EFSA Journal最新文献

{"title":"Surveillance of West Nile virus infections in humans and animals in Europe, monthly report","authors":"European Centre for Disease Prevention and Control (ECDC),&nbsp;European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9594","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9594","url":null,"abstract":"<div>\u0000 \u0000 <p>In 2025, and as of 2 July 2025, no countries in Europe reported any locally acquired1 human cases of WNV infection with known place of infection.</p>\u0000 <p>In the previous five years, the first locally acquired cases of the WNV transmission season usually had symptom onset in June. However, the absence of notification of locally acquired cases of WNV in the EU/EEA and EU-neighbouring countries is not unexpected at this time of the year. This could either be due to the absence of WNV infections in humans or due to a delay in diagnosis and reporting of cases of WNV infection. Furthermore, a majority of WNV infections in humans remain asymptomatic or pauci-symptomatic.</p>\u0000 <p>From the veterinary perspective, 2 WNV outbreaks among equids and 3 outbreaks among birds have been reported in Europe in 2025. The earliest start date of an outbreak among equids and birds was on 15 January 2025 in Germany and 16 February 2025 in Italy, while the latest onset of an outbreak among equids and birds was, respectively, on 12 June 2025 in Hungary and 11 June 2025 in Italy.</p>\u0000 <p>The number of outbreaks in birds and equids reported during this first period of 2025 is below the mean monthly outbreak count for the same time frame (calculated from 2015–2024). During the same period in 2024, 16 outbreaks were reported. In 2025, as of 2 July, this is the lowest number of outbreaks in birds and equids reported during the same period since 2022. All three countries (and their associated regions) reported WNV outbreaks in birds and/or equids in 2024 and in prior years, indicating endemic WNV activity in these regions.</p>\u0000 <p>In temperate regions like Europe, WNV transmission typically occurs from mid-June to mid-November, when mosquito activity is highest. Off-season reports of WNV outbreaks in birds and equids should be carefully evaluated as they raise questions about the timing of infection. The two early-season WNV outbreak reports (Germany's equid case in January and Italy's bird case in February) require cautious interpretation, as they may reflect residual detection (e.g. lingering antibodies or viral RNA from prior infections) rather than active transmission in 2025.</p>\u0000 <p>The absence of reported human West Nile virus infections in Europe as of 2 July 2025, alongside a notably lower number of outbreaks in birds and equids compared to 2024, suggests a reduced level of viral circulation in the environment during the early transmission season in 2025. Natural fluctuations in virus prevalence can occur year to year, influenced by immunity levels in bird populations and ecological conditions.</p>\u0000 <p>Human cases are expected to occur in the coming weeks.</p>\u0000 </div>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9594","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144598261","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":"Peer review of the pesticide risk assessment for the active substance pendimethalin in light of confirmatory data submitted","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Angelo Colagiorgi,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Franco Ferilli,&nbsp;German Giner Santonja,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Alberto Linguadoca,&nbsp;Tunde Molnar,&nbsp;Simone Rizzuto,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9511","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9511","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance pendimethalin are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information in the area of ecotoxicology. The conclusions were reached on the basis of the evaluation of the representative uses of pendimethalin as a herbicide on cereals, pulse and carrots. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and/or literature in the dossier peer reviewed, are presented. Concerns are identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9511","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144598451","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 of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA),&nbsp;Dominique Turck,&nbsp;Torsten Bohn,&nbsp;María de la Montaña Cámara Hurtado,&nbsp;Jacqueline Castenmiller,&nbsp;Stefaan De Henauw,&nbsp;Karen Ildico Hirsch-Ernst,&nbsp;Ángeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Breige Mcnulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Francesco Cubadda,&nbsp;Thomas Frenzel,&nbsp;Ursula Gundert-Remy,&nbsp;Francesca Marcon,&nbsp;Miguel Prieto Maradona,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Alexandros Siskos,&nbsp;Matt Wright,&nbsp;Leonard Matijević,&nbsp;Harry McArdle","doi":"10.2903/j.efsa.2025.9528","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9528","url":null,"abstract":"<p>Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF is produced by chemical synthesis and is proposed to be used in food supplements at a maximum intake level of 6100 mg per day by adults. This intake level corresponds to around 5000 mg/day orotic acid and 400 mg/day magnesium. The