Regulation 2(3)(a)
| “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source) | Description: 2’-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white powder or agglomerate thereof that is produced by a microbial process. Source: Genetically modified strain of Escherichia coli K-12 DH1 Characteristics/Composition: Appearance: White to off white powder or agglomerates Sum of 2′-Fucosyllactose, Difucosyllactose, D-Lactose, L-Fucose, and 3-Fucosyllactose (% of dry matter): ≥ 92.0 % (w/w) Sum of 2′-Fucosyllactose and Difucosyllactose (% of dry matter): ≥ 85.0 % (w/w) 2′-Fucosyllactose (% of dry matter): ≥ 75.0 % (w/w) Difucosyllactose (% of dry matter): ≥ 5.0 % (w/w) D-Lactose: ≤ 10.0 % (w/w) L-Fucose: ≤ 1.0 % (w/w) 2′-Fucosyl-D-lactulose: ≤ 2.0 (w/w) Sum of other carbohydrates(1) (11): ≤ 6.0 % (w/w) Moisture: ≤ 6.0 % (w/w) Ash, sulfated: ≤ 0.8 % (w/w) pH (20 °C, 5 % solution): 4.0 -6.0 Residual protein: ≤ 0.01 % (w/w) Microbiological criteria: Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: ≤ 10 CFU/g Salmonella sp.: Negative/25 g Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units” |
2’-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.