Portal de Periódicos da CAPES

Guidance on the requirements for the development of microbiological criteria

2017; Wiley; Volume: 15; Issue: 11 Linguagem: Inglês

10.2903/j.efsa.2017.5052

1831-4732

Antonia Ricci, Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernández Escámez, Rosina Gironés, Lieve Herman, Konstantinos Koutsoumanis, Roland Lindqvist, Lucy J. Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, Helene Wahlström, Jens Kirk Andersen, Mieke Uyttendaele, Antonio Valero, Maria Teresa da Silva Felício, Winy Messens, Birgit Nørrung,

Food Allergy and Anaphylaxis Research

EFSA JournalVolume 15, Issue 11 e05052 Scientific OpinionOpen Access Guidance on the requirements for the development of microbiological criteria EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this authorAntonia Ricci, Antonia RicciSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorPablo Salvador Fernández Escámez, Pablo Salvador Fernández EscámezSearch for more papers by this authorRosina Girones, Rosina GironesSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorKonstantinos Koutsoumanis, Konstantinos KoutsoumanisSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorLucy Robertson, Lucy RobertsonSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMoez Sanaa, Moez SanaaSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorEmma Snary, Emma SnarySearch for more papers by this authorNiko Speybroeck, Niko SpeybroeckSearch for more papers by this authorBenno Ter Kuile, Benno Ter KuileSearch for more papers by this authorJohn Threlfall, John ThrelfallSearch for more papers by this authorHelene Wahlström, Helene WahlströmSearch for more papers by this authorJens Kirk Andersen, Jens Kirk AndersenSearch for more papers by this authorMieke Uyttendaele, Mieke UyttendaeleSearch for more papers by this authorAntonio Valero, Antonio ValeroSearch for more papers by this authorMaria Teresa Da Silva Felício, Maria Teresa Da Silva FelícioSearch for more papers by this authorWiny Messens, Winy MessensSearch for more papers by this authorBirgit Nørrung, Birgit NørrungSearch for more papers by this author EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this authorAntonia Ricci, Antonia RicciSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorPablo Salvador Fernández Escámez, Pablo Salvador Fernández EscámezSearch for more papers by this authorRosina Girones, Rosina GironesSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorKonstantinos Koutsoumanis, Konstantinos KoutsoumanisSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorLucy Robertson, Lucy RobertsonSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMoez Sanaa, Moez SanaaSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorEmma Snary, Emma SnarySearch for more papers by this authorNiko Speybroeck, Niko SpeybroeckSearch for more papers by this authorBenno Ter Kuile, Benno Ter KuileSearch for more papers by this authorJohn Threlfall, John ThrelfallSearch for more papers by this authorHelene Wahlström, Helene WahlströmSearch for more papers by this authorJens Kirk Andersen, Jens Kirk AndersenSearch for more papers by this authorMieke Uyttendaele, Mieke UyttendaeleSearch for more papers by this authorAntonio Valero, Antonio ValeroSearch for more papers by this authorMaria Teresa Da Silva Felício, Maria Teresa Da Silva FelícioSearch for more papers by this authorWiny Messens, Winy MessensSearch for more papers by this authorBirgit Nørrung, Birgit NørrungSearch for more papers by this author First published: 13 November 2017 https://doi.org/10.2903/j.efsa.2017.5052Citations: 7 Correspondence: biohaz@efsa.europa.eu Requestor: EFSA Question number: EFSA-Q-2016-00227 Panel members: Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernández Escámez, Rosina Girones, Lieve Herman, Konstantinos 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 Wahlström. Acknowledgements: The Panel wishes to thank the members of the Working Group on 'Guidance on the requirements for the development of microbiological criteria': Ana Allende, Jens Kirk Andersen, Birgit Nørrung, Panagiotis Skandamis, Mieke Uyttendaele and Antonio Valero for the preparatory work on this scientific output and, the EFSA staff members: Maria Teresa Da Silva Felício and Winy Messens for the support provided to this scientific output. Adopted: 19 October 2017 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 onFacebookTwitterLinkedInRedditWechat Abstract The European Food Safety Authority asked the Panel on Biological Hazards (BIOHAZ) to deliver a scientific opinion providing: (i) a review of the approaches used by the BIOHAZ Panel to address requests from risk managers to suggest the establishment of microbiological criteria; (ii) guidance on the required scientific evidence, data and methods/tools necessary for considering the development of microbiological criteria for pathogenic microorganisms and indicator microorganisms; (iii) recommendations on methods/tools to design microbiological criteria and (iv) guidelines for the requirements and tasks of risk assessors, compared to risk managers, in relation to microbiological criteria. This document provides guidance on approaches when: (i) a quantitative microbial risk assessment (QMRA) is available, (ii) prevalence and concentration data are available, but not a QMRA model, and (iii) neither a QMRA nor prevalence and/or concentration data are available. The role of risk assessors should be focused on assessing the impact of different microbiological criteria on public health and on product compliance. It is the task of the risk managers to: (1) formulate unambiguous questions, preferably in consultation with risk assessors, (2) decide on the establishment of a microbiological criterion, or target in primary production sectors, and to formulate the specific intended purpose for using such criteria, (3) consider the uncertainties in impact assessments on public health and on product compliance and (4) decide the point in the food chain where the microbiological criteria are intended to be applied and decide on the actions which should be taken in case of non-compliance. It is the task of the risk assessors to support risk managers to ensure that questions are formulated in a way that a precise answer can be given, if sufficient information is available, and to ensure clear and unambiguous answers, including the assessment of uncertainties, based on available scientific evidence. Summary The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a scientific opinion providing guidance for risk assessors on which information and assessments could be provided to risk managers to support them in their decision-making on microbiological criteria, as defined in Regulation (EC) No 2073/2005, or on targets in primary production sectors, as defined in Regulation (EC) No 2160/2003 (see glossary). Within this opinion, when reference is made to microbiological criteria it includes both Food Safety Criteria (FSC) and Process Hygiene Criteria (PHC) as defined in the EC legislation. FSC are applicable for food products placed on the market during their shelf-life, while PHC are applicable typically for food during processing or at the end of a production line before putting a product on the market. If a FSC is not met, then the food has to be removed from the market or reprocessed (if not at retail). If a process hygiene criterion, or a target in primary production sectors, is not met, the food business operator (FBO) sometimes in collaboration with the competent authority (CA), in the case of national prevalence targets, should take corrective actions. Currently within the EU legislation, FSC are set for pathogenic microorganisms but also, in a few cases, for indicator microorganisms. In addition, PHC are set for non-pathogenic indicator microorganisms but also, in some cases, for pathogenic microorganisms. In this opinion, the guidance on estimation of the effect of microbiological criteria is based on the assumption that all foods/batches comply with the microbiological criteria regardless of the action taken to meet this level of compliance. For these reasons, PHC and FSC are described together and are not considered separately in this document. In particular, this scientific opinion addresses four terms of reference; namely to provide: (i) a review of the approaches used by the BIOHAZ Panel to address requests from risk managers to suggest the establishment of microbiological criteria; (ii) guidance on the required scientific evidence, data and methods/tools necessary for considering the development of microbiological criteria, including both PHC and FSC. These approaches should take into account the different purposes of applying microbiological criteria; (iii) recommendations on methods/tools to design microbiological criteria (limits, sampling plans, stage of the food chain, method, etc.) and (iv) guidelines for the requirements and tasks of risk assessors, compared to risk managers, in relation to microbiological criteria. The establishment of microbiological criteria, targets in primary production sectors and/or food safety targets (e.g. Appropriate level of protection (ALOP), Food Safety Objective (FSO), Performance Objective (PO) and Performance Criterion (PC)) is a risk management activity where governments agree on the maximum level of a food safety hazard in a food animal population or food that is technically achievable and appropriate for consumer protection. The role of risk assessors should be focused on assessing the impact of different microbiological criteria on public health and on the product compliance according to the needs of the risk managers, and, if relevant, to link different microbiological criteria with food safety targets (e.g. ALOP, FSO, PO and PC values). It is the task of the risk managers to (1) formulate unambiguous questions, preferably in consultation with risk assessors, (2) decide on the establishment of a microbiological criterion, or target in primary production sectors, and to specify the intended purpose for using the microbiological criteria (i.e. indicator of process failure, indicator of faecal contamination or general improved food safety), (3) consider the uncertainties in impact assessments on public health and on product compliance (performed by the risk assessors) and (4) decide the point in the food chain where the microbiological criteria are intended to be applied and decide on the actions which should be taken in case of non-compliance. It is the task of the risk assessors to support risk managers to ensure that questions are formulated in a way that a precise answer can be given, if sufficient information is available, and to ensure clear and unambiguous answers, including the assessment of uncertainties, based on available scientific evidence. In this document, former BIOHAZ scientific opinions related to microbiological criteria, and targets in primary production sectors, as part of their Terms of Reference (TOR) were reviewed and discussed giving examples of best practices in relation to phrasing of TOR's and addressing lack of data and/or incomplete knowledge. Following this, the present guidance focuses on the required scientific evidence and data relevant for considering the development of microbiological criteria for pathogenic microorganisms and indicator microorganisms (depending on the requests from risk managers) without taking into account actions taken in case of unsatisfactory results. The estimated public health risk related to a specific food/pathogen combination is a function of the hazard characterisation (i.e. the pathogenicity of the pathogen including the dose/response relationships) and the exposure assessment (i.e. the prevalence and concentration of the pathogen in the food at the time of consumption, combined with the consumption frequency and serving size). Information from risk assessors to risk managers in relation to decision-making on microbiological criteria in specific foods includes: (1) evidence linking a food or animal reservoir/pathogen combination to human disease (hazard identification), (2) risk assessment (hazard characterisation, exposure assessment and risk characterisation) of the food or animal reservoir/pathogen (may be quantitative or qualitative), (3) the impact of different microbiological criteria/limits on the public health and product compliance and (4) uncertainties of the above evidence and assessments, including the main sources of such uncertainties. This document provides guidance on approaches when a quantitative microbial risk assessment (QMRA) is available, when prevalence and concentration data are available, but not a QMRA model and in situations when neither a QMRA nor prevalence and/or concentration data are available. In the latter case the risk assessors can only provide data and expert opinion on available epidemiological studies, including outbreak data, dose/response data (if available), and other relevant scientific data i.e. in the format of a risk profile. This document also deals with the data needed to use indicator microorganisms like Enterobacteriaceae, coliform bacteria, enterococci or Escherichia coli in microbiological criteria, including data needed to evaluate the usefulness of an indicator microorganism and its concentration as the basis for monitoring adequate process hygiene and data needed to evaluate whether an indicator microorganism and its concentration could serve as a marker for a pathogen. If a relationship between an indicator microorganism and the pathogen of concern is found, a risk assessment approach may be applied. But it is concluded that even if data are available, caution should be taken in extrapolation of relationships between indicator microorganisms and pathogenic microorganisms as defined in a particular study to situations very different from those encountered in the initial data collection. In addition, it is concluded that the estimation of the impact of microbiological criteria on public health/food safety using indicator microorganisms is, if at all possible, more complicated, demanding of data, and with more uncertainty and variability, than when performed for pathogenic microorganisms. The importance of addressing the uncertainties in the assessments is emphasised with reference to EFSA's draft guidance on uncertainty in EFSA scientific assessment (EFSA Scientific Committee, 2016), and finally, the document also deals with available online technical tools to operationalise microbiological criteria. 1 Introduction 1.1 Background and Terms of Reference as provided by the requestor A microbiological criterion is a risk management tool based on the outcome of sampling and testing for microorganisms, their toxins/metabolites or markers associated with pathogenicity or other traits at a specified point of the food chain that indicates the acceptability of a food, or the performance of either a process or a food safety control system. The Codex Alimentarius Commission (CAC) has established in 1997 general principles and considerations for the establishment of microbiological criteria which were revised in 2013 (CAC, 2013) as follows: A microbiological criterion should be appropriate to protect the health of the consumer and, where appropriate, also ensure fair practices in food trade. A microbiological criterion should be practical and feasible and established only when necessary. The purpose of establishing and applying a microbiological criterion should be clearly articulated. The establishment of microbiological criteria should be based on scientific information and analysis and follow a structured and transparent approach. Microbiological criteria should be established based on knowledge of the microorganisms and their occurrence and behaviour along the food chain. The intended, as well as the actual, use of the final product by consumers needs to be considered when setting a microbiological criterion. The required stringency of a microbiological criterion used should be appropriate to its intended purpose. Periodic reviews of microbiological criteria should be conducted, as appropriate, in order to ensure that microbiological criteria continue to be relevant to the stated purpose under current conditions and practices. There may be multiple reasons for establishing and applying microbiological criteria. The purposes of microbiological criteria include, but are not limited to, the following: Evaluating a specific lot of food to determine its acceptance or rejection, in particular, if its history is unknown. Verifying the performance of a food safety control system or its elements along the food chain, e.g. prerequisite programmes and/or HACCP systems. Verifying the microbiological status of foods in relation to acceptance criteria specified between food business operators. Verifying that the selected control measures are meeting Performance Objectives (POs) and/or Food Safety Objectives (FSOs). Providing information to food business operators on microbiological levels, which should be achieved when applying best practices (CAC, 2013). The microbiological safety of foods is managed by the effective implementation of control measures within a food safety management system (FSMS) including prerequisite programme (PRP) and hazard analysis and critical control points (HACCP) that have been validated, where appropriate, throughout the food chain to minimise contamination and improve food safety. This preventative approach offers more advantages than sole reliance on microbiological testing through acceptance sampling of individual lots of the final product to be placed on the market. The establishment of microbiological criteria may also be appropriate for verifying that these FSMS are implemented correctly (EFSA, 2007; CAC, 2013). When recommending the establishment of microbiological criteria, a variety of approaches can be used, depending on the risk management objectives and the available level of knowledge and data. These approaches can range from developing microbiological criteria based on empirical knowledge related to Good Hygienic Practices (GHP), to using scientific knowledge of FSMS such as PRP and HACCP, or by conducting risk assessments. The choice of the approach should be aligned with the risk management objectives and decisions relating to food safety and suitability. The need for a microbiological criterion should be demonstrated, e.g. by epidemiological evidence and/or as the result of a risk assessment indicating that the food under consideration represents a significant public health risk and that a criterion is meaningful for consumer protection. Although meeting microbiological criteria offers some assurance that particular pathogens are not present at unacceptably high concentrations, these do not guarantee 'absence' of those pathogens (EFSA, 2007). However, microbiological criteria can also be used as a way to communicate the level of hazard control that should be achieved. Regulation (EC) No 2073/20051 on microbiological criteria for foodstuffs introduces two different criteria: Food Safety Criteria (FSC) and Process Hygiene Criteria (PHC). An advantage of establishing food safety criteria for pathogenic microorganisms is that harmonised standards on the acceptability of food are provided for both authorities and industry within the EU and for products imported from third countries. Food safety criteria will impact the entire food chain, as they are set for products placed on the market. Risk of recalls and the economic losses, as well as loss of consumer confidence, will be a strong motivation to meet the criteria. Food Safety Criteria are assumed to have an impact on food safety and public health where there is an actual or perceived risk. However, it has proved difficult to evaluate the extent of public health protection provided by a specific food safety criterion (EFSA, 2007). The EFSA Panel on Biological Hazards (BIOHAZ Panel) previously undertook a self-tasking activity to: (i) provide an overview of FSMS including microbiological criteria; (ii) provide a short description of the current Codex concepts, viz. Appropriate Level of Protection (ALOP), Food Safety Objective (FSO), Performance Objective (PO), Performance Criteria (PC) and microbiological criteria; (iii) describe the types of microbiological criteria (food safety criteria, process hygiene criteria) and targets contained in the EU legislation in regard to public health and (iv) consider the application of microbiological criteria and targets in the food chain at the EU level based on risk analysis (EFSA, 2007). This Opinion envisaged that there would be the need for periodic review as subsequent advances in this field have taken place, both in the technologies available for the detection of a wider range of hazards as well as in understanding their prevalence and distribution in foods, and the evolution of the science of risk assessment, including the estimation of variabilities and uncertainties. EFSA's BIOHAZ Panel has previously received mandates where risk managers ask the Panel to provide suggestions, where relevant, for the establishment of microbiological criteria. However, despite the existing CAC document (CAC, 2013) and EFSA Opinion (EFSA, 2007) on general principles and terminology for microbiological criteria, as described above, addressing mandates to the BIOHAZ Panel have proved problematic. Thus these requests generated much discussion on what would be an appropriate approach and end-point to address questions from risk managers, and how to deal with data gaps, variability and uncertainties in an open and transparent way. In order to increase clarity and transparency in EFSA's future work, as well as to capitalise on advances in the application of risk assessment, it is suggested to initiate a BIOHAZ self-tasking mandate on the required scientific evidence, data and methods/tools for supporting decision-making on microbiological criteria in the future. This should include a clear framework/agreement of the tasks of risk assessors and what are the tasks of risk managers. 1.1.1 Terms of reference (TOR) The BIOHAZ Panel is asked to issue an opinion that specifies a framework to increase the transparency and clarity of EFSA's future BIOHAZ opinions where considerations of microbiological criteria are a part of the mandate. The mandate should provide: A review of the approaches used by the BIOHAZ Panel to address requests from risk managers to suggest the establishment of microbiological criteria. Guidance on the required scientific evidence, data and methods/tools necessary for considering the development of microbiological criteria, including both Process Hygiene Criteria and Food Safety Criteria. These approaches should take into account the different purposes of applying microbiological criteria. Recommendations on methods/tools to design microbiological criteria (limits, sampling plans, stage of the food chain, method, etc.). Guidelines for the requirements and tasks of risk assessors, compared to risk managers, in relation to microbiological criteria. 1.2 Interpretation of the Terms of Reference (TOR) This scientific opinion aims to provide guidance for risk assessors on which information and assessments could be provided to risk managers to support them in their decision-making on microbiological criteria, as defined in Regulation (EC) No 2073/20051, or on targets in primary production sectors, as defined in Regulation (EC) No 2160/20032 (see Glossary). This guidance takes into account the different degrees of evidence and tools available for specific assessments and also aims to provide guidance on the different roles of risk managers and risk assessors. Within this opinion, when reference is made to microbiological criteria, it includes both FSC and PHC as defined in the EC legislation. FSC are applicable for food products placed on the market during their shelf-life, while PHC are applicable typically for food during processing or at the end of a production line before putting a product on the market. If a FSC is not met, then the food has to be removed from the market or reprocessed (if not at retail). If a process hygiene criterion, or a target in primary production sectors, is not met, the food business operator (FBO) sometimes in collaboration with the competent authority (CA) in the case of national prevalence targets, should take corrective action. To be consistent with the European legislation, this opinion considers targets in primary production sectors as well as PHC and FSC further up in the food chain using both pathogenic and indicator microorganisms. Currently within the EU legislation, FSC are set for pathogenic microorganisms but also, in a few cases, for indicator microorganisms. In addition, PHC are set for non-pathogenic indicator microorganisms but also, in some cases, for pathogenic microorganisms. In this opinion, the guidance on estimation of the effect of microbiological criteria is based on the assumption that, no matter which stage in the food chain, all foods/batches comply with the microbiological criteria regardless of the action taken to meet this level of compliance. For these reasons, PHC and FSC are described together and are not considered separately in this document. In addition, this opinion also addresses briefly the food safety targets (ALOP, FSO, PO and PC), although these are not yet used in the current EU legislation. This scientific opinion does not include evaluations of microbiological criteria included in the existing legislation (Commission Regulation (EC) No 2073/2005) but provides a framework for a structured approach to be used by risk assessors when risk managers (e.g. the European Commission or the national competent authorities) seek advice on microbiological criteria. The establishment of microbiological criteria by FBOs is outside the scope of this Opinion. 1.3 Additional information Microbiological criteria are used worldwide as one of several risk management tools to ensure the safety of foods. The CAC, International Commission on Microbiological Specifications for Foods (ICMSF) and others have provided guidelines to Food Safety Authorities and industries and all these guidelines emphasise that establishment of microbiological criteria should be risk based. Several scientific publications in the last decade have shown how a microbiological criterion can be linked to, or be derived from, a quantitative microbiological risk assessment (QMRA) (Uyttendaele et al., 2006; Nauta et al., 2012; Andersen et al., 2015; Lee et al., 2015; Zwietering et al., 2015; Seliwiorstow et al., 2016) but little information or guidance is provided on how to deal with microbiological criteria in the absence of such QMRAs. Older literature provides information to set, in particular, PHC to evaluate hygiene during meat animal slaughtering or in food processing. The objective of many of these publications was to assess baseline data on hygiene indicators and the relationship between the indicators and zoonotic agents to support the basic assumption that adherence to Good agricultural practices (GAP), Good manufacturing practices (GMP) and GHP (being PRPs) throughout the food chain will contribute to a reduction in public health risks (Zeitoun et al., 1994; Mossel et al., 1998; Ghafir et al., 2008). A microbiological criterion consists of the following components: (i) the purpose of the microbiological criterion; (ii) the food, process or food safety control system to which the microbiological criterion applies; (iii) the specified point in the food chain where the microbiological criterion applies; (iv) the microorganism(s) and the reason for its selection; (v) the microbiological limits (m, M) or other limits (e.g. a level of risk); (vi) a sampling plan defining the number of sample units to be taken (n), the size of the analytical unit and where appropriate, the acceptance number (c); (vii) depending on its purpose, an indication of the statistical performance of the sampling plan; and (viii) analytical methods and their performance characteristics. Consideration should be given to the action to be taken when the microbiological criterion is not met and the action should be specified (CAC, 2013). 2 Data and methodologies Data used for this opinion are tools and methods for risk assessments and establishment of microbiological criteria that have been published as stand-alone scientific reports or guidance documents by international organisations (Codex Alimentari