2 Glanbia ingredients self-affirmed GRAS

2 Glanbia ingredients self-affirmed GRAS

PepForm Leucine Peptides and PepForm Tryptophan Peptides are produced in a cGMP facility and meet appropriate food-grade specifications.

Glanbia Nutritionals has determined its PepForm® Leucine Peptides and PepForm® Tryptophan Peptides to be GRAS on the basis of Scientific Procedures pursuant to FDA implementing regulations 21 CFR 170.3 and 21 CFR 170.30, as well as the proposed regulations 21 CFR 170.36 [62 FR 18938: April 17, 1997 Substances Generally Recognized as Safe (GRAS), the GRAS Proposal]. The notified substances are generally recognized among a qualified expert panel as having been adequately shown to be safe under the conditions of their intended use consistent with Section 201 of the Federal Food, Drug and Cosmetic Act.

Glanbia’s PepForm Leucine Peptides and PepForm Tryptophan Peptides are produced in a current good manufacturing process (cGMP) facility and meet appropriate food-grade specifications. The products are processed using dairy equipment that is commonly used in the manufacturing of other dairy products already accepted as GRAS.

PepForm Leucine Peptides is intended for use at levels up to 15 grams per serving, but not to exceed 20 grams per serving in (but not limited to) non-milk and milk-based foods, including meal replacements, sports, isotonic beverages, vitamin enhanced waters, meal replacement bars, cereal, sauces, bakery, dairy food and processed foods.

PepForm Tryptophan Peptides is intended for use at levels up to 7.5 grams per serving in (but not limited to) non-milk and milk-based foods, including meal replacements, sports, isotonic beverages, vitamin enhanced waters, meal replacement bars, cereal, sauces, bakery, dairy food and processed foods.

 

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