Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p10
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 29001–32639

USS screen; and
 (b) the chemical specifications are the following:
 (i) moisture—maximum 6%;
 (ii) molybdenum—1.8–2.25 g/kg.
S3—33 Specifications for Salmonella phage preparation (S16 and FO1a)
 (1) In this section:
a preparation means a Salmonella phage preparation (S16 and FO1a).
Salmonella phage preparation (S16 and FO1a) means a solution of a 1:1 blend of Salmonella phage S16 and Salmonella phage FO1a.
 (2) Salmonella phage S16 in a preparation must comply with the specification in subsection (4).
 (3) Salmonella phage FO1a in a preparation must comply with the specification in subsection (5).
 (4) The biological classification for Salmonella phage S16 in a preparation is the following:
 (a) order—Caudavirales;
 (b) family—Myoviridae;
 (c) genus—T4-like;
 (d) species—Salmonella phage S16;
 (e) GenBank Accession Number—HQ331142
 (5) The biological classification for Salmonella phage FO1a in a preparation is the following:
 (a) order—Caudavirales;
 (b) family—Myoviridae;
 (c) genus—FelixO1-like;
 (d) species— Salmonella phage FO1a;
 (e) GenBank Accession Number—JF461087.
S3—34 Specification for sulphonate agarose ion exchange resin
 (1) This specification relates to agarose, cross-linked with epichlorohydrin and reacted with allyl glycidyl ether or propylene oxide, then derivatised with sulphonate groups whereby the amount of epichlorohydrin plus allyl glycidyl ether or propylene oxide does not exceed 250% by weight of the starting quantity of agarose.
 (2) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH 2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.
S3—35 Specification for steviol glycosides produced by enzymatic conversion

  (1)      In this section:

       prescribed rebaudiosides are:

                        (a)      rebaudioside D;
                             (b)      rebaudioside M; and
                              (c)      rebaudioside AM.

               rebaudioside AM means the steviol glycoside with the chemical name: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester.

                               (1A)    This specification relates to a steviol glycosides preparation obtained from the  leaves of the Stevia rebaudiana Bertoni plant.

           (2) The preparation must be obtained from the leaves of the Stevia rebaudiana   Bertoni plant by using one of the following processes:

               (a) by enzymatic conversion of purified stevia leaf extract to produce rebaudioside M using protein engineered enzymes that:
                   (i) contain both UDP‑glucosyltransferase and sucrose synthase (EC 2.4.1.13) components; and
                    (ii) are sourced from both of the following:
                      (a) a Pichia pastoris strain expressing UGT-A;
                      (b) a Pichia pastoris strain expressing both UGT-B1 and UGT-B2;
               (b) by enzymatic conversion of purified stevia leaf extract to produce rebaudioside D using a protein engineered enzyme that:
                   (i) contains both UDP‑glucosyltransferase and sucrose synthase (EC 2.4.1.13) components; and
                   (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