Table 3.
Specifications of the NF
| Description: 6’‐Sialyllactose (6’‐SL) sodium salt is a white to ivory‐coloured powder produced by microbial fermentation and further isolated, purified and concentrated. | |
| Source: Two genetically modified strains of Escherichia coli BL21 (DE3). | |
| Parameter | Specification |
| Composition | |
| 6’‐SL sodium salt (% w/w DM) | ≥ 90.0 |
| 6’‐Sialyllactulose (% w/w DM) | ≤ 3.0 |
| d‐Lactose (% w/w DM) | ≤ 5.0 |
| Sialic acid (% w/w DM) | ≤ 2.0 |
| N‐acetyl‐d‐glucosamine (% w/w DM) | ≤ 3.0 |
| Sum of other carbohydrates 1 (% w/w DM) | ≤ 5.0 |
| Water (%) | ≤ 9.0 |
| Protein (%) | ≤ 0.01 |
| Ash (%) | ≤ 8.5 |
| Sodium (%) | ≤ 4.2 |
| Contaminants | |
| Arsenic (mg/kg) | ≤ 0.2 |
| Aflatoxin M1 (μg/kg) | ≤ 0.025 |
| Microbial parameters | |
| Standard plate count (CFU/g) | ≤ 1,000 |
| Yeast and mould (CFU/g) | ≤ 100 |
| Enterobacteriaceae (CFU/g) | ≤ 10 |
| Salmonella (in 25 g) | ND |
| Cronobacter spp. (in 10 g) | ND |
| Endotoxins (EU/mg) | ≤ 10 |
6’‐SL: 6’‐Sialyllactose; CFU: Colony forming unit; DM: Dry matter; EU: Endotoxin unit; ND: Not detected.
(1)
Sum of other carbohydrates = 100 (% w/w DM) – 6’‐SL sodium salt (% w/w DM) – Quantified carbohydrates (% w/w DM) – Ash (% w/w DM). For those batches of the NF where the levels of any carbohydrate by‐product were below the respective limit of quantification (LOQ), the concentration of the corresponding compound has been considered to be equal to the respective LOQ value for the purpose of calculating the sum of other carbohydrates.