Evaluation of the safety and efficacy of Listex TM P100 for reduction of pathogens on different ready-to-eat (RTE) food products

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1 SCIENTIFIC OPINION ADOPTED: 7 July 2016 doi: /j.efsa Evaluation of the safety and efficacy of Listex TM P100 for reduction of pathogens on different ready-to-eat (RTE) food products Abstract EFSA Panel on Biological Hazards (BIOHAZ) Studies evaluating the safety and efficacy of Listex TM P100 during processing of three ready-to-eat (RTE) product categories (meat and poultry, fish and shellfish, and dairy products) were assessed. Treatments consisted of application of up to plaque forming units (PFU) of P100 per cm 2 of product. No food safety concerns are foreseen concerning the use of Listex TM P100 during processing of these foods. Reduction of Listeria monocytogenes in artificially inoculated samples of the three RTE food categories was demonstrated both after treatment and during storage. Reduction depends on the P100 dose applied with a best estimate for the mean ranging from 1.7 to 3.4 log 10 colony forming units (CFU) at the maximum dose. As the P100 dose is reduced tenfold, the magnitude of reduction would be decreased by about 0.5 log 10 units. In naturally contaminated foods, P100 is expected to reduce the proportion of RTE food units containing > 100 CFU/g of L. monocytogenes at the end of shelf-life. Predictions of the magnitude of the efficacy of Listex TM P100 in reducing L. monocytogenes contamination of RTE foods in specific processing plants are highly uncertain. al studies indicate that a proportion of naturally occurring Listeria strains exhibit resistance to P100. Furthermore, P100-resistant variants might be selected as a consequence of its use in industrial settings but cleaning and disinfection of the areas where P100 is used, together with proper use of P100 and disposal of unsold treated products would eliminate or minimise this risk. s have shown that P100 resistance can be accompanied by changes in the spectrum of resistance to certain therapeutic antimicrobials. The likelihood of persistence of P100 in the environment is low. Validation of the efficacy of P100 applied in specific processing plants and monitoring of the susceptibility of L. monocytogenes strains isolated from processing plants to Listex TM P100 is recommended European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: decontamination, ready-to-eat food products, Listex TM P100, efficacy, toxicological safety, antimicrobial resistance, environmental impact Requestor: European Commission Question number: EFSA-Q Correspondence: biohaz@efsa.europa.eu EFSA Journal 2016;14(8):4565

2 Panel members: Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernandez Escamez, Rosina Girones, Lieve Herman, Kostas Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Antonia Ricci, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall and Helene Wahlstr om. Acknowledgements: The Panel wishes to thank the members of the Working Group on Listex TM P100 treatment of ready-to-eat foods: Aidan Coffey, Birgit Nørrung, Panagiotis Skandamis, Juan Evaristo Suarez and John Threlfall for the preparatory work on this scientific opinion and the hearing expert: Andrew Hart and EFSA staff members: Winy Messens, Elisa Aiassa, Fulvio Barizzone, Ana Garcia, Gilles Guillot and Mirena Ivanova for the support provided to this scientific opinion. Suggested citation: EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Scientific opinion on the evaluation of the safety and efficacy of Listex TM P100 for reduction of pathogens on different ready-to-eat (RTE) food products. EFSA Journal 2016;14(8):4565, 94 pp. doi: /j.efsa ISSN: European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2016;14(8):4565

3 Summary Following a request from the European Commission, the Panel on Biological Hazards (BIOHAZ Panel) was asked to deliver a scientific opinion on an application dossier submitted by Micreos Food Safety BV (the Netherlands) for the approval of Listex TM P100 for reduction of Listeria monocytogenes in ready-to-eat (RTE) meat and poultry, fish and seafood, and dairy products. The European Food Safety Authority (EFSA) was requested to evaluate the safety and efficacy of Listex TM P100 solution intended to be used by food business operators (FBOs) during processing for the reduction of L. monocytogenes in RTE products, considering: (i) the toxicological safety of the substance (Term of Reference (ToR) 1); (ii) the efficacy, i.e. does the use of this substance significantly reduce the level of contamination of L. monocytogenes in the RTE products (ToR 2); (iii) the potential for the emergence of reduced susceptibility to biocides and/or resistance to therapeutic antimicrobials linked to the use of the substance (ToR 3); (iv) the risk related to the release of the processing plant effluents, linked to the use of the substance, into the environment (ToR 4). The definition of RTE food in Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs has been used: Food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to acceptable level microorganisms of concern and the RTE groups RTE meat and poultry, fish and seafood, and dairy products (later indicated as product categories RTE meat, fish and dairy) considered. The impact of reducing L. monocytogenes on the RTE food products on the reduction of human listeriosis cases had already been shown by others and was not further addressed or quantified in this scientific opinion. The formulated product has the trade name Listex TM P100 and contains bacteriophage P100 at a concentration of plaque forming units (PFU) per ml. Approval was sought for spraying or dipping treatments (or use in smear suspension for smeared cheese) of above-mentioned RTE food products using up to PFU of P100 per gram of product. The EFSA revised guidance on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption was used for the development of this scientific opinion. In addition, this assessment was chosen as a case study to test the importance of performing the assessment in four steps, i.e. planning/conducting/verifying/reporting, as illustrated in the EFSA PROMETHEUS project (PROMoting METHods for Evidence Use in Scientific assessments). For the planning phase of this assessment, a protocol was developed with the aim of defining beforehand the panel s strategy for assessing the comprehensiveness and relevance of the data provided by the applicant and for appraising the evidence and synthesising the results. The questions as specified in the ToRs 1, 3 and 4 have been addressed by following the same approach as in previous assessments, while for the question about the efficacy of Listex TM P100, as specified in ToR 2, a systematic, stepwise approach was applied. The reason for choosing the latter approach for the efficacy assessment was that an earlier EFSA assessment on Listex TM P100 treatment of raw fish found that it was not possible to derive conclusions on efficacy while conclusions were made for the other ToRs. No food safety concerns (answer to ToR 1) are foreseen concerning the use of the industrially produced Listex TM P100 preparation during processing of RTE foods. This is because the bacteriophage P100 is not considered to pose a risk to human health because of the lack of toxicity in rats and because it is strictly lytic to bacteria while being unable to transduce bacterial DNA. In addition, the propagation procedures and purification steps of Listex TM P100 are well described in the dossier and the applicant states that there is a Hazard Analysis and Critical Control Point (HACCP)-based control programme in place to control the process. Moreover, the organism on which P100 is propagated is a non-pathogenic Listeria innocua strain. In relation to the efficacy (answer to ToR 2), the stepwise approach consisted of (1) formulation of the question under assessment and definition of eligibility criteria for selecting experiments; (2) ascertainment of the comprehensiveness and relevance of the evidence provided by the applicant; (3) data extraction from the included experiments; (4) appraisal of individual eligible experiments; (5) data synthesis and interpretation of results in light of identified uncertainties. There were very limited data on the effect of Listex TM P100 on RTE foods naturally contaminated with L. monocytogenes. All except one of the 33 eligible experiments were performed using artificially contaminated RTE foods. Listex TM P100 reduced the number of L. monocytogenes in artificially inoculated RTE samples of fish, meat and dairy products when measured immediately after treatment 3 EFSA Journal 2016;14(8):4565

4 and at the end of storage, except in two experiments where two values at the end of storage were higher than in the controls. The quality of the experiments differed but the results of the reliability appraisal did not identify any bias which would change the log reduction estimates. A random-effect metaregression was used accounting for the RTE food category-specific effect of the (log 10 )-P100 dose on the food to predict the L. monocytogenes log reduction when applying a certain P100 dose on each of the three RTE food subcategories. Based on the evaluated studies, for all three RTE food categories, the magnitude of the L. monocytogenes log reduction was influenced by the P100 dose, with high statistically significance (p < ). The model predicts that a mean L. monocytogenes log reduction of 2.52 (95% CI 2.15; 2.89), 1.74 (95% CI 1.31; 2.17) and 3.42 (95% CI 2.68; 4.16) log 10 colony forming units (CFU) would be achieved by application of 10 9 PFU/cm 2 on RTE fish, meat and dairy products, respectively. If the P100 dose on the RTE food is reduced tenfold, then L. monocytogenes would be decreased by about 0.5 log 10 for the three RTE foods products. For P100 doses below 10 6 PFU/cm 2, few data were provided and estimations for these doses are uncertain, in particular, for dairy and meat where data are lacking. Results should therefore be interpreted with caution. There was no evidence that time and temperature of storage or the L. monocytogenes level on the product before treatment affected the L. monocytogenes log reduction significantly (p > 0.05). L. monocytogenes present in a product at the level ,000 CFU/g is not eliminated by Listex TM P100 in doses PFU/cm 2 and growth may occur after treatment. Listex TM P100 should only be considered as an additional tool, to further reduce the load of L. monocytogenes, following the application of Good Hygienic Practices (GHP) and Good Manufacturing Practices (GMP), and not as a substitute for those practices. In addition, reductions can only be expected if the strains which contaminate the products that are susceptible to P100. In naturally contaminated RTE foods, as derived through Expert Knowledge Elicitation (EKE), Listex TM P100, when applied at a dose of 10 9 PFU/cm 2, is expected to reduce the proportion of RTE food units that would exceed 100 CFU/g of L. monocytogenes at the end of shelf-life. The degree of reduction is uncertain but is considered very likely (9 out of 10 chance) to be in the region between 20% and 95%. The magnitude of reduction for phage concentrations below 10 9 PFU/cm 2 was not evaluated. Reductions are expected to be similar for surface contaminated meat and dairy products. For lower Listex TM P100 doses (10 7 and 10 8 PFU/cm 2 ), the percentage of reduction are expected to be lower. Predictions of the magnitude of the efficacy of Listex TM P100 in reducing L. monocytogenes contamination of RTE foods in specific processing plants are highly uncertain due mainly to the following: (1) the efficacy of P100 is dose dependent and the applicant does not specify which doses are to be used in different RTE product; (2) there is only one study using naturally contaminated RTE foods; (3) the inoculation level using artificially contaminated samples is above what is normally found on naturally contaminated samples; (4) some strains of L. monocytogenes are naturally resistant to P100; (5) within each category of RTE food (i.e. RTE meat and poultry, fish and seafood, and dairy products), only a selected type/limited number of RTE foods have been tested and specific foods have different physical and chemical properties, and may be processed under different conditions including use of other hurdles; (6) the causes and possibilities for contamination with L. monocytogenes, the contamination level as well as the possibilities of growth differs widely between and within RTE foods and thereby impact the degree of reduction (efficacy) in a given product. In relation to the answer to ToR 3, experimental studies provided by the applicant and by others indicate that between 2.5% and 9.5% of naturally occurring Listeria strains exhibit resistance to P100. Furthermore, L. monocytogenes P100-resistant variants might be selected as a consequence of the use of Listex TM P100 in industrial settings. However, proper cleaning and disinfection of the areas where P100 is used, together with proper use of the P100 and proper disposal of unsold treated products would eliminate or minimise this risk. From experimental results provided by the applicant, P100 resistance can be accompanied by changes in the spectrum of resistance to certain therapeutic antimicrobials. The reasons behind these changes are not known. Although, no reports of environmental studies are available, the likelihood of persistence of P100 in the environment is low (answer to ToR 4) as the population of bacteriophages naturally decline over time in the absence of a susceptible host. It was recommended that more studies on the efficacy of Listex TM P100 in naturally contaminated RTE foods should be undertaken, acknowledging the difficulties in examining the efficacy of Listex TM P100 in samples of RTE foods contaminated with L. monocytogenes. In addition, if Listex TM P100 is authorised and used, the FBO should validate the efficacy of the P100 dose applied in the specific product before it leaves the processing plant and, on a regular basis, examine the susceptibility to Listex TM P100 of L. monocytogenes strains isolated from the raw material/processing plant to Listex TM 4 EFSA Journal 2016;14(8):4565

