LISTEX P100 Phages for Control of Listeria Approved as GRAS by US FDA

25/10/06 EBI Food Safety of the Netherlands announced that its bacteriophage P100 preparation, marketed as LISTEX, has been approved as GRAS (Generally Recognized As Safe) by the US FDA, to control Listeria monocytogenes (LM) in cheese. This acknowledgement by the FDA is based on a thorough safety review, and is recognized by food companies and national governments worldwide. GRAS affirmation is an essential step in the commercialization of LISTEX. LISTEX is the first bacteriophage product to receive GRAS recognition by the FDA.

Listeria monocytogenes is generally viewed as the most dangerous food pathogen. It can cause Listeriosis, a fatal disease in roughly 30% of the cases, especially dangerous for newborns, the elderly and persons with weakened immune systems. Listeriosis is also a major concern to pregnant women, causing spontaneous abortion. In the US, the costs of acute illness from foodborne Listeria poisoning alone are estimated at $2.3 million per year. Expenses for food processing companies to combat Listeria likewise run into the billions.

Phages are the most abundant micro-organisms on earth and are present in significant numbers in water and foods of various origins, often in very large numbers. Fermented foods, such as cheese, sausages or sauerkraut always contain phages, again often in large numbers. On fresh and processed meat and meat products, more than 100 million viable phages per gram are often present. Phages are harmless to humans, animals and plants, and are extremely specific in regard to the bacteria they recognize. This fact is the basis for their acknowledged potential for combating dangerous bacteria including food-borne pathogens.

"In January of this year an independent expert panel of internationally recognized scientists unanimously concluded that LISTEX meets the GRAS safety requirements. Now that the FDA has given its formal approval, we will make our product available to the US market. The high end market, requesting 'green' and organic products, has been asking for LISTEX, but we wanted an official endorsement by the FDA first." says Mark Offerhaus, CEO of EBI Food Safety. "We are presently negotiating with prospective partners in North America and Europe to find the fastest way to market".

Prevention of food safety defects results in considerable gains of profitability and productivity. Offerhaus: "Food safety and quality systems are not only good corporate policy, they are simply good business. Appropriate use of LISTEX in food processing as an integral part of HACCP and GMP/GHP programs fits that concept perfectly".