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FDA Extends GRAS Approval Listex to All Food Products

The FDA and USDA Announced Today They Have Approved LISTEX(TM) P100, the Natural Bacteriophage Product Against Listeria, as GRAS (Generally Recognised as Safe), for all Food Products .

In the fight against Listeria, one of the most dangerous food pathogens, US food processing companies can now apply a novel yet natural tool: LISTEX(TM) bacteriophages. The FDA and USDA have approved this product from The Netherlands as GRAS, based on extensive safety and efficacy data and organoleptics tests confirming that LISTEX(TM) is safe and has no impact on taste, smell, colour, and other physical properties of treated products.

Bacteriophages ('phage') are the most abundant micro-organisms on earth. Fresh water and seawater can contain as many as 1 billion phages per ml, while in 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 target only bacterial cells. They are extremely specific in regard to the bacteria they recognize. The LISTEX(TM) bacteriophages target only Listeria bacteria (leaving desirable bacteria in place), and are easy to apply in production processes.

In October 2006 the FDA had already proclaimed GRAS for LISTEX(TM) against Listeria in cheese. The extension to all products susceptible to Listeria, opens the door for the meat and fish industry to apply LISTEX(TM). Earlier this month, the Dutch designated inspection office SKAL confirmed the 'organic' status of LISTEX(TM) under EU law, as a result of which it can be used in the EU in regular and organic products.

EBI Food Safety's CEO, Mark Offerhaus: "Food Safety now tops the agenda of US food processing companies and consumers, who are insisting on 'green' solutions, rather than chemicals. Natural bacteriophages prove to be a unique solution, where increased safety does not come at the expense of product characteristics. US food processors can now benefit from LISTEX(TM), like their European counterparts."

According to the World Health Organization (WHO), Listeriosis, the disease caused by Listeria monocytogenes, is one of the most severe food borne infections, with a mortality rate of 30%. It can take weeks after exposure before an infection becomes apparent. The US Food Safety and Inspection Service maintains a zero tolerance policy for the bacterium, which grows at refrigeration temperature and is omnipresent. Risk groups include the Young, Old, Immunocompromised and Pregnant.


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