5 P100 and if resistant strains occur consider corrective actions. It was also recommended to undertake experiments to investigate the currently unknown mechanism(s) by which strains of L. monocytogenes exhibiting resistance to certain therapeutic antimicrobials become sensitive to these antimicrobials following the development of resistance to P EFSA Journal 2016;14(8):4565

6 Table of contents Abstract... 1 Summary Introduction Background and Terms of Reference as provided by the requestor EFSA guidance Application for approval Terms of reference Interpretation of the Terms of Reference Additional information Additional background information Introduction Parameters for treatment application Previous EFSA assessments in relation to bacteriophages and Listex TM P Previous assessments from other agencies in relation to Listex TM P Approved uses of Listex TM for surface decontamination Approach to answer the ToR Data and methodologies Data Efficacy (ToR 2) Toxicological safety, potential emergence of resistance to biocides and/or to therapeutic antimicrobials, and the environmental risk (ToRs 1, 3, 4) Methodologies Efficacy (ToR 2) Toxicological safety, potential emergence of resistance to biocides and/or to therapeutic antimicrobials, and the environmental risk (ToRs 1, 3, 4) Assessment The toxicological safety of the substance to humans (ToR 1) The bacteriophage P The production purification process The potential effect of bacteriophage P100 on consumer s health Concluding remarks The efficacy (ToR 2) Introduction Study selection and identification of relevant experiments Description of the eligible experiments Synthesis of the results of the eligible experiments Evaluation of the efficacy of Listex TM P100 to naturally contaminated RTE foods and evaluation of the magnitude of reduction using EKE Concluding remarks Recommendations The potential emergence of reduced susceptibility to biocides and/or resistance to therapeutic antimicrobials linked to the use of the substance (ToR 3) Treatment of listeria infections Resistance to biocides, bacteriophages and therapeutic antimicrobials Resistance to biocides Resistance to bacteriophages Resistance to therapeutic antimicrobials Concluding remarks Recommendations The risk related to the release of the processing plant effluents, linked to the use of the substance, into the environment (ToR 4) Concluding remarks Conclusions Recommendations Documentation provided to EFSA References Abbreviations Appendix A Protocol for the assessment of the application dossier Appendix B Analysis of the numbers of records screened and the reasons for exclusion EFSA Journal 2016;14(8):4565

7 Appendix C Data extracted from the eligible experiments Appendix D R code for statistical analysis Appendix E Summary of the Expert Knowledge Elicitation (EKE) Appendix F Summary of the eligible experiments EFSA Journal 2016;14(8):4565

