Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 1: Methodology, general data gaps and uncertainties
2021; Wiley; Volume: 19; Issue: 10 Linguagem: Inglês
10.2903/j.efsa.2021.6852
ISSN1831-4732
AutoresKonstantinos Koutsoumanis, Ana Allende, Avelino Álvarez‐Ordóñez, Declan Bolton, Sara Bover‐Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Roland Lindqvist, Maarten Nauta, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Elisabetta Suffredini, Dan I. Andersson, Vasileios Bampidis, Johan Bengtsson‐Palme, Damien Bouchard, Aude Ferran, Maryline Kouba, Secundino López Puente, Marta López‐Alonso, Søren Saxmose Nielsen, Alena Pechová, Mariana Petkova, Sebastien Girault, Alessandro Broglia, Beatriz Guerra, Matteo Lorenzo Innocenti, E. Liébana, Gloria López‐Gálvez, Paola Manini, Pietro Stella, Luísa Peixe,
Tópico(s)Pesticide Residue Analysis and Safety
ResumoEFSA JournalVolume 19, Issue 10 e06852 Scientific OpinionOpen Access Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 1: Methodology, general data gaps and uncertainties EFSA Panel on Biological Hazards (BIOHAZ), Corresponding Author EFSA Panel on Biological Hazards (BIOHAZ) biohaz@efsa.europa.eu Correspondence:biohaz@efsa.europa.euSearch for more papers by this authorKonstantinos Koutsoumanis, Konstantinos KoutsoumanisSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorAvelino Alvarez-Ordóñez, Avelino Alvarez-OrdóñezSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorSara Bover-Cid, Sara Bover-CidSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorAlessandra De Cesare, Alessandra De CesareSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorFriederike Hilbert, Friederike HilbertSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorMaarten Nauta, Maarten NautaSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorElisabetta Suffredini, Elisabetta SuffrediniSearch for more papers by this authorDan I Andersson, Dan I AnderssonSearch for more papers by this authorVasileios Bampidis, Vasileios BampidisSearch for more papers by this authorJohan Bengtsson-Palme, Johan Bengtsson-PalmeSearch for more papers by this authorDamien Bouchard, Damien BouchardSearch for more papers by this authorAude Ferran, Aude FerranSearch for more papers by this authorMaryline Kouba, Maryline KoubaSearch for more papers by this authorSecundino López Puente, Secundino López PuenteSearch for more papers by this authorMarta López-Alonso, Marta López-AlonsoSearch for more papers by this authorSøren Saxmose Nielsen, Søren Saxmose NielsenSearch for more papers by this authorAlena Pechová, Alena PechováSearch for more papers by this authorMariana Petkova, Mariana PetkovaSearch for more papers by this authorSebastien Girault, Sebastien GiraultSearch for more papers by this authorAlessandro Broglia, Alessandro BrogliaSearch for more papers by this authorBeatriz Guerra, Beatriz GuerraSearch for more papers by this authorMatteo Lorenzo Innocenti, Matteo Lorenzo InnocentiSearch for more papers by this authorErnesto Liébana, Ernesto LiébanaSearch for more papers by this authorGloria López-Gálvez, Gloria López-GálvezSearch for more papers by this authorPaola Manini, Paola ManiniSearch for more papers by this authorPietro Stella, Pietro StellaSearch for more papers by this authorLuisa Peixe, Luisa PeixeSearch for more papers by this author EFSA Panel on Biological Hazards (BIOHAZ), Corresponding Author EFSA Panel on Biological Hazards (BIOHAZ) biohaz@efsa.europa.eu Correspondence:biohaz@efsa.europa.euSearch for more papers by this authorKonstantinos Koutsoumanis, Konstantinos KoutsoumanisSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorAvelino Alvarez-Ordóñez, Avelino Alvarez-OrdóñezSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorSara Bover-Cid, Sara Bover-CidSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorAlessandra De Cesare, Alessandra De CesareSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorFriederike Hilbert, Friederike HilbertSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorMaarten Nauta, Maarten NautaSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorElisabetta Suffredini, Elisabetta SuffrediniSearch for more papers by this authorDan I Andersson, Dan I AnderssonSearch for more papers by this authorVasileios Bampidis, Vasileios BampidisSearch for more papers by this authorJohan Bengtsson-Palme, Johan Bengtsson-PalmeSearch for more papers by this authorDamien Bouchard, Damien BouchardSearch for more papers by this authorAude Ferran, Aude FerranSearch for more papers by this authorMaryline Kouba, Maryline KoubaSearch for more papers by this authorSecundino López Puente, Secundino López PuenteSearch for more papers