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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, 2020.

Fiscal Year - 2020

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TimeTargetPercentage
Oct 2019N/A90
Nov 2019N/A100
Dec 2019N/A100
Jan 2020N/A60
Feb 2020N/A67
Mar 2020N/A89
Apr 2020N/A100
May 2020N/A100
Jun 2020N/A86
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 89%

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 - 2020
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TimeTargetNumber
Oct 2019N/A9
Nov 2019N/A1
Dec 2019N/A8
Jan 2020N/A3
Feb 2020N/A2
Mar 2020N/A8
Apr 2020N/A6
May 2020N/A4
Jun 2020N/A6
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 47

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

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A10
Nov 2019N/A1
Dec 2019N/A8
Jan 2020N/A5
Feb 2020N/A3
Mar 2020N/A9
Apr 2020N/A6
May 2020N/A4
Jun 2020N/A7
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 53

Median number of days to complete review during the month

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A96
Nov 2019N/A83
Dec 2019N/A92
Jan 2020N/A102
Feb 2020N/A94
Mar 2020N/A96
Apr 2020N/A70
May 2020N/A85
Jun 2020N/A95
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 90

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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