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United States Pharmacopeial Convention; Filing of Food Additive Petition

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Food and Drug Administration, HHS.




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.

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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.

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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

21 CFR SectionFCC Edition and/or Supplement Currently ReferencedName of AdditiveCurrent FCC Reference
172.167(b)6th Ed.Hydrogen peroxideMeets FCC specifications.
172.320(b)(1)3d Ed.Amino acidsMeets FCC specifications.
172.345(b)4th Ed.Folic acid (folacin)Meets FCC specifications.
172.379(b)6th Ed.Vitamin D2Meets FCC specifications.
172.380(b)5th Ed.Vitamin D3Meets FCC specifications.
172.665(d)(2)4th Ed.Gellan gumResidual 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 glycolConforms to FCC identity and specifications.
172.723(b)(3)4th Ed.Epoxidized soybean oilHeavy 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 polyglycides of hydrogenated vegetable oilsAcid value not greater than 2, and hydroxyl value, not greater than 56 as determined by “Acid Value” and “Hydroxyl Value” methods.
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172.780(b)5th Ed.Acacia (gum arabic)Meets FCC specifications.
172.800(b)(2)3d Ed.Acesulfame potassiumFluoride content not more than 30 ppm as determined by Method III of the Fluoride Limit Test.
172.804(b)3d Ed., 1st Supp.AspartameMeets FCC specifications.
172.8103d Ed.Dioctyl sodium sulfosuccinateMeets FCC specifications.
172.812(a)3d Ed.GlycineMeets FCC specifications.
172.831(b)4th Ed.SucraloseMeets FCC specifications.
172.833(b)(4)4th Ed.Sucrose acetate isobutyrate (SAIB)Lead not to exceed 1.0 milligram/kilogram (mg/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.PolydextroseMeets FCC specifications.
172.846(b)3d Ed.Sodium stearoyl lactylateMeets FCC specifications.
172.858(a)3d Ed.Propylene glycol alginateMeets FCC specifications.
172.862(b)(1)3d Ed.Oleic acid derived from tall oil fatty acidsMeets FCC specifications except that titer (solidification point) shall not exceed 13.5 degrees Celsius and unsaponifiable matter shall not exceed 0.5%.
172.867(b)4th Ed., 1st Supp.OlestraMeets FCC specifications.
172.869(b)(6)4th Ed.Sucrose oligoestersAcid 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 oligoestersResidue 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 oligoestersResidual 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 oligoestersResidual 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 oligoestersResidual 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 oligoestersLead 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 decarboxylase (a-ALDC) enzyme preparation derived from a recombinant Bacillus subtilisEnzyme preparation must meet general and additional requirements for enzyme preparations in FCC.
173.160(d)3d Ed.Candida guilliermondiiCitric acid produced must conform to FCC specifications (under “Citric acid”).
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173.165(d)3d Ed.Candida lipolyticaCitric acid produced must conform to FCC specifications (under “Citric acid”).
173.228(a)4th Ed.Ethyl acetateMeets FCC specifications.
173.280(c)3d Ed.Solvent extraction process for citric acidMeets FCC specifications.
173.310(c)4th Ed.Boiler water additives; Sodium carboxymethylcelluloseContains not less than 95% sodium carboxymethylcellulose on a dry-weight basis, 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; Sorbitol anhydride estersMeets FCC specifications.
173.368(c)4th Ed.OzoneMeets FCC specifications.
178.1005(c)3d Ed.Hydrogen peroxide solutionMeets FCC specifications.
180.25(b)3d Ed.MannitolMeets FCC specifications.
180.30(a)3d Ed.Brominated vegetable oilMeets FCC specifications.
180.37(b)3d Ed.Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharinMeets FCC specifications.

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.

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Dated: August 4, 2010.

Catherine L. Copp,

Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.

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[FR Doc. 2010-19722 Filed 8-9-10; 8:45 am]