Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p3
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 8777–11927

of Federal Regulations;
 (i) the Specifications and Standards for Food Additives, 9th Edition (2018)', Ministry of Health and Welfare (Japan); or
 (j) the International Oenological Codex (2022), Organisation Internationale de la Vigne et du Vin (OIV).
S3—4 Additional and supplementary requirements
  If there is no relevant specification under section S3—2 or S3—3, or if the monographs referred to in those sections do not contain a specification for identity and purity of a substance relating to arsenic or heavy metals, the specification is that the substance must not contain on a dry weight basis more than:
 (a) 2 mg/kg of lead; or
 (b) 1 mg/kg of arsenic; or
 (c) 1 mg/kg of cadmium; or
 (d) 1 mg/kg of mercury.
S3—5 Specifications for advantame
  For advantame, the specifications are:
 (a) purity, using the analytical methodology indicated:
 (i) assay:
 (A) specification—not less than 97.0% and not more than 102.0% on anhydrous basis; and
 (B) analytical methodology—high pressure liquid chromatography; and
 (ii) specific rotation [α] 20 D:
 (A) specification—between -45° and -38°; and
 (B) analytical methodology—Japanese Pharmacopeia; and
 (iii) advantame-acid:
 (A) specification—not more than 1.0%; and
 (B) analytical methodology—HPLC; and
 (iv) total other related substances:
 (A) specification—not more than 1.5%; and
 (B) analytical methodology—HPLC; and
 (v) water:
 (A) specification—not more than 5.0%; and
 (B) analytical methodology—Karl Fischer coulometric titration; and
 (vi) residue on ignition:
 (A) specification—no more than 0.2%; and
 (B) analytical methodology—Japanese Pharmacopeia; and
 (b) residual solvents, using gas chromatography:
 (i) methyl acetate—no more than 500 mg/kg; and
 (ii) isopropyl acetate—no more than 2 000 mg/kg; and
 (iii) methanol—no more than 500 mg/kg; and
 (iv) 2-Propanol—no more than 500 mg/kg.
S3—6 Specification for amine agarose ion exchange resin
 (1) This specification relates to agarose, cross-linked and alkylated with epichlorohydrin and propylene oxide, then derivatised with tertiary amine groups whereby the amount of epichlorohydrin plus propylene oxide does not exceed 250% by weight of the starting amount 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—7 Specification for bentonite
  Bentonite must comply with a monograph specification in section S3—2 or section S3—3, except that the pH determination for a bentonite dispersion must be no less than 4.5 and no more than 10.5.
S3—8 Specification for bromo-chloro-dimethylhydantoin
 (1) In this section:
bromo-chloro-dimethylhydantoin (CAS Number: 126-06-7) is the chemical with:
 (a) the formula C5H6BrClN2O2; and
 (b) the formula weight 241.5.
 (2) For bromo-chloro-dimethylhydantoin, the chemical specifications are the following:
 (a) appearance—solid or free flowing granules;
 (b) colour—white:
 (c) odour—faint halogenous odour;
 (d) melting point—163–164ºC;
 (e) specific gravity—1.8–2;
 (f) solubility