ANNEX ISupplementary provisions
ANNEX I SPECIFICATIONS OF 2′-FUCOSYLLACTOSE Definition: Chemical name α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranoside Chemical formula C 18 H 32 O 15 Molecular mass 488,44 Da CAS No. 41263-94-9 Description: 2′-fucosyllactose powder produced with a genetically modified strain of Escherichia coli BL21 is a white to ivory powder that is derived from 2′-fucosyllactose liquid concentrate by spray drying. The 2′-fucosyllactose liquid concentrate is a colourless to slight yellow clear 45 % w/v ± 5 % w/v aqueous solution. Specifications of 2′-fucosyllactose powder Specification Parameter Limits Physical parameter White to ivory colour Chemical analysis 2′-fucosyllactose ≥ 90 % Lactose ≤ 5 % 3-fucosyllactose ≤ 5 % Difucosyllactose ≤ 5 % Fucosylgalactose ≤ 3 % Glucose ≤ 3 % Galactose ≤ 3 % Fucose ≤ 3 % GMO detection Negative Water content ≤ 9,0 % Protein content ≤ 100 μg/g Total Ash ≤ 0,5 % Contaminants Lead ≤ 0,02 mg/kg Arsenic ≤ 0,2 mg/kg Cadmium ≤ 0,1 mg/kg Mercury ≤ 0,5 mg/kg Aflatoxin M 1 ≤ 0,025 μg/kg Microbial Parameters Total Plate Count (TPC) ≤ 10 4 CFU/g Enterobacteria /Coliforms absent in 11 g Yeast and Mould ≤ 100 CFU/g Salmonella spp. Negative/100 g Cronobacter spp. Negative/100 g Endotoxins ≤ 100 EU/g CFU: Colony Forming Units; EU: Endotoxin Units Specifications of 2′-fucosyllactose liquid concentrate Specification Parameter Limits Physical parameter Colourless to slightly yellow, clear solution Solids content 45 % w/v (+/– 5 % w/v) dry matter in water Chemical analysis 2′-fucosyllactose ≥ 90 % Lactose ≤ 5 % 3-fucosyllactose ≤ 5 % Difucosyllactose ≤ 5 % Fucosylgalactose ≤ 3 % Glucose ≤ 3 % Galactose ≤ 3 % Fucose ≤ 3 % GMO detection Negative Protein content ≤ 100 μg/g Total Ash ≤ 0,5 % Contaminants Lead ≤ 0,02 mg/kg Arsenic ≤ 0,2 mg/kg Cadmium ≤ 0,1 mg/kg Mercury ≤ 0,5 mg/kg Aflatoxin M 1 ≤ 0,025 μg/kg Microbial Parameters Total Plate Count (TPC) ≤ 5 000 CFU/g Enterobacteria /Coliforms absent in 11 g Yeast and Mould ≤ 50 CFU/g Salmonella spp. Negative/200 ml Cronobacter spp. Negative/200 ml Endotoxins ≤ 100 EU/ml CFU: Colony Forming Units; EU: Endotoxin Units