I1SCHEDULE 4
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 carbohydrates8 (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
Sch. 4 in force at 30.6.2022, see reg. 1(3)