Regulation 5
SCHEDULE 6Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of 3-fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) as a novel food
1. In Table 1 (authorised novel foods), after the entry for 2’-Fucosyllactose / Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source) insert the following entry—
2. In Table 2 (specifications), after the entry for 2’-Fucosyllactose / Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source) insert the following entry—
| “3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) | Description/Definition: |
|---|---|
| 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) is a purified carbohydrate powder or agglomerate containing at least 90% of 3-fucosyllactose on a dry matter basis obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1. Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranose Chemical formula: C18H32O15 Molecular mass: 488.44 Da CAS No: 41312-47-4 Characteristics/Composition: Appearance: Powder, agglomerates, powder with agglomerates Colour: White to off-white Assay (water free) – Specified saccharides (includes 3-FL, D-lactose, L-fucose and 3-fucosyllactose): ≥ 92.0 w/w % Assay (water free) – 3-FL: ≥ 90.0 w/w % L-Fucose: ≤ 1.0 w/w % D-Lactose: ≤ 5.0 w/w % 3-Fucosyllactulose: ≤ 1.5 w/w % Sum of other carbohydrates: ≤ 5.0 w/w % pH in 5% solution (20°C): 3.2–7.0 Water: ≤ 6.0 w/w% Ash, sulphated: ≤ 0.5 w/w % Acetic acid (relevant only for crystallised 3-FL) : ≤ 1.0 w/w % Residual protein by Bradford assay: ≤ 0.01 w/w % Residual endotoxins: ≤ 10 EU/mg Heavy metals: Lead: ≤ 0.1 mg/kg Arsenic: ≤ 0.2 mg/kg Mycotoxins: Aflatoxin M1: ≤ 0.025 µg/kg Microbiological criteria: Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: absent in 10g Salmonella spp: absent in 25g Bacillus cereus: ≤ 50 CFU/g Listeria monocytogenes: absent in 25g Cronobacter spp.: absent in 10g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g EU: Endotoxin Units CFU: Colony Forming Units”. |