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

3.  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-fucosyllactulose): ≥ 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 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”.