8 1. Introduction 1.1. Background and Terms of Reference as provided by the requestor The EU food hygiene legislation is aimed at protecting consumers against potential risks to health and maintaining a high level of consumer protection at all stages of the food chain. This objective must be achieved by applying the appropriate measures, including Good Hygiene Practices (GHP) and hazard control measures at each step of the food chain. According to EU scientific advice, 1 decontamination practices can constitute a useful tool in further reducing the number of pathogenic microorganisms but the use of substances intended to remove microbial surface contamination should only be permitted if a fully integrated control programme is applied throughout the entire food chain. Those substances shall be assessed thoroughly before their use is authorised. Article 3 (2) of Regulation (EC) No 853/ provides a legal basis to approve, and therefore authorise, the use of substances other than potable water to remove surface contamination from products of animal origin. In addition to the safety of the substance, are also a matter of concern the potential emergence of reduced susceptibility to biocides and/or resistance to therapeutic antimicrobials and the impact of the substance or its by-products on the environment. Therefore, before taking any risk management decisions on their approval, a risk analysis process should be carried out taking into account the results of a risk assessment based on the available scientific evidence and undertaken in an independent, objective and transparent manner, other legitimate factors and the precautionary principle EFSA guidance On March 2010, the European Food Safety Authority (EFSA) issued a revision of a guidance document 3 on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption Application for approval On 19 June 2015, the Commission received an application dossier from Micreos, a Dutch company (Contact person: Dirk de Meester), for the approval of Listex TM P100 for reduction of Listeria monocytogenes in RTE meat and poultry, fish and seafood, and dairy products. The dossier is enclosed to this request Terms of reference In accordance with Article 29 (1) (a) of Regulation (EC) No 178/ EFSA is requested to evaluate the safety and efficacy of Listex TM P100 solution intended to be used by food business operators (FBOs) during processing for the reduction of L. monocytogenes in RTE products, considering: the toxicological safety of the substance (ToR 1); the efficacy, i.e. does the use of this substance significantly reduce the level of contamination of Listeria monocytogenes in the RTE products (ToR 2); the potential for the emergence of reduced susceptibility to biocides and/or resistance to therapeutic antimicrobials linked to the use of the substance (ToR 3); the risk related to the release of the processing plant effluents, linked to the use of the substance, into the environment (ToR 4). 1 SCVPH (Scientific Committee on Veterinary Measures Relating to Public Health), Report on the benefits and limitations of antimicrobial treatments for poultry carcasses, 30 October SCVPH (2003) Opinion on the evaluation of antimicrobial treatments for poultry carcasses EFSA Journal 388: Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. OJ L 139, , p EFSA Journal 2010;8(4): See Section Documentation provided to EFSA. 5 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, , p EFSA Journal 2016;14(8):4565

9 1.2. Interpretation of the Terms of Reference The European Commission agreed that the definition of RTE food in Commission Regulation (EC) No 2073/ on microbiological criteria for foodstuffs is to be used: Food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to acceptable level microorganisms of concern. In the mandate it was specified to consider RTE meat and poultry, fish and seafood, and dairy products (later indicated as RTE meat, fish and dairy). These groups will be dealt with separately. In line with the EFSA guidance document (EFSA BIOHAZ Panel, 2010), the use of Listex TM P100 solution as a decontaminating agent will be regarded efficacious when any reduction of the prevalence and/or numbers of L. monocytogenes is statistically significant as compared to the control (e.g. water) and, at the same time, this reduction has a positive impact on lessening human illness cases. The impact of reducing L. monocytogenes on the RTE food products on the reduction of human listeriosis cases has already been shown, e.g. Chen et al. (2003) and will not be further addressed or quantified in this scientific opinion. The European Commission requested that, if possible, the expected efficacy under practical conditions also needs to be assessed. The efficacy of Listex TM P100 of the RTE foods tested needs to be assessed. In case extrapolations can be made, EFSA should try to make an overall conclusion about the efficiency for foods on which data are missing Additional information Additional background information Introduction As indicated in the application dossier, the purpose of the proposed treatment is to eradicate or decrease Listeria monocytogenes surface contamination of ready-to-eat food products (RTE food products), such as deli meat products, frankfurter products, soft cheeses, smoked and cooked fish, and other seafood products, etc. The formulated product has the trade name Listex TM P100 and contains bacteriophage P100 at a concentration of plaque-forming units (PFU) per ml. Approval was sought for spraying or dipping treatments (or use in smear suspension for smeared cheese) of above-mentioned RTE food products using up to PFU of P100 per gram of product. As stated in the application dossier, the concentration to be used depends on the log unit reduction desired by the FBO. The lower limit was not specified by the applicant Parameters for treatment application The applicant includes the following information in relation to the parameters for treatment in the application dossier: Application type: Listex TM P100 is usually applied as a spraying or dipping suspension. 7 In the case of smeared cheeses, Listex TM P100 can be added in the smear suspension. Concentration: The concentration of Listex TM P100 to be used depends on the intended log reduction of L. monocytogenes counts on the product, but does not exceed PFU/g product. Type of application in the processing line: The time of application in the processing line depends on the food that is treated. The best time of application of Listex TM P100 for RTE foodstuffs is just after post-lethal treatment or during the packaging process. Regarding coldand hot-smoked salmon, the application time depends on the challenge (the place where contamination takes place). Condition of use: The conditions of use vary between certain limits: Temperature: optimum at 30 C, range 1 35 C; ph: optimum at 7.7, range ; 6 Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. OJ L 338, , p In the application dossier, it is referred to solution. 9 EFSA Journal 2016;14(8):4565

