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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 49

Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4

Intended Use: Ingredients in milk-based infant formula that is intended for consumption by infants four months and older, at levels not to exceed good manufacturing practice
Basis: Scientific procedures
Notifier: Nestle USA
Notifier Address: 800 North Brand Boulevard; Glendale, CA 91203
Date of filing: Jun 14, 2000
GRAS Notice (releasable information): GRN 49 part 1 (in PDF) (18.5 MB)
  Part 2: GRN 49 part 2 with amendments (in PDF) (9.0 MB)
Date of closure: Mar 19, 2002
FDA's Letter: FDA has no questions (additional correspondence available)
Additional correspondence: Nov 28, 2005
Additional correspondence clarifying new information on B. lactis strain Bb12