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U.S. Department of Health and Human Services

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Percentage of food contact substance notification reviews completed within 110 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 June 30, 2021.

Fiscal Year - 2021

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TimeTargetPercentage
Oct 2020N/A83
Nov 2020N/A100
Dec 2020N/A86
Jan 2021N/A83
Feb 2021N/A88
Mar 2021N/A60
Apr 2021N/A83
May 2021N/A100
Jun 2021N/A90
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: 85%

Footnotes

  • During the government shutdown (furlough) from December 22, 2018 through January 25, 2019, the majority of CFSAN employees were on furlough status, which directly impacted the FY 2019 Q2 data for various food safety programs. Because the furloughed staff were not permitted to work, CFSAN’s ability to accomplish many performance targets, including conducting timely reviews of industry submissions received during the shutdown were either delayed, deferred to the next reporting cycle, or, not met.

Number of food contact substance notification reviews completed during the month within 110 days of original or amended receipt

Fiscal Year - 2021
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TimeTargetNumber
Oct 2020N/A5
Nov 2020N/A2
Dec 2020N/A6
Jan 2021N/A5
Feb 2021N/A7
Mar 2021N/A3
Apr 2021N/A5
May 2021N/A5
Jun 2021N/A9
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: 47

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

Fiscal Year - 2021
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TimeTargetNumber
Oct 2020N/A6
Nov 2020N/A2
Dec 2020N/A7
Jan 2021N/A6
Feb 2021N/A8
Mar 2021N/A5
Apr 2021N/A6
May 2021N/A5
Jun 2021N/A10
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: 55

Median number of days to complete review during the month

Fiscal Year - 2021
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TimeTargetNumber
Oct 2020N/A94
Nov 2020N/A83
Dec 2020N/A94
Jan 2021N/A99
Feb 2021N/A92
Mar 2021N/A101
Apr 2021N/A93
May 2021N/A82
Jun 2021N/A89
Jul 2021N/ATBD
Aug 2021N/ATBD
Sep 2021N/ATBD

FY 2021 YTD: 92

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.

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