GRAS NOTICE 820, Lactobacillus Fermentum CECT5716
GRAS Notice (GRN) No. 820 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory ~ b . ? •~::!~ ... BIOSEARCH •::• LIFE October 23, 2018 Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition, Food and Drug Administration 5001 Campus Drive College Park - MD 20740 USA Dear Office of Food Additive Safety, Please accept these documents as submission for Generally Recognized as Safe (GRAS) evaluation of the probiotic, Lactobacillus fermentum CECT57 I 6, according to the Final Rule 21 CFR Parts 20, 25, 170, 184, 186 and 570. Do not hesitate to contact me for further clarification or to request additional i. Thank you for your time. BiOSEARCH, S .A C I F A - 18550111 Camino de Purchil, n° 66 18004 GRANADA OCT 2 6 2018 Laura Macho Valls Regulatory Affairs Manager OFFICE OF Biosearch Life. FOOD ADDITIVE SAFETY IIJOS~ARCH S.A. • Camino de Purcl'lil, 66 • 18004 GRANADA (Spain) • Tlfno: {+34) 958240152 • Fax: (+34) 958240160 • lnfo~ b1osearchlile.com • 28031 Madnd (Spa,n) • Tlrno: (•34) 913 802 973 • Fax: (•34) 913 802 279 • sales(a1biosearchlife.com inscr,ta en el Registro Mercantil de Granada. T. 914, F. 164, seccl6n 8, H GR-17202. Fecha 13-11-2000. • CIF es A-185S0111 blOSHl'Chllle.com GRAS ASSESSMENT Lactobacillus fermentum CECT5716 Version 1 ... •~::~~ BIOSEARCH 1 •••·- LIFE Madrid, 23 rd October 2018. OCT 2 6 2018 OFFICE OF FOOD ADDITIVE SAFETY I .-:~~~ BIOSEARCH •::• LIFE Content Part 1. Signed statements and certification ......................................................... 4 I. I GRAS notice accordi ng to 2 1 CFR § 170.225 ........... .. .. .... ..... .. ............ .. .. .................................... .. ..... ... ..... .. ... .. .4 1.2 ame and address of notifier.
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