Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p16
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 50223–54895

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) sum of 2′-FL and DFL––not less than 85.0% (water free);
               (i) sum of human identical milk saccharides: 2′-FL, DFL, D-lactose, L-fucose, 3-fucosyllactose ––not less than 92.0% (water free);
               (j) D-lactose––not more than 10%;
               (k) L-fucose––not more than 1.0%;
               (l) 2'-fucosyl-D-lactulose––not more than 2.0%;
               (m) pH (20°C, 5% solution)––4.0-6.0;
               (n) water––not more than 6.0%;
               (o) ash, sulphated––not more than 0.8%;
               (p) residual protein––not more than 0.01%;
               (q) lead––not more than 0.1 mg/kg;
               (r) microbiological:
                   (i) aerobic mesophilic bacteria total 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—48 Specification for lacto-N-tetraose sourced from Escherichia coli K-12

             For lacto-N-tetraose (LNT) sourced from Escherichia coli K-12 containing the gene for beta-1,3-N-acetylglucosaminyltransferase from Neisseria meningitides and the gene for beta-1.3-galactosyltransferase from Helicobacter pylori, the specifications are the following:

               (a)  chemical name––β-D-galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucose;
               (b) chemical formula––C26H45NO21;
               (c) molecular weight––707.63 g/mol;
               (d) CAS number––14116-68-8;
               (e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;
               (f) LNT––not less than 70.0% (water free);
               (g) sum of human identical milk saccharides: LNT, D-lactose, lacto-N-triose II––not less than 90.0% (water free);
               (h) D-lactose––not more than 12.0%;
               (i) lacto-N-triose II––not more than 10.0%;
               (j) para-lacto-N-hexaose-2––not more than 3.5%;
               (k) β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-fructose (LNT fructose isomer)––not more than 1.0%;
               (l) pH (20°C, 5% solution)––4.0-6.0;
               (m) water––not more than 6.0%;
               (n) residual protein––not more than 0.01%;
               (o) ash, sulphated––not more than 0.5%;
               (p) lead––not more than 0.1 mg/kg;
               (q) microbiological:
                   (i) aerobic mesophilic bacteria total 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—49 Specification for 6′-sialyllactose sodium salt sourced from Escherichia coli K-12

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

               (a) chemical name––N-acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt;
               (b) chemical formula––C23H38NO19Na;
               (c) molecular weight––655.53 g/mol;
               (d) CAS number––157574-76-0;
               (e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;
               (f) 6′-SL sodium salt––not less than 90.0% (water free);
               (g) sum of human identical milk saccharides: 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;