Agency Response Letter GRAS Notice No. GRN 000262
CFSAN/Office of Food Additive Safety
December 23, 2008
George Weston Foods, Ltd.
1 Braidwood Street
Enfield, NSW, 2136
Re: GRAS Notice No. GRN 000262
Dear Mr. Schutz:
The Food and Drug Administration (FDA) is responding to the notice, dated September 26, 2008, 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 October 3, 2008, filed it on October 8, 2008, and designated it as GRAS Notice No. GRN 000262.
The subject of the notice is sweet lupin protein. The notice informs FDA of the view of George Weston Foods, Ltd. that sweet lupin protein is GRAS, through scientific procedures, for use as an ingredient in baked goods and baking mixes, dairy product analogs, frozen dairy desserts and mixes, gelatins, puddings, and fillings, jams and jellies, meat products, milk products, and soft candy at levels ranging from 1 to 20 per cent.
In a letter dated December 10, 2008, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective December 16, 20008, the date that we received your letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000262, 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. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Dr. John Hicks, Jr. DVM, MPH
Risk Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U.S. Department of Agriculture
1400 Independence Avenue., S.W., Room 3549, South Agriculture Building
Washington, DC 20250-3700