Return to inventory listing: GRAS Notice Inventory

See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

May 24, 2016

Emmanuel Treuil
Armor Protéines S.A.S.
19 bis, rue de la Liberation
35460 saint-Brice-en-Cogles
FRANCE

Re: GRAS Notice No. GRN 000612

Dear Mr. Treuil:

The Food and Drug Administration (FDA) is responding to the notice, dated November 12, 2015, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on November 25, 2015, filed it on December 15, 2015, and designated it as GRAS Notice No. GRN 000612.

The subject of the notice is fractionated whey protein isolate containing cow’s milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2. The notice informs FDA of the view of Armor Protéines S.A.S. that fractionated whey protein isolate containing cow’s milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2 is GRAS, through scientific procedures, for use as an ingredient in powdered, nonexempt term infant formulas and toddler formulas at levels up to 30 milligrams per 100 gram of powdered formula.

In an email dated May 19, 2016, you asked that FDA cease to evaluate your notice. Given your email, we ceased to evaluate your GRAS notice, effective May 19, 2016, the date that we received your email. You indicated that withdrawing and resubmitting your notice would be the best option for you to provide FDA with additional information.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000612, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov/grasnoticeinventory.

Sincerely,

Antonia Mattia, Ph.D.
Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition