Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p11
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 32316–35934

(ii) is sourced from Pichia pastoris strain UGT-A;
               (c)        by enzymatic conversion of purified stevia leaf extract to produce one or more prescribed rebaudiosides using a combination of enzymes that contains:
                   (i) a UDP-glucosyltransferase from Stevia rebaudiana sourced from Escherichia coli; and
                   (ii) a UDP-glucosyltransferase from Solanum lycopersicum sourced from Escherichia coli; and
                   (iii) a sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli.
               (d) by enzymatic conversion of purified stevia leaf extract to produce  rebaudioside E using a protein engineered enzyme that:
                   (i) contains both of the following components:
                      (A) UDP‑glucosyltransferase; and
                      (B) sucrose synthase (EC 2.4.1.13); and
                   (ii) is sourced from Pichia pastoris strain UGT-A;
             (e)    by enzymatic conversion of purified stevia leaf extract to produce rebaudioside M using all of the following protein engineered enzymes:
                  (i) UTP-glucose-1-phosphate uridylyltransferase (EC 2.7.7.9) sourced from Escherichia coli K-12; and
                   1.             UDP-glucosyltransferase sourced from Escherichia coli K-12; and
                   2.           sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli K-12;

             (f)      by enzymatic conversion of purified stevia leaf extract to produce rebaudioside I using both of the following protein engineered enzymes:
                  (i) UTP-glucose-1-phosphate uridylyltransferase (EC 2.7.7.9) sourced from Escherichia coli K-12; and
                  (ii) sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli K-12.

 (2A) The final product may be spray dried.

 (3) The preparation may contain different individual steviol glycosides.
 (4) The specifications are the following:
 (a) Description—white to light yellow powder, approximately 150 to 300 times sweeter than sucrose;
 (b) Assay—not less than 95% of steviol glycosides on the dried basis;
 (c) Solubility—freely soluble in water;
 (d) pH—between 4.5 and 7.0 (1% solution);
 (e) Total ash—not more than 1%;
 (f) Loss on drying—not more than 6% (105°C, 2 hour);
 (g) Residual solvents:  Not more than 200 mg/kg methanol
   Not more than 5000 mg/kg ethanol
 (h) Arsenic—not more than 1 mg/kg;
 (i) Lead—not more than 1 mg/kg;
 (j) INS number—960.

S3—36 Specification for oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)
  For oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695), the specifications are the following:
 (a) full chemical name—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3 DHA);
 (b) DHA (%)—minimum 35;
 (c) EPA (%)—maximum 10;
 (d) *trans fatty acids (%)—maximum 2.0;
 (e) lead (mg/kg)—maximum 0.1;
 (f) arsenic (mg/kg)—maximum 0.1;
 (g) mercury (mg/kg)—maximum 0.1;
 (h) hexane (mg/kg)—maximum 0.3.
S3—37 Specification for isomalto-oligosaccharide
  For isomalto-oligosaccharide (IMO), the specifications are the following:
 (a) chemical structure—IMO is a mixture of glucose oligomers with α 1→6 glycosidic linkages that include isomaltose, panose, isomaltotriose, isomaltopentaose and various branched oligosaccharides;
 (b) description—a white crystalline powder or transparent clear pale yellow coloured syrup;
 (c) IMO content (dry weight)—not less than 90% (powder) and not less than 75% (syrup);
 (d) oligosaccharides—not less than 55% with a degree of polymerisation