U.S. REGULATORY STATUS

Xanthan Gum - Purified by Recovery with Ethanol has been self-affirmed as a GRAS (Generally Recognized as Safe) food ingredient in accordance with 21 CFR 170.30. The GRAS determination is based on scientific procedures, as is supported by a 4-volume GRAS report. The report was reviewed by a panel of experts, who are qualified to evaluate the safety of food ingredients.

The conclusions of the expert panel were endorsed by September 18, 2002 clearing the way for xanthan gum - purified by recovery with ethanol to be marketed as a food ingredient in the United States.

USE IN FOODS

Xanthan Gum - Purified by Recovery with Ethanol may be used as a food ingredilent without limitation, providing that current good manufacturing practices are used.

LABELING

Xanthan Gum - Purified by Recovery with Ethanol should be labeled:

MANUFACTURING AND SPECIFICATIONS

Xanthan Gum - Purified by Recovery with Ethanol is the subject of the Ingredients Solutions, Inc. (ISI) and Zibo Zhongxuan Biological Product Co., Ltd. (ZZBP) GRAS Report. It is manufactured under cGMP via a fermentation process using the Xanthomonas campestris. The product meets certain specifications for nitrogen, lead and arsenic. The expert panel concluded that the fermentation process was conducted under cGMP, and that the product provided a safe and consistent ingredient for food processing.

GENERAL RECOGNITION OF SAFETY

The ISI and ZZBP GRAS Report refers to safety studies in humans and several animal species. The studies cited represent research on the safety and use of xanthan gum, which have been published over a period of decades by scientists from around the world. This large body of scientific literature satisfies the requirement in 21 CFR 170.30 (a), that a general recognition of safety requries common knowledge about the substance throughout the scientific community.

GRAS NOTIFICATION

Under proposed 21 CFR 170.36, ISI and ZZBP have notified the U.S. Food and Drug Administration, of its determination that xanthan gum, purified by recovery with ethanol, can be considered generally recognized as safe.

REVISED 2/23/05