2009 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 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 2009. 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. 





74 FR 207


74 FR 10483

(formerly 1998P-0724)

Final Rule: Center for Science in the Public Interest; Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; The Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carmine-containing food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. 21 CFR 73.100 21 CFR 101.22

Final Rule: Confirmation of Effective Date

03/16/2009 74 FR 11019 FAP 7A4769 FDA-2007-F-0274 (formerly Docket No. 2007F-0355) Final Rule: Dean Foods Co; Food Additives Permitted for Direct Addition to Food for Human Consumption; safe use of vitamin D2 as a nutrient supplement in soy-based food products 21 CFR 172.379
03/18/2009 74 FR 11476 FAP 5A4759 FDA-2005-F-0505 (formerly Docket No. 2005F-0138 Final Rule: Kareem I. Batarseh; Food Additives Permitted for Direct Addition to Food for Human Consumption; safe use of an aqueous solution of silver nitrate and hydrogen peroxide as an antimicrobial agent in bottled water 21 CFR 172.167




74 FR 57248

75 FR 5887

CAP 7C0284 Docket No. FDA–2007–C–0044 (formerly
Docket No. 2007C–0474)

Final Rule:  DSM Nutritional Products, Inc.; Listing of Color Additives Exempt From Certification; Astaxanthin Dimethyldisuccinate 21 CFR 73.37


Final rule; confirmation of effective date




74 FR 58843

75 FR 5887

CAP 7C0283 Docket No. FDA-2007-C-0456 (formerly Docket No. 2007-C-0245)

Final Rule: Nippon Oil Corp.; Listing of Color Additives Exempt From Certification; Paracoccus Pigment 21 CFR 73.352


Final rule; confirmation of effective date


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