS) Substances on 10 August 2026, it is more important than ever for companies and stakeholders to understand the process for submitting GRAS Notifications and Food Contact Notifications (FCNs) to the Agency. This workshop will provide an overview of the purpose of both types of submissions; when and how they are best utilized from a strategic and regulatory compliance standpoint; the contents and data requirements for both submissions; and the mechanics of communicating with FDA before, during, and after the review process.
FDA’s Proposed Rule on GRAS Substances of 10 August 2026 states that FDA plans to implement a mandatory notification system for GRAS substances that will be both retroactive and proactive in nature. New GRAS submissions will, therefore, require a thorough understanding of the GRAS submission process. For food-contact substances in particular, the Food Contact Notification Program provides an FDA-encouraged approach that provides additional competitive benefits for the notifier that a GRAS Notice does not offer.
This workshop is specially designed for anyone who is responsible for the implementation, oversight, management, or compliance obligations for FDA-regulated food-contact materials. The material will be presented at a level suitable for newcomers and well-seasoned professionals alike, in an easy-to-understand and interactive format. Individuals with backgrounds in product stewardship, legal and regulatory compliance, and even sales and marketing will benefit from a basic understanding of FDA notification processes and how best to communicate with the Agency.
Attendees will become familiar with the basic contours of GRAS and FCN submissions to FDA; how and when they are best utilized from a compliance standpoint; and the basic information and processes that are needed to support the submissions.
If you have any questions about the workshop, please contact us at eventseu@smithers.com.