by this authorMarta López-Alonso, Marta López-AlonsoSearch for more papers by this authorSøren Saxmose Nielsen, Søren Saxmose NielsenSearch for more papers by this authorAlena Pechová, Alena PechováSearch for more papers by this authorMariana Petkova, Mariana PetkovaSearch for more papers by this authorSebastien Girault, Sebastien GiraultSearch for more papers by this authorAlessandro Broglia, Alessandro BrogliaSearch for more papers by this authorBeatriz Guerra, Beatriz GuerraSearch for more papers by this authorMatteo Lorenzo Innocenti, Matteo Lorenzo InnocentiSearch for more papers by this authorErnesto Liébana, Ernesto LiébanaSearch for more papers by this authorGloria López-Gálvez, Gloria López-GálvezSearch for more papers by this authorPaola Manini, Paola ManiniSearch for more papers by this authorPietro Stella, Pietro StellaSearch for more papers by this authorLuisa Peixe, Luisa PeixeSearch for more papers by this author First published: 26 October 2021 https://doi.org/10.2903/j.efsa.2021.6852 Requestor: European Commission Question number: EFSA-Q-2019-00221 Panel members: Ana Allende, Avelino Alvarez-Ordóñez, Declan Bolton, Sara Bover-Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Konstantinos Koutsoumanis, Roland Lindqvist, Maarten Nauta, Luisa Peixe, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis and Elisabetta Suffredini. Declarations of interest: The declarations of interest of all scientific experts active in EFSA's work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch. Acknowledgements: The BIOHAZ Panel, leading Panel in charge of the adoption of the scientific opinion and assessment of Term of Reference 1 (ToR1, antimicrobial resistance) wishes to thank the following for the support provided to this scientific output: EFSA Panel on Animal Health and Welfare (AHAW Panel), who supported ToR1 assessments development and endorsement of those sections under their remit (animal production, main use of antimicrobials); EFSA Panel for Additives and Products or Substances used in Animal Feed (FEEDAP), in charge of the assessment and endorsement of ToR2, and providing advice and data needed for ToR1 assessments; European Medicines Agency (EMA), who was represented by an external expert and EMA secretariat as members of the Working Group (WG); Valeria Bortolaia, who was member of the WG until 17 April 2020; EFSA staff members: Angelica Amaduzzi, Gina Cioacata, Pilar García-Vello, Michaela Hempen, Rita Navarrete, Daniel Plaza, Anita Radovnikovic and Cristiana Ventura; EMA staff members: Barbara Freischem, Zoltan Kunsagi, Nicholas Jarrett, Jordi Torren and Julia Fábrega (currently EFSA staff). The BIOHAZ Panel wishes also to acknowledge the EMA Committee for Medicinal Products for Veterinary Use (CVMP) and their experts, as well as the members of the EARS-Vet and the EURL-AR that provided data and/or information for this scientific output. Reproduction of the images listed below is prohibited and permission must be sought directly from the copyright holder:Figure 3: © 2011 Gullberg et al. Adopted: 15 September 2021 The Outcome of the public consultation is available under the Supporting Information section. AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract The European Commission requested EFSA to assess, in collaboration with EMA, the specific concentrations of antimicrobials resulting from cross-contamination in non-target feed for food-producing animals below which there would not be an effect on the emergence of, and/or selection for, resistance in microbial agents relevant for human and animal health, as well as the levels of the antimicrobials which could have a growth promotion/increase yield effect. The assessment was performed for 24 antimicrobial active substances, as specified in the mandate. This scientific opinion describes the methodology used, and the main associated data gaps and uncertainties. To estimate the antimicrobial levels in the non-target feed that would not result in emergence of, and/or selection for, resistance, a model was developed. This 'Feed Antimicrobial Resistance Selection Concentration' (FARSC) model is based on the minimal selective concentration (MSC), or the predicted MSC (PMSC) if MSC for the most susceptible bacterial species is unavailable, the fraction of antimicrobial dose available for exposure to microorganisms in the large intestine or rumen (considering pharmacokinetic parameters), the daily faecal output or rumen volume and the daily feed intake. Currently, lack of data prevents the establishment of PMSC and/or FARSC for several antimicrobials and animal species. To address growth promotion, data from an extensive