Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p17
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 54510–59485

6′-SL sodium salt, D-lactose, sialic acid––not less than 94.0% (water free);
               (h) D-lactose––not more than 5.0%;
               (i) sialic acid––not more than 2.0%;
               (j) sialyl-lactulose––6'- isomer––not more than 3.0%;
               (k) sodium––2.5-4.5%;
               (l) chloride––not more than 1.0%;
               (m) pH (20°C, 5% solution)––4.5-6.0;
               (n) water––not more than 6.0%;
               (o) residual protein––not more than 0.01%;
               (p) lead––not more than 0.1 mg/kg;
               (q) microbiological:
                   (i) aerobic mesophilic total plate count––not more than 1,000 cfu/g;
                   (ii) Enterobacteriaceae––absent in 10 g;
                   (iii) yeasts––not more than 100 cfu/g;
                   (iv) moulds––not more than 100 cfu/g;
                   (v) residual endotoxins––not more than 10 EU/mg.

           S3—50 Specification for 3′-sialyllactose sodium salt sourced from Escherichia coli K-12

             For 3′-sialyllactose (3′-SL) sodium salt sourced from Escherichia coli K-12 containing the gene for alpha-2,3-sialyltransferase from Neisseria meningitides and CMP-Neu5Ac synthetase, Neu5ac synthase, N-acetylglucosamine-6-phosphatase epimerase from Campylobacter jejuni, the specifications are the following:

               (a) chemical name––N-acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt;
               (b) chemical formula––C23H38NO19Na;
               (c) molecular weight––655.53 g/mol;
               (d) CAS number––128596-80-5;
               (e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;
               (f) 3′-SL sodium salt––not less than 88.0% (water free);
               (g) sum of human identical milk saccharides: 3′-SL sodium salt, D-lactose, sialic acid––not less than 90.0% (water free);
               (h) D-lactose––not more than 5.0%;
               (i) sialic acid––not more than 1.5%;
               (j) sialyl-lactulose-3′-isomer––not more than 5.0%;
               (k) sodium––2.5-4.5%;
               (l) chloride––not more than 1.0%;
               (m) pH (20°C, 5% solution)––4.5-6.0;
               (n) water––not more than 8.0%;
               (o) residual protein––not more than 0.01%;
               (p) lead––not more than 0.1 mg/kg;
               (q) microbiological:
                   (i) aerobic mesophilic total plate count––not more than 1,000 cfu/g;
                   (ii) Enterobacteriaceae––absent in 10 g;
                   (iii) yeasts––not more than 100 cfu/g;
                   (iv) moulds––not more than 100 cfu/g;
                   (v) residual endotoxins––not more than 10 EU/mg.

           S3—51  Specification 2′-fucosyllactose sourced from Corynebacterium glutamicum

            For 2′-fucosyllactose (2′-FL) sourced from Corynebacterium glutamicum, 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)        molecular weight—488.44 g/mol;
                         (d)        CAS number—41263-94-9;
                         (e)        description—white to off-white/ivory powder;
                         (f)        2′-FL—not less than 94% (water free);
                         (g)        D-lactose—not more than 3.0% (water free);
                         (h)        L-fucose—not more than 3.0% (water free);
                         (i)         3-fucosyllactose—not more than 3.0% (water free);
                         (j)         difucosyl-D-lactose—not more than 2.0% (water free);
                         (k)        glucose—not more than 3.0% (water free);
                         (l)         galactose—not more than 3.0% (water free);
                         (m)      water—not more than 9.0%;
                         (n)        ash, sulphated—not more than 0.5%;
              (o)        ethanol—not more than 1,000 mg/kg (for crystallised product from solvent only);
                         (p)        residual proteins—not more than 0.005%;
                         (q)        lead—not more than 0.02 mg/kg;
                         (r)         arsenic—not more than 0.03 mg/kg;
                         (s)        cadmium—not more than 0.01 mg/kg;
                         (t)         mercury—not more than 0.05 mg/kg;
                         (u)        microbiological:
                                (i)         total plate count—not more than 500 cfu/g;
                                (ii)        coliforms—not more than 10 cfu/g;
                                (iii)       yeasts and moulds—not more than 100 cfu/g;
                                (iv)       aflatoxin M1—not more than 0.025 µg/kg;
                                (v)        residual endotoxins—not more than 10 EU/mg