FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Office of Food Additive Safety
December 2005

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Federal Register Rules Issued by the Office of Food Additive Safety
Year 2005 Approvals

(See also Approvals for Years 2000-present)

One of the charges of the Center for Food Safety and Applied Nutrition is to assure that the use of food ingredients and color additives is safe. The authority for this mission is derived from the 1958 food additive and 1960 color additive amendments to the Federal Food, Drug and Cosmetic Act. Towards this end, CFSAN evaluates new petitions to determine if substances are considered safe for addition to the food supply. When a petition for a food ingredient or color additive is approved, a regulation identifying the conditions of use is published in the Federal Register. For information about additional food ingredient review programs in the Office of Food Additive Safety, consult the Inventory of Effective Premarket Notifications for Food Contact Substances and the Summary of all GRAS Notices.

The following listing documents the Final rules issued by the Office of Food Additive Safety during calendar year 2005. This list will be updated quarterly. The exact date of the Publication and the Federal Register citation is listed along with other identifying information that can be found in the published Federal Register document. For more information about the petition process visit Questions and Answers About the Petition Process on the Office of Food Additive Safety's web site. Approvals for years 2000-present are also available.

DATE FEDERAL REGISTER CITATION PETITION NUMBER DOCKET NUMBER SUBJECT
2/14/2005 70 FR 7394 4A4751 2003F-0535 Final Rule; Vulcan Chemicals, amending regulation to permit manufacture of chlorine dioxide by electrolysis of an aqueous solution of sodium chlorite. 21 CFR 173.300
2/17/2005 70 FR 8032 1A4730 2003F-0023 Final Rule; Kerry, Inc., amending to permit the safe use of acacia (gum arabic) as a thickener, emulsifier, or stabilizer for use in alcoholic beverages at a maximum use level of 20 percent. 21 CFR 172.780
3/23/2005 70 FR 14530 6G0316 1999P-5332 Final Rule; National Fish Meal and Oil Association, amending existing GRAS affirmation regulation for menhaden oil to preclude its use with other oils that are significant sources of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). 21 CFR 184.1472
3/29/2005 70 FR 15756 3A4749 2003F-0471 Final rule; T&R Chemicals, Inc., amending the food additive regulations to provide for the safe use of Glycerol Ester of Gum Rosin to adjust the density of citrus oils used in the preparation of beverages 21 CFR 172.735
6/22/2005 70 FR 36021 2A4734 2002F-0160 Final rule; correcting amendments; Minute Maid Co., amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in calcium-fortified fruit juices and fruit juice drinks. 21 CFR 172.380
6/29/2005 70 FR 37255 3A4746 2003F-0370 Final Rule; Unilever United States, Inc., amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight. 21 CFR 172.380
8/16/2005 70 FR 48057 9M4682 1999F-4372 Final rule; National Fisheries Institute and the Louisiana Department of Agriculture and Forestry: amending the food additive regulations to provide for the safe use of ionizing radiation for control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish (e.g., oysters, mussels, clams, etc.) 21 CFR 179.26.
11/16/2005 70 FR 69435 4A4758 2004F-0374 Final rule; Kraft Foods Global Inc.: amending the food additive regulations to provide for the safe use of Vitamin D3 as a nutrient supplement in cheese and cheese products at a level above that currently allowed by the regulations. 21 CFR 172.380.
12/08/2005 70 FR 72906 4A4419 1994F-0153 Final rule; Kuraray International Corp.: amending the food additive regulations to provide for the safe use of n-octanol (n-octyl alcohol) produced by a new manufacturing process, the hydrodimerization of 1,3-butadiene. 21 CFR 172.864.
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