REGULATORY POSITION LISTEX™ P100

USA

In July 2007 the US Food and Drug Administration (FDA) and USDA have approved  LISTEX™ P100 as GRAS (Generally Recognized As Safe) for all food products susceptible to Listeria, including meat, poultry, and fish. The notification is designated as GRN (GRAS Notification Number) 000.218 and is based on a thorough review of safety and efficacy data and organoleptics tests, confirming that the product is safe, suitable, and does noet affect the characteristics of the treated product (taste, color, odor, texture). [Press release PDF] 

On October 17, 2006 the FDA had already issued a GRAS approval for LISTEX™ on cheese. This notification was granted based on a thorough safety review and scientific procedures and is designated by the FDA as: GRN (GRAS Notice Number) 000.198. [Press release PDF] 
 

Europe

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). In accordance with this text, the use of LISTEX as a (safe) processing aid is exempted from pre-market approval.

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 one 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™, as the product is safe and its use has no impact on the characteristics of the treated food product.

Organic approval

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, June 2007
  [Full Text PDF]