EFSA Journal最新文献

{"title":"Safety and efficacy of a feed additive consisting of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 (Bafasal®) for all poultry (Proteon Pharmaceuticals S.A.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Vasileios Bampidis,&nbsp;Pier Sandro Cocconcelli,&nbsp;Lieve Herman,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño,&nbsp;Rosella Brozzi","doi":"10.2903/j.efsa.2024.9132","DOIUrl":"10.2903/j.efsa.2024.9132","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting <i>Salmonella enterica</i> ser. Gallinarum B/00111, intended for be as a zootechnical additive (functional group: other zootechnical additives) for all poultry species. Bafasal® is proposed for use in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 10⁶ PFU/bird, to reduce the <i>Salmonella</i> spp. contamination of poultry carcasses and load in the environment, and to improve the zootechnical performance of the treated animals. In previous opinions, the FEEDAP Panel concluded that Bafasal® is safe for the target species, consumers and the environment and is not a skin or eye irritant but should be considered a respiratory sensitiser. No conclusion could be drawn on its dermal sensitisation potential. The additive showed the potential to decrease the counts of two Salmonella Enteritidis strains in boots swabs and caecal digesta of chickens for fattening. However, the Panel was not in the position to conclude on the capacity of Bafasal® to improve the zootechnical performance of poultry, to reduce the contamination of other <i>Salmonella enterica</i> strains, serovars or other <i>Salmonella</i> spp. in chickens, or to reduce the <i>Salmonella</i> spp. contamination of poultry other than chickens. In the current application, the claim on zootechnical performance has been withdrawn. Bafasal® is not a skin or eye irritant but should be considered a potential skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. Based on the new data provided, the Panel concluded that Bafasal® has the potential to reduce the environmental contamination with <i>S.</i> Enteritidis when used in feed and water for all poultry species. No conclusions could be drawn on the effects of the additive on other <i>Salmonella</i> serotypes.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11647178/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revised dietary exposure assessment of the food enzyme endo 1,4-β-xylanase from the genetically modified Aspergillus oryzae strain NZYM-FB","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9163","DOIUrl":"10.2903/j.efsa.2024.9163","url":null,"abstract":"<p>The food enzyme endo 1,4-β-xylanase (4-β-<span>d</span>-xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified <i>Aspergillus oryzae</i> strain NZYM-FB by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to five food manufacturing processes and recalculated the dietary exposure. As the food enzyme-total organic solids (TOS) are removed in two food manufacturing processes, the dietary exposure to the food enzyme-TOS was estimated only for the remaining three processes. It was calculated to be up to 0.383 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (106 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 277. Based on the revised exposure estimate, the margin of exposure calculated thereof and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11647172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Scientific opinion on the extension of uses of quillaia extract (E 999) as a food additive","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;José Manuel Barat Baviera,&nbsp;Jean-Charles Leblanc,&nbsp;Alexandra Tard,&nbsp;Sam Vermeiren,&nbsp;Panagiota Zakidou,&nbsp;Laura Ruggeri","doi":"10.2903/j.efsa.2024.9140","DOIUrl":"10.2903/j.efsa.2024.9140","url":null,"abstract":"<p>The EFSA Panel on Food Additives and Flavourings (FAF Panel) evaluated the safety of the extension of uses of quillaia extract (E 999) as a food additive in food supplements supplied in a solid or liquid form, excluding food supplements for infants and young children. Quillaia extract (E 999) was re-evaluated in 2019 by the EFSA FAF Panel, which derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999, while in 2024 a follow-up of the re-evaluation was published by the FAF Panel, recommending some modifications of the existing EU specifications for quillaia extract (E 999). Currently, quillaia extract (E 999) is authorised in two food categories (FCs) i.e. FC 4.1.4 ‘Flavoured drinks’ and FC 14.2.3 ‘Cider and perry’ (excluding <i>cidre bouché, cydr jakościowy, perry jakościowe, cydr lodowy, perry lodowe</i>). A ‘food supplements consumers only’ scenario was calculated for this opinion considering the proposed extension of uses, together with the current authorised uses at both the maximum permitted level (MPLs) and the typical reported use levels of quillaia extract (E 999) at the time of the 2019 re-evaluation. The Panel concluded that the exposure estimates using the typical reported use levels for the currently authorised food categories and considering the proposed extension of uses for E 999 in FC 17.1 ‘Food supplements supplied in a solid form, excluding food supplement for infants and young children’ and FC 17.2 ‘Food supplements supplied in a liquid form, excluding food supplement for infants and young children’, if authorised, would not result in an exceedance of the ADI in any population group.