The qualified presumption of safety (QPS) provides a generic pre‐assessment of the safety of microorganisms intended for use in the food or feed chains, to support the work of EFSA's Scientific ...Panels. QPS assessment allows a fast track evaluation of strains belonging to QPS taxonomic units (TUs): species for bacteria, yeast, fungi, protists/microalgae and families for viruses. QPS TUs are assessed for their body of knowledge and safety. Safety concerns related to a QPS TU are reflected, when possible, as ‘qualifications’, which should be tested at strain and/or product level. Based on the possession of potentially harmful traits by some strains, filamentous fungi, bacteriophages, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and Clostridium butyricum are excluded from the QPS assessment. Between October 2019 and September 2022, 323 notifications of TUs were received, 217 related to feed additives, 54 to food enzymes, food additives and flavourings, 14 to plant protection products and 38 to novel foods. The list of QPS‐recommended TUs is reviewed every 6 months following an extensive literature search strategy. Only sporadic infections with a few QPS status TUs in immunosuppressed individuals were identified and the assessment did not change the QPS status of these TUs. The QPS list has been updated in relation to the most recent taxonomic insights and the qualifications were revised and streamlined. The qualification ‘absence of aminoglycoside production ability’ was withdrawn for Bacillus velezensis. Six new TUs received the QPS status: Bacillus paralicheniformis with the qualification ‘absence of toxigenic activity’ and ‘absence of bacitracin production ability’; Bacillus circulans with the qualifications for ‘production purposes only’ and ‘absence of cytotoxic activity’; Haematococcus lacustris (synonym Haematococcus pluvialis) and Ogataea polymorpha, both with the qualification ‘for production purposes only’; Lactiplantibacillus argentoratensis; Geobacillus thermodenitrificans with the qualification ‘absence of toxigenic activity’.
The 2011 EFSA opinion on Campylobacter was updated using more recent scientific data. The relative risk reduction in EU human campylobacteriosis attributable to broiler meat was estimated for on‐farm ...control options using Population Attributable Fractions (PAF) for interventions that reduce Campylobacter flock prevalence, updating the modelling approach for interventions that reduce caecal concentrations and reviewing scientific literature. According to the PAF analyses calculated for six control options, the mean relative risk reductions that could be achieved by adoption of each of these six control options individually are estimated to be substantial but the width of the confidence intervals of all control options indicates a high degree of uncertainty in the specific risk reduction potentials. The updated model resulted in lower estimates of impact than the model used in the previous opinion. A 3‐log10 reduction in broiler caecal concentrations was estimated to reduce the relative EU risk of human campylobacteriosis attributable to broiler meat by 58% compared to an estimate larger than 90% in the previous opinion. Expert Knowledge Elicitation was used to rank control options, for weighting and integrating different evidence streams and assess uncertainties. Medians of the relative risk reductions of selected control options had largely overlapping probability intervals, so the rank order was uncertain: vaccination 27% (90% probability interval (PI) 4–74%); feed and water additives 24% (90% PI 4–60%); discontinued thinning 18% (90% PI 5–65%); employing few and well‐trained staff 16% (90% PI 5–45%); avoiding drinkers that allow standing water 15% (90% PI 4–53%); addition of disinfectants to drinking water 14% (90% PI 3–36%); hygienic anterooms 12% (90% PI 3–50%); designated tools per broiler house 7% (90% PI 1–18%). It is not possible to quantify the effects of combined control activities because the evidence‐derived estimates are inter‐dependent and there is a high level of uncertainty associated with each.