10 water activity: minimum 0.92, optimum at 0.99; and NaCl: high tolerance up to saturated solutions. Duration of exposure: Once Listex TM P100 is applied to the surface of the foodstuffs approximately half an hour is needed for the bacteriophages to find their Listeria host bacteria and kill them. The exposure time depends on the shelf-life. Volume to apply: The volume to apply is not indicated. Subsequent removal conditions: Neutralisation or removal of Listex TM P100 from the treated products is not needed as bacteriophages only work for a limited amount of time and their breakdown products are the same as the substances already present in food (proteins and nucleic acids). In addition, lytic bacteriophages are completely safe. Recycling: There will not be any recycling of the Listex TM P100 suspension Previous EFSA assessments in relation to bacteriophages and Listex TM P100 Following a request from the European Commission, the Panel on Biological Hazards (BIOHAZ Panel) was asked to deliver a scientific opinion on an application dossier submitted by Micreos BV (the Netherlands) for the approval of Listex TM P100 for spraying or dipping uses aimed to reduce L. monocytogenes surface contamination of raw fish (EFSA BIOHAZ Panel, 2012). EFSA concluded that the material should not present human toxicological problems because the bacteriophage P100, used as active principle, is not regarded as harmful to consumers nor to organisms other than Listeria spp., and because the fabrication parameters do not include anything obvious that might compromise safety. Data from studies considered indicated that Listex TM P100 is listericidal on inoculated catfish and salmon samples, but did not allow definitive conclusions on efficacy in reducing L. monocytogenes counts on raw fish nor on its impact on L. monocytogenes contamination levels in finished product. It was not possible to estimate the potential listeriosis risk reduction by treating raw fish with Listex TM P100. The data were not adequate to allow firm conclusions on persistence or activity of P100 in stored fish. The proposed use of Listex TM P100 was thought unlikely to result in emergence of reduced susceptibility to biocides and/or resistance to key therapeutic antimicrobials. However, this conclusion may need verification. No information was provided on survival of P100 in processing wastewater or the environment, or on the potential accumulation of naturally P100-resistant L. monocytogenes variants. Pilot and industrial scale studies should consider parameters affecting decontaminating efficacy, and should verify that application on raw fish has an impact on reduction of L. monocytogenes contamination on the final product. The persistence or activity of P100 as well as potential changes in L. monocytogenes counts should be evaluated during fish storage. Tests to investigate potential development of resistance or reduced susceptibility to biocides and key therapeutic antimicrobials, following use of Listex TM P100, are recommended. The continuous effectiveness of Listex TM P100 against L. monocytogenes and the potential for selection and dominance of strains naturally resistant to P100 should be monitored. In 2009, the BIOHAZ Panel self-tasked a scientific opinion on bacteriophage-based treatments of foods of animal origin, with the main focus on their mode of action and continual functioning in the food (EFSA, 2009). The continual functioning refers to whether bacteriophages preserve against recontamination or whether there is no continuing action effect in the final food. It was concluded that for the purposes of decontamination treatments in foods, virulent bacteriophages are the choice for applications. This is because virulent bacteriophages kill their host bacteria while temperate bacteriophages do not always kill their hosts, and may confer unforeseen properties to their host bacteria. Some bacteriophages, under specific conditions, are very effective in eliminating specific pathogens from foods. Bacteriophages have narrow host ranges. Bacteriophage-insensitive mutants might exist among the populations of target bacteria. The frequency of these mutations and their consequences are likely to vary according to the bacteriophage, the conditions of its application and the target bacteria. The persistence of bacteriophages in/on food varies with each bacteriophage and with the conditions of application. Due to high uncertainty and lack of data, it could not be concluded whether bacteriophages protect against recontamination of food with bacterial pathogens. This is likely to vary with each bacteriophage, each food matrix and with conditions of application EFSA Journal 2016;14(8):4565

