[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48353-48355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19722]
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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.
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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
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FCC Edition and/or Supplement
21 CFR Section Currently Referenced Name of Additive Current FCC Reference
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172.167(b) 6th Ed. Hydrogen peroxide Meets FCC specifications.
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172.320(b)(1) 3d Ed. Amino acids Meets FCC specifications.
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172.345(b) 4th Ed. Folic acid (folacin) Meets FCC specifications.
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172.379(b) 6th Ed. Vitamin D2 Meets FCC specifications.
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172.380(b) 5th Ed. Vitamin D3 Meets FCC specifications.
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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.
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172.712(b) 4th Ed. 1,3-Butylene glycol Conforms to FCC identity and specifications.
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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.''
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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.
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172.780(b) 5th Ed. Acacia (gum arabic) Meets FCC specifications.
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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.
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172.804(b) 3d Ed., 1st Supp. Aspartame Meets FCC specifications.
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172.810 3d Ed. Dioctyl sodium Meets FCC specifications.
sulfosuccinate
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172.812(a) 3d Ed. Glycine Meets FCC specifications.
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172.831(b) 4th Ed. Sucralose Meets FCC specifications.
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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.
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172.841(b) 5th Ed., 1st Supp. Polydextrose Meets FCC specifications.
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172.846(b) 3d Ed. Sodium stearoyl Meets FCC specifications.
lactylate
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172.858(a) 3d Ed. Propylene glycol Meets FCC specifications.
alginate
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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%.
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172.867(b) 4th Ed., 1st Supp. Olestra Meets FCC specifications.
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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).
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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).
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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.''
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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.''
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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.''
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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.
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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
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173.160(d) 3d Ed. Candida guilliermondii Citric acid produced must conform to FCC
specifications (under ``Citric acid'').
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[[Page 48355]]
173.165(d) 3d Ed. Candida lipolytica Citric acid produced must conform to FCC
specifications (under ``Citric acid'').
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173.228(a) 4th Ed. Ethyl acetate Meets FCC specifications.
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173.280(c) 3d Ed. Solvent extraction Meets FCC specifications.
process for citric acid
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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.
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173.310(c) 4th Ed. Boiler water additives; Meets FCC specifications.
Sorbitol anhydride
esters
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173.368(c) 4th Ed. Ozone Meets FCC specifications.
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178.1005(c) 3d Ed. Hydrogen peroxide Meets FCC specifications.
solution
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180.25(b) 3d Ed. Mannitol Meets FCC specifications.
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180.30(a) 3d Ed. Brominated vegetable Meets FCC specifications.
oil
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180.37(b) 3d Ed. Saccharin, ammonium Meets FCC specifications.
saccharin, calcium
saccharin, and sodium
saccharin
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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