Main Percentage of food and color additive petition reviews completed during the quarter within 360 days of filing FDA has the primary legal responsibility for determining the safe use of food and color additives. Before a food additive is marketed that will have technical effect in food, there must first be a regulation issued by FDA that authorizes such use. Similarly, before a color additive is marketed for use in food, drugs, cosmetics, or in certain medical devices, FDA must issue an authorizing regulation. A company that seeks a regulation for a new use of a food or color additive must submit a petition to FDA with evidence that the substance is safe for the intended use. A substance for which the use is generally recognized by qualified experts as safe is exempt from premarket approval as a food additive. "GRAS" is an acronym for the phrase Generally Recognized As Safe. The GRAS notification program is a voluntary procedure that is operating under a proposed rule issued in 1997. FDA reviews the notice and responds to the notifier by letter. In general, FDA’s response has been in one of three categories: does not question the basis for the GRAS determination, concludes the notice does not provide a sufficient basis for a GRAS determination, or at the notifier’s request has ceased to evaluate the GRAS notice. FDA also has responsibility for the regulation of components of food contact materials (food contact substances) under the same authority as for direct food additives. To market a new food contact substance or an existing substance for a new use, manufacturers must notify FDA 120 days prior to marketing the substance. Notifications must establish that the proposed use is safe in accordance with the same safety standard as direct food additives. In the event safety is not established, FDA may object to the notification to prevent marketing. In addition, FDA may ask for additional information based on our review or request that a notifier withdraw a deficient notification. Increasing the efficiency of review of food and color additive petitions, GRAS notices, and notifications for food contact substances:<ul><li>Increases consumer choices for safe packaging materials, food ingredients, and color additives;</li><li>Provides consumers and industry with additional tools to mitigate or prevent microbial contamination that may lead to food borne illness; and</li><li>Maximizes the use of FDA resources applied to food safety and public health protection.</li></ul> <i>Information is current as of December 31, 2012.</i> Percentage column 0 100 2010 FY 2010 Overall: 100% 2011 FY 2011 Overall: 100% 2012 FY 2012 Overall: 92% 2013 FY 2013 YTD: 100% Submeasure 1SubPercentage of food and color additive petition reviews completed during the quarter within 360 days of filingNumber of food and color additive petitions reviews completed during the quarter within 360 days of filingNumbercolumn2010FY 2010 Total: 92011FY 2011 Total: 102012FY 2012 Total: 12 2013 FY 2013 YTD: 4 Submeasure 2SubPercentage of food and color additive petition reviews completed during the quarter within 360 days of filingTotal number of food and color additive petitions reviews completed during the quarterNumbercolumn2010FY 2010 Total: 92011FY 2011 Total: 102012FY 2012 Total: 13 2013 FY 2013 YTD: 4 Submeasure 3SubPercentage of food and color additive petition reviews completed during the quarter within 360 days of filingMedian number of days to complete review during the monthNumbercolumn2010FY 2010 Overall: 1122011FY 2011 Overall: 1312012FY 2012 Overall: 159 Submeasure 3SubPercentage of food and color additive petition reviews completed during the quarter within 360 days of filingMean number of days to complete review during the quarterNumbercolumn2013FY 2013 YTD:151 http://www.fda.gov/AboutFDA/Transparency/track/ucm206221.htmFDA-TRACK CFSAN Dashboard਍††਍਍਍਍਍਍਍