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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.”

We will update this information approximately monthly. More information about this inventory is available on the GRAS Notice Inventory Introduction page.


Search and display hints:

  • 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.
  • To browse the records, use the Show All, First/Previous/Next/Last, and Jump To options at the bottom of the data table.
  • 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.)
  • The search results will return hits of records containing words that include the search term. For example, a search for the color red will return results that include terms such as reduce, ingredient, and cultured. To limit results to only the searched term, place a space before and after the word in the basic search or in the advanced search “this exact phrase” field.
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Records Found: 194 Show All Page 1 of 4
GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter Date of add'l correspondence Resubmitted as GRN No.
  1186
Fungal oil (≥38% arachidonic acid (ARA)) from Mortierella alpina FJRK-MA01 Pending
  1185
Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. FJRK-SCH3 Pending
  1182
Hydroxytyrosol
   (Resubmission of GRN 1138)
Pending
  1162
Fungal oil (≥38% arachidonic acid (ARA)) from Mortierella alpina FJRK-MA01 Feb 8, 2024 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (236 kB)
  1161
Triacylglycerol lipase enzyme preparation produced by Candida cylindracea Pending
  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)
  1153
Pongamia bean oil Pending
  1138
Hydroxytyrosol Sep 28, 2023 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (173 kB)
  1182
  1128
Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. Pending
  1122
Canola concentrate Pending
  1119
Olea europaea L. leaf extract Pending
  1115
Fungal oil (≥40% arachidonic acid (ARA)) from Mortierella alpina strain AF Sep 18, 2023 FDA has no questions (in PDF) (256 kB)
  1103
Canola protein isolate Pending
  1095
Bacillus subtilis strain ATCC AAN000002 spore preparation Sep 11, 2023 FDA has no questions (in PDF) (286 kB)
  1077
Oat polar lipid extract Pending
  1050
High 2-palmitic acid vegetable oil Jul 18, 2022 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (175 kB)
  1042
Menaquinone-7 derived from a specific strain of Bacillus subtilis natto Apr 3, 2023 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (188 kB)
  1031
Barley and rice protein hydrolysate Oct 20, 2022 FDA has no questions (in PDF) (219 kB)
  1009
Water-soluble palm fruit extract Jun 24, 2022 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (129 kB)
  1008
Algal oil (≥45% docosahexaenoic acid) from Aurantiochytrium limacinum TKD-1 Feb 25, 2022 FDA has no questions (in PDF) (166 kB)
  978
Hydrolyzed aqueous olive pulp extract Dec 10, 2021 FDA has no questions (in PDF) (256 kB)
  971
Bacillus clausii strain 088AE spore preparation Mar 3, 2022 FDA has no questions (in PDF) (150 kB)
  963
Fungal oil (≥40% arachidonic acid) from Mortierella alpina Oct 19, 2021 FDA has no questions (in PDF) (429 kB)
  962
Rice bran wax Mar 17, 2022 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (138 kB)
  958
Fungal oil (≥40% arachidonic acid) from Mortierella alpina strain AF Mar 26, 2021 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (94 kB)
  955
Bacillus subtilis strain BS-MB40 PTA-122264 spore preparation Mar 26, 2021 FDA has no questions (in PDF) (243 kB) Sep 11, 2023
  948
Enzyme-treated pea protein Sep 9, 2021 FDA has no questions (in PDF) (151 kB)
  943
Citrus fiber from the peels of oranges, lemons, or limes Apr 9, 2021 FDA has no questions (in PDF) (181 kB)
  941
Oat polar lipid extract Jun 11, 2021 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (124 kB)
  937
Staphylococcus carnosus DSM 25010 Apr 21, 2021 FDA has no questions (in PDF) (195 kB)
  936
Leuconostoc carnosum DSM 32756 Apr 19, 2021 FDA has no questions (in PDF) (212 kB)
  934
Algal oil (≥35% docosahexanoic acid (DHA)) derived from Schizochytrium sp. strain CABIO-A-2 Jul 20, 2021 FDA has no questions (in PDF) (214 kB)
  933
Algal oil (≥36% docosahexaenoic acid) from Schizochytrium sp. strain DHF Nov 13, 2020 FDA has no questions (in PDF) (757 kB)
  914
Alpha-linolenic acid diacylglycerol Mar 15, 2021 FDA has no questions (in PDF) (175 kB)
  913
Algal oil (minimum 35% DHA) Nov 10, 2020 FDA has no questions (in PDF) (906 kB)
  908
Lipase from Penicillium camemberti Feb 5, 2021 FDA has no questions (in PDF) (184 kB)
  907
Wheat seed oil Aug 21, 2020 FDA has no questions (in PDF) (593 kB)
  904
Fungal protein from fermented Fusarium sp. mycelia Mar 26, 2021 FDA has no questions (in PDF) (956 kB)
  903
Quillaia extract type 2 Apr 21, 2021 FDA has no questions (in PDF) (195 kB)
  900
Corn oil Oct 30, 2020 FDA has no questions (in PDF) (540 kB)
  892
Refined shea butter Jul 7, 2020 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (162 kB)
  890
Corn oil derived from distillers grains Dec 23, 2020 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (189 kB)
  876
Hydroxytyrosol Jan 21, 2020 FDA has no questions (in PDF) (88 kB)
  866
Lipase from Penicillium camemberti Feb 5, 2020 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (257 kB)
  862
Algal oil (40% docosahexaenoic acid) from Schizochytrium sp. strain ONC-T18 Jun 15, 2020 FDA has no questions (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)
  857
Phospholipase A1 produced by Aspergillus niger Dec 20, 2019 FDA has no questions (in PDF) (465 kB)
  848
Pea and rice protein fermented by shiitake mycelia Jan 9, 2020 FDA has no questions (in PDF) (479 kB)
  844
Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. strain FCC-3204 Oct 18, 2019 FDA has no questions (in PDF) (105 kB)
  843
Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. strain FCC-1324 Oct 18, 2019 FDA has no questions (in PDF) (85 kB)

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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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