EFSA Journal最新文献

{"title":"Modification of the existing maximum residue levels for propyzamide in oilseeds and honey","authors":"European Food Safety Authority (EFSA),&nbsp;Sofia Batista Leite,&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Marco Binaglia,&nbsp;Irene Castellan,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Monica Del Aguila,&nbsp;Lucien Ferreira,&nbsp;Frederique Istace,&nbsp;Anna Lanzoni,&nbsp;Renata Leuschner,&nbsp;Jochem Louisse,&nbsp;Iris Mangas,&nbsp;Silvia Mazzega,&nbsp;Andrea Mioč,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Simone Rizzuto,&nbsp;Marta Szot,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani","doi":"10.2903/j.efsa.2026.10324","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10324","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva submitted a request to the competent national authority in Sweden to modify the existing maximum residue levels (MRLs) for the active substance propyzamide in oilseed rape, mustard seeds, gold of pleasure seeds, linseeds, sesame seeds, hemp seeds, borage seeds and honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all the crops under assessment. Adequate analytical methods for enforcement are available to control the residues of propyzamide in plant matrices and honey at the validated limit of quantification (LOQ) of 0.01 and 0.05 mg/kg, respectively. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of propyzamide according to the reported agricultural practices is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10324","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149083922","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 cellulase from the genetically modified Trichoderma reesei strain NZYM-FS","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;Cristina Andreoli,&nbsp;Andrea Terron,&nbsp;Andrey Yurkov,&nbsp;Ana Gomes,&nbsp;Daniele Cavanna,&nbsp;Cristina Fernández-Fraguas,&nbsp;Natália Kovalkovičová,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2026.10331","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10331","url":null,"abstract":"<p>The food enzyme cellulase (4-(1,3; 1,4)-β-<span>d</span>-glucan-4-glucanohydrolase, EC 3.2.1.4) is produced with the genetically modified <i>Trichoderma reesei</i> strain NZYM-FS by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The food enzyme was considered 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 food enzyme–total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining two food manufacturing processes. It was estimated to be up to 0.140 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 1292 mg TOS/kg bw per day, the highest dose tested which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 9229. A search for the homology of the amino acid sequence of the cellulase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that 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":"24 10","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10331","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149083918","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 aspergillopepsin I from the non-genetically modified Aspergillus sp. strain LPL 3U-3-10","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;Cristina Andreoli,&nbsp;Andrea Terron,&nbsp;Andrey Yurkov,&nbsp;Daniele Cavanna,&nbsp;Jaime Aguilera,&nbsp;Silvia Peluso,&nbsp;Magdalena Andryszkiewicz,&nbsp;Natalia Kovalkovicova,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2026.10338","DOIUrl":"10.2903/j.efsa.2026.10338","url":null,"abstract":"<p>The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified <i>Aspergillus</i> sp. strain LPL 3U-3-10 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in 16 food manufacturing processes. Since residual amounts of food enzyme–Total Organic Solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining 14 food manufacturing processes. It was estimated to be up to 4.673 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 1800 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 385. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and matches with three respiratory allergens and one injected allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but that 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":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624930/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105788","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":"Avian influenza overview June-August 2026.","authors":"Cyril Barbezange, Mariette Ducatez, Alice Fusaro, Jose L Gonzales, Thijs Kuiken, Raffaella Melilli, Gražina Mirinavičiūtė, Karl Ståhl, Christoph Staubach, Olov Svartström, Calogero Terregino, Katriina Willgert, Evelyn Alarcón, Lisa Kohnle","doi":"10.2903/j.efsa.2026.10369","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10369","url":null,"abstract":"<p><p>Between 5 June and 28 August 2026, 110 highly pathogenic avian influenza (HPAI) A(H5N1) virus detections were reported in domestic (7) and wild (103) birds in 12 countries in Europe. The number of detections remained at a seasonal low throughout the summer, continuing the decline observed since spring. In contrast to previous years, fewer colony-breeding seabirds were affected, and the geographical range of detections was more limited. Further sporadic detections of HPAI A(H5) virus were reported in wild terrestrial carnivores and pinnipeds. Outside Europe, the epidemic continued in the Americas, where also the HPAI A(H7N3) subtype was detected in Mexico. Following its first introduction to mainland Australia, HPAI A(H5N1) virus spread within local wild bird populations and spilled over to terrestrial carnivores and marine mammals. In the US, the number of dairy cattle farms reportedly affected by HPAI A(H5N1) increased, while detections in captive American minks were reported for the first time. Between 5 June and 31 August 2026, 15 cases of avian influenza virus infection were publicly reported in humans (no fatal cases) in three countries and territories: Bangladesh (one A(H5N1) case), Cambodia (one A(H5N1) case) and China (13 A(H9N2) cases). All human cases reported exposure to poultry or a poultry environment prior to detection or onset of illness. Human infections with avian influenza viruses remain rare and no sustained human-to-human transmission has been documented. The risk posed by avian influenza A(H5N1) clade 2.3.4.4b viruses currently circulating in Europe remains low for the general public in the European Union/European Economic Area (EU/EEA) and low-to-moderate for those occupationally or otherwise exposed to infected animals or contaminated environments.