Information Request

GRAS status received for fungal chitosan KiOnutrime-Cs® and beta-glucan KiOnutrime® Protect

Format: Link | Document type: Information Request


On January 12th 2012, pursuant to 21 CFR §173.280, KiOnutrime-Cs® and KiOnutrime® Protect were determined by KitoZyme to be Generally Recognized as Safe (GRAS), as a direct food ingredient in Foods and Beverages. An independent Panel of qualified Experts concluded that the intended uses and use-levels of both fibers, produced using suitable and safe raw material sources of A. niger obtained from manufacturers of food grade citric acid, and manufactured in accordance with current good manufacturing practice (cGMP), are Generally Recognized as Safe (GRAS), based on scientific procedures.

The Expert Panel reviewed information pertaining to the conditions of use and use levels of chitosan and beta-glucan. Chitosan from A. niger is intended to be used as a dietary fiber (nutritive use) in various food and beverage products across multiple food categories at use levels of between 0.25 to 3.5% (w/v). Chitosan also is proposed for use a multi-use direct and indirect food additive at use levels of 0.005 to 1% (w/v). Beta-glucan from A.niger is intended to be used in multiple food categories at 200mg/per serving.

In the area of improving global health and well-being through nutrition, KitoZyme has successfully designed KiOnutrime-Cs®, the leading vegetal fat-binder.
Its unique benefits mean that KiOnutrime-Cs® is ideal for all weight management and cholesterol products: unbeatable fat binding power (at least 800 times its own weight in fat), high quality and purity, safe, non-allergenic, Kosher and Halal certified. Major leaders evolving in the nutraceutical industry trust in the efficacy of fungal chitosan as a potent and pioneering fat-binder for weight and cholesterol management. Moreover, in June 2011, the European Food Safety Authority (EFSA) issued a positive evaluation for chitosan and the maintenance of normal blood LDL-cholesterol.

In response to the increasing demand for improving global health and with the aim of stimulating positive immune system enhancement, KitoZyme has also designed a high purity beta(1,3)-glucan,KiOnutrime®Protect. This features superior glucan content (≥75%) as compared to the other beta-glucans. Supported by in vitro and in vivo tests, KiOnutrime®Protect decreases health challenges and improves the immune response by supporting the oxidative burst and the degranulation.

KitoZyme is a leading manufacturer of functional biopolymers and a full-service provider of medical device products. More specifically, KitoZyme, which is based in Liège, Belgium, develops and produces chitosan (and derivatives), chitin-glucan and beta-glucan, which are exclusively extracted from renewable, non-GMO vegetal sources. In obtaining self-affirmed GRAS status for KiOnutrime-Cs® and KiOnutrime®Protect, KitoZyme has further confirmed its commitments to providing safe solutions.

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