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 “Lactitol” insert the following entry—

“Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture

Description/Definition Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture is a purified carbohydrate powder or agglomerate obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1 containing at least 75% of LNFP-I and 2’-FL of dry matter, where ≥ 50% is LNFP-I (dry weight) and ≥ 15% is 2’-FL (dry weight). Characteristics/Composition Appearance: Powder, agglomerates, powder with agglomerates Colour: White to off-white Assay (water-free) Specified saccharides (includes LNFP-I, 2’-FL, lacto-N-tetraose, difucosyl-D-lactose, 3-fucosyllactose, D-lactose, L-fucose and 2’-fucosyl-lactitol, LNFP-I fructose isomer, and 2’-fucosyl-D-lactulose): ≥ 90.0 % (w/w) Assay (water-free) – LNFP-I and 2’-FL: ≥ 75.0 % (w/w) Assay (water-free) – LNFP-I: ≥ 50.0 % (w/w) Assay (water-free) – 2’-FL: ≥ 15.0 % (w/w) Lacto-N-tetraose: ≤ 5.0 % (w/w) 3-Fucosyllactose: ≤ 1.0 % (w/w) Sum of L-Fucose and 2’-fucosyl-lactitol: ≤ 1.0 % (w/w) D-Lactose: ≤ 10.0 % (w/w) Difucosyl-D-lactose: ≤ 2.0 % (w/w) LNFP-I fructose isomer: ≤ 1.5 % (w/w) 2’-Fucosyl-D-lactulose: ≤ 1.0 % (w/w) Sum of other carbohydrates: ≤ 6.0 % (w/w) pH in 5% solution (20°C): 4.0–7.0 Water: ≤ 8.0 % (w/w) Ash, sulphated: ≤ 0.5 % (w/w) Residual protein by Bradford assay: ≤ 0.01 % (w/w) Heavy metals Arsenic: ≤ 0.2 mg/kg Mycotoxins Residual endotoxins: ≤ 10 EU/mg Aflatoxin M1: ≤ 0.025 µg/kg Microbiological criteria Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: Absent in 10g Salmonella spp.: Absent in 25 g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g Bacillus cereus: ≤ 50 CFU/g Listeria monocytogenes: Absent in 25g Cronobacter spp.: Absent in 10g EU: Endotoxin Units CFU: Colony Forming Units”.