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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1061

Deactivated alkaline serine protease produced by Bacillus licheniformis strain CICC 10266

Intended Use: Intended for use as a source of low (less than 25 mg phenylalanine per serving) phenylalanine protein in nutritionally complete medical food in the diet of individuals with phenylketonuria (PKU) ages one year and older. The intended use as the primary protein source (up to 15 g/serving) in medical foods would not result in an excess of 80% of the total protein intake per day.
Basis: Scientific procedures
Notifier: Tanea Medical AB
Notifier Address: Bredgrand 14
75320 Uppsala
Sweden
FDA's Letter: Pending
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