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U.S. Department of Health and Human Services

Food

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2013 Food and Color Additive Final Rules

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 Food Contact Substance (FCS) Notifications 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 2013. 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. A link in the column entitled Federal Register documents provides access to the text of the document.

For more information about the petition process, see Questions and Answers About the Petition Process.

Final rules for years 2000-present are also available.  

DATEFEDERAL REGISTER CITATIONPETITION NUMBERDOCKET NUMBERSUBJECT
4/1/2013

6/25/2013
78 FR 19413

78 FR 37962
CAP 1C0291
(Coopervision, Inc.)
FDA–2011–C–0344Final Rule; amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) ... as color additives in contact lenses; 21 CFR 73.3106; Effective May 2, 2013.
Final Rule; Confirmation of Effective Date.
4/1/2013

6/25/2013
78 FR 19413

78 FR 37962
CAP 1C0292
(Coopervision, Inc.)
FDA–2011–C–0463Final Rule; amending the color additive regulations to provide for the safe use of additional ... copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic) ester (C.I. Reactive Blue 247) as color additives in contact lenses; 21 CFR 73.3100; Effective May 2, 2013.
Final Rule; Confirmation of Effective Date.
6/12/2013

9/6/2013
78 FR 35115

78 FR 54758
CAP 2C0294
(E. & J. Gallo Winery)
FDA–2012–C–0224Final Rule; amending the color additive regulations to provide for the safe use of mica–based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis; 21 CFR 73.350; Effective July 15, 2013.
Final Rule; Confirmation of Effective Date.
8/13/2013

11/15/2013
78 FR 49117

78 FR 68713
CAP 2C0293
(Mars, Inc.)
FDA–2011–C–0878Final Rule; amending the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum. This final rule is effective on September 13, 2013, except as to any provisions that may be stayed by the filing of proper objections.
11/29/201378 FR 71457FAP 0A4782 (United States Pharmacopeial Convention)FDA-2010-F-0320Final Rule; amending select food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition (FCC 7)
12/6/201378 FR 73434FAP 1A4784 (Nexira)FDA–2011–F–0765Final rule; amending the food additive regulations to provide for the expanded safe use of acacia (gum arabic) in foods; 21 CFR 172.780