REGULATORY POSITION LISTEX™ 

USA

LISTEX™ has been approved as GRAS (Generally Recognised as Safe) by the FDA (GRAS 198) and USDA (GRAS 218) and can be used as a processing aid in all food products susceptible to Listeria, including meat, poultry, and fish, based on a thorough review of safety and efficacy data and organoleptics tests, confirming that the product is safe, suitable, and does not change the characteristics of the treated food product, such as taste, color, odor or texture.

In 2011 the USDA approved the use of LISTEX™ as a processing aid (USDA-FSIS response letter).

Organic approval in USA

LISTEX™ is listed by the Organic Materials Review Institute (OMRI). This means that LISTEX™ may be used in the certified organic production of food processing and handling according to the USDA National Organic Program Rule (Certificate PDF)

CANADA

Health Canada has accepted LISTEX as a safe processing aid for use on all food products susceptible to Listeria:
Health Canada response letter

EUROPE

The Dutch Ministry of Health has issued a formal statement confirming that LISTEX™ can be used as a processing aid.

TNO has prepared an Expert Opinion on the safety of bacteriophages product LISTEX™ P100 used for the eradication of Listeria monocytogenes contamination during food processing. TNO concludes that LISTEX™ P100 can be regarded as safe for the claimed use and for use as a processing aid in food production. PDF

An extensive description by Dr. Von Jagow and Dr. Teufer on the applicable European legal framework for bacteriophages can be found in: European Food and Feed Law Review, 2007/03 (pp 136 - 145), (see first link listed below).

OTHER

The P100 phages in LISTEX™ are broadly documented as safe micro-organisms, effective only against Listeria, rapidly inactivated (within 6-24 hours after application) and have no function in the final food product. Their use inside and/or on the foodstuff against harmful bacteria of the strain Listeria monocytogenes should be viewed as a part of an integral hygiene program, not as a replacement of hygiene. LISTEX™ can thus be viewed as a processing aid against Listeria monocytogenes (often present as a natural contamination, .i.e. inside or on cheese, fish, salad, meat, fruit, etc.) and to prevent possible cross contamination of Listeria monocytogenes during the production process. Such processing aids, pursuant to European law, are exempted from pre-market authorization, provided they are safe, and are exempted from labelling requirements in connection with the foodstuff they are used for.

Legal framework: Since LISTEX™ P100 is safe and used in the production process of foodstuffs and has no technological effect on the finished product, it is under the scope of the definition of Processing Aids in the Footnote of Art. 1 subsec. 3 a) of the Framework Directive on Additives 89/107/EEC.  According to Art. 1 subsec. 3 a) Directive 89/107/EEC Processing Aids are defined as follows:

"For the purpose of this Directive, 'Processing Aid' means any substance not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product."

There are also specific rules on the labelling of Processing Aids. Based on Art. 6 subsec. 1 of Directive 2000/13/EC, only ingredients of a foodstuff have to be labelled on the foodstuff in a list of ingredients. According to Art. 6 subsec. 4 lit. c iv) of the EU Directive 2000/13/EC on the Labelling of Foodstuffs, Processing Aids are not regarded as ingredients, so that their labelling is not necessary. The exemption of Processing Aids from the ingredient definition is based on Art. 6 subsec. 4 lit. c iv) of the EU Directive 2000/13/EC on the Labelling of Foodstuffs. The classification of Listex™ P100 as a Processing Aid means that it does not have to be labelled on the foodstuff it has been used for.

Switzerland

The Swiss Bundesamt fur Gesundheit allows the use of LISTEX™ during the manufacturing of cheese.

Organic approval in Europe

SKAL, the designated Public Inspection Authority of The Netherlands for organic ('EKO-certified') products, has confirmed that, in conformity with EU Regulation (EEC) nr. 2092/91 Annex  VI Section B,  LISTEX™ can be used as a processing aid in organic food products. SKAL surveys the organic production in accordance with the public law, based on EU-Regulation (EEC) nr. 2092/91. This occurs by order of the Dutch Ministry of Agriculture, Nature and Food Quality. Products certified as organic by an EU recognized inspection body can be marketed as such within the entire EU.

References:

• Teufer, T., Von Jagow, C., Which Path to Go? European Food and Feed Law Review (EFFL), June 2007, Vol 3 pp136-145 [Full Text PDF]
• Teufer, T., Von Jagow, C., Das grosse Fressen; Bakteriofagen in der Lebensmittelherstellung: eine rechtliche Einordnung,  Zeitschrift für das gesamte Lebensmittelrecht (ZLR), Feb 2007, 34. Jahrgang, Vol 1 pp 25-50
  [Full Text PDF]
  Translation in English: Bacteriophages in the food production: a legal classification
  [Full Text PDF]
• Organic Approval confirmatory document - SKAL
  [Full Text PDF]
• References: Mario Vaneechoutte, Jean-Paul Pirnay, et al
  [Full Text PDF]