Agency Response Letter GRAS Notice No. GRN 000011
CFSAN/Office of Premarket Approval
January 29, 1999
W. G. Flamm, Ph. D.
Flamm Associates and
G. A. Burdock, Ph.D.
Burdock and Associates, Inc.
622 Beachland Blvd.
Vero Beach, FL 32963
Re: GRAS Notice No. GRN 000011
Dear Dr. Flamm and Dr. Burdock:
This is in response to your notice dated November 19, 1998, which was received by the Food and Drug Administration (FDA) on November 23, 1998. This notice was submitted to FDA on behalf of Bonlac Foods Limited (Bonlac) of Melbourne, Australia, 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)). FDA designated your notice as GRAS Notice No. GRN 000011.
Your notice states that Flamm Associates and Burdock and Associates, Inc., as agents for Bonlac, have determined through scientific procedures that a mixture of calcium casein peptone and calcium phosphate (CCP-CP) is GRAS for use as a texturizer in chewing gum at a level not to exceed 5% (weight/weight). For your information, we consider that Bonlac is the notifier for GRN 000011 within the meaning of proposed §170.36.
Bonlac's notice describes generally available information about the identity, characteristic properties, method of manufacture, and conditions of use of CCP-CP. The notice also includes a report on CCP-CP prepared by a GRAS panel. Based on the information provided by Bonlac, as well as other information available to FDA, the agency has no questions at this time regarding Bonlac's conclusion that CCP-CP 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 CCP-CP. As always, it is the continuing responsibility of Bonlac 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 this letter, as well as a copy of the information in Bonlac's notice that conforms to the information in proposed § 170.36(c)(1), is available for public review and copying in the public reading room of the agency's Freedom of Information Staff.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition