The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre‐evaluation of the safety of microorganisms, intended for use in the food or feed chains, to ...support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this Statement, no new information was found that would change the status of previously recommended QPS TUs. Of 38 microorganisms notified to EFSA between October 2022 and March 2023 (inclusive) (28 as feed additives, 5 as food enzymes, food additives and flavourings, 5 as novel foods), 34 were not evaluated because: 8 were filamentous fungi, 4 were Enterococcus faecium and 2 were Escherichia coli (taxonomic units that are excluded from the QPS evaluation) and 20 were taxonomic units (TUs) that already have a QPS status. Three of the other four TUs notified within this period were evaluated for the first time for a possible QPS status: Anaerobutyricum soehngenii, Stutzerimonas stutzeri (former Pseudomonas stutzeri) and Nannochloropsis oculata. Microorganism strain DSM 11798 has also been notified in 2015 and as its taxonomic unit is notified as a strain not a species, it is not suitable for the QPS approach. A. soehngenii and N. oculata are not recommended for the QPS status due to a limited body of knowledge of its use in the food and feed chains. S. stutzeri is not recommended for inclusion in the QPS list based on safety concerns and limited information about the exposure of animals and humans through the food and feed chains.
To control the risks of
Campylobacter in broiler meat, microbiological criteria in the food chain are proposed for testing and scheduling, that is testing the level of contamination in a flock and ...diverting highly contaminated flocks away from fresh meat production. By applying quantitative risk assessment, the effects of this strategy for different test sensitivities at different stages in the food chain are evaluated for their expected impact on consumer health risk and the percentage of flocks to be scheduled. This offers a practical tool to compare costs and benefits of different risk management options and demonstrates the use of quantitative risk assessment to set risk-based standards.
•Two approaches for translating numbers of Campylobacter in broiler intestinal content into human health risk are comparted.•One approach uses linear regression of concentration data from caeca and ...skins, the other a risk assessment model•No generally valid simple relation exists between intestinal concentrations and concentrations on meat.•A one to two log reduction in intestinal Campylobacter concentration has a large effect on the human health risk.•The differences in effect of reduction of concentrations on risk between different European countries are small.
One option for Campylobacter control in broiler chickens is to reduce the concentration in the intestinal content of the birds prior to slaughter, for example by vaccination or phage therapy. It is however unsure how such a reduction in concentration can be translated into a reduction in concentration on the meat and a reduction in the human health risk of campylobacteriosis. In this study, two methods are presented and compared. The first is a linear regression model, based on count data from caecal contents and skin sample data, obtained after processing from the same flocks. Alternatively, a previously published risk assessment model is used, that describes the dynamics of transfer and survival of Campylobacter during broiler processing at the slaughterhouse. Data from five European countries are used as inputs for the models. For both approaches the analyses show that a one to two log reduction in concentration in the intestinal content has a large impact on the risk of campylobacteriosis due to the consumption of chicken meat: a relative risk reduction between 44% and 95%. Therefore it seems promising to aim interventions at a reduction of the concentration of Campylobacter in the broiler intestines. However, it is not possible to derive a generic rule that can be used to relate a reduction in concentration in broiler intestines into a reduction in human health risk. Regression models based on different data sets predict different relationships between bacterial count data from caeca and skins, whereas the risk assessment model requires data on contamination of the birds’ exterior, which is not sufficiently available in combination with caecal concentration data. Simulations performed with the risk assessment model show that it can pretty well adequately describe the observed correlation in the data and the variation in regression lines obtained.
The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific ...Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain level by the EFSA's Scientific Panels. During the current assessment, no new information was found that would change the previously recommended QPS taxonomic units and their qualifications. Between April and September 2018, the QPS notification list was updated with 48 microorganisms from applications for market authorisation. Of these, 30 biological agents already had QPS status, 15 were excluded from the QPS exercise by the previous QPS mandate (five filamentous fungi) or from further evaluations within the current mandate (two notifications of Enterococcus faecium, one of Streptomyces spp. and seven of Escherichia coli). One taxonomic unit was (re)evaluated: Pseudomonas fluorescens had been previously evaluated in 2016, and was now re‐evaluated within this mandate. The revision of the literature supports the previously identified safety concerns (e.g. production of biocompounds with antimicrobial activity and virulence features), preventing the inclusion of P. fluorescens in the QPS list. Mycobacterium setense and Komagataeibacter sucrofermentans were evaluated for the first time. M. setense cannot be considered for the QPS assessment because there are significant safety concerns. K. sucrofermentans (Acetobacter xylinus subsp. sucrofermentans) can be proposed for the QPS list but only for production purposes. The QPS status of Corynebacterium glutamicum is confirmed with the qualification extended to other production purposes.
The European Commission requested an analysis of the Chronic Wasting Disease (CWD) monitoring programme in Norway, Sweden, Finland, Iceland, Estonia, Latvia, Lithuania and Poland (9 January 2017–28 ...February 2022). Thirteen cases were detected in reindeer, 15 in moose and 3 in red deer. They showed two phenotypes, distinguished by the presence or absence of detectable disease‐associated normal cellular prion protein (PrP) in lymphoreticular tissues. CWD was detected for the first time in Finland, Sweden and in other areas of Norway. In countries where the disease was not detected, the evidence was insufficient to rule out its presence altogether. Where cases were detected, the prevalence was below 1%. The data also suggest that the high‐risk target groups for surveillance should be revised, and ‘road kill’ removed. Data show that, in addition to differences in age and sex, there are differences in the prion protein gene (PRNP) genotypes between positive and negative wild reindeer. A stepwise framework has been proposed with expanded minimum background surveillance to be implemented in European countries with relevant cervid species. Additional surveillance may include ad hoc surveys for four different objectives, specific to countries with/without cases, focusing on parallel testing of obex and lymph nodes from adult cervids in high‐risk target groups, sustained over time, using sampling units and a data‐driven design prevalence. Criteria for assessing the probability of CWD presence have been outlined, based on the definition of the geographical area, an annual assessment of risk of introduction, sustained minimum background surveillance, training and engagement of stakeholders and a surveillance programme based on data‐driven parameters. All positive cases should be genotyped. Sample sizes for negative samples have been proposed to detect and estimate the frequency of PRNP polymorphisms. Double‐strand sequencing of the entire PRNP open reading frame should be undertaken for all selected samples, with data collated in a centralised collection system at EU level.
Two alternative methods for producing compost in a tunnel, from certain category (Cat.) 3 animal by‐products (ABP) and other non‐ABP material, were assessed. The first method proposed a minimum ...temperature of 55°C for 72 h and the second 60°C for 48 h, both with a maximum particle size of 200 mm. The assessment of the Panel on Biological Hazards (BIOHAZ) exclusively focused on Cat. 3 ABP materials (catering waste and processed foodstuffs of animal origin no longer intended for human consumption). The proposed composting processes were evaluated for their efficacy to achieve a reduction of at least 5 log10 of Enterococcus faecalis and Salmonella Senftenberg (775W, H2S negative) and at least 3 log10 of relevant thermoresistant viruses. The applicant provided a list of biological hazards that may enter the composting process and selected parvoviruses as the indicator of the thermoresistant viruses. The evidence provided by the applicant included: (a) literature data on thermal inactivation of biological hazards; (b) results from validation studies on the reduction of E. faecalis, Salmonella Senftenberg 775W H2S negative and canine parvovirus carried out in composting plants across Europe; (c) and experimental data from direct measurements of reduction of infectivity of murine parvovirus in compost material applying the time/temperature conditions of the two alternative methods. The evidence provided showed the capacity of the proposed alternative methods to reduce E. faecalis and Salmonella Senftenberg 775W H2S negative by at least 5 log10, and parvoviruses by at least 3 log10. The BIOHAZ Panel concluded that the two alternative methods under assessment can be considered to be equivalent to the processing method currently approved in the Commission Regulation (EU) No 142/2011.
•Structuring of relevant terms in microbiological risk assessment modelling domain.•Definition of metadata and controlled vocabularies for annotation of QMRA models.•Harmonized model annotation will ...support knowledge exchange between software tools.•Establishment of curated food safety knowledge repository is proposed.•Need of rules for knowledge annotation essential for knowledge reusability.
In the last decades the microbial food safety community has developed a variety of valuable knowledge (e.g., mathematical models and data) and resources (e.g., databases and software tools) in the areas of quantitative microbial risk assessment (QMRA) and predictive microbiology. However, the reusability of this knowledge and the exchange of information between resources are currently difficult and time consuming. This problem has increased over time due to the lack of harmonized data format and rules for knowledge annotation. It includes the lack of a common understanding of basic terms and concepts and of a harmonized information exchange format to describe and annotate knowledge. The existence of ambiguities and inconsistencies in the use of terms and concepts in the QMRA and predictive microbial (PM) modelling necessitates a consensus on their refinement, which will allow a harmonized exchange of information within these areas. Therefore, this work aims to harmonize terms and concepts used in QMRA and PM modelling spanning from high level concepts as defined by Codex Alimentarius, Food and Agriculture Organization (FAO) and World Health Organization (WHO), up to terms generally used in statistics or data and software science. As a result, a harmonized schema for metadata that allows consistent annotation of data and models from these two domains is proposed. This metadata schema is also a key component of the Food Safety Knowledge Markup Language (FSK-ML), a harmonized format for information exchange between resources in the QMRA and PM modelling domain. This work is carried out within a research project that aims to establish a new community resource called Risk Assessment Modelling and Knowledge Integration Platform (RAKIP). This platform will facilitate the sharing and execution of curated QMRA and PM models using the foundation of the proposed harmonized metadata schema and information exchange format. Furthermore, it will also provide access to related open source software libraries, converter tools and software-specific import and export functions that promote the adoption of FSK-ML by the microbial food safety community. In the future, these resources will hopefully promote both the knowledge reusability and the high-quality information exchange between stakeholders within the areas of QMRA and PM modelling worldwide.
Superchilling entails lowering the fish temperature to between the initial freezing point of the fish and about 1–2°C lower. The temperature of superchilled fresh fishery products (SFFP) in boxes ...without ice was compared to that of products subject to the currently authorised practice in boxes with ice (CFFP) under the same conditions of on‐land storage and/or transport. A heat transfer model was developed and made available as a tool to identify under which initial configurations of SFFP the fish temperature, at any time of storage/transport, is lower or equal to CFFP. A minimum degree of superchilling, corresponding to an ice fraction in the fish matrix of SFFP equal or higher than the proportion of ice added per mass of fish in CFFP, will ensure with 99–100% certainty (almost certain) that the fish temperature of SFFP and the consequent increase of relevant hazards will be lower or equal to that of CFFP. In practice, the degree of superchilling can be estimated using the fish temperature after superchilling and its initial freezing point, which are subject to uncertainties. The tool can be used as part of ‘safety‐by‐design’ approach, with the reliability of its outcome being dependent on the accuracy of the input data. An evaluation of methods capable of detecting whether a previously frozen fish is commercially presented as ‘superchilled’ was carried out based on, amongst others, their applicability for different fish species, ability to differentiate fresh fish from fish frozen at different temperatures, use as a stand‐alone method, ease of use and classification performance. The methods that were considered ‘fit for purpose’ are Hydroxyacyl‐coenzyme A dehydrogenase (HADH) test, α‐glucosidase test, histology, ultraviolet–visible–near–infrared (UV‐VIS/NIR) spectroscopy and hyperspectral imaging. These methods would benefit from standardisation, including the establishment of threshold values or classification algorithms to provide a practical routine test.
Shifting from traditional hazard-based food safety management toward risk-based management requires statistical methods for evaluating intermediate targets in food production, such as microbiological ...criteria (MC), in terms of their effects on human risk of illness. A fully risk-based evaluation of MC involves several uncertainties that are related to both the underlying Quantitative Microbiological Risk Assessment (QMRA) model and the production-specific sample data on the prevalence and concentrations of microbes in production batches. We used Bayesian modeling for statistical inference and evidence synthesis of two sample data sets. Thus, parameter uncertainty was represented by a joint posterior distribution, which we then used to predict the risk and to evaluate the criteria for acceptance of production batches. We also applied the Bayesian model to compare alternative criteria, accounting for the statistical uncertainty of parameters, conditional on the data sets. Comparison of the posterior mean relative risk, E(RR|data) = E (P (illness| criterion is met)/P (illness|data), and relative posterior risk, RPR = P (illness|data, criterion is met)/P (illness|data), showed very similar results, but computing is more efficient for RPR. Based on the sample data, together with the QMRA model, one could achieve a relative risk of 0.4 by insisting that the default criterion be fulfilled for acceptance of each batch.
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.
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