Main 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 September 30, 2012.</i> Percentage line 0 100 Annual Target

FY 2010 Overall: 82%

Oct 2009 70 100 Nov 2009 70 80 Dec 2009 70 80 Jan 2010 70 57 Feb 2010 70 83 Mar 2010 70 60 Apr 2010 70 88 May 2010 70 100 Jun 2010 70 70 Jul 2010 70 88 Aug 2010 70 100 Sep 2010 70 91 Annual Target

FY 2011 Overall: 78%

Oct 2010 70 100 Nov 2010 70 80 Dec 2010 70 83 Jan 2011 70 86 Feb 2011 70 90 Mar 2011 70 55 Apr 2011 70 85 May 2011 70 83 Jun 2011 70 71 Jul 2011 70 75 Aug 2011 70 57 Sep 2011 70 100 Annual Target

FY 2012 Overall: 70%

Oct 2011 70 100 Nov 2011 70 100 Dec 2011 70 100 Jan 2012 70 29 Feb 2012 70 50 Mar 2012 70 67 Apr 2012 70 40 May 2012 70 60 Jun 2012 70 33 Jul 2012 70 100 Aug 2012 70 73 Sep 2012 70 100 Submeasure 1SubPercentage of food contact substance notification reviews completed during the month within 100 days of original or amended receiptNumbercolumn

FY 2010 Total: 74

Oct 2009N/A4Nov 2009N/A4Dec 2009N/A4Jan 2010N/A4Feb 2010N/A5Mar 2010N/A6Apr 2010N/A7May 2010N/A10Jun 2010N/A7Jul 2010N/A7Aug 2010N/A6Sep 2010N/A10

FY 2011 Total: 75

Oct 2010N/A5Nov 2010N/A4Dec 2010N/A10Jan 2011N/A6Feb 2011N/A9Mar 2011N/A6Apr 2011N/A11May 2011N/A5Jun 2011N/A5Jul 2011N/A9Aug 2011N/A4Sep 2011N/A1

FY 2012 Total: 60

Oct 20116Nov 20114Dec 20116Jan 20122Feb 20121Mar 20124Apr 20122May 20123Jun 20125Jul 201210Aug 20128Sep 20129Submeasure 2SubPercentage of food contact substance notification reviews completed during the month within 100 days of original or amended receiptNumbercolumn

FY 2010 Total: 90

Oct 2009N/A4Nov 2009N/A5Dec 2009N/A5Jan 2010N/A7Feb 2010N/A6Mar 2010N/A10Apr 2010N/A8May 2010N/A10Jun 2010N/A10Jul 2010N/A8Aug 2010N/A6Sep 2010N/A11

FY 2011 Total: 96

Oct 2010N/A5Nov 2010N/A5Dec 2010N/A12Jan 2011N/A7Feb 2011N/A10Mar 2011N/A11Apr 2011N/A13May 2011N/A6Jun 2011N/A7Jul 2011N/A12Aug 2011N/A7Sep 2011N/A1

FY 2012 Total: 86

Oct 20116Nov 20114Dec 20116Jan 20127Feb 20122Mar 20126Apr 20125May 20125Jun 201215Jul 201210Aug 201211Sep 20129Submeasure 3SubPercentage of food contact substance notification reviews completed during the month within 100 days of original or amended receiptNumbercolumn

FY 2010 Overall: 87

Oct 20099593Nov 20099578Dec 20099599Jan 20109598Feb 20109588Mar 20109595Apr 20109584May 20109578Jun 20109561Jul 20109586Aug 20109556Sep 20109591

FY 2011 Overall: 86

Oct 20109589Nov 20109578Dec 20109583Jan 20119587Feb 20119581Mar 20119595Apr 20119586May 20119585Jun 20119558Jul 20119588Aug 201195100Sep 20119561

FY 2012 Overall: 87

Oct 201166Nov 201177Dec 201176Jan 2012107Feb 2012109Mar 201293Apr 2012114May 201299Jun 2012118Jul 201268Aug 201273Sep 201281http://www.fda.gov/AboutFDA/Transparency/track/ucm206221.htmFDA-TRACK CFSAN Dashboard਍††਍਍਍਍