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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 - 2010

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TimeAnnual TargetPercentage
Oct 200970100
Nov 20097080
Dec 20097080
Jan 20107057
Feb 20107083
Mar 20107060
Apr 20107088
May 201070100
Jun 20107070
Jul 20107088
Aug 201070100
Sep 20107091

FY 2010 Overall: 82%

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A4
Nov 2009N/A4
Dec 2009N/A4
Jan 2010N/A4
Feb 2010N/A5
Mar 2010N/A6
Apr 2010N/A7
May 2010N/A10
Jun 2010N/A7
Jul 2010N/A7
Aug 2010N/A6
Sep 2010N/A10

FY 2010 Total: 74

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A4
Nov 2009N/A5
Dec 2009N/A5
Jan 2010N/A7
Feb 2010N/A6
Mar 2010N/A10
Apr 2010N/A8
May 2010N/A10
Jun 2010N/A10
Jul 2010N/A8
Aug 2010N/A6
Sep 2010N/A11

FY 2010 Total: 90

Median number of days to complete review during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 20099593
Nov 20099578
Dec 20099599
Jan 20109598
Feb 20109588
Mar 20109595
Apr 20109584
May 20109578
Jun 20109561
Jul 20109586
Aug 20109556
Sep 20109591

FY 2010 Overall: 87

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.