11 Previous assessments from other agencies in relation to Listex TM P100 In 2006, 8 the US Food and Drug Administration (FDA) responded to the notice of EBI Food Safety (former name of Micreos Food Safety; GRAS Notice No. GRN ) that the P100 preparation is Generally Recognized as Safe (GRAS), through scientific procedures, as an antimicrobial to control L. monocytogenes in brie, cheddar, Swiss and other cheeses that are normally aged and ripened. The notice included host and phage identities, method of manufacture, specifications, an estimated dietary intake for the intended use in cheese and safety studies for the P100 preparation. It discussed an assessment of the gene protein products in P100 preparation to determine its potential pathogenicity, virulence and allergenicity, and concluded that the P100 preparation is GRAS as an antimicrobial at levels up to 10 9 PFU/g of cheese. The US FDA had no questions regarding EBI s conclusion that the P100 preparation is GRAS under the intended conditions of use. The US FDA, however, did not made its own determination regarding the P100 preparation as it is the continuing responsibility of EBI to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements. In 2007, 9 the US FDA responded to the notice of EBI (GRAS Notice No. GRN ) that the P100 preparation is GRAS, through scientific procedures, as an antimicrobial to control L. monocytogenes in food in general, including meat and poultry products, at levels up to 10 9 PFU/g of food. During its evaluation, the US FDA consulted with Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA) as FSIS was responsible for determining the efficacy and suitability of food ingredients in meat and poultry products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers. It was concluded that EBI provided information in support of the use of the P100 preparation on RTE meat and poultry products, including hot dogs, minced meat, turkey breast and ham. Those foods were artificially contaminated with L. monocytogenes and then treated with the P100 preparation. FSIS considers that the data show that the P100 preparation was effective in reducing L. monocytogenes on these meat and poultry products. It noted that companies applying the preparation to meat and poultry products whose formulations contain added phosphates must ensure that the treatment does not increase the levels of phosphates beyond the regulatory limits for meat and poultry. It was concluded that the use of this phage preparation on RTE meat and poultry products would not have any adverse effects on the organoleptic properties. Consequently, FSIS did not have any objection to the use of the P100 preparation, under the conditions described in the notice, for use as an antimicrobial agent on various non-standardised RTE meat and poultry products, and standardised meat and poultry products that permit the use of any safe and suitable antimicrobial agent. The US FDA had the same conclusion as for the GRAS Notice No GRN above. Food Standards Australia New Zealand (FSANZ) has assessed an application submitted by the same applicant to permit the use of Listex TM P100 as a processing aid (FSANZ, 2012). Analysis performed by FSANZ confirmed that the use of P100, in the form and amounts proposed by the applicant, is technologically justified and demonstrated to be effective in achieving its stated purpose and that it does not have an ongoing technological function when used with a range of solid RTE foods. The studies assessed to make this conclusion investigated the effects on solid RTE meat (including poultry) and meat products, fish and fish products, fruits and vegetables and their products, and cheese. FSANZ also concluded that resistance development to bacteriophage treatment is minimal in food processing environments when appropriate user instructions are provided and adhered to. FSANZ further concluded that there would be no negative impact on humans caused by ingestion of, or contact with, P100. Ongoing assistance is provided by the applicant to food manufacturers who use P100 to continually check for the development of L. monocytogenes resistance to P100. FSANZ concluded that to date such resistance development has not been found. L Agence Nationale de Securite Sanitaire de L alimentation, de L environnement et du Travail (ANSES) assessed the use of bacteriophages in food of animal origin to control Listeria (ANSES, 2014). It was concluded that Listex TM P100 treatment was efficient to reduce L. monocytogenes levels in the tested foods. The efficacy of Listex TM P100 appears to be dependent on the concentration used and the choice of the process step when it is applied. Each category of food appears to have a specific EFSA Journal 2016;14(8):4565

