New York City, February 10, 2004 - Kaneka Corporation today announced that KanekaQ10 has been self-affirmed GRAS (Generally Recognized As Safe) through an independent evaluation by an expert panel.
KanekaQ10, a fat-soluble, vitamin-like nutrient found naturally in the human body, is vital to the production of energy and is a potent antioxidant. It is produced by Kaneka through a non-genetically modified fermentation process and is comprised almost entirely of the coenzyme Q10 all-trans isomer, making it bioidentical to the body’s own CoQ10.
In making this announcement, Mr. K. Kuruma, President of Kaneka America Corporation, a U. S. subsidiary of Kaneka and distributor of KanekaQ10, said, “Kaneka has been the leader in supplying natural CoQ10 to the world’s dietary supplement market. Now, with the GRAS status, we can begin to provide functional food manufacturers with a natural, safe and beneficial additive to their product lines in order to satisfy consumer demand for foods and drinks that offer the benefits of this nutritional supplement.”
Last year Kaneka asked an expert panel of independent scientists to review information compiled by Cantox Health Sciences International, a leading scientific and regulatory company. After examination of this material and publicly available scientific information, including safety studies on KanekaQ10, the panel concluded that KanekaQ10, as produced by Kaneka, is safe for the addition to foods at specified levels.
The panel also found that as preclinical toxicological studies have demonstrated KanekaQ10 is not associated with chronic effects or mutagenic activity and that there is supporting evidence of the safety of KanekaQ10 in humans from clinical investigations.
Kaneka began production of CoQ10 in 1977. Since then it has been continuously supplying, under strict GMP control, high quality, yeast fermented CoQ10 to the world’s food supplement industry. Recently Kaneka announced that it will increase its yearly CoQ10 production capacity to 150 metric tons, an expansion scheduled to be completed in the Spring of 2004.
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