Document Overview
This document presents a GRAS (Generally Recognized As Safe) Notice submitted to the U.S. Food and Drug Administration (FDA). It details the comprehensive safety assessment and intended applications for Purified 2'-Fucosyllactose (2'-FL) as a food ingredient.
Key Parties Involved
The GRAS notification is submitted on behalf of:
- Glycosyn, LLC
- FrieslandCampina Domo B.V.
GRAS Associates, LLC serves as the designated agent for this submission.
Product Information
Product: Purified 2'-Fucosyllactose (2'-FL)
Description: 2'-Fucosyllactose is a trisaccharide naturally found in human milk, produced via microbial fermentation.
Intended Food Uses
The substance is intended for use as a food ingredient in the following categories:
- Infant formulas
- Conventional foods
- Medical foods
The submission includes extensive data supporting the safety of 2'-FL under these specified conditions of use.
Regulatory Context
This notice follows the FDA's established procedures for GRAS notifications, providing scientific evidence and expert panel reviews to support the safety conclusion. For more information on the GRAS process, please visit the FDA GRAS Notice Inventory.