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzym endo-1,4-β-xylanase from the genetically modified Bacillus subtilis strain AR-153","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Jaime Aguilera,&nbsp;Giulio di Piazza,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9123","DOIUrl":"10.2903/j.efsa.2024.9123","url":null,"abstract":"<p>The food enzyme endo-1,4-β-xylanase (4-β-<span>d</span>-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified <i>Bacillus subtilis</i> strain AR-153 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in four food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed during one food manufacturing process, dietary exposure was only calculated for the remaining three processes. Exposure was estimated to be up to 0.463 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme endo-1,4-β-xylanase from the non-genetically modified Trichoderma citrinoviride strain HBI-TX01","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Yi Liu,&nbsp;Ana Criado,&nbsp;Kyriaki Apergi,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Eleonora Marini","doi":"10.2903/j.efsa.2024.9127","DOIUrl":"10.2903/j.efsa.2024.9127","url":null,"abstract":"<p>The food enzyme endo-1,4-β-xylanase (4-β-<span>d</span>-xylan xylanohydrolase; EC 3.2.1.8) is produced with <i>Trichoderma citrinoviride</i> strain HBI-TX01 by HBI Enzymes Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining two processes. It was estimated to be up to 1.488 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1101 mg TOS/kg bw, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 740. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. Known sources of food allergens were used in the manufacturing process. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revised safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified Bacillus subtilis strain LMG S-24584 produced by a modified process","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Silvia Peluso,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Ana Gomes,&nbsp;Natalia Kovalkovicova,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9126","DOIUrl":"10.2903/j.efsa.2024.9126","url":null,"abstract":"<p>The food enzyme endo-1,4-β-xylanase (4-β-<span>d</span>-xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified <i>Bacillus subtilis</i> strain LMG S-24584 by Puratos NV. In a previous opinion, the Panel noted the presence of recombinant DNA in all food enzyme batches tested. As a follow-up, the applicant changed the manufacturing process of the food enzyme and provided new data. The genetic modifications do not give rise to safety concerns and the production strain fulfils the requirements for the QPS approach to safety assessment. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure is estimated to be up to 0.010 mg TOS/kg body weight per day in European populations. As no concerns arising from the microbial source and its genetic modifications or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11632244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revised safety evaluation of the food enzyme glucose oxidase from the genetically modified Trichoderma reesei strain AR-352","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Jaime Aguilera,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9122","DOIUrl":"10.2903/j.efsa.2024.9122","url":null,"abstract":"<p>The food enzyme glucose oxidase (β-<span>d</span>-glucose: oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with the genetically modified <i>Trichoderma reesei</i> strain AR-352 by AB Enzymes GmbH. In a previous opinion, the Panel on Food Contact Materials, Enzymes and Processing Aids of the European Food Safety Authority could not conclude on the absence of recombinant DNA from the production strain in the food enzyme due to uncertainties about the limit of detection of the applied methodology. New data provided by the applicant showed that no DNA from the production strain was found in the food enzyme with a limit of detection meeting the requirements of the applicable guidance. Based on the new data provided, the Panel concludes that this food enzyme is free from recombinant DNA from the production strain.