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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 435

Preparation consisting of six bacterial monophage specific to Salmonella enterica (monophage cocktail)

Intended Use: As an antimicrobial for ready-to-eat and raw poultry products; ready-to-eat and raw red meat carcasses, subprimals, and trimmings; fish; shellfish; and fresh and processed fruits and vegetables at 107 plaque-forming units per gram of food.
Basis: Scientific procedures
Notifier: Intralytix, Inc.
Notifier Address: 701 E. Pratt Street
Baltimore, MD 21202
Date of filing: Jul 6, 2012
GRAS Notice (releasable information): GRN 435 (in PDF) (7.5 MB)
Date of closure: Feb 22, 2013
FDA's Letter: FDA has no questions
Additional correspondence: Feb 13, 2015
Additional correspondence regarding an additional intended use
Additional correspondence: Nov 15, 2019
Supplemental Letter (in PDF) (74 kB)
Additional correspondence: Jun 28, 2021
Supplemental Letter (in PDF) (235 kB)
Additional correspondence: Jan 17, 2024
Supplemental Letter (in PDF) (220 kB)