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Abstract The objective of this opinion was to determine if any wild caught fish species, originating from specific fishing grounds and consumed in the EU/EFTA could be considered free of zoonotic parasites. In this Opinion the term ‘fishery products’ only refers to fresh finfish. As there are multiple fish species and numerous potential parasites, Anisakis sp. was used as an indicator of zoonotic parasites in marine areas. This parasite species is particularly suited as it is common in marine environments, capable of infecting multiple fish species and is the subject of the majority of published studies. On the rare occasion where Anisakis sp. data were not available, or all tests were negative, other parasites such as Contracaecum osculatum (s.l.) and/or Phocanema spp. were considered. In freshwater systems, all zoonotic parasites were investigated. Consumption, import and landing data were used to determine the most relevant fish species and, where possible, the source fishing areas were identified. The most commonly consumed wild caught fish species in the EU/EFTA include tuna, cod, Alaskan pollock, hake, herring, sardines, mackerel, trout and saithe. Although the majority of these fish are caught in the Atlantic Ocean, the Mediterranean and the Black Sea (37) as well as several areas in the Indian Ocean, imported fish may originate from any global fishing areas, with the exception of Antarctica. Based on the data, at least one zoonotic parasite has been reported in at least one fish species in each of the FAO marine fishing areas. Thus, due to relative low fish host specificity of the zoonotic parasites, the panel concluded that all wild caught fish species may be exposed to and infected with zoonotic parasites. The same applies to freshwater fishing areas, with many areas having multiple studies reporting the presence of zoonotic parasites in the wild caught fish species.

Abstract 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.

Abstract This scientific opinion focuses on the welfare of laying hens, pullets and layer breeders on farm. The most relevant husbandry systems used in Europe are described. For each system, highly relevant welfare consequences were identified, as well as related animal‐based measures (ABMs), and hazards leading to the welfare consequences. Moreover, measures to prevent or correct the hazards and/or mitigate the welfare consequences are recommended. The highly relevant welfare consequences based on severity, duration and frequency of occurrence are bone lesions, group stress, inability to avoid unwanted sexual behaviour, inability to perform comfort behaviour, inability to perform exploratory or foraging behaviour, isolation stress, predation stress, resting problems, restriction of movement, skin disorders and soft tissue lesions and integument damage. The welfare consequences of non‐cage compared to cage systems for laying hens are described and minimum enclosure characteristics are described for laying hens, pullets and layer breeders. Beak trimming, which causes negative welfare consequences and is conducted to reduce the prevalence and severity of pecking, is described as well as the risks associated with rearing of non‐beak‐trimmed flocks. Alternatives to reduce sharpness of the beak without trimming are suggested. Finally, total mortality, plumage damage, wounds, keel bone fractures and carcass condemnations are the most promising ABMs for collection at slaughterhouses to monitor the level of laying hen welfare on farm. Main recommendations include housing all birds in non‐cage systems with easily accessible, elevated platforms and provision of dry and friable litter and access to a covered veranda. It is further recommended to implement protocols to define welfare trait information to encourage progress in genetic selection, implement measures to prevent injurious pecking, rear pullets with dark brooders and reduce male aggression in layer breeders.

