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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.

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.
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Records Found: 22 Page 1 of 1
GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter
982 Polygalacturonase enzyme preparation produced by Aspergillus oryzae expressing a polygalacturonase gene from A. tubingensis Mosseray Pending
979 Pectin esterase enzyme preparation produced by Aspergillus oryzae expressing a pectin esterase gene from A. tubingensis Pending
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)
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 (additional correspondence available)
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 (additional correspondence available)
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

2362  

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