literature search were used. Specific assessments of the different substances grouped by antimicrobial classes are addressed in separate scientific opinions. General conclusions and recommendations were made. 1 Introduction 1.1 Background and Terms of Reference as provided by the requestor Combatting antimicrobial resistance (AMR) is a priority in the European Union (EU). Several measures have already been put in place to limit its development. In 2006, the EU banned the use of antibiotics as feed additives for growth promotion. The provisions established in the new Medicated Feed Regulation11 Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC. OJ L 4, 7.1.2019, p. 1–23. are further concrete actions to deal with the issue. The cross-contamination of non-target feed (feed, whether medicated or not, which is not intended to contain a specific active substance) with antimicrobials has been identified as one of the core issues addressed in this context. Cross-contamination may occur during manufacture, processing, storage or transport of feed where the same production and processing equipment, including for mobile mixing, storage facilities or means of transport are used for feed with different components. For the purposes of the Medicated Feed Regulation, the concept of cross-contamination is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed. Contamination of non-target feed with active substances contained in medicated feed should be avoided or kept as low as possible. The respective Article 7 on cross-contamination stipulates in paragraph 3: The Commission shall, by 28 January 2023, adopt delegated acts in accordance with Article 20 in order to supplement this Regulation by establishing, as regards the antimicrobial active substances listed in Annex II, specific maximum levels of cross-contamination for active substances in non-target feed and methods of analysis for active substances in feed. Regarding maximum levels of cross-contamination, those delegated acts shall be based on a scientific risk assessment carried out by EFSA. Moreover, recital 17 of that Regulation highlights the protection of animal health, human health and the environment and suggests EFSA to do the risk assessment in cooperation with the European Medicines Agency (EMA). Finally, Article 107 of the new Regulation on veterinary medicinal products22 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC. OJ L 4, 7.1.2019, p. 43–167. stipulates in its paragraph 2: Antimicrobial medicinal products shall not be used in animals for the purpose of promoting growth nor to increase yield. The development of AMR and the resulting impact on human health, animal health and the environment, represents an important consequence of low-level concentration of antimicrobials in feed. Only very limited data are available on the chain between a low concentration of an antimicrobial in feed, the development of resistance to microbial agents relevant for human and animal health (zoonotic bacteria, commensals, animal pathogens) and the possible transfer of resistance determinants and/or resistant agents to humans. Therefore, it would be appropriate to investigate the effect of the exposure to the antimicrobials at low concentrations via feed on the microbiota of animals, and in particular the selection for resistance in microbial agents relevant for human and animal health. Subject to availability of supporting scientific evidence, the impact of the low-level presence in feed on the environment should be considered, too. Further, in order to avoid any misuse of the antimicrobials, use levels of the antimicrobials for promoting growth or increasing yield should, where applicable, be identified and assessed. With respect to the scope of the non-target feed to be addressed it has to be noted that medicated feed for food-producing animals and medicated pet food are produced and distributed in separate ways. Moreover, the antimicrobials at stake are not authorised for incorporation into medicated pet food. Therefore, the scope of this assessment should be focused on the low-level concentration of the antimicrobials in feed for food-producing animals. The European Commission will mandate the European Union Reference Laboratory (EURL) for Feed Additives (Commission Directorate General JRC, Geel) to recommend methods of analysis for the antimicrobials in feed. For this task, some data might be relevant which is to be compiled for the assessment of the cross-contamination levels. Therefore, an exchange of information between the EURL, EFSA and EMA, including national authorisation authorities, would be useful. In order to protect animal