Parasites are important food‐borne pathogens. Their complex lifecycles, varied transmission routes, and prolonged periods between infection and symptoms mean that the public health burden and ...relative importance of different transmission routes are often difficult to assess. Furthermore, there are challenges in detection and diagnostics, and variations in reporting. A Europe‐focused ranking exercise, using multicriteria decision analysis, identified potentially food‐borne parasites of importance, and that are currently not routinely controlled in food. These are Cryptosporidium spp., Toxoplasma gondii and Echinococcus spp. Infection with these parasites in humans and animals, or their occurrence in food, is not notifiable in all Member States. This Opinion reviews current methods for detection, identification and tracing of these parasites in relevant foods, reviews literature on food‐borne pathways, examines information on their occurrence and persistence in foods, and investigates possible control measures along the food chain. The differences between these three parasites are substantial, but for all there is a paucity of well‐established, standardised, validated methods that can be applied across the range of relevant foods. Furthermore, the prolonged period between infection and clinical symptoms (from several days for Cryptosporidium to years for Echinococcus spp.) means that source attribution studies are very difficult. Nevertheless, our knowledge of the domestic animal lifecycle (involving dogs and livestock) for Echinoccocus granulosus means that this parasite is controllable. For Echinococcus multilocularis, for which the lifecycle involves wildlife (foxes and rodents), control would be expensive and complicated, but could be achieved in targeted areas with sufficient commitment and resources. Quantitative risk assessments have been described for Toxoplasma in meat. However, for T. gondii and Cryptosporidium as faecal contaminants, development of validated detection methods, including survival/infectivity assays and consensus molecular typing protocols, are required for the development of quantitative risk assessments and efficient control measures.
The European Commission asks scientific and technical assistance from EFSA to determine the impact of the revision of the Australian monitoring programme on its ability to detect microbiological ...contamination. Considering that, in 2010, the European Commission determined the current Australian monitoring programme to be equivalent to the EU requirements for microbiological monitoring further to an EFSA scientific assessment, the current and proposed programmes were described and the total number of alerts was compared using a probabilistic modelling approach. In the current programme, only beef and sheep carcasses are monitored using three‐class moving window sampling plans, while in the proposed programme, carcass, bulk meat, primal and offal are monitored using four two‐class sampling plans and Salmonella testing is excluded. The models revealed that the current programme provides a higher number of alerts for APC, while the proposed monitoring programme provides a higher number of alerts for E. coli. For APC and E. coli combined, the mean, 5th and 95th centiles of the uncertainty distribution of the total number of alerts in the current and the proposed monitoring programme are 201 179, 227 and 172 149, 194 for beef, and 199 175, 222 and 2897 2795, 3008 for sheep, respectively. For Salmonella, there are no alerts for the proposed programme since sampling is excluded while for the current programme, the estimated mean, 5th and 95th centiles of the uncertainty distribution of the number of alerts for a 5‐year period were 143 126, 144 for heifer/steer, 1.6 0, 4 for cow/bull and 0 0, 0 for lamb/sheep. Overall, for APC and E. coli, the estimated total number of alerts was similar (beef) or higher (sheep) for the proposed compared to the current programme. In contrast, Salmonella sampling is excluded from the proposed programme and thus cannot detect the number of current alerts.
The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre‐evaluation of the safety of biological agents, intended for addition to food or feed, 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, safety concerns and occurrence of antimicrobial resistance. 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. Schizochytrium limacinum, which is a synonym for Aurantiochytrium limacinum, was added to the QPS list. Of the 78 microorganisms notified to EFSA between October 2020 and March 2021, 71 were excluded; 16 filamentous fungi, 1 Dyella spp., 1 Enterococcus faecium, 7 Escherichia coli, 1 Streptomyces spp., 1 Schizochytrium spp. and 44 TUs that had been previously evaluated. Seven TUs were evaluated: Corynebacterium stationis and Kodamaea ohmeri were re‐assessed because an update was requested for the current mandate. Anoxybacillus caldiproteolyticus, Bacillus paralicheniformis, Enterobacter hormaechei, Eremothecium ashbyi and Lactococcus garvieae were assessed for the first time. The following TUs were not recommended for QPS status: A. caldiproteolyticus due to the lack of a body of knowledge in relation to its use in the food or feed chain, E. hormaechei, L. garvieae and K. ohmeri due to their pathogenic potential, E. ashbyi and C. stationis due to a lack of body of knowledge on their occurrence in the food and feed chain and to their pathogenic potential. B. paralicheniformis was recommended for the QPS status with the qualification ‘absence of toxigenic activity’ and ‘absence of genetic information to synthesize bacitracin’.
The impact of dry‐ageing of beef and wet‐ageing of beef, pork and lamb on microbiological hazards and spoilage bacteria was examined and current practices are described. As ‘standard fresh’ and ...wet‐aged meat use similar processes these were differentiated based on duration. In addition to a description of the different stages, data were collated on key parameters (time, temperature, pH and aw) using a literature survey and questionnaires. The microbiological hazards that may be present in all aged meats included Shiga toxin‐producing Escherichia coli (STEC), Salmonella spp., Staphylococcus aureus, Listeria monocytogenes, enterotoxigenic Yersinia spp., Campylobacter spp. and Clostridium spp. Moulds, such as Aspergillus spp. and Penicillium spp., may produce mycotoxins when conditions are favourable but may be prevented by ensuring a meat surface temperature of −0.5 to 3.0°C, with a relative humidity (RH) of 75–85% and an airflow of 0.2–0.5 m/s for up to 35 days. The main meat spoilage bacteria include Pseudomonas spp., Lactobacillus spp. Enterococcus spp., Weissella spp., Brochothrix spp., Leuconostoc spp., Lactobacillus spp., Shewanella spp. and Clostridium spp. Under current practices, the ageing of meat may have an impact on the load of microbiological hazards and spoilage bacteria as compared to standard fresh meat preparation. Ageing under defined and controlled conditions can achieve the same or lower loads of microbiological hazards and spoilage bacteria than the variable log10 increases predicted during standard fresh meat preparation. An approach was used to establish the conditions of time and temperature that would achieve similar or lower levels of L. monocytogenes and Yersinia enterocolitica (pork only) and lactic acid bacteria (representing spoilage bacteria) as compared to standard fresh meat. Finally, additional control activities were identified that would further assure the microbial safety of dry‐aged beef, based on recommended best practice and the outputs of the equivalence assessment.
A risk‐based approach was developed to be followed by food business operators (FBO) when deciding on the type of date marking (i.e. ‘best before’ date or ‘use by’ date), setting of shelf‐life (i.e. ...time) and the related information on the label to ensure food safety. The decision on the type of date marking needs to be taken on a product‐by‐product basis, considering the relevant hazards, product characteristics, processing and storage conditions. The hazard identification is food product‐specific and should consider pathogenic microorganisms capable of growing in prepacked temperature‐controlled foods under reasonably foreseeable conditions. The intrinsic (e.g. pH and aw), extrinsic (e.g. temperature and gas atmosphere) and implicit (e.g. interactions with competing background microbiota) factors of the food determine which pathogenic and spoilage microorganisms can grow in the food during storage until consumption. A decision tree was developed to assist FBOs in deciding the type of date marking for a certain food product. When setting the shelf‐life, the FBO needs to consider reasonably foreseeable conditions of distribution, storage and use of the food. Key steps of a case‐by‐case procedure to determine and validate the shelf‐life period are: (i) identification of the relevant pathogenic/spoilage microorganism and its initial level, (ii) characterisation of the factors of the food affecting the growth behaviour and (iii) assessment of the growth behaviour of the pathogenic/spoilage microorganism in the food product during storage until consumption. Due to the variability between food products and consumer habits, it was not appropriate to present indicative time limits for food donated or marketed past the ‘best before’ date. Recommendations were provided relating to training activities and support, using ‘reasonably foreseeable conditions’, collecting time–temperature data during distribution, retail and domestic storage of foods and developing Appropriate Levels of Protection and/or Food Safety Objectives for food–pathogen combinations.
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, safety concerns and occurrence of antimicrobial resistance. 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 the 50 microorganisms notified to EFSA in October 2021 to March 2022 (inclusive), 41 were not evaluated: 10 filamentous fungi, 1 Enterococcus faecium, 1 Clostridium butyricum, 3 Escherichia coli and 1 Streptomyces spp. because are excluded from QPS evaluation, and 25 TUs that have already a QPS status. Nine notifications, corresponding to seven TUs were evaluated: four of these, Streptococcus salivarius, Companilactobacillus formosensis, Pseudonocardia autotrophica and Papiliotrema terrestris, being evaluated for the first time. The other three, Microbacterium foliorum, Pseudomonas fluorescens and Ensifer adhaerens were re‐assessed. None of these TUs were recommended for QPS status: Ensifer adhaerens, Microbacterium foliorum, Companilactobacillus formosensis and Papiliotrema terrestris due to a limited body of knowledge, Streptococcus salivarius due to its ability to cause bacteraemia and systemic infection that results in a variety of morbidities, Pseudonocardia autotrophica due to lack of body of knowledge and uncertainty on the safety of biologically active compounds which can be produced, and Pseudomonas fluorescens due to possible safety concerns.
The potential effects of a 24 or 72‐h delay in post‐mortem inspection (PMI) of ungulates on public health and monitoring of animal health and welfare was evaluated. The assessment used a survey of ...meat inspectors, expert opinion, literature search and a stochastic model for Salmonella detection sensitivity. Disease detection sensitivity at a delayed PMI is expected to reduce detection sensitivity to a variable extent, depending on the hazard and on the signs/lesions and organs involved. No reduction is expected for Trichinella detection in meat from susceptible animal species and any decrease in detection of transmissible spongiform encephalopathies (TSEs) will not exceed the current tolerance for fallen stock. A 24‐h delay in PMI could result in a small reduction in sensitivity of detection for tuberculosis, echinococcosis and cysticercosis. A greater reduction is expected for the detection of pyaemia and Rift valley fever. For the detection of Salmonella, the median model estimates are a reduction of sensitivity of 66.5% (90% probability interval (PI) 0.08–99.75%) after 24‐h delay and 94% (90% PI 0.83–100%) after 72‐h delay of PMI. Laboratory testing for tuberculosis following a sampling delay of 24–72 h could result in no, or a moderate, decrease in detection depending on the method of confirmation used (PCR, culture, histopathology). For chemical contaminants, a delay in meat inspection of 24 or 72 h is expected to have no impact on the effectiveness of detection of persistent organic pollutants and metals. However, for certain pharmacologically active substances, there will be a reduced effectiveness to detect some of these substances due to potential degradation in the available matrices (tissues and organs) and the non‐availability of specific preferred matrices of choice.
A risk‐based approach was used to develop guidance to be followed by food business operators (FBOs) when deciding on food information relating to storage conditions and/or time limits for consumption ...after opening a food package and thawing of frozen foods. After opening the package, contamination may occur, introducing new pathogens into the food and the intrinsic (e.g. pH and aw), extrinsic (e.g. temperature and gas atmosphere) and implicit (e.g. interactions with competing background microbiota) factors may change, affecting microbiological food safety. Setting a time limit for consumption after opening the package (secondary shelf‐life) is complex in view of the many influencing factors and information gaps. A decision tree (DT) was developed to assist FBOs in deciding whether the time limit for consumption after opening, due to safety reasons, is potentially shorter than the initial ‘best before’ or ‘use by’ date of the product in its unopened package. For products where opening the package leads to a change of the type of pathogenic microorganisms present in the food and/or factors increasing their growth compared to the unopened product, a shorter time limit for consumption after opening would be appropriate. Freezing prevents the growth of pathogens, however, most pathogenic microorganisms may survive frozen storage, recover during thawing and then grow and/or produce toxins in the food, if conditions are favourable. Moreover, additional contamination may occur from hands, contact surfaces or contamination from other foods and utensils. Good practices for thawing should, from a food safety point of view, minimise growth of and contamination by pathogens between the food being thawed and other foods and/or contact surfaces, especially when removing the food from the package during thawing. Best practices for thawing foods are presented to support FBOs.
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