Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p15
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 46328–50627

sourced from Escherichia coli BL21, the specifications are the following:

               (a)        chemical name—α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

               (b)        chemical formula—C18H32O15

               (c)        CAS number—41263-94-9

               (d)        description—either a white to ivory powder, or a colourless to slightly yellow liquid

               (e)        2′-FL—not less than 90.0%

               (f)         D-lactose—not more than 5.0%

               (g)        L-fucose—not more than 3.0%

               (h)        3-fucosyllactose—not more than 5.0%

               (i)         difucosyllactose—not more than 5.0%

               (j)         fucosyl-galactose—not more than 3.0%

               (k)        glucose—not more than 3.0%

               (l)         galactose—not more than 3.0%

               (m)       water—not more than 9.0% for powder, not applicable for liquid

               (n)        solids—45% w/v (± 5%) dry matter in water, not applicable for powder

               (o)        ash, sulphated—not more than 0.5%

               (p)        residual proteins—not more than 0.01%

               (q)        lead—not more than 0.02 mg/kg

               (r)         arsenic—not more than 0.2 mg/kg

               (s)        cadmium—not more than 0.1 mg/kg

               (t)         mercury—not more than 0.5 mg/kg

               (u)        microbiological:

              (i)         Salmonella—absent in 100 g for powder, absent in 200 mL for liquid

                  (ii)        total plate count—not more than 10000 cfu/g for powder, not more than 5000 cfu/g for liquid

                  (iii)       coliform/Enterobacteriaceae—absent in 11 g for powder, absent in 22 mL for liquid

                  (iv)       Cronobacter sakazakii—absent in 100 g for powder, absent in 200 mL for liquid

                  (v)        yeast and mould—not more than 100 cfu/g for powder, not more than 50 cfu/g for liquid

              (vi)       aflatoxin M1—not more than 0.025 μg/kg

              (vii)      endotoxins—not more than 10 EU/mg

              (viii)     GMO detection—not detected.

S3—46  Specification for bovine lactoferrin

            1.            In this section, bovine lactoferrin is a protein derived from cow's milk and consisting of a single polypeptide chain of 689 amino acids.

 (2) For bovine lactoferrin, the specifications are the following:
(a) description—a pink to reddish brown coloured, free-flowing powder;
(b) protein (N x 6.38)—more than 93.0%;
(c) purity—more than 95.0%;
(d) moisture—less than 4.5 g/100 g;
(e) ash—not more than 1.5 g/100 g;
(f) iron—not more than 35 mg/100 g;
(g) pH (2% solution)—5.2 to 7.2;
(h) solubility transmittance (2% solution, 20°C)—transparent;
(i) lead—not more than 1 mg/kg;
(j) microbial limits:
                 (i) Salmonella spp.—absent in 25 g;
                 (ii) Listeria monocytogenes—–absent in 25 g;
                 (iii) Cronobacter spp.—–absent in 10 g.

           S3—47 Specification for a combination of 2′-fucosyllactose and difucosyllactose sourced from Escherichia coli K-12

             For a mixture of 2′-fucosyllactose (2′-FL) and difucosyllactose (DFL) sourced from Escherichia coli K-12 containing the gene for alpha-1,2-fucosyltransferase from Helicobacter pylori, the specifications are the following:

               (a) chemical names:
                   (i) for 2′-FL––α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose;
                   (ii) for DFL––α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-[α-L-fucopyranosyl-(1→3)]-D-glucose;
               (b) chemical formulas:
                   (i) for 2′-FL––C18H32O15;
                   (ii) for DFL––C24H42O19;
               (c) molecular weights:
                   (i) for 2′-FL––488.44 g/mol;
                   (ii) for DFL––634.58 g/mol;
               (d) CAS numbers:
                   (i) for 2′-FL––41263-94-9;
                   (ii) for DFL––20768-11-0;
               (e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;
               (f) 2′-FL––not less than 75.0% (water free);
               (g) DFL––not less than 5.0% (water free);
               (h)