12 application dose, which requires validation of treatment efficacy for a given production process. Depending on the type of product tested, single or multiple applications may be needed to achieve the intended antimicrobial effect. Use of P100 may be an additional tool that can be used to control the Listeria hazard in foods but not in the agrofood environment or in the event of recontamination of the product. It could supplement Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Point (HACCP) but cannot be considered a means of extending the shelf-life of products or of obtaining a product that is fully decontaminated in the event of contamination of a production facility with Listeria. It is also possible that this treatment may have no real effect, particularly in the context of contamination with Listeria occurring subsequent to treatment with bacteriophages or in certain specific matrices. With regard to the factors restricting the action of bacteriophages in the agrofood sector, ANSES concluded that the free water content in a food matrix and the free or adsorbed state of the phage are key points for its activity. P100 has no effect once adsorbed on the matrix in the event of recontamination with Listeria post-treatment. Once desorbed from the food matrix, the phage may become active again in the host or in the environment. Given the concentrations used, ANSES concluded that the emergence of bacteria resistant to P100 in the agrofood environment is highly likely and could in the long term lead to reduced efficacy of treatment. Use of phage cocktails or the rotation of phages are strategies that may help to limit the development of phage-resistant strains. ANSES concluded that it seems to be unlikely that bacteriophages in food matrices could be a vector of genetic material through non-controlled mechanisms, e.g. acquisition of pathogenicity of bacteria, given the available data. However, in the environment near industrial sites, in the host, or in the environment after release via waste water, this cannot be ruled out. With regard to the maintenance of the specificity and the absence of pathogenicity of bacteriophages, ANSES concluded that P100, like all Listeria phages, appears to be genus specific. Furthermore, phages are the most abundant organisms on the planet. Despite this, no phage has been shown to cause infection in humans and no phage sequence has been identified in the human genome. Phages have already been administered to humans as part of viral phage therapy (oral or rectal route, or topically) with no adverse effects on health. Possible adverse effects linked to phage use in the agrofood sector can therefore only be secondary, through changes in the intestinal flora, in the bacterial host, or in the balance of the ecosystem inhabited by L. monocytogenes and Listeria innocua Approved uses of Listex TM for surface decontamination Bacteriophage P100, formulated under the product name Listex TM P100, has been determined to be GRAS by the US FDA in 2006, 8 through scientific procedures, as an antimicrobial to control L. monocytogenes in brie, cheddar, Swiss and other cheeses that are normally aged and ripened (GRAS Notice No GRN ). In 2007, 9 it was determined to be GRAS as an antimicrobial to control L. monocytogenes in food in general, including meat and poultry products, at levels up to 10 9 PFU/g of food (GRAS Notice No GRN ). 10,11 Ingredient label requirements were specified. In 2011, USDA permitted its use as a processing aid on the surface of RTE meat and poultry products to achieve a level of PFU/g. 12 The letter of permission requires that the treatment is integrated into the HACCP programmes of the industry. In 2010, Health Canada issued a letter of no objection for the use of the P100 preparation as a processing aid in several foods, mainly deli meat and poultry products (e.g. wieners, sliced ham), cold-smoked fish, vegetable prepared dishes, soft cheeses and/or other dairy foods. A recommendation was made to provide clear instructions on the conditions of application to potential users. A proposed level of use within the range of PFU/g was specified. FSANZ has approved Listex TM P100 for use in Australia and New Zealand as a processing aid for use on meat, seafood, cheese and RTE foods Approach to answer the ToR To assist in assessing the safety and efficacy of a proposed decontaminating agent of foods of animal origin, EFSA issued in 2010 a revised guidance document titled Revision of the joint AFC/BIOHAZ guidance document on the submission of data for the evaluation of the safety and 10 &search=p EFSA Journal 2016;14(8):4565

13 efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption (EFSA BIOHAZ Panel, 2010). The document presents the major components and data that an application dossier should contain. These guidelines, terminology and procedure have been used in this scientific opinion on the evaluation of the safety and efficacy of Listex TM P100 for reduction of pathogens on different RTE food products. This scientific assessment was chosen as a case study to test the importance of performing the assessment in four steps, i.e. planning/conducting/verifying/reporting, as illustrated in the EFSA PROMETHEUS project (PROMoting METHods for Evidence Use in Scientific assessments) (EFSA, 2015). For the planning phase of this assessment, a protocol (see Appendix A) was developed with the aim of defining beforehand the Panel s strategy for assessing the comprehensiveness and relevance of the data provided by the applicant, and for appraising the evidence and synthesising the results. The experience gained with this specific scientific assessment will be used as guidance for further refinement of the methodological framework developed in the PROMETHEUS project. 2. Data and methodologies 2.1. Data Efficacy (ToR 2) The steps followed for the acquisition of data, their selection and appraisal are documented in the protocol in Appendix A to this scientific opinion and summarised in Section The search strategies adopted for retrieving the literature used for this assessment are included in the protocol in Appendix A to this scientific opinion. The search term was broad as it only considered the bacteriophage itself (P100 or Listex). A detailed analysis of the numbers of records screened and of the reasons for exclusion is reported in Appendix B. Briefly, the studies on efficacy included records provided by the applicant consisting of literature studies and in-house studies (IHS) conducted by the applicant. These were complemented with studies on efficacy prescreened for relevance by hand searching the reference lists of the two above-mentioned reports (FSANZ, 2012; ANSES, 2014) and studies on efficacy provided via the Microbial Risk Assessment (MRA) Network through a call for data on 13 November 2015 and also prescreened for relevance. In addition, one bibliographic database (Web of Science TM Core Collection) was searched. A of the search strings used for the literature searches is provided in Appendix A. At the end of the systematic review process, a total of 150 records were screened at title/ abstract level and further screened for eligibility based on the full text (part I), with 23 records being eligible. In total, 55 experiments were defined. Of these, 33 experiments fulfilled the criteria for inclusion predefined in the protocol in Appendix A to this scientific opinion (see Figure 1 for PRISMA flow chart). The quantitative synthesis included 18 records and 33 eligible experiments from which 156 comparisons (reduction estimates) were derived. Of the 18 records, 12 records (five from IHS) and out of the 33 experiments, 21 experiments (nine from IHS) were provided by the applicant. In total, 99 comparisons out of 156 comparisons were derived from the records provided by the applicant EFSA Journal 2016;14(8):4565

