CELEX: 
Language: en
Date: 2017-07-12
Title: COMMISSION REGULATION (EU) …/… permitting the use of Listex™ P100 for the reduction of Listeria monocytogenes on ready-to-eat products of animal origin

COMMISSION REGULATION (EU) …/…
            
            
               of XXX
            
            
               permitting the use of Listex™ P100 for the reduction of Listeria monocytogenes on  ready-to-eat products of animal origin
            
            
               (Text with EEA relevance)
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to Regulation (EC) No 853/2004 of 29 April 2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin
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               , and in particular Article 3(2) thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs
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                lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the principle concerning the general implementation of procedures based on hazard analysis and critical control point (HACCP).
            
            
               (2)Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. It provides that food business operators are not to use any substance other than potable water to remove surface contamination from products of animal origin, unless the use of the substance has been approved in accordance with that Regulation.
            
            
               (3)Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
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                lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when implementing the general and specific hygiene measures referred to in Regulation (EC) No 852/2004. It lays down, in particular, the microbiological criteria for Listeria monocytogenes in ready-to-eat products of animal origin. 
            
            
               (4)On 19 June 2015, the Commission received an application for approval of the use of the product, Listex™P100, intended to reduce Listeria monocytogenes in a broad range of ready-to-eat products of animal origin. 
               
            
               (5)Listex™ P100, the trade name of the formulated product, contains bacteriophage P100 at a concentration of 2 x 1011 plaque forming units (PFU) per mL, which multiplies only in Listeria resulting in its destruction. The bacteriophage P100 belongs to the family Myoviridae, subfamily Spounavirinae, genus Twortlikevirus (GenBank reference: DQ004855).
            
            
               (6)Listeria monocytogenes, which is responsible for the disease “listeriosis”, is a foodborne pathogen frequently reported as being present in the Union. The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2015
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                reported that in 2015 there were more than 2 200 confirmed human cases of listeriosis, causing 270 deaths, making Listeria monocytogenes the foodborne pathogen with the highest mortality rate in the Union. 
            
            
               (7)Listex™ P100 is Listeria monocytogenes-specific and it does not affect other bacterial populations, including microorganisms associated with bad hygiene conditions, that is to say, spoilage bacteria and microorganisms which are indicators of faecal contamination. This targeted action on a potentially fatal pathogen cannot correct any hygienic failure that could happen along the food chain prior to its application. 
            
            
               (8)On 10 August 2016, the European Food Safety Agency (EFSA) adopted the Scientific Opinion on the evaluation of the safety and efficacy of Listex™ P100 for reduction of Listeria monocytogenes in different ready-to-eat (RTE) food products
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               , which confirmed the safety of the product, its efficacy in terms of Listeria monocytogenes reduction and the fact that the use of Listex™ P100 is unlikely to result in the emergence of resistance to key therapeutic antimicrobials. That Scientific Opinion also underlined that strains of Listeria monocytogenes resistant to this bacteriophage might be selected as a result of its use, but that cleaning and disinfection of the areas where Listex™ P100 is used, together with proper use of the Listex™ P100 and the disposal of unsold treated products, would mitigate this risk. As regards environmental concerns, the EFSA also concluded that the likelihood of the persistence of Listex™ P100 in the environment is low, as the population of bacteriophages naturally declines over 24 hours. The residual presence of the phage has no longer a technological effect in the final product. 
            
            
               (9)As pointed out by the EFSA in its Analysis of the baseline survey on the prevalence of Listeria monocytogenes in certain ready-to-eat foods in the EU, 2010-2011 Part A: Listeria monocytogenes prevalence estimates
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               , certain Listeria monocytogenes strains can be very persistent in the production environment in the form of biofilms and in some circumstances, despite the correct application of cleaning and disinfecting by food business operators, hygiene measures may not be sufficiently effective to fight against Listeria. Offering a tool to food business operators to effectively fight against Listeria monocytogenes would contribute to food safety. 
            
            
               (10)The use of Listex™ P100 for the reduction of Listeria monocytogenes on ready-to-eat products of animal origin must not affect the food business operator's duty to comply with the hygiene requirements laid down in Regulations (EC) No 852/2004 and (EC) No 853/2004 and with the microbiological criteria laid down in Regulation (EC) No 2073/2005. 
            
            
               (11)Food business operators should be permitted to use Listex™ P100 for the reduction of Listeria monocytogenes on ready-to-eat meat products, on ready-to-eat fishery products and on ready-to-eat dairy products subject to certain conditions. 
               They should include in their HACCP plan the sampling plans in order to validate the efficacy of Listex™ P100 and its condition of application, and in order to monitor on a regular basis the susceptibility to Listex™ P100 of Listeria monocytogenes strains isolated from the raw materials or processing plant and if resistant strains occur consider corrective actions.
            
         
         
            
               (12)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council has opposed them,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
            
               Food business operators may use Listex™ P100
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                for the reduction of Listeria monocytogenes on ready-to-eat meat products, on ready-to-eat fishery products and on ready-to-eat dairy products in accordance with the conditions set out in the Annex.
            
            
            
               Article 2
            
            
               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Jean-Claude JUNCKER
               
            
         
         
            
                  
                     (1)
                  OJ L 139, 30.4.2004, p. 55.
               
               
                  
                     (2)
                  OJ L 139, 30.4.2004, p. 1.
               
               
                  
                     (3)
                  OJ L 338, 22.12.2005, p. 1.
               
               
                  
                     (4)
                  EFSA Journal 2016;14 (12):4634.
               
               
                  
                     (5)
                  EFSA Journal 2016;14(8):4565. 
               
               
                  
                     (6)
                  EFSA Journal 2013;11(6):3241.
               
               
                  
                     (7)
                  [DG: I would suggest inserting the specifications of the product either in Article 1 or in the Annex – not in a footnote, as footnotes are generally used for publication references. Also, I am concerned about the internet link being used as a specification – as the link could be deleted or altered.]
               
            
      
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               ANNEX
            
            
               A. Description of Listex™ P100
            
            
               Registration number: 0796845- Date: 31-03-2006 - Benelux trademark
            
            
               European Patent number: EP 1 531 692 B1-
            
            
               
               https://data.epo.org/publication-server/pdf-docume
               nt?pn=1531692&ki=B1&cc=EP
            
            
               Referencing of characterisation of Listex P100 in EFSA opinion Chapter 3.1.1
            
            
               
               http://onlinelibrary.wiley.com/doi/
               10.2903/j.efsa.2016.4565/full
               
            
            
               B. Conditions for the use of Listex™ P100.
            
            
               1.Listex™ P100 must:
            
            
               (a)contain bacteriophage P100 at a concentration of 2 x 1011 plaque forming units (PFU) per mL;
            
            
               (b)be applied up to 1×109 of P100 per gramme of product, either as spray or dipping treatment or in smeared solution depending on the type of product treated;
            
            
               (c)be used at temperatures between 1°C and 35°C and pH between 5.5 and 9.5.
            
            
               2.Listex™ P100 must be applied under controlled and verifiable conditions integrated in a hazard analysis and critical control point (HACCP)-based management system. 
                  That system shall include, in particular, regular monitoring of end products for the presence of Listeria monocytogenes and susceptibility testing for ListexTM P100 where isolates are found. 
            
            
               3.Food business operators applying Listex™ P100 for the reduction of Listeria monocytogenes in ready-to-eat foods of animal origin must inform duly the food business operators receiving the treated foods of such use.