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":"e10369"},"PeriodicalIF":3.8,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13625667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105785","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":"EFSA needs for scientific excellence and regulatory readiness","authors":"European Food Safety Authority (EFSA),&nbsp;Stef Bronzwaer,&nbsp;Fabrizio Abbinante,&nbsp;Maria Bastaki,&nbsp;Bernard Bottex,&nbsp;Maya Carvalho-Evans,&nbsp;Paul Devalier,&nbsp;Ernesto Liebana,&nbsp;Joana S. Lourenco,&nbsp;Angelo Maggiore,&nbsp;Estefania Noriega Fernandez,&nbsp;Didier Verloo,&nbsp;Carlos G. das Neves","doi":"10.2903/j.efsa.2026.e240901","DOIUrl":"10.2903/j.efsa.2026.e240901","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The European Food Safety Authority (EFSA) must keep pace with food system innovation, policy change and systemic pressures, while maintaining robust, faster risk assessment. This paper identifies the scientific needs for EFSA to sustain excellence, and remain regulatorily prepared.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Building on EFSA strategic documents, scientific roadmaps, EU policy developments and lessons from the 2022 ONE Conference, current achievements and unmet needs were synthesised across six interdependent pathways: innovation and competitiveness; methodological and technical advances; sustainability and One Health; preparedness and rapid response; risk communication and social science; and artificial intelligence and data.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Priorities for Europe include fit-for-purpose methods for novel products, advanced materials, emerging evidence streams and multiple-hazard scenarios; greater investment in new approach methodologies, quantitative adverse outcome pathways, omics, exposure science and probabilistic assessment; and structured One Health cooperation on sustainability, surveillance, antimicrobial resistance and climate-related risks. Preparedness can become anticipatory with the support of AI-enabled foresight, predictive modelling and coordinated governance. Social science can inform assessment and communication earlier, using innovation in audience-centred and iteratively tested approaches, supported by AI-enabled segmentation, social listening, consumer-behaviour data, virtual respondents and closer Member State partnerships to deliver timely, tailored and trustworthy communication. Ultimately, a human-led, AI-enabled operating model is essential for transparent, reusable, consistent and trusted regulatory science across Europe.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Scientific excellence and regulatory readiness will depend on sustained R&amp;I in methods, data infrastructure, specialist expertise, capacity building, partnerships and research engagement. Integrating these capabilities will enable faster, more consistent and anticipatory scientific advice while preserving scientific rigour, transparency and public trust across an increasingly complex European food safety system.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13621334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080170","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":"Surveillance of West Nile virus infections in humans and animals in Europe, monthly report - data submitted up to 3 September 2026.","authors":"","doi":"10.2903/j.efsa.2026.10329","DOIUrl":"10.2903/j.efsa.2026.10329","url":null,"abstract":"<p><p>As part of their One Health activities, the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) jointly conduct surveillance of West Nile virus (WNV) infections in humans, equids and birds and assess the epidemiological situation in Europe. This surveillance informs public health and veterinary authorities and supports timely prevention and control measures. As of 3 September 2026, intense WNV circulation has been observed in humans and animals in several European countries, although there is currently no indication of increased disease severity among human cases in EU/EEA countries. Italy remains the most affected country, reporting the highest numbers of human cases and avian outbreaks, while Greece has recorded an unusually high number of human cases for this time of year. The Netherlands has reported its first human infections since 2020, alongside outbreaks in birds and equids across a wide geographic area. In Belgium, where no human WNV infections have ever been reported, circulation in birds and equids across eight regions indicates a risk of human infection. North Macedonia is experiencing an unprecedented outbreak in the capital region, involving human cases and detections in birds. Further human cases and animal outbreaks may occur across Europe in the coming weeks. ECDC and EFSA continue to monitor the situation closely.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":"e10329"},"PeriodicalIF":3.8,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13617534/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149073336","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 a food enzyme containing carboxypeptidase C, oryzin and leucyl aminopeptidase activities from the non-genetically modified Aspergillus sp. strain FP 12-385","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;Cristina Andreoli,&nbsp;Andrea Terron,&nbsp;Andrey Yurkov,&nbsp;Daniele Cavanna,&nbsp;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Natalia Kovalkovicova,&nbsp;Silvia Peluso,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2026.10337","DOIUrl":"10.2903/j.efsa.2026.10337","url":null,"abstract":"<p>The food enzyme containing carboxypeptidase C (EC 3.4.16.5), oryzin (EC 3.4.21.63) and leucyl aminopeptidase (EC 3.4.11.1) activities is produced with the non-genetically modified <i>Aspergillus</i> sp. strain FP 12-385 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in 14 food manufacturing processes. Since residual amounts of food enzyme–Total Organic Solids (TOS) are removed in one process, dietary exposure was calculated for the remaining 13 food manufacturing processes. It was estimated to be up to 1.146 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 2010 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1754. A search for the homology of the three amino acid sequences of the food enzyme to known allergens was made and matches with three food allergens, 20 respiratory allergens and three contact allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded. 