14 Identification Records identified by the applicant N = 17 Records identified through database searching N= 148 Records identified through other sources N = 26 Records after duplicates removed N = 150 Screening Records screened at title/abstract level N = 150 Records excluded with reasons N = 120 Eligibility Full text records assessed for eligibility; Part I N = 30 Full text records assessed for eligibility; Part II N = 23 (55 experiments) Records excluded with reasons N = 7 Records excluded with reasons N = 5 (22 experiments) Included Records included in quantitative synthesis N = 18 of which 12 provided by the applicant (33 eligible experiments of which 21 provided by the applicant) with 156 comparisons Figure 1: PRISMA flow chart (adapted from Moher et al. (2010)) Toxicological safety, potential emergence of resistance to biocides and/or to therapeutic antimicrobials, and the environmental risk (ToRs 1, 3, 4) The information provided by the applicant has been considered. Relevant studies identified through extensive literature searches dealing with ToR2 (efficacy of Listex TM P100), have also been taken into account Methodologies The method followed to perform this risk assessment is detailed in the protocol in Appendix A to this scientific opinion. The questions as specified in the ToRs 1, 3 and 4 have been addressed by following the same approach as in previous assessments (EFSA BIOHAZ Panel, 2011a,b, 2012; EFSA BIOHAZ Panel and EFSA CEF Panel, 2012). An evaluation was done for the information provided by the applicant complemented with relevant studies identified through extensive literature searches dealing with ToR2 (see Section ) and literature reviews based on the knowledge and expertise of the Working Group (WG) members. For the question about the efficacy of Listex TM P100, as specified in ToR 2, a systematic, stepwise approach was applied. The reason for choosing the latter approach 14 EFSA Journal 2016;14(8):4565

15 for the efficacy assessment was that an earlier EFSA assessment on Listex TM P100 treatment of raw fish (EFSA BIOHAZ Panel, 2012) found that it was not possible to derive conclusions on efficacy while conclusions were made for the other ToRs (1, 3 and 4), i.e. the toxicological safety, potential emergence of resistance to biocides and/or to therapeutic antimicrobials, and the environmental risk Efficacy (ToR 2) The question as specified in ToR 2 (efficacy of Listex TM P100) has been assessed by applying a systematic, stepwise approach as follows: 1) formulation of the question under assessment and definition of the eligibility criteria for selecting experiments relevant to answer the question; 2) ascertainment of the comprehensiveness and relevance of the evidence provided by the applicant (search for further studies, study selection process and identification of relevant experiments); 3) data extraction from the included experiments, using predefined data extraction forms; 4) appraisal of individual experiments included in the assessment, using a predefined critical appraisal tool (CAT) for the reliability; 5) data synthesis and interpretation of results in the light of identified uncertainties. The following eligibility criteria were used in the selection of studies to be used in the evaluation of decontamination efficacy by Listex TM P100: s should be performed using RTE food from animal origin contaminated with L. monocytogenes including RTE meat and poultry, fish and seafood, and dairy products. RTE is defined as any food intended by the producer or manufacturer for direct human consumption, without the need for cooking or other processing effective to eliminate or reduce microorganisms of concern to an acceptable level (Commission Regulation (EC) No 2073/2005). Bacteriophage P100 should be applied on the surface of the food by spraying, spreading, dipping or in the smear suspension (for smeared cheese) up to a maximum concentration on the food product right after treatment of PFU/g or PFU/cm 2 product. By doing so, experiments might have been included with doses higher than the one applied for by the applicant (maximum of 10 9 PFU/g). There should be a proper comparator used against the treated samples: either water (or other solution)-treated or untreated control. The change in number (log reduction) and/or the presence of L. monocytogenes on the treated food must be reported at any time point after the treatment (e.g. right after treatment, during storage or at the end of shelf-life). Also, combined treatments have been included in the assessment; that is when P100 has been applied together with another hurdle on RTE food if there is a proper corresponding control (i.e. the hurdle alone). Data has been extracted from the experiments included in the assessment by using a predefined data extraction form and has been translated, whenever possible, into predefined codes (e.g. harmonised units of measurement) to facilitate subsequent data analysis. The data extracted can be found in Appendix C. The reliability of the experiments was appraised through a CAT for four elements: (a) comparability of control and treated groups, (b) L. monocytogenes inoculation procedure and bacteriophage P100 distribution, (c) L. monocytogenes detection and enumeration method, and (d) statistical analysis and reproducibility. The rating scale was applied for each element individually and ranged from 4 to 1 with 4 being a definitively appropriate experiment, 3 a probably appropriate experiment, 2 a probably not appropriate experiment and 1 a definitively not appropriate experiment for each element. The mean log reductions of L. monocytogenes on the RTE food samples were calculated based on the counts of L. monocytogenes of the control group and treatment group, immediately after treatment and at the end of storage. These counts were expressed per g or cm 2 of product depending on how it was expressed in the records. The mean log reduction is the log 10 count of L. monocytogenes of the control group minus the log 10 count of L. monocytogenes of the treatment group. The 95% confidence interval (95% CI) of the mean log reduction has been calculated when the standard deviation (SD) and sample size or standard error of the mean (SEM) were known and/or raw 15 EFSA Journal 2016;14(8):4565

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