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 2011. 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.
|FEDERAL REGISTER CITATION||PETITION NUMBER||DOCKET NUMBER||SUBJECT|
|3/2/2011||76 FR 11328||FAP 0A4781||Docket No. FDA–2010–F–0200||Final Rule: Fonterra (USA), Inc.; amending the food additive regulations to permit the use of hydrogen peroxide as an antimicrobial agent in the manufacture of modified whey by ultrafiltration methods. 21 CFR 173.356|
|7/15/2011||76 FR 41687||FAP 0A4780||Docket No. FDA–2010–C–0103||Final Rule: Nisso America Inc.; amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. 21 CFR 172.870|
|CAP 8C0287||Docket No. FDA–2009–C–0543||
Final Rule: Sauflon Pharmaceuticals Ltd. amending the color additive regulations to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (CAS Reg. No. 70209–99–3), also known as Reactive Blue 69, as a color additive in contact lenses. 21 CFR 73.3129
Final Rule: Confirmation of Effective Date