RANCHO SANTA MARGARITA, CA –Blue California, a GMP-registered ingredient manufacturer in Southern California, announced that it anticipates receiving GRAS self-affirmation by August 2008 for Rebaudioside A 99%, an isolated compound from the Stevia plant.
Blue California started production of this purified ingredient in December 2007 and offers the highest purity Rebaudioside A in the market. Its GRAS self-affirmation review began in February of this year by a panel of scientists with extensive knowledge and expertise regarding FDA regulations for GRAS self-affirmation. This independent scientific panel has completed the preliminary review of all available scientific data and the final documents are expected to be signed by August, 2008.
Cecilia McCollum, Blue California’s Executive Vice President, noted that “Blue California was extremely confident from the very beginning that a product of this level of purity would easily meet the safety requirements for GRAS self-affirmation and the level of scientific data necessary to meet FDA’s required criteria for safety.” The FDA’s safety criteria is a “reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.”
Rebaudioside A is a non-caloric compound derived from Stevia that is 400 times sweeter than sugar. Rebaudioside A and other Stevia products are authorized for general food uses in Japan, South Korea, Brazil, Argentina, and Paraguay, but not in Hong Kong, US, UK, or the EU. It is approved for as a dietary supplement in the US, China, and certain countries in Western Europe and it is under active evaluation in New Zealand and by JECFA.
Blue California offers unique contract manufacturing services such as micro-encapsulation, extraction processing and complete R&D solutions under strict ISO-9001:2000 (Quality Management), ISO-14001 (Environmental Management) and GMP standards. Blue California manufactures Kosher-certified standardized botanical extracts and specialty ingredients for the dietary supplements, cosmetics and functional foods industries.