Abstract This Scientific Opinion considers the welfare of domestic fowl (Gallus gallus) related to the production of meat (broilers) and includes the keeping of day‐old chicks, broiler breeders, and broiler chickens. Currently used husbandry systems in the EU are described. Overall, 19 highly relevant welfare consequences (WCs) were identified based on severity, duration and frequency of occurrence: ‘bone lesions’, ‘cold stress’, ‘gastro‐enteric disorders’, ‘group stress’, ‘handling stress’, ‘heat stress’, ‘isolation stress’, ‘inability to perform comfort behaviour’, ‘inability to perform exploratory or foraging behaviour’, ‘inability to avoid unwanted sexual behaviour’, ‘locomotory disorders’, ‘prolonged hunger’, ‘prolonged thirst’, ‘predation stress’, ‘restriction of movement’, ‘resting problems’, ‘sensory under‐ and overstimulation’, ‘soft tissue and integument damage’ and ‘umbilical disorders’. These WCs and their animal‐based measures (ABMs) that can identify them are described in detail. A variety of hazards related to the different husbandry systems were identified as well as ABMs for assessing the different WCs. Measures to prevent or correct the hazards and/or mitigate each of the WCs are listed. Recommendations are provided on quantitative or qualitative criteria to answer specific questions on the welfare of broilers and related to genetic selection, temperature, feed and water restriction, use of cages, light, air quality and mutilations in breeders such as beak trimming, de‐toeing and comb dubbing. In addition, minimal requirements (e.g. stocking density, group size, nests, provision of litter, perches and platforms, drinkers and feeders, of covered veranda and outdoor range) for an enclosure for keeping broiler chickens (fast‐growing, slower‐growing and broiler breeders) are recommended. Finally, ‘total mortality’, ‘wounds’, ‘carcass condemnation’ and ‘footpad dermatitis’ are proposed as indicators for monitoring at slaughter the welfare of broilers on‐farm.

Abstract 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.

Abstract 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’.

Abstract 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.

Abstract The qualified presumption of safety (QPS) approach was developed to provide a generic pre‐evaluation of the safety of biological agents. 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 are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. The QPS list was updated in relation to the revised taxonomy of the genus Bacillus, to synonyms of yeast species and for the qualifications ‘absence of resistance to antimycotics’ and ‘only for production purposes’. Lactobacillus cellobiosus has been reclassified as Limosilactobacillus fermentum. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS taxonomic units (TU)s. Of the 70 microorganisms notified to EFSA, 64 were not evaluated: 11 filamentous fungi, one oomycete, one Clostridium butyricum, one Enterococcus faecium, five Escherichia coli, one Streptomyces sp., one Bacillus nakamurai and 43 TUs that already had a QPS status. Six notifications, corresponding to six TUs were evaluated: Paenibacillus lentus was reassessed because an update was requested for the current mandate. Enterococcus lactis synonym Enterococcus xinjiangensis, Aurantiochytrium mangrovei synonym Schizochytrium mangrovei, Schizochytrium aggregatum, Chlamydomonas reinhardtii synonym Chlamydomonas smithii and Haematococcus lacustris synonym Haematococcus pluvialis were assessed for the first time. The following TUs were not recommended for QPS status: P. lentus due to a limited body of knowledge, E. lactis synonym E. xinjiangensis due to potential safety concerns, A. mangrovei synonym S. mangrovei, S. aggregatum and C. reinhardtii synonym C. smithii, due to lack of a body of knowledge on its occurrence in the food and feed chain. H. lacustris synonym H. pluvialis is recommended for QPS status with the qualification ‘for production purposes only’.

Abstract 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’.

Abstract 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.

Abstract 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. It is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at 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 36 microorganisms notified to EFSA between April and September 2020, 33 were excluded; seven filamentous fungi (including Aureobasidium pullulans based on recent taxonomic insights), one Clostridium butyricum, one Enterococcus faecium, three Escherichia coli, one Streptomyces spp. and 20 TUs that had been previously evaluated. Three TUs were evaluated; Methylorubrum extorquens and Mycobacterium aurum for the first time and Bacillus circulans was re‐assessed because an update was requested in relation to a new mandate. M. extorquens and M. aurum are not recommended for QPS status due to the lack of a body of knowledge in relation to use in the food or feed chain and M. aurum, due to uncertainty concerning its pathogenicity potential. B. circulans was recommended for QPS status with the qualifications for ‘production purposes only’ and ‘absence of cytotoxic activity’.

Abstract 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.

Abstract 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.

