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Agency Response Letter GRAS Notice No. GRN 000009

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

CFSAN/Office of Premarket Approval

April 2, 1999

Angel Diaz de Leon
Quest International
5115 Sedge Blvd.
Hoffman, IL 60192

Re: GRAS Notice No. GRN 000009

Dear Mr. Diaz de Leon:

In a letter dated March 2, 1999, the Food and Drug Administration (FDA) responded to your notice, dated October 10, 1998, 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)). FDA received your notice on October 22, 1998, and designated your notice as GRAS Notice No. GRN 000009. Your notice states that Quest International (Quest) has determined, through scientific procedures, that polyglycerol polyricinoleic acid (PGPR) is GRAS for use as an emulsifier for chocolate at a level up to 0.3 per cent.

In our March 2, 1999, letter, we mistakenly reported the maximum use level to be 3.0 per cent. To clarify that we evaluated a maximum use level of 0.3 per cent, we are issuing a second letter. This letter repeats the text of our letter dated March 2, 1999, with the exception of the maximum use level, which is corrected. We apologize for any inconvenience or confusion that may have resulted from our mistake.

Your notice describes (1) published information relating to the method of manufacture of PGPR, (2) published studies conducted with PGPR, (3) unpublished studies conducted with PGPR, and (4) published information on the functionality of PGPR in chocolate. In addition, your notice includes a report of a specially convened GRAS panel and a toxicological monograph on PGPR, which was published by the Joint Food and Agriculture Organization / World Health Organization's (FAO/WHO) Expert Committee on Food Additives (JECFA).

Based on the information provided by Quest, as well as other information available to FDA, the agency has no questions at this time regarding Quest's conclusion that PGPR 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 PGPR. As always, it is your continuing responsibility to ensure that food ingredients that you market are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity. Standards of identity regarding chocolate products are described in 21 CFR Part 163 (Cacao Products). For your information, the standard of identity for chocolate liquor (§ 163.111) does not permit the addition of emulsifying agents as an optional ingredient in this standardized food.

We consulted with the Office of Food Labeling (OFL) regarding your view that PGPR is the common or usual name for polyglycerol polyricinoleic acid. OFL advised us that, in general, an ingredient should be declared using a common or usual term or term, i.e., terms that would be recognized by consumers. Because U.S. consumers have no prior experience with the use of PGPR, it is not clear that the consumer would recognize that PGPR stands for polyglycerol polyricinoleic acid. One mechanism to develop the requisite recognition is to declare PGPR using both the chemical term (polyglycerol polyricinoleic acid) and the abbreviation PGPR. After a period of time, PGPR would be recognized by consumers and the abbreviation could stand alone. If you have any questions about the appropriate name of this food ingredient, for labeling purposes, we recommend that you discuss those questions with OFL. An initial contact for such questions is Mr. John Foret, who can be reached at (202)205-4122.

In accordance with proposed § 170.36(f), a copy of this letter, as well as a copy of the information in your 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. A copy of our letter dated March 2, 1999, which was placed in the public file during the week of March 22, 1999, has been removed from that file.

Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition

cc:  Mr. Gary Yingling
McKenna and Cuneo, L.L.P.
1900 K Street, N.W.
Washington, DC 20006-1108

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