Panel notes that this would exceed the established UL for supplemental magnesium of 250 mg/day, therefore the use of the NF could be nutritionally disadvantageous. The Panel also notes the previous safety assessment of magnesium orotate dihydrate, where concerns were raised regarding the exposure to orotic acid, based on several animal studies demonstrating tumour-promoting effects. The ANS Panel derived a no observed adverse effect level (NOAEL) for orotic acid of 50 mg/kg bw per day. The margin between the derived NOAEL for orotic acid and the exposure resulting from the proposed maximum use level of the NF is 0.7 (based on the average bw of an adult person of 70 kg) which is even lower than the margin considered by the ANS Panel of being inadequate. The applicant has not provided any toxicological data on the NF or on orotic acid that could address or mitigate these safety concerns. The Panel concludes that the safety of the NF, magnesium orotate dihydrate, cannot be established under the proposed conditions of use. The assessment of bioavailability of magnesium from the NF in comparison to natural sources was not conducted.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9528","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144589669","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 an extension of use of the food enzyme β-galactosidase from the genetically modified Aspergillus niger strain TOL","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;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9559","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9559","url":null,"abstract":"<p>The food enzyme β-galactosidase (β-<span>d</span>-galactoside galactohydrolase, EC 3.2.1.23) is produced with the genetically modified <i>Aspergillus niger</i> strain TOL by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include two additional processes. In the present assessment, EFSA has updated the safety evaluation of this food enzyme when used in a total of three food manufacturing processes. The dietary exposure was calculated to be up to 3.144 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1038 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 330. Based on the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9559","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144589667","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":"Assessment of the 2024 post-market monitoring report of genetically modified oilseed rape 73496","authors":"European Food Safety Authority (EFSA),&nbsp;Michele Ardizzone,&nbsp;Thomas Frenzel,&nbsp;José Ángel Gomez Ruiz,&nbsp;Tilemachos Goumperis,&nbsp;Giovanni Savoini,&nbsp;Robin Ornsrud,&nbsp;Elena Sánchez-Brunete,&nbsp;Reinhilde Schoonjans","doi":"10.2903/j.efsa.2025.9579","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9579","url":null,"abstract":"<p>Following a request from the European Commission (EC), the European Food Safety Authority (EFSA) analysed the 2024 post-market monitoring (PMM) report of genetically modified oilseed rape (OSR) 73496 and the additional information provided during the assessment. EFSA concluded that the assumptions for consumption and for the intended uses considered during the pre-market risk assessment (human and animal dietary exposure) remain valid. The authorisation holder did not provide consumption data for humans and animals of OSR 73496 and of products derived from OSR 73496 as requested in the authorisation. However, EFSA concluded that the methodology used and the information provided is sufficient to conclude that the conditions considered during the pre-market risk assessment are still applicable.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9579","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144589668","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":"Update of the list of qualified presumption of safety (QPS) recommended microbiological agents intentionally added to food or feed as notified to EFSA 22: Suitability of taxonomic units notified to EFSA until March 2025","authors":"EFSA Panel on Biological Hazards (BIOHAZ),&nbsp;Ana Allende,&nbsp;Avelino Alvarez-Ordóñez,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Alessandra De Cesare,&nbsp;Wietske Dohmen,&nbsp;Laurent Guillier,&nbsp;Liesbeth Jacxsens,&nbsp;Maarten Nauta,&nbsp;Lapo Mughini-Gras,&nbsp;Jakob Ottoson,&nbsp;Luisa Peixe,&nbsp;Fernando Perez-Rodriguez,&nbsp;Panagiotis Skandamis,&nbsp;Elisabetta Suffredini,&nbsp;Pier Sandro Cocconcelli,&nbsp;Pablo Salvador Fernández Escámez,&nbsp;Miguel Prieto Maradona,&nbsp;Amparo Querol,&nbsp;Lolke Sijtsma,&nbsp;Juan Evaristo Suarez,&nbsp;Marianne Chemaly,&nbsp;Ingvar Sundh,&nbsp;Fulvio Barizzone,&nbsp;Justine Dastouet,&nbsp;Nadya Doyle,&nbsp;Sandra Correia,&nbsp;Lieve Herman","doi":"10.2903/j.efsa.2025.9510","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9510","url":null,"abstract":"<p>The qualified presumption of safety (QPS) process was developed to assess the safety of microorganisms used in food and feed chains. During the period covered by this Statement, no new information warranted changes to the status of previously recommended QPS taxonomic units. The QPS list was updated to verify the correctness of the names and the completeness of synonyms. Of the 47 microorganisms notified to EFSA between October 2024 and March 2025 (25 as feed additives, 7 as food enzymes or additives, 6 as novel foods, 8 as plant protection products and 1 as food contact materials), 41 were not evaluated. These latter included 11 filamentous fungi, 4 <i>Escherichia coli</i> and 1 <i>Streptomyces</i> spp. (all excluded from the QPS evaluation), and 25 already on the QPS list. Two of the other six notifications, <i>Bacillus thuringiensis</i> and <i>Ensifer adhaerens</i>, had been previously assessed. The remaining four were assessed for a possible QPS status. <i>Bacillus sonorensis</i> is recommended for the QPS list with the qualifications: ‘absence of bacitracin production ability’ and ‘absence of toxigenic activity’. <i>Vibrio natriegens</i> is also recommended but for ‘production purposes only’. <i>Corynebacterium stationis</i> is not recommended due to a limited body of knowledge on its occurrence in the food and feed chain and possible safety concerns in relation to human and animal health. <i>Papilotrema terrestris</i> is not recommended due to a limited body of knowledge. Furthermore, <i>Lactobacillus paragasseri</i> (formerly included in <i>Lactobacillus gasseri</i>) is recommended for the QPS list. The QPS approach can also be followed if the qualifications for QPS are met due to the removal of a gene(s) of concern, by means of genetic modification. For QPS yeasts, used as active agents (viable cells), the qualification ‘for production purposes only’ was added for when they are used as production strains or as biomass (non-viable cells).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9510","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144573765","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":"Assessment of genetically modified soybean DBN9004 (application EFSA-GMO-BE-2019-165)","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Giovanni Savoini,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Michele Ardizzone,&nbsp;Giacomo De Sanctis,&nbsp;Antonio Fernández Dumont,&nbsp;Arianna Ferrari,&nbsp;José Ángel Gómez Ruiz,&nbsp;Tilemachos Goumperis,&nbsp;Dafni Maria Kagkli,&nbsp;Aleksandra Lewandowska,&nbsp;Ana M. Camargo,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello,&nbsp;Elena Sánchez-Brunete","doi":"10.2903/j.efsa.2025.9503","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9503","url":null,"abstract":"<p>Genetically modified soybean DBN9004 was developed to confer tolerance to glufosinate-ammonium- and glyphosate-containing herbicides. These properties were achieved by introducing the <i>cp4 epsps</i> and <i>pat</i> expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between soybean DBN9004 and its conventional counterpart needs further assessment. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the CP4 EPSPS and PAT proteins as expressed in soybean DBN9004 and finds no evidence that the genetic modification would change the overall safety of soybean DBN9004, as food and feed. In the context of this application, the consumption of food and feed from soybean DBN9004 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean DBN9004 is as safe as the conventional counterpart and non-GM soybean varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of release of soybean DBN9004 material, including viable grains, into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DBN9004. The GMO Panel concludes that soybean DBN9004 is as safe as its conventional counterpart and the tested non-GM soybean varieties with respect to potential effects on human and animal health, and the environment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9503","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144573764","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":"Re-evaluation of neotame (E 961) as 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;Monika Batke,&nbsp;Ellen Bruzell,&nbsp;James Chipman,&nbsp;Riccardo Crebelli,&nbsp;Cristina Fortes,&nbsp;Peter Fürst,&nbsp;Eric Gaffet,&nbsp;Cheyns Karlien,&nbsp;Thorhallur Halldorsson,&nbsp;Jean-Charles Leblanc,&nbsp;Oliver Lindtner,&nbsp;Katrin Loeschner,&nbsp;Jan Mast,&nbsp;Manuela Mirat,&nbsp;Alicja Mortensen,&nbsp;Anna Undas,&nbsp;Matthew Wright,&nbsp;Stefania Barmaz,&nbsp;Consuelo Civitella,&nbsp;Jose Cortiñas Abrahantes,&nbsp;Pauline Le Gall,&nbsp;Elena Mazzoli,&nbsp;Agnieszka Mech,&nbsp;Josef Daniel Rasinger,&nbsp;Ana Rincon,&nbsp;Francesca Riolo,&nbsp;Camilla Smeraldi,&nbsp;Alexandra Tard,&nbsp;Panagiota Zakidou,&nbsp;Federica Lodi","doi":"10.2903/j.efsa.2025.9480","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9480","url":null,"abstract":"<p>The present opinion deals with the re-evaluation of neotame (E 961) as a food additive. Neotame is the chemically manufactured compound N-[N-(3,3-dimethylbutyl)-<span>l</span>-α-aspartyl]-<span>l</span>-phenylalanine 1-methyl ester. The main impurity of neotame (E 961) is also a degradation product (de-esterified form), N-[N-(3,3-dimethylbutyl)-<span>l</span>-α-aspartyl]-<span>L</span>-phenylalanine (NC-00751) and the primary metabolite. No new data were received following the call for biological and toxicological data. A summary of the toxicological studies available in the EFSA opinion of 2007 is presented and studies gathered from the literature are summarised. Neotame is rapidly absorbed and pre-systemically metabolised, systemic intact neotame is likely to be excreted in the urine with its metabolites. The potential aneugenic effects at the site of contact are not expected to occur; overall, there is no concern