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U.S. Department of Health and Human Services

About FDA

Percentage of food contact substance notification reviews completed during the month within 100 days of original or amended receipt

Dictionary: 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:

  • Increases consumer choices for safe packaging materials, food ingredients, and color additives;
  • Provides consumers and industry with additional tools to mitigate or prevent microbial contamination that may lead to food borne illness; and
  • Maximizes the use of FDA resources applied to food safety and public health protection.

Information is current as of September 30, 2012.

Fiscal Year - 2011

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TimeAnnual TargetPercentage
Oct 201070100
Nov 20107080
Dec 20107083
Jan 20117086
Feb 20117090
Mar 20117055
Apr 20117085
May 20117083
Jun 20117071
Jul 20117075
Aug 20117057
Sep 201170100

FY 2011 Overall: 78%

Number of food contact substance notification reviews completed during the month within 100 days of original or amended receipt

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A5
Nov 2010N/A4
Dec 2010N/A10
Jan 2011N/A6
Feb 2011N/A9
Mar 2011N/A6
Apr 2011N/A11
May 2011N/A5
Jun 2011N/A5
Jul 2011N/A9
Aug 2011N/A4
Sep 2011N/A1

FY 2011 Total: 75

Total number of food contact substance notification reviews completed during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A5
Nov 2010N/A5
Dec 2010N/A12
Jan 2011N/A7
Feb 2011N/A10
Mar 2011N/A11
Apr 2011N/A13
May 2011N/A6
Jun 2011N/A7
Jul 2011N/A12
Aug 2011N/A7
Sep 2011N/A1

FY 2011 Total: 96

Median number of days to complete review during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 20109589
Nov 20109578
Dec 20109583
Jan 20119587
Feb 20119581
Mar 20119595
Apr 20119586
May 20119585
Jun 20119558
Jul 20119588
Aug 201195100
Sep 20119561

FY 2011 Overall: 86

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.