Agency Response Letter GRAS Notice No. GRN 000207
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CFSAN/Office of Food Additive Safety
December 19, 2006
Lore W. Kolberg
Mgr. Regulatory & Scientific Affairs
15407 McGinty Road West
Wayzata, MN 55391
Re: GRAS Notice No. GRN 000207
Dear Ms. Kolberg:
The Food and Drug Administration (FDA) is responding to the notice, dated June 21, 2006, 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 June 23, 2006, filed it on June 23, 2006, and designated it as GRAS Notice No. GRN 000207.
The subject of the notice is barley fiber. The notice informs FDA of the view of Cargill Inc. (Cargill) that barley fiber is GRAS, through scientific procedures, for use as an ingredient in food in general, except for infant formula and meat and poultry products.
As part of its notice, Cargill includes the report 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 discusses barley fiber's identity, specifications, method of manufacture, proposed estimated dietary intake, and published and unpublished studies on barley fiber. Based on this review, Cargill's GRAS panel concludes that barley fiber is GRAS, by scientific procedures, when used as an ingredient in foods in general, except for infant formula and meat and poultry products, at levels consistent with current Good Manufacturing Practices (cGMP).
Cargill describes the identity and method of manufacture of barley fiber, and provides information on its composition. Barley fiber is obtained from food grade barley by water extraction at an elevated temperature. Starch is removed during the extraction process by treatment with alpha-amylases that are safe and suitable for food use. The barley fiber is recovered by centrifugation after treatment with denatured food grade ethanol. The obtained fiber product has a weight average molecular weight of 50 to 400 kDa. Barley fiber is composed of about 91% carbohydrate, 3% protein, 3% inorganic salts, and less than 1% lipids. Cargill provides specifications for barley fiber including a specification for ≥70% beta-glucan.
In estimating the consumer intake of barley fiber, Cargill assumes that use levels of barley fiber are self-limiting for technological reasons. Excessive levels of barley fiber impact taste. In most food applications, the concentration of barley fiber approaches a technically feasible maximum level of approximately 4.3 grams (g) of barley fiber per serving. Cargill estimates that the average intake of barley fiber by consumers of the proposed uses would be 10.5-28.2 g per day. Cargill estimates that barley fiber would be added at levels up to 4.3 g per serving, resulting in approximately 3 g of beta-glucan per serving.
Cargill concluded that there was no reason to conduct any classical absorption, disposition, metabolism and excretion studies since beta-glucan, the main component of barley fiber, is not digested by human digestive enzymes and its molecular size precludes absorption of significant amounts while passing through the small intestine. Nevertheless, in the notice Cargill described the results of a rat study, a mouse study, and a bone marrow micronucleus study to further reinforce the safety of barley fiber and its constituent, beta-glucan. These animal studies did not identify any adverse reactions or toxicity as revealed by histopathologic examinations, among various endpoints studied. The bone marrow micronucleus study demonstrated that barley fiber and its beta-glucan are not genotoxic.
Cargill describes several published studies on barley derived beta-glucan and on barley fiber. Some of these studies show that beta-glucan, ingested with barley-based foods, is solubilized and extracted from the food matrix during the initial stages of digestion and then it is entirely utilized by the intestinal flora.
Standards of Identity
In the notice, Cargill states its intention to use barley fiber 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.
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 barley fiber 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 barley fiber. 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 000207, 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 on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition