• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

GRAS Notices

  • Print
  • Share
  • E-mail
-

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.
Download GRAS Notices data in Microsoft Excel web format Download data from this searchable database in Excel format. If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Search within these results
Records Found: 24 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.
  1145
β-lactoglobulin produced by Aspergillus oryzae strain Ao_st0002 Pending
  1039
Lactase enzyme preparation produced by Aspergillus oryzae Pending
  982
Polygalacturonase enzyme preparation produced by Aspergillus oryzae expressing a polygalacturonase gene from A. tubingensis Mosseray Feb 2, 2022 FDA has no questions (in PDF) (154 kB)
  979
Pectin esterase enzyme preparation produced by Aspergillus oryzae expressing a pectin esterase gene from A. tubingensis Oct 18, 2021 FDA has no questions (in PDF) (140 kB)
  841
Saccharomyces cerevisiae expressing L-lactate dehydrogenase from Rhizopus oryzae Mar 10, 2020 FDA has no questions (in PDF) (604 kB)
  829
Powdered Aspergillus oryzae grown with one or more added minerals Dec 9, 2019 FDA has no questions (in PDF) (110 kB) May 18, 2020
  811
Phospholipase A1 produced by Aspergillus oryzae Jul 19, 2019 FDA has no questions (in PDF) (64 kB)
  800
gamma-oryzanol Mar 8, 2019 FDA has no questions (in PDF) (628 kB)
  783
Triacylglycerol lipase from Rhizopus oryzae produced in Aspergillus niger Dec 20, 2018 FDA has no questions (in PDF) (75 kB)
  708
Triacylglycerol lipase from Rhizopus oryzae produced in Aspergillus niger Oct 10, 2017 At the notifier's request, FDA ceased to evaluate this notice (in PDF) (52 kB)
  510
Acid lactase from Aspergillus oryzae expressed in Aspergillus niger Sep 29, 2014 FDA has no questions
  216
Lipase enzyme preparation from Rhizopus oryzae May 18, 2007 FDA has no questions
  201
Asparaginase enzyme preparation from Aspergillus oryzae expressing the asparaginase gene from A. oryzae Nov 24, 2006 FDA has no questions
  142
Phospholipase enzyme preparation from Aspergillus oryzae expressing the gene encoding a phospholipase A1 from Fusarium venenatum Jun 23, 2004 FDA has no questions
  122
Laccase enzyme preparation produced by Aspergillus oryzae expressing the gene encoding a laccase from Myceliophthora thermophila Jul 18, 2003 FDA has no questions
  113
Lipase enzyme preparation from Aspergillus oryzae Jan 27, 2003 FDA has no questions
  106
Glucose oxidase enzyme preparation from Aspergillus oryzae carrying a gene encoding a glucose oxidase from Aspergillus niger Oct 3, 2002 FDA has no questions
  103
Lipase enzyme preparation from Aspergillus oryzae carrying a gene constructed from a modified Thermomyces lanuginosus lipase gene and a portion of the Fusarium oxysporum lipase gene Aug 19, 2002 FDA has no questions
  90
Carbohydrase enzyme preparation from Aspergillus oryzae, protease enzyme preparation from Aspergillus oryzae, and carbohydrase enzyme preparation from Rhizopus oryzae Apr 4, 2002 FDA has no questions Jan 13, 2004
  75
Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Fusarium oxysporum Aug 14, 2001 FDA has no questions
  43
Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces lanuginosus Sep 22, 2000 FDA has no questions Apr 21, 2010
  34
Aspartic proteinase derived from Aspergillus oryzae carrying a gene encoding aspartic proteinase from Rhizomucor miehei Apr 19, 2000 FDA has no questions
  10
Exopeptidase derived from Aspergillus oryzae carrying a gene encoding a leucine aminopeptidase from Aspergillus sojae Jan 29, 1999 Notice does not provide a basis for a GRAS determination
  8
Pectin esterase derived from Aspergillus oryzae carrying a gene encoding pectin esterase from Aspergillus aculeatus Mar 2, 1999 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.
-
-