2012 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 2012. 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.

5/11/2012 77 FR 27586 FAP 9M4673 FDA–1999-F-0021 Final rule; denial of requests for a hearing and response to objections: The Food and Drug Administration (FDA) is denying requests for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the control of microbial pathogens in seeds for sprouting. After reviewing objections to the final rule and requests for a hearing, FDA has concluded that the objections do not justify a hearing or otherwise provide a basis for revoking the regulation. 21 CFR 179.26
6/11/2012 77 FR 34212 FAP 7M7468 FDA–2007–F–0390 (Formerly 2007F–0115)  Final Rule; amending the food additive regulations to provide for the safe use of a carbon dioxide laser for etching information on the surface of fresh, intact citrus fruit. 21 CFR 179.43
77 FR 39921
77 FR 55693
CAP 1C0290 FDA–2011–C–0050  Final Rule; revising its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for ‘‘Ether-soluble matter’’ with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. 21 CFR 74.1306 and 74.1307
8/29/2012 77 FR 52228 FAP 9A4779 FDA–2009–F–0570 Final Rule; amending the food additive regulations to provide for the safe use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food. This action is in response to a petition filed by Lallemand, Inc. 21 CFR 172.381.
11/30/2012 77 FR 71312 FAP 9M4695 FDA-1999-F-4617 (formerly 1999F-5321) Final Rule; amending the food additive regulations to provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life. 21 CFR 179.26
11/30/2012 77 FR 71316 FAP 9M4696 FDA-1999-F-1267 (formerly 1999F-5322) Final Rule; amending the food additive regulations to increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen. 21 CFR 179.26
12/4/2012 77 FR 71695 FAP 2A4785 FDA–2011–F–0853 Final Rule; amending the food additive regulations to provide for the safe use of sodium dodecylbenzenesulfonate (CAS No. 25155–30–0) as an antimicrobial agent for use in wash water for fruits and vegetables without the requirement of a potable water rinse. 21 CFR 173.405

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