Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p13
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 38584–43036

– no more than 1.5;
 (c) Metals:
 (i) Lead (mg/kg) – no more than 0.5;
 (d) Microbiological:
 (i) Total plate count (cfu/g) no more than 10,000; and
 (ii) Escherichia coli (cfu/10g) absent; and
 (iii) Salmonella spp. (cfu/25g) absent; and
 (iv) Yeasts and moulds (cfu/g) less than 100.
S3—40 Specification for 2′-fucosyllactose sourced from Escherichia coli K-12
  For 2′-fucosyllactose (2′-FL) sourced from Escherichia coli K-12 containing the gene for alpha-1,2-fucosyltransferase from either Heliobacter enhydrae, Helicobacter pylori or Bacteroides vulgatus, 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 powder
               (f) 2′-FL—not less than 83%;
               (g) D-lactose—not more than 10.0%;
               (h) L-fucose—not more than 2.0%;
               (i) difucosyl-D-lactose—not more than 5.0 %;
               (j) 2′-fucosyl-D-lactulose—not more than 1.5 %;
               (k) sum of saccharides (2′-FL, D-lactose, L-fucose, difucosyl-D-lactose, 2′-fucosyl-D-lactulose)—not less than 90%;
               (l) pH (20°C, 5% solution)—3.0-7.5;
               (m) water—not more than 9.0%;
               (n) ash, sulphated—not more than 2.0%;
               (o) acetic acid—not more than 1.0%;
                (p) residual proteins—not more than 0.01%;
               (q) microbiological:
               1.              aerobic mesophilic bacteria total count—not more than 3,000 cfu/g;
               2.             yeasts—not more than 100 cfu/g;
               3.           moulds—not more than 100 cfu/g;
               4.           endotoxins—not more than 10 EU/mg.

S3—41 Specification for lacto-N-neotetraose
  For lacto-N-neotetraose (LNnT), the specifications are the following:
               (a)  chemical name—–β-D-galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
                (b)  chemical formula—–C26H45NO21
               (c)  CAS number—–13007-32-4
               (d) description—–white to off white powder or agglomerates
               (e)  assay (water free) for sum of LNnT, lactose, lacto-N-triose II, and para-lacto-N-hexaose—–not less than 95.0%
               (f) assay (water free) LNnT—–not less than 92.0%
               (g)  D-lactose—–not more than 3.0%
               (h) lacto-N-triose II—–not more than 3.0%
               (i) para-lacto-N-neohexaose—–not more than 3.0%
               (j) LNnT fructose isomer—–not more than 1.0%
               (k)  pH (20°C, 5% solution) —–4.0 to 7.0
               (l) water—–not more than 9.0%
               (m)  ash, sulphated—–not more than 1.5%
               (n) methanol—–not more than 100 mg/kg
               (o) residual proteins—–not more than 0.01%
               (p) lead—–not more than 0.1 mg/kg
               (q) microbiological:
                   (i)  Salmonella—–absent in 25 g
                    (ii)  total plate count—–not more than 500 cfu/g
                   (iii)  Enterobacteriaceae—–absent in 10 g
                   (iv)  Cronobacter (Enterobacter) sakazakii—–absent in 10 g
                   (v)  Listeria monocytogenes—–absent in 25 g
                   (vi)  Bacillus cereus—–not more than 50 cfu/g
                   (vii)  yeasts—–not more than 10 cfu/g
                    (viii) moulds—–not more than 10 cfu/g
                   (ix) residual endotoxins—–not more than 10 EU/mg

S3—42 Specification for a soy leghemoglobin preparation
 Note  Subsections S26—3(5) and (7) require a soy leghemoglobin preparation to comply with the specifications set out in this section.
 For a soy leghemoglobin preparation, the specifications are the following:
              1.     soy leghemoglobin protein—maximum 9.0%;
              2.     soy leghemoglobin protein purity—minimum 65%;
              3.     appearance—dark red concentrated liquid;
              4.     solids— maximum 26%;
              5.     fat—maximum 2.0%;
              6.       carbohydrate—maximum 6.0%;
              7.     pH—5-10;
              8.     moisture—maximum 90%;
              9.       ash—maximum 4.0%;
             10.       lead—maximum 0.4 mg/kg;
             11.     arsenic—maximum 0.05 mg/kg;