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U.S. Department of Health and Human Services

GRAS Notices

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The inventory of GRAS notices provides information about GRAS notices filed since 1998, when FDA received its first GRAS notice. As of October 17, 2016, the GRAS final rule (81 FR 54960; August 17, 2016) requires a specific format for a GRAS notice. Prior to that date, FDA processed GRAS notices under the framework of the GRAS proposed rule (62 FR 18938; April 17, 1997). Notices received prior to the effective date of the GRAS final rule provide examples for potential notifiers for the types of information that may support a GRAS conclusion. In the inventory, notices follow the requirements for the format and content of a GRAS notice as of the effective date of the GRAS final rule.

The inventory notes what type of response letter the FDA sent in response to the notice. Notifiers often resubmit notices that FDA previously ceased to evaluate at the notifier’s request, and resubmitted notices commonly receive a letter indicating FDA has no questions, after addressing deficiencies. In the inventory, entries for notices that were later resubmitted link to the newer entry in the final column. Newer entries for notices that were resubmitted include a link to the previous submission below the substance name.

Some GRNs that FDA previously ceased to evaluate at the notifier’s request were later resubmitted as a food additive petition. For each of these cases, the GRN detail page links to the food additive petition.

After issuing a response letter, we may issue a subsequent letter as circumstances warrant. The issue dates of any subsequent letters are listed under the column, "Date of add’l correspondence.”

As of July 2025, FDA is posting notices in a Docket at www.regulations.gov. In these cases, the link for the notices will take you to the document posted at www.regulations.gov. We will update this information approximately monthly. More information about this inventory is available on the GRAS Notice Inventory Introduction page.


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  • Select the specific GRN number below to view additional details about any GRAS Notice.
  • To sort by a specific field, click on the column header for that field.
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  • To search for a specific substance/term, enter the term in the Search box and select Show Items to display only those records that contain the selected term. (The search results also includes terms not shown on this page, but included in the full record on the detail page.)
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Records Found: 29 Page 1 of 1
GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter Date of add'l correspondence Resubmitted as GRN No.
  1313
Algal oil (≥35% docosahexaenoic acid) from Schizochytrium limacinum CCAP A2 Pending
  1301
Algal oil (≥45% docosahexaenoic acid from Schizochytrium sp. JDW-108) Pending
  1236
Algal oil (≥40% docosahexaenoic acid) from Aurantiochytrium limacinum H Sc-01 Jun 10, 2025 FDA has no questions; some uses may require a color additive listing (in PDF) (240 kB)
  1217
Algal oil (≥40% docosahexaenoic acid) from Aurantiochytrium limacinum CCAP A1 May 7, 2025 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (202 kB)
  1209
Algal oil (≥35% docosahexaenoic acid) from Schizochytrium limacinum A2 May 7, 2025 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (378 kB)
  1185
Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. " FJRK-SCH3" Mar 14, 2025 Notice does not provide a basis for a GRAS determination (in PDF) (204 kB)
  1156
Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. FJRK-SCH3 Feb 8, 2024 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (204 kB)
  1128
Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. Dec 13, 2023 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (321 kB)
  1008
Algal oil (≥45% docosahexaenoic acid) from Aurantiochytrium limacinum TKD-1 Feb 25, 2022 FDA has no questions; some uses may require a color additive listing (in PDF) (166 kB)
  934
Algal oil (≥35% docosahexanoic acid (DHA)) derived from Schizochytrium sp. strain CABIO-A-2 Jul 20, 2021 FDA has no questions; some uses may require a color additive listing (in PDF) (214 kB) Aug 8, 2025
  933
Algal oil (≥36% docosahexaenoic acid) from Schizochytrium sp. strain DHF
   (Resubmission of GRN 860)
Nov 13, 2020 FDA has no questions; some uses may require a color additive listing (in PDF) (757 kB)
  913
Algal oil (minimum 35% DHA) Nov 10, 2020 FDA has no questions; some uses may require a color additive listing (in PDF) (906 kB)
  862
Algal oil (40% docosahexaenoic acid) from Schizochytrium sp. strain ONC-T18 Jun 15, 2020 FDA has no questions; some uses may require a color additive listing (in PDF) (748 kB)
  860
Algal oil (36% docosahexaenoic acid) from Schizochytrium sp. strain DHF Sep 3, 2019 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (59 kB)
  933
  857
Phospholipase A1 produced by Aspergillus niger Dec 20, 2019 FDA has no questions (in PDF) (465 kB)
  844
Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. strain FCC-3204 Oct 18, 2019 FDA has no questions; some uses may require a color additive listing (in PDF) (105 kB)
  843
Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. strain FCC-1324 Oct 18, 2019 FDA has no questions; some uses may require a color additive listing (in PDF) (85 kB)
  836
Algal oil (50-60% docosahexaenoic acid) from Schizochytrium sp. HS01 Sep 3, 2019 FDA has no questions; some uses may require a color additive listing (in PDF) (74 kB)
  777
Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. strain FCC-3204 Oct 26, 2018 FDA has no questions; some uses may require a color additive listing (in PDF) (233 kB)
  776
Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. strain FCC-1324 Oct 26, 2018 FDA has no questions; some uses may require a color additive listing (in PDF) (573 kB)
  754
Algal oil (87% oleic acid) derived from Prototheca moriformis strain S6697 Jul 23, 2018 FDA has no questions (in PDF) (111 kB)
  621
Emulsified algal oil May 13, 2016 At the notifier's request, FDA ceased to evaluate this notice
  553
Algal oil (40% docosahexaenoic acid) derived from Schizochytrium sp. Jun 19, 2015 FDA has no questions; some uses may require a color additive listing
  527
Algal oil (87% oleic acid) derived from Prototheca moriformis strain S2532 Feb 6, 2015 FDA has no questions
  384
Algal oil derived from Chlorella protothecoides strain S106 (Cp algal oil) Jun 13, 2012 FDA has no questions
  331
Algal oil (Chlorella protothecoides) Jun 1, 2010 At the notifier's request, FDA ceased to evaluate this notice
  319
Micro-algal oil Ulkenia sp. SAM2179
   (Resubmission of GRN 160)
Aug 4, 2010 FDA has no questions; some uses may require a color additive listing
  160
Micro-algal oil (Ulkenia sp.) Apr 1, 2005 At the notifier's request, FDA ceased to evaluate this notice
  319
  137
Algal oil (Schizochytrium sp.) Feb 12, 2004 FDA has no questions

GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter Date of add'l correspondence Resubmitted as GRN No.
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