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CFSAN/Office of Food Additive Safety
March 27, 2007
Mr. Denis O'Neill
Co. Cork, IRELAND
Re: GRAS Notice No. GRN 000028
Dear Mr. O'Neill:
The Food and Drug Administration (FDA) is responding to your correspondence dated December 6, 2006, that you sent regarding additional uses for the subject of GRAS Notice No. GRN 000028. Marigot Limited (Marigot) submitted GRN 000028 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 this notice on July 28, 1999, and designated it as GRAS Notice No. GRN 000028. In a letter dated April 21, 2000, FDA informed Marigot that the agency had no questions at that time regarding the conclusion of Marigot that seaweed-derived calcium as a source of dietary calcium for food enrichment and fortification purposes, the subject of the notice, is GRAS under the intended conditions of use.
In a letter dated December 6, 2006, Marigot informed FDA of their determination that the addition of seaweed-derived calcium is GRAS, through scientific procedure, for the following additional food uses: ice cream, noodles, bread, confectionary, chocolate, carbonated beverages, non carbonated beverages, cakes, cookies, tofu, cream crackers, flavoured and unflavoured milk, jams, jellies, muffins, ready to eat cereals, cereal breakfast bars, sorbets and sherbets, breakfast juices and dairy spreads.
Based on the information provided by Marigot in GRN 000028, the supplement dated December 6, 2006, and other information available to FDA, the agency has no questions at this time regarding Marigot's conclusion that seaweed-derived calcium is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of seaweed-derived calcium. As always, it is the continuing responsibility of Marigot to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to the additional information submitted regarding GRN 000028, as well as a copy of the information in the notice that conforms to the information in the proposed GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition