75 FR 153 pgs. 48353-48355 - United States Pharmacopeial Convention; Filing of Food Additive Petition
Type: NOTICEVolume: 75Number: 153Pages: 48353 - 48355
Docket number: [Docket No. FDA-2010-F-0320]
FR document: [FR Doc. 2010-19722 Filed 8-9-10; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
| 21 CFR Section | FCC Edition and/or Supplement 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 D 2 | Meets FCC specifications. |
| 172.380(b) | 5th Ed. | Vitamin D 3 | 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 polyglycides of hydrogenated vegetable oils | Acid value not greater than 2, and hydroxyl value, not greater than 56 as determined by "Acid Value" and "Hydroxyl Value" methods. |
| 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 sulfosuccinate | Meets FCC specifications. |
| 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 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. | Polydextrose | Meets FCC specifications. |
| 172.846(b) | 3d Ed. | Sodium stearoyl lactylate | Meets FCC specifications. |
| 172.858(a) | 3d Ed. | Propylene glycol alginate | Meets FCC specifications. |
| 172.862(b)(1) | 3d Ed. | Oleic acid derived from tall oil fatty acids | Meets 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. | 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 decarboxylase ( a -ALDC) enzyme preparation derived from a recombinant Bacillus subtilis | Enzyme preparation must meet general and additional requirements for enzyme preparations in FCC. |
| 173.160(d) | 3d Ed. | Candida guilliermondii | Citric acid produced must conform to FCC specifications (under "Citric acid"). |
| 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 process for citric acid | Meets FCC specifications. |
| 173.310(c) | 4th Ed. | Boiler water additives; Sodium carboxymethylcellulose | Contains 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 esters | Meets FCC specifications. |
| 173.368(c) | 4th Ed. | Ozone | Meets FCC specifications. |
| 178.1005(c) | 3d Ed. | Hydrogen peroxide solution | Meets FCC specifications. |
| 180.25(b) | 3d Ed. | Mannitol | Meets FCC specifications. |
| 180.30(a) | 3d Ed. | Brominated vegetable oil | Meets FCC specifications. |
| 180.37(b) | 3d Ed. | Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin | Meets 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.
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