Safety evaluation of the human-identical milk monosaccharide, l-fucose.
l-Fucose is a natural monosaccharide present in mammals where it is found predominantly as an O-glycosidically linked component of glycoproteins, glycolipids, and oligosaccharides. It is also present in its free form in human breast milk (human milk monosaccharide). l-Fucose plays important roles in the development of the immune and nervous systems and is involved in cognitive function and memory formation. The human-identical milk monosaccharide l-fucose is therefore proposed for use in infant formulas to better simulate the free saccharides present in human breast milk. As part of the safety evaluation of l-fucose, a subchronic dietary toxicity study preceded by an in utero phase was conducted in Sprague-Dawley rats. l-Fucose was without maternal toxicity or compound-related adverse effects on female reproduction and general growth and development of offspring at a maternal dietary level up to 1%, equivalent to a dose of 1655 mg/kg body weight (bw)/day. During the subchronic phase, no compound-related adverse effects were observed in first generation rats at dietary levels of up to 1% (highest level tested), corresponding to doses of 516 and 665 mg/kg bw/day in males and females, respectively. l-Fucose was non-genotoxic in a series of in vitro genotoxicity/mutagenicity tests. These results support the safe use of l-fucose in infant formula and as a food ingredient at levels equivalent to those present in human breast milk.
Intertek Scientific & Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario L5N 2X7, Canada. Electronic address: sharon.choi@intertek.com.
Sharon S H
SS
Choi
Intertek Scientific & Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario L5N 2X7, Canada.
Barry S
BS
Lynch
Intertek Scientific & Regulatory Consultancy, Room 1036, Building A8, Cody Technology Park, Ively Road, Farnborough, Hampshire GU14 0LX, UK.
Nigel
N
Baldwin
BioReliance Corporation, 9630 Medical Center Drive, Rockville, MD 20850, USA.
Emily W
EW
Dakoulas
BioReliance Corporation, 9630 Medical Center Drive, Rockville, MD 20850, USA.
Shambhu
S
Roy
MPI Research, Inc., 54943 North Main Street, Mattawan, MI 49071-8353, USA.
Carey
C
Moore
MPI Research, Inc., 54943 North Main Street, Mattawan, MI 49071-8353, USA.
Bjorn A
BA
Thorsrud
Glycom A/S, Diplomvej 373, DK-2800 Kongens Lyngby, Denmark.
Christoph H
CH
Röhrig
D000818:Animals; D005260:Female; D005643:Fucose / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000494:pharmacology*; D008297:Male; D008895:Milk, Human / Q000378:metabolism*; D009005:Monosaccharides / Q000009:adverse effects*; D009152:Mutagenicity Tests / Q000379:methods; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects; D012449:Safety
D009005:Monosaccharides; D005643:Fucose
Genotoxicity; Human milk monosaccharide; Infant formula; Subchronic toxicity; l-Fucose