Agency Response Letter GRAS Notice No. GRN 000258
CFSAN/Office of Food Additive Safety
February 3, 2009
Phillip L. Casterton, M.S., D.A.B.T.
15407 McGinty Road West, MS-163
Wayzata, MN 55391
Re: GRAS Notice No. GRN 000258
Dear Mr. Casterton:
The Food and Drug Administration (FDA) is responding to the notice, dated May 16, 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 September 4, 2008, filed it on September 8, 2008, and designated it as GRAS Notice No. GRN 000258.
The subject of the notice is sucromalt. The notice informs FDA of the view of Cargill, Incorporated (Cargill) that sucromalt is GRAS, through scientific procedures, for use as a nutritive sweetener as shown in Table 1.
|Food Categories||Percent of sucromalt added to foods|
|Condiments and relishes||5-25|
|Confectionery and frostings||20-40|
|Gelatins and puddings||8-18|
|Dairy products and non-dairy analogs||5-8|
|Jams and jellies||12-60|
|Processed fruits and fruit juices||5-20|
Cargill includes the findings of a panel of individuals (Cargill's GRAS panel) who evaluated the data and information that are the basis for Cargill's GRAS determination. Cargill considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Cargill's GRAS panel evaluated estimates of dietary exposure, method of production, and product specifications, as well as published and unpublished studies. Based on this review, Cargill's GRAS panel concluded that sucromalt meeting the established food grade specifications is GRAS under the conditions of its intended use.
Cargill describes sucromalt as a mixture of carbohydrates produced by reacting sucrose and maltose utilizing the enzyme, alternansucrase.1 Cargill further describes sucromalt as a mixture of fructose, leucrose, and oligosaccharides containing α-(1-3), α-(1-4) and α-(1-6) glycosidic linkages with a degree of polymerization less than 12. Additionally, the mixture contains other mono- and disaccharides, primarily isomers of sucrose, unreacted sucrose and maltose, and glucose.
Cargill describes the method of manufacture of, and provides specifications for, sucromalt. Sucromalt is produced by the enzymatic reaction of a mixture of food grade sucrose and maltose or sucrose and high-maltose corn syrup. The resulting syrup is heated to inactivate the enzyme and further processed. The purified product is then concentrated by evaporation of the water to a final percent dry weight of 75-80 percent. Specifications for sucromalt include: fructose (35-45, percent dry), leucrose (7-15, percent dry), saccharides with two degrees of polymerization (<5, percent dry), higher saccharides and polymer (>40, percent dry), brix (>70), moisture (<30 percent), pH (3.5-6.0) and appearance (taste and odor - passes test).
Cargill provides an estimated daily intake (EDI) of sucromalt based on consumption data available from the 2003-2004 Continuing Survey of Food Intake by Individuals. For eaters only, the EDI for sucromalt would be 1 gram per kilogram body weight per day (g/kg bw/day) at the mean and 2.5 g/kg bw/day at the 90th percentile, based on maximum anticipated use of sucromalt in food categories specified in Table 1.
Cargill discusses the safety of sucromalt based on the long-term safety of its components (glucose, fructose, maltose, leucrose and oligosaccharides) in the human diet. Cargill discusses published and unpublished studies conducted with sucromalt, as well as studies with its components. These studies include in vitro studies to assess digestibility and mutagenicity and in vivo animal toxicity studies where no treatment related effects were reported. Based on these studies, the notifier concluded that sucromalt is well digested and absorbed. Cargill further concludes that consumption of sucromalt at the intended levels to replace other sweeteners is safe.
Standards of Identity
In the notice, Cargill states its intention to use sucromalt in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. 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.
Potential label claims
Under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FFDCA lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. In describing the intended use of sucromalt and in describing the information that Cargill relies on to conclude that sucromalt is GRAS under the conditions of its intended use, Cargill raises a potential issue under these labeling provisions of the FFDCA. If products that contain sucromalt bear any claims on the label or in labeling, such claims are the purview of the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition. The Office of Food Additive Safety neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about sucromalt on the label or in labeling.
Section 301(ll) of the FFDCA
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of Cargill's notice that sucromalt is GRAS for use in various food categories, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing sucromalt. Accordingly, this response should not be construed to be a statement that foods that contain sucromalt, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Cargill, as well as other information available to FDA, the agency has no questions at this time regarding Cargill's conclusion that sucromalt 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 sucromalt.
As always, it is the continuing responsibility of Cargill 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 GRN 000258, as well as a copy of the information in this 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 via the FDA homepage at http://www.fda.gov. To view or obtain an electronic copy of the text of this 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.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
(1)Alternansucrase is the enzyme used in the production of sucromalt. Cargill states that the enzyme is derived from one of two sources: (1) Leuconostoc citreum or (2) Bacillus licheniformis carrying a gene coding a modified alternansucrase from Leuconostoc mesenteroides. The notifier considers that both L. citreum and B. licheniformis are non-pathogenic and non-toxigenic organisms widely used in food manufacturing, and that the introduced DNA from L. mesenteroides is well-characterized and safe. The notifier further states that L. mesenteroides is used in the production of fermented foods.