for genotoxicity of neotame (E 961) at the maximum permitted levels or reported use levels. A review of the other endpoints from the already available toxicological database did not indicate an adverse effect for neotame at the highest doses tested. The Panel established an acceptable daily intake (ADI) of 10 mg/kg bw per day for neotame based on the no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day from a 52-week chronic and 104-week carcinogenicity studies in rats. This ADI replaces the ADI of 2 mg/kg bw per day established by EFSA in 2007. The resulting exposure to methanol and its metabolite formaldehyde from the use of neotame at the ADI of 10 mg/kg bw per day does not raise a concern. The dietary exposure estimates of neotame (E 961) for the different population groups of all exposure scenarios did not exceed the ADI. The Panel concluded that there is no safety concern for neotame (E 961) at the currently permitted and reported uses and use levels. The Panel recommended the European Commission to consider revising the EU specifications of neotame (E 961).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9480","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144550989","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":"Modification of the existing maximum residue level for aclonifen in anise/aniseed","authors":"European Food Safety Authority (EFSA),&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Luis Carrasco Cabrera,&nbsp;Irene Castellan,&nbsp;Monica del Aguila,&nbsp;Lucien Ferreira,&nbsp;Luna Greco,&nbsp;Samira Jarrah,&nbsp;Renata Leuschner,&nbsp;Andrea Mioč,&nbsp;Stefanie Nave,&nbsp;Hermine Reich,&nbsp;Silvia Ruocco,&nbsp;Alessia Pia Scarlato,&nbsp;Andrea Simonati,&nbsp;Marta Szot,&nbsp;Anne Theobald,&nbsp;Olha Timofieieva,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani,&nbsp;Elena Zioga","doi":"10.2903/j.efsa.2025.9514","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9514","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaft und Gartenbau submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance aclonifen in anise/aniseed. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for the crop of interest. Adequate analytical methods for enforcement are available to control the residues of aclonifen in the plant matrix under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of aclonifen according to the reported agricultural practice is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9514","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144551036","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 posed by the HPAI virus H5N1, Eurasian lineage goose/Guangdong clade 2.3.4.4b. genotype B3.13, currently circulating in the US","authors":"European Food Safety Authority (EFSA),&nbsp;Julio Alvarez,&nbsp;Alessio Bortolami,&nbsp;Mariette Ducatez,&nbsp;Claire Guinat,&nbsp;Jan Arend Stegeman,&nbsp;Alessandro Broglia,&nbsp;Helene Jensen,&nbsp;Kamela Kryemadhi,&nbsp;Andrea Gervelmeyer","doi":"10.2903/j.efsa.2025.9508","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9508","url":null,"abstract":"<p>The emergence of highly pathogenic avian influenza (HPAI) A(H5N1), clade 2.3.4.4b, genotype B3.13 in U.S. dairy cattle marks a significant shift in the virus' host range and epidemiological profile. Infected cattle typically exhibit mild clinical signs, such as reduced milk production, mastitis and fever, with morbidity generally below 20% and mortality averaging 2%. Transmission within farms is primarily driven by contaminated milk and milking procedures, while farm-to-farm spread is mainly linked to cattle movement and shared equipment. The virus demonstrates high replication in mammary glands, with infected cows shedding large quantities of virus in milk for up to 3 weeks, even in the absence of clinical signs. Shedding through other routes appears limited. Infected cattle develop virus-specific antibodies within 7–10 days, offering short-term protection, though the duration and robustness of immunity remain unclear. Between March 2024 and May 2025, the virus was confirmed in 981 dairy herds across 16 U.S. states, with California particularly affected. Risk factors identified for between-farm spread include cattle movement, shared equipment and contact with external personnel, while biosecurity measures, including waste management and wildlife deterrence, may reduce the risk of virus introduction. In response to the outbreaks, U.S. authorities implemented strict movement controls, mandatory testing and enhanced biosecurity protocols. Potential pathways of introduction of HPAI B3.13 virus into EU via trade from US could be the import of lactating cows and bovine meat, although strict trade regulations, absence of animal import and limited virus detection in meat, especially in muscle tissue, do not support this occurrence. Import of products containing raw milk could also be potential pathways for virus introduction. Migratory birds – particularly waterfowl – pose potential pathways for introduction during seasonal migrations. The detection of mammalian-adaptive mutations and zoonotic cases underscores the virus' public health relevance and the need for research, surveillance and cross-sectoral preparedness.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9508","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144536906","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}