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":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13618386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149073353","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 containing endo-1,3(4)-β-glucanase, endo-1,4-β-xylanase and cellulase activities from the non-genetically modified Mycothermus thermophiloides strain NZYM-ST","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;Alessandro Manghi,&nbsp;Daniele Cavanna,&nbsp;Yi Liu,&nbsp;Cristina Andreoli,&nbsp;Andrea Terron,&nbsp;Andrey Yurkov","doi":"10.2903/j.efsa.2026.10336","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10336","url":null,"abstract":"<p>The food enzyme containing endo-1,3(4)-β-glucanase (3-(1,3;1,4)-β-<span>d</span>-glucan 3(4)-glucanohydrolase, EC 3.2.1.6), endo-1,4-β-xylanase (4-β-<span>d</span>-xylan xylanohydrolase, EC 3.2.1.8) and cellulase (4-(1,3;1,4)-β-<span>d</span>-glucan-4-glucanohydrolase, EC 3.2.1.4) activities is produced with the non-genetically modified <i>Mycothermus thermophiloides</i> strain NZYM-ST by Novozymes A/S. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of four food manufacturing processes. The dietary exposure to the food enzyme–Total Organic Solids (TOS) was calculated to be up to 0.511 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (620 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1213. Based on the revised exposure estimation, the newly derived 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":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10336","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149048336","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 Acheta domesticus (house cricket) spray-dried powder as a Novel food pursuant to Regulation (EU) 2015/2283","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA),&nbsp;Dominique Turck,&nbsp;Torsten Bohn,&nbsp;Montaña Cámara,&nbsp;Jacqueline Castenmiller,&nbsp;Stefaan De Henauw,&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;Margarita Aguilera-Gómez,&nbsp;Thomas Frenzel,&nbsp;Harry J. McArdle,&nbsp;Peter Moldeus,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Josef Rudolf Schlatter,&nbsp;Henk van Loveren,&nbsp;Areti Favata,&nbsp;Fernando Rivero-Pino,&nbsp;Ermolaos Ververis,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2026.9946","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.9946","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 a spray-dried powder from house cricket (<i>Acheta domesticus</i>) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is intended as a whole food and for potential use as an ingredient in foods that can be consumed by the general population. The pilot-scale production process has been described in adequate detail. The Panel notes that the production process, as reported by the applicant, involves steps and practices which may have contributed to cross-contamination and batch-to-batch variability of certain microbiological parameters. The reported mineral oil aromatic hydrocarbons content in the NF raised safety concerns. Phthalates were also detected in the NF, and due to the limited information provided on materials in contact with the NF, the source of this contamination cannot be determined. The Panel identified major issues related to the microbiological quality of the NF. High variability of total aerobic mesophilic counts and, in some cases, elevated counts of presumptive <i>Bacillus cereus</i>, yeasts and moulds were observed across batches. The Panel cannot conclude on these aspects based on the available evidence. Regarding specifications, the Panel considers that the proposed limits do not adequately capture the variability of the NF and are insufficient to ensure product safety. The Panel considers that consumption of the NF may trigger primary sensitisation to <i>A. domesticus</i> proteins. Allergic reactions may also occur in subjects allergic to crustaceans, mites and molluscs (cross-reactivity). Additionally, allergens from the feed may be present in the NF. The Panel concludes that the safety of the NF under the proposed uses and use levels cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.9946","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149048426","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 endo-1,4-β-xylanase from the genetically modified Aspergillus oryzae strain NZYM-FA","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;Alessandro Manghi,&nbsp;Daniele Cavanna,&nbsp;Yi Liu,&nbsp;Cristina Andreoli,&nbsp;Andrea Terron,&nbsp;Andrey Yurkov","doi":"10.2903/j.efsa.2026.10335","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10335","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-FA by Novozymes A/S. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of four food manufacturing processes. The dietary exposure to the food enzyme–Total Organic Solids (TOS) was calculated to be up to 0.031 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1101.3 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 35,526. Based on the revised exposure estimation, the newly derived 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":"24 9","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10335","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149048425","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}