health, human health and the environment, maximum levels of cross-contamination for active substances in non-target feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority (EFSA) and in cooperation with EMA. The maximum levels should be compared with the use levels of the antimicrobials for promoting growth or increasing yield, where applicable, to determine a final appropriate level. TERMS OF REFERENCE AS PROVIDED TO EFSA: The European Commission requests the EFSA to assess the impact of the presence of low-level concentration in feed of the antimicrobial active substances listed in the Annex on animal health, human health and, where possible, on the environment. In particular, EFSA, in close collaboration with EMA, is asked, by 30 September 2021: To assess the specific concentrations of antimicrobials resulting from cross-contamination in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in microbial agents relevant for human and animal health, i.e. the end point for this assessment should be the excretion of resistant bacteria from the animals. However, the assessment should also consider the impact on the environment of the low-level concentrations in feed, where possible. To assess which levels of the antimicrobials have a growth promotion/increase yield effect. Annex: List of antimicrobial active substances to be assessed Active substance 1. Amoxicillin 2. Amprolium 3. Apramycin 4. Chlortetracycline 5. Colistin 6. Doxycycline 7. Florfenicol 8. Flumequine 9. Lincomycin 10. Neomycin 11. Spectinomycin 12. Sulfonamides 13. Tetracycline 14. Oxytetracycline 15. Oxolinic Acid 16. Paromomycin 17. Penicillin V 18. Tiamulin 19. Thiamphenicol 20. Tilmicosin 21. Trimethoprim 22. Tylosin 23. Valnemulin 24. Tylvalosin 1.2 Interpretation of the Terms of Reference The terms of reference of the current opinion require an assessment of the antimicrobial concentrations in non-target feed below which there would not be an effect on the emergence of, and/or selection for, resistant bacteria as well as levels that have a growth promotion effect and increase yield. Therefore, depending on the availability of data, the outcome of the assessments will be the calculation or description of these levels, considering only scientific aspects relevant to derive these concentrations. All other aspects relating to: use of antimicrobial medications or general aspects relating to the occurrence of antimicrobial resistance in bacteria from animals, feed and/or the environment; use of good manufacturing practices when producing feed, other possible sources of traces of antimicrobials in non-medicated feed (e.g. co-products of the ethanol industry) or any potential synergy between feed medication carry-over residues and occurrence of antimicrobials in the farm environment; feasibility aspects such as compatibility of the antimicrobial concentration values that would be obtained in the current assessment with practices in feed manufacturing, storage, transport, analysis or regulatory surveillance (e.g. detection limits); proposing recommendations to set maximum antimicrobial levels derived from cross-contamination in feed, are outside the scope of the current opinion and of EFSA, whose remit is limited to risk assessment and scientific advice and does not include risk management. As indicated in the background above, such aspects will be evaluated at a later stage by risk managers, who will aim to establish, according to the Medicated Feed Regulation 2019/4, specific maximum levels of cross-contamination for active substances in non-target feed and methods of analysis for active substances in feed. Depending on the availability of data, extrapolations may be needed, uncertainties will be explored, data gaps will be listed and recommendations to fill those data gaps will be made. To answer ToR1, the Assessment question 1 (AQ1) that will be answered is: which are the specific antimicrobial concentrations in non-target feed below which there would not be emergence of, and/or selection for, resistance in the large intestines/rumen? Low levels of antimicrobials contaminating a non-target feed could lead to the development of resistance in the microbiota of animals consuming the feed. To avoid the emergence and/or selection of resistant bacteria, concentrations at or above the lowest concentration of antimicrobials that promote the emergence and/or give the resistant strains a competitive advantage should not be present. The levels of antimicrobials below which selection for AMR is not expected to occur that will be provided in this opinion are those that would be present in the feed immediately before consumption. The selective