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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000459

Return to inventory listing: GRAS Notice Inventory

See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory


CFSAN/Office of Food Additive Safety

April 2, 2013

Stefano Germani
Phenofarm S.r.l.
Domenico Chelini 5
00197 Rome
ITALY

Re: GRAS Notice No. GRN 000459

Dear Mr. Germani:

The Food and Drug Administration (FDA) is responding to the notice, dated November 12, 2012, 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 January 30, 2013, filed it on February 4, 2013, and designated it as GRAS Notice No. GRN 000459.

The subject of the notice is olive pulp extract. The notice informs FDA of the view of Phenofarm S.r.l. that olive pulp extract is GRAS, through scientific procedures, for use as antioxidant in baked goods, beverages, cereals, sauces and dressings, seasonings, snacks, and functional foods at a level up to 3,000 milligram per kilogram in the final food.

In an electronic mail message dated March 25, 2013, you asked that FDA cease to evaluate the notice. Given your request, we ceased to evaluate the GRAS notice, effective March 25, 2013, the date that we received your electronic mail message.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000459, 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