SCHEDULE 5Authorisation for the placing on the market of 6’-Sialyllactose (6’-SL) sodium salt (microbial source) as a novel food
2
In Table 2 (specifications), after the entry for “3’-Sialyllactose (3’-SL) sodium salt (microbial source)” (as inserted by Paragraph 2 of Schedule 4 to these Regulations), insert the following entry—
"6’-Sialyllactose (6’-SL) sodium salt (microbial source)
Description:
6’-Sialyllactose (6’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 6’-sialyl-lactulose, and sialic acid
Source:
Genetically modified strain of Escherichia coli K-12 DH1
Definition:
Chemical formula: C23H38NO19Na
Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt
Molecular mass: 655.53 Da
CAS No 157574-76-0
Characteristics/Composition:
Appearance: White to off-white powder or agglomerate
Sum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): ≥ 94.0 % (w/w)
6’-Sialyllactose sodium salt (% of dry matter): ≥ 90.0 % (w/w)
D-Lactose: ≤ 5.0 % (w/w)
Sialic acid: ≤ 2.0 % (w/w)
6’-Sialyl-lactulose: ≤ 3.0 % (w/w)
Sum of other carbohydrates: ≤ 3.0 % (w/w)
Moisture: ≤ 6.0 % (w/w)
Sodium: 2.5-4.5 % (w/w)
Chloride: ≤ 1.0 % (w/w)
pH (20 °C, 5 % solution): 4.5-6.0
Residual protein: ≤ 0.01 % (w/w)
Microbiological criteria:
Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g
Enterobacteriaceae: ≤ 10 CFU/g
Salmonella sp.: Absence in 25 g
Yeast: ≤ 100 CFU/g
Mould: ≤ 100 CFU/g
Residual endotoxins: ≤ 10 EU/mg
CFU: Colony Forming Units; EU: Endotoxin Units."