activity of feed antimicrobial residues reaching the rumen and large intestine will be assessed in order to calculate these values. The end point will be the bacteria present in the rumen and large intestine, where selection of resistant bacteria by the intake of the antimicrobial should not occur at the specified concentrations of antimicrobials in feed. The reasons for selecting these bacteria as the end point are: (i) rumen and large intestinal bacteria are exposed to antimicrobials ingested through feed intake; (ii) there is a high density and diversity of bacteria at rumen and large intestine level which will increase the possibilities of emerging resistance; (iii) the release of a great number of rumen and large intestinal bacteria exposed to antimicrobials that can further disperse systemically within the animal, on foods derived from the animal and in the environment via shedding in faeces, post- or ante-mortem. Assessment of specific antimicrobials will only be performed in relation to the animal species for which minimal selective concentrations (MSC) and pharmacokinetics parameters associated with oral administration (at least the oral bioavailability) are available. If pharmacokinetics data are limited, different scenarios will be considered. Among food-producing animals, based on their importance in the EU production, it was agreed to select swine, ruminants (cattle, goats, sheep), poultry (broilers, laying hens), rabbits, finfish (salmon) and horses as targets for the assessment. The bacterial species to be included in the assessment will not be restricted to the target bacterial species considered in the therapeutic indications for each antimicrobial, but will include all bacterial species for which susceptibility data are available, to capture the width of the sensitivity distribution. This wide bacterial diversity functions as a proxy for the diversity of intestinal and rumen bacteria (either commensals or pathogens) that could potentially be exposed to antimicrobial residues within the animal after the ingestion of feed, as explained below. The possible impact on the environment of the low-level concentrations in feed was not assessed. Resistant bacteria or antimicrobial residues released from the animals due to these low concentrations may impact on the environment, but the magnitude and duration of the impact cannot currently be evaluated due to lack of data. Thus, the possible impact on the environment of the low-level concentrations in feed was not assessed as agreed with the requestor. To answer ToR2, 'To assess which levels of the antimicrobials have a growth promotion/increase yield effect', the (FEEDAP) Panel will collect and examine the available data. Only food-producing animals will be considered in the assessment. The Assessment question (AQ2) is: which are the specific antimicrobial concentrations in feed of food-producing animals that have an effect in terms of growth promotion/increased yield? 'Growth promotion' covers growth, lactating, laying and reproductive, quantitative and/or qualitative, performance of animals. The end points considered as a sign of growth promotion/increase yield effect on animals include: (i) Intake-related parameters: feed intake, feed/gain ratio (feed conversion ratio), feed efficiency, feed intake/milk yield, feed intake/egg mass; (ii) Weight-related parameters: body weight, body weight gain; (iii) Carcass-related parameters: carcass weight, carcass yield, carcass chemical composition, relative weight of the (different sections of) intestine; (iv) Milk or egg production/quality: milk yield, fat/protein yield, egg production/laying rate, egg weight, egg mass; (v) Digestibility/utilisation of nutrients: utilisation of some nutrients (e.g. dry matter (DM), Ca, P), digestibility; (vi) Health-related parameters: reduction of morbidity and/or mortality; (vii) Herd/flock-related parameters; (viii) Other end points: e.g. intestinal morphological characteristics (villi height/width), changes in microbiota. Any level of antimicrobial showing an effect (positive or negative) on these parameters will be reported. 