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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.
  • To sort by a specific field, click on the column header for that field.
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Records Found: 17 Page 1 of 1
GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter
877 Bifidobacterium longum BB536 Dec 26, 2019 FDA has no questions (in PDF) (75 KB)
875 Bifidobacterium animalis subsp. lactis AD011 Pending
872 Bifidobacterium animalis subsp. lactis UABla-12 Dec 9, 2019 FDA has no questions (in PDF) (62 KB)
856 Bifidobacterium animalis subsp. lactis strain BB-12 Dec 9, 2019 FDA has no questions (in PDF) (63 KB)
855 Bifidobacterium animalis subsp. lactis strain R0421 Pending
814 Bifidobacterium bifidum BGN4 Jun 25, 2019 FDA has no questions (in PDF) (78 kB)
813 Bifidobacterium longum BORI Pending
758 Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, and Bifidobacterium bifidum R0071 Aug 20, 2018 FDA has no questions (in PDF) (103 kB)
579 Lactase from Bifidobacterium bifidum produced in Bacillus subtilis Nov 5, 2015 FDA has no questions
572 Lactase from Bifidobacterium bifidum produced in Bacillus licheniformis Aug 28, 2015 FDA has no questions
455 Bifidobacterium breve M-16V Sep 30, 2013 FDA has no questions
454 Bifidobacterium breve M-16V Sep 27, 2013 FDA has no questions
453 Bifidobacterium breve M-16V Sep 27, 2013 FDA has no questions
445 Bifidobacterium animalis subsp. lactis strains HN019, Bi-07, Bl-04 and B420 Apr 10, 2013 FDA has no questions
377 Bifidobacterium animalis subsp. lactis strain Bf-6 Sep 29, 2011 FDA has no questions
268 Bifidobacterium longum strain BB536 Jul 8, 2009 FDA has no questions
49 Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4 Mar 19, 2002 FDA has no questions (additional correspondence available)

GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter

679663  

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