Abstract The qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels. It is based on an assessment of the taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by ‘qualifications’. No new information was found that would change the previously recommended QPS TUs of the 39 microorganisms notified to EFSA between October 2019 and March 2020, 33 were excluded, including five filamentous fungi, five Escherichia coli, two Enterococcus faecium, two Streptomyces spp. and 19 TUs already evaluated. Six TUs were evaluated. Akkermansia muciniphila was not recommended for QPS status due to safety concerns. Clostridium butyricum was not recommended because some strains contain pathogenicity factors. This TU was excluded for further QPS evaluation. Galdieria sulphuraria and Pseudomonas chlororaphis were also rejected due to a lack of body of knowledge. The QPS status of Corynebacterium ammoniagenes (with the qualification ‘for production purposes only’) and of Komagataella pastoris (with the qualification ‘for enzyme production’) was confirmed. In relation to the taxonomic revision of the Lactobacillus genus, previously designated Lactobacillus species will be reassigned to the new species and both the old and new names will be retained in the QPS list.

Abstract 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.

Abstract 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.

Abstract In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter presents several novel food safety challenges because donated food may be nearing the end of its shelf‐life and several actors are involved in the food donation chain, each reliant on each other to assure food safety. In this opinion, the simplified approach to food safety management is presented based on a fundamental understanding of processing stages and the activities contributing to increased occurrence of the hazards (biological, chemical (including allergens) or physical) that may occur. Control is achieved using PRP activities as previously described but with a modified ‘temperature control’ PRP and the addition of PRPs covering shelf‐life control, handling returned foods, shelf‐life evaluation for food donation, allocation of remaining shelf‐life, and freezing food intended for donation. Examples of the simplified approach are presented for retail distribution centres, supermarkets, restaurants and food donation.

Abstract Hepatitis E virus (HEV) is an important infection in humans in EU/EEA countries, and over the last 10 years more than 21,000 acute clinical cases with 28 fatalities have been notified with an overall 10‐fold increase in reported HEV cases; the majority (80%) of cases were reported from France, Germany and the UK. However, as infection in humans is not notifiable in all Member States, and surveillance differs between countries, the number of reported cases is not comparable and the true number of cases would probably be higher. Food‐borne transmission of HEV appears to be a major route in Europe; pigs and wild boars are the main source of HEV. Outbreaks and sporadic cases have been identified in immune‐competent persons as well as in recognised risk groups such as those with pre‐existing liver damage, immunosuppressive illness or receiving immunosuppressive treatments. The opinion reviews current methods for the detection, identification, characterisation and tracing of HEV in food‐producing animals and foods, reviews literature on HEV reservoirs and food‐borne pathways, examines information on the epidemiology of HEV and its occurrence and persistence in foods, and investigates possible control measures along the food chain. Presently, the only efficient control option for HEV infection from consumption of meat, liver and products derived from animal reservoirs is sufficient heat treatment. The development of validated quantitative and qualitative detection methods, including infectivity assays and consensus molecular typing protocols, is required for the development of quantitative microbial risk assessments and efficient control measures. More research on the epidemiology and control of HEV in pig herds is required in order to minimise the proportion of pigs that remain viraemic or carry high levels of virus in intestinal contents at the time of slaughter. Consumption of raw pig, wild boar and deer meat products should be avoided.

Abstract Under current European hygiene legislation, food businesses are obliged to develop and implement food safety management systems (FSMS) including prerequisite programme (PRP) activities and hazard analysis and critical control point principles. This requirement is especially challenging for small food retail establishments, where a lack of expertise and other resources may limit the development and implementation of effective FSMS. In this opinion, a simplified approach to food safety management is developed and presented based on a fundamental understanding of processing stages (flow diagram) and the activities contributing to increased occurrence of the hazards (biological, chemical (including allergens) or physical) that may occur. The need to understand and apply hazard or risk ranking within the hazard analysis is removed and control is achieved using PRP activities as recently described in the European Commission Notice 2016/C278, but with the addition of a PRP activity covering ‘product information and customer awareness’. Where required, critical limits, monitoring and record keeping are also included. Examples of the simplified approach are presented for five types of retail establishments: butcher, grocery, bakery, fish and ice cream shop.