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The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Scotland) Regulations 2024

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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.

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