United States Pharmacopeial Convention; Filing of Food Additive Petition, 48353-48355 [2010-19722]
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[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)] [Notices] [Pages 48353-48355] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2010-19722] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-F-0320] United States Pharmacopeial Convention; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that the U.S. Pharmacopeial Convention has filed a petition proposing that the food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition. FOR FURTHER INFORMATION CONTACT: Mical E. Honigfort, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1278. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 0A4782) has been filed by U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852. The petition proposes that the food additive regulations in table 1 of this document, which incorporate by reference food-grade specifications from prior editions of the FCC, be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition. Table 1.--List of Regulations -------------------------------------------------------------------------------------------------------------------------------------------------------- FCC Edition and/or Supplement 21 CFR Section Currently Referenced Name of Additive Current FCC Reference -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.167(b) 6th Ed. Hydrogen peroxide Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.320(b)(1) 3d Ed. Amino acids Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.345(b) 4th Ed. Folic acid (folacin) Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.379(b) 6th Ed. Vitamin D2 Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.380(b) 5th Ed. Vitamin D3 Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.665(d)(2) 4th Ed. Gellan gum Residual isopropyl alcohol limit not to exceed 0.075% by the procedure described in the Xanthan Gum monograph. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.712(b) 4th Ed. 1,3-Butylene glycol Conforms to FCC identity and specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.723(b)(3) 4th Ed. Epoxidized soybean oil Heavy metals (as lead) content cannot be more than 10 parts per million (ppm) as determined by the ``Heavy Metals Test.'' -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.736(b)(2) 5th Ed. Glycerides and Acid value not greater than 2, and hydroxyl polyglycides of value, not greater than 56 as determined by hydrogenated vegetable ``Acid Value'' and ``Hydroxyl Value'' oils methods. -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 48354]] 172.780(b) 5th Ed. Acacia (gum arabic) Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.800(b)(2) 3d Ed. Acesulfame potassium Fluoride content not more than 30 ppm as determined by Method III of the Fluoride Limit Test. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.804(b) 3d Ed., 1st Supp. Aspartame Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.810 3d Ed. Dioctyl sodium Meets FCC specifications. sulfosuccinate -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.812(a) 3d Ed. Glycine Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.831(b) 4th Ed. Sucralose Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.833(b)(4) 4th Ed. Sucrose acetate Lead not to exceed 1.0 milligram/kilogram (mg/ isobutyrate (SAIB) kg) determined by the ``Atomic Absorption Spectrophotometric Graphite Furnace Method, Method I,'' with an attached modification to sample digestion section. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.841(b) 5th Ed., 1st Supp. Polydextrose Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.846(b) 3d Ed. Sodium stearoyl Meets FCC specifications. lactylate -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.858(a) 3d Ed. Propylene glycol Meets FCC specifications. alginate -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.862(b)(1) 3d Ed. Oleic acid derived from Meets FCC specifications except that titer tall oil fatty acids (solidification point) shall not exceed 13.5 degrees Celsius and unsaponifiable matter shall not exceed 0.5%. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.867(b) 4th Ed., 1st Supp. Olestra Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.869(b)(6) 4th Ed. Sucrose oligoesters Acid value not more than 4.0 as determined by the method ``Acid Value,'' Appendix VII, Method I (Commercial Fatty Acids). -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.869(b)(7) 4th Ed. Sucrose oligoesters Residue on ignition not more than 0.7% as determined by ``Residue on Ignition,'' Appendix IIC, Method I (using a 1 gram sample). -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.869(b)(8) 4th Ed., 1st Supp. Sucrose oligoesters Residual methanol not more than 10 mg/kg as determined by the method listed in the monograph for ``Sucrose Fatty Acid Esters.'' -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.869(b)(9) 4th Ed., 1st Supp. Sucrose oligoesters Residual dimethyl sulfoxide not more than 2.0 mg/kg as determined by the method listed in the monograph ``Sucrose Fatty Acid Esters.'' -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.869(b)(10) 4th Ed., 1st Supp. Sucrose oligoesters Residual isobutyl alcohol not more than 1.0 mg/kg as determined by the method listed in the monograph ``Sucrose Fatty Acid Esters.'' -------------------------------------------------------------------------------------------------------------------------------------------------------- 172.869(b)(11) 4th Ed. Sucrose oligoesters Lead not more than 1.0 mg/kg as determined by ``Atomic Absorption Spectrophotometric Graphite Furnace Method,'' Method I. -------------------------------------------------------------------------------------------------------------------------------------------------------- 173.115(b)(3) 4th Ed. Alpha-acetolactate Enzyme preparation must meet general and decarboxylase (a-ALDC) additional requirements for enzyme enzyme preparation preparations in FCC. derived from a recombinant Bacillus subtilis -------------------------------------------------------------------------------------------------------------------------------------------------------- 173.160(d) 3d Ed. Candida guilliermondii Citric acid produced must conform to FCC specifications (under ``Citric acid''). -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 48355]] 173.165(d) 3d Ed. Candida lipolytica Citric acid produced must conform to FCC specifications (under ``Citric acid''). -------------------------------------------------------------------------------------------------------------------------------------------------------- 173.228(a) 4th Ed. Ethyl acetate Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 173.280(c) 3d Ed. Solvent extraction Meets FCC specifications. process for citric acid -------------------------------------------------------------------------------------------------------------------------------------------------------- 173.310(c) 4th Ed. Boiler water additives; Contains not less than 95% sodium Sodium carboxymethylcellulose on a dry-weight basis, carboxymethylcellulose with maximum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2% by weight aqueous determined by the method cited in FCC. -------------------------------------------------------------------------------------------------------------------------------------------------------- 173.310(c) 4th Ed. Boiler water additives; Meets FCC specifications. Sorbitol anhydride esters -------------------------------------------------------------------------------------------------------------------------------------------------------- 173.368(c) 4th Ed. Ozone Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 178.1005(c) 3d Ed. Hydrogen peroxide Meets FCC specifications. solution -------------------------------------------------------------------------------------------------------------------------------------------------------- 180.25(b) 3d Ed. Mannitol Meets FCC specifications. -------------------------------------------------------------------------------------------------------------------------------------------------------- 180.30(a) 3d Ed. Brominated vegetable Meets FCC specifications. oil -------------------------------------------------------------------------------------------------------------------------------------------------------- 180.37(b) 3d Ed. Saccharin, ammonium Meets FCC specifications. saccharin, calcium saccharin, and sodium saccharin -------------------------------------------------------------------------------------------------------------------------------------------------------- The agency has determined under 21 CFR 25.30(i) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. Dated: August 4, 2010. Catherine L. Copp, Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2010-19722 Filed 8-9-10; 8:45 am] BILLING CODE 4160-01-S
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