1.3 Additional information 1.3.1 Definitions and information relevant for the present opinion according to the Regulation (EU) 2019/4 '(6) Medicated feed is one of the routes for the oral administration of veterinary medicinal products. Medicated feed is a homogeneous mixture of feed and veterinary medicinal products. Other routes for oral administration, such as mixing of water for drinking with a veterinary medicinal product or manual mixing of a veterinary medicinal product into feed should not fall within the scope of this Regulation. The authorisation for use in feed, the manufacture, distribution, advertising and supervision of those veterinary medicinal products are governed by Regulation (EU) 2019/6 of the European Parliament and of the Council.' '(16) Cross-contamination may occur during manufacture, processing, storage or transport of feed where the same production and processing equipment, including for mobile mixing, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of cross-contamination is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed. Contamination of non-target feed with active substances contained in medicated feed should be avoided or kept as low as possible.' '(17) In order to protect animal health, human health and the environment, maximum levels of cross-contamination for active substances in non-target feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority (EFSA) and in cooperation with the European Medicines Agency, as well as taking into account the application of good manufacturing practice and the 'as low as reasonably achievable' ('ALARA') principle. Until the completion of that scientific risk assessment, national maximum levels of cross-contamination for active substances in non-target feed, regardless of its origin, should apply, taking into account the unavoidable cross-contamination and the risk caused by the active substances concerned'. According to Art. 3 of the Regulation (EU) 2019/4, the following definitions also apply: (a) "medicated feed" means a feed, which is ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products or intermediate products with feed materials or compound feed; (b) "intermediate product" means a feed, which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products with feed materials or compound feed, exclusively intended to be used for the manufacture of medicated feed; (c) "non-target feed" means feed, whether medicated or not, which is not intended to contain a specific active substance; (d) "cross-contamination" means contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment.' The importance of antimicrobial resistance from the One-health perspective is included also in the preambles of the Regulation (EU) 2019/4: '(22) It is important to take into consideration the international dimension of the development of antimicrobial resistance. Antimicrobial resistant organisms can spread to humans and animals in the Union and third countries through consumption of products of animal origin, from direct contact with animals or humans or by other means. This has been recognised in Article 118 of Regulation 2019/6 which provides that operators in third countries are to respect certain conditions relating to antimicrobial resistance for animals and products of animal origin exported from such third countries to the Union. This is to be taken into consideration also in respect of the use of antimicrobial medicinal products concerned if they are administered via medicated feed. Furthermore, in the context of international cooperation and in line with the activities and policies of international organisations such as the World Health Organization (WHO) Global Action Plan and the Strategy on Antimicrobial Resistance and the Prudent use of Antimicrobials of the World Organization- for Animal Health, steps restricting the use of medicated feed containing antimicrobials in order to prevent a disease should be considered worldwide for animals and products of animal origin exported from third countries to the Union'. '(30) The "One Health" concept, endorsed by the WHO and the World Organization for Animal Health (OIE), recognises that human health, animal health and ecosystems are interconnected and it is therefore essential for both animal and human health to ensure prudent use of antimicrobial medicinal products in food-producing animals'. '(31) On 17 June 2016, the Council adopted conclusions on the next steps under a One Health approach to combat antimicrobial resistance. On 13 September 2018, the European Parliament adopted a resolution on a European One Health Action Plan against Antimicrobial Resistance'. 1.3.2 Antimicrobial resistance Food-producing animal production is an important reservoir, in EU and non-EU countries, of antimicrobial-resistant bacteria with relevance for human and animal health (EMA CVMP and EFSA BIOHAZ Panel, 2017; EFSA and ECDC, 2020). Antimicrobials are currently used in food-producing animal production for treatment, prevention and/or metaphylaxis of a large number of infections, and also for growth promotion in non-EU countries. In the EU, in future, use of antimic
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