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11632242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Plain Language Summary of the European Union One Health 2023 zoonoses report","authors":"","doi":"10.2903/j.efsa.2024.p221202","DOIUrl":"10.2903/j.efsa.2024.p221202","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The European Union One Health 2023 Zoonoses report","authors":"European Food Safety Authority (EFSA),&nbsp;European Centre for Disease Prevention and Control (ECDC)","doi":"10.2903/j.efsa.2024.9106","DOIUrl":"10.2903/j.efsa.2024.9106","url":null,"abstract":"<p>This report by the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring and surveillance activities carried out in 2023 in 27 Member States (MSs), the United Kingdom (Northern Ireland) and 10 non-MSs. Key statistics on zoonoses and zoonotic agents in humans, food, animals and feed are provided and interpreted historically. In 2023, the first and second most reported zoonoses in humans were campylobacteriosis and salmonellosis, respectively. For both agents, an increase in the absolute number of cases was observed in comparison with 2022. Fifteen MSs and the United Kingdom (Northern Ireland) reached all the established targets in poultry populations with regard to the reduction in <i>Salmonella</i> prevalence for the relevant serovars. <i>Salmonella</i> samples from carcases of various animal species, and samples for <i>Campylobacter</i> quantification from broiler carcases, were more frequently positive when performed by the competent authorities than when own-checks were conducted. Shiga toxin-producing <i>Escherichia coli</i> (STEC) was the third most reported zoonotic agent in humans, followed by <i>Yersinia enterocolitica</i> and <i>Listeria monocytogenes</i>. <i>L. monocytogenes</i> and West Nile virus infections were the most severe zoonotic diseases, with the highest percentage of hospitalisations among cases and the highest case fatality rates. Twenty-seven MSs and the United Kingdom (Northern Ireland) reported a slight decrease in food-borne outbreaks in 2023 overall in comparison with 2022, although the overall number of reported human cases and hospitalisations increased. <i>Salmonella</i> Enteritidis remained the most frequently reported causative agent for reported cases and food-borne outbreaks. <i>Salmonella</i> in ‘eggs and egg products’ was the agent/food pair of most concern. In 2023 this combination caused the largest number of outbreaks and cases among all agent/food combination and ranked second in number of hospitalisations. <i>Salmonella</i> was also the causative agent associated with the majority of multi-country outbreaks reported in the EU in 2023. This report also provides updates on brucellosis, echinococcosis, Q fever, rabies, toxoplasmosis, trichinellosis, tuberculosis due to <i>Mycobacterium bovis</i> or <i>M. caprae</i>, and tularaemia.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk assessment of complex organoarsenic species in food","authors":"EFSA Panel on Contaminants in the Food Chain (CONTAM),&nbsp;Helle Katrine Knutsen,&nbsp;Agneta Åkesson,&nbsp;Vasileios Bampidis,&nbsp;Margherita Bignami,&nbsp;Laurent Bodin,&nbsp;James Kevin Chipman,&nbsp;Gisela Degen,&nbsp;Antonio Hernández-Jerez,&nbsp;Tim Hofer,&nbsp;Christer Hogstrand,&nbsp;Stefano Landi,&nbsp;Jean-Charles Leblanc,&nbsp;Kyriaki Machera,&nbsp;Evangelia Ntzani,&nbsp;Guido Rychen,&nbsp;Salomon Sand,&nbsp;Katharina Vejdovszky,&nbsp;Barbara Viviani,&nbsp;Lars Barregård,&nbsp;Diane Benford,&nbsp;Eugenia Dogliotti,&nbsp;Kevin Francesconi,&nbsp;Jose Ángel Gómez Ruiz,&nbsp;Hans Steinkellner,&nbsp;Tanja Schwerdtle","doi":"10.2903/j.efsa.2024.9112","DOIUrl":"10.2903/j.efsa.2024.9112","url":null,"abstract":"<p>The European Commission asked EFSA for a risk assessment on complex organoarsenic species in food. They are typically found in marine foods and comprise mainly arsenobetaine (AsB), arsenosugars and arsenolipids. For AsB, no reference point (RP) could be derived because of insufficient toxicity data. AsB did not show adverse effects in the two available repeat dose toxicity tests in rodents. It has not shown genotoxicity in <i>in vitro</i> assays. There is no indication of an association with adverse outcomes in human studies. The highest 95th percentile exposure for AsB was observed in ‘Toddlers’ with an estimate of 12.5 μg As/kg bw per day (AsB expressed as elemental arsenic). There is sufficient evidence to conclude that AsB at current dietary exposure levels does not raise a health concern. For glycerol arsenosugar (AsSugOH) a RP of 0.85 mg As/kg bw per day was derived based on the BMDL₁₀ values for cognitive and motor function in mice. A margin of exposure (MOE) of ≥ 1000 would not raise a health concern. The highest 95th percentile estimate of exposure for AsSugOH (for adult consumers of red seaweed Nori/Laver) was 0.71 μg As/kg bw per day (AsSugOH expressed as elemental arsenic), which results in an MOE &gt; 1000, not raising a health concern. Based on qualitative consideration of all identified uncertainties, it is regarded likely that the dietary exposures to AsB and AsSugOH do not raise a health concern. No conclusions could be drawn regarding other arsenosugars. No risk characterisation could be conducted for arsenolipids, due to the lack of data.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}