EFSA Journal最新文献

{"title":"Surveillance of West Nile virus infections in humans and animals in Europe, monthly report – data submitted up to 6 August 2025","authors":"European Centre for Disease Prevention and Control (ECDC), European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9624","DOIUrl":"10.2903/j.efsa.2025.9624","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Epidemiological summary</h3>\u0000 \u0000 <p>In 2025, and as of 6 August 2025, 6 countries in Europe reported 202 locally acquired1 human cases of WNV infection with known place of infection. The earliest and latest date of onset were respectively on 2 June 2025 and 2 August 2025. Locally acquired cases were reported by <b>Italy</b> (168), <b>Greece</b> (26), <b>France</b> (3, of which 1 with unknown place of infection), <b>Romania</b> (3), <b>Bulgaria</b> (1) and <b>Hungary</b> (1). In Europe, 10 deaths were reported.</p>\u0000 \u0000 <p>Case numbers reported so far this year are slightly above the average for the past decade in the same period (163). However, these figures remain lower than those seen in 2024 and 2018—years when virus circulation was particularly intense, with 382 and 385 cases reported by this point in the year, respectively.</p>\u0000 \u0000 <p>As of 6 August, locally acquired human cases of West Nile virus (WNV) infection have been reported in 40 regions across six countries. This compares with 108 regions (11 countries) during the same period in 2024 and 68 regions in 2018 (seven countries). All six countries have previously reported human cases of WNV. Italy is currently experiencing a significant outbreak, with 168 confirmed human infections, including 10 fatalities. For the first time in Italy, the provinces of Latina (ITI44) and Frosinone (ITI45) have reported human cases. Similarly, Romania has reported its first cases in Sălaj County (RO116).</p>\u0000 \u0000 <p>As observed in previous years, most cases were among males aged 65 years and older. The hospitalisation rate was high compared with previous years, with 100% of cases hospitalised this year compared to 93% in the past decade. That most cases are hospitalised is most likely due to the nature of WNV surveillance, which tends to predominantly capture the most severe cases. The case fatality rate so far this year is 7%, which is comparable to the 11% observed in the previous decade. Neurological manifestations were reported in 56% of cases this year compared to 66% in the previous decade. In general, a dominance of neurological cases is expected, as cases with more severe symptoms are more likely to be diagnosed.</p>\u0000 \u0000 <p>From the veterinary perspective, 16 WNV outbreaks among equids and 20 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 29 July 2025 in Italy and 29 July 2025 in Austria. Outbreaks among equids were reported by <b>Italy</b> (11), <b>Greece</b> (2), <b>Germany</b> (1), <b>Hungary</b> (1) and <b>Spain</b> (1). Outbreaks among birds were reported by <b>Italy</b> (19) and <b>Austria</b> (1).</p>\u0000 ","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9624","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144915241","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":"Literature horizon scan for new scientific data on plants and their products obtained by new genomic techniques (January 2022 to May 2025)","authors":"European Food Safety Authority (EFSA),&nbsp;Martina Bonatti,&nbsp;Paolo Lenzi,&nbsp;Aleksandra Lewandowska,&nbsp;Irene Pilar Munoz Guajardo,&nbsp;Nikoletta Papadopoulou,&nbsp;Tommaso Raffaello,&nbsp;Elena Sánchez-Brunete","doi":"10.2903/j.efsa.2025.9619","DOIUrl":"10.2903/j.efsa.2025.9619","url":null,"abstract":"<p>The European Food Safety Authority has issued several scientific opinions on plants obtained through certain new genomic techniques (NGTs) following requests received by the European Commission. These scientific opinions provided considerations on the potential risks associated with NGTs, as compared to conventional breeding techniques and established genomic techniques (EGTs), and on the applicability of existing guidelines for the risk assessment of plants obtained by NGTs and products thereof. Against this background, EFSA was asked by the European Commission ‘to provide scientific and technical assistance for a regular horizon scanning to assess new scientific data on plants, animals, microorganisms and products thereof obtained by new genomic techniques’, to assess any new data and evidence emerging from these studies and to consider whether it may have implications for EFSA's relevant scientific opinions. A critical assessment of the quality and relevance of these studies should also be conducted, and biannual reports delivered to the Commission. This report presents the outcome of the pilot literature search on new scientific data on plants and products thereof obtained by NGTs, performed as described in the protocol made available for public consultation in May–June 2025. The report describes search strategies and inclusion/exclusion criteria applied for the literature review and presents the results of the assessment performed for new scientific data (January 22 to May 25) on plants and their products obtained by NGTs. The report discusses the limitations of the search and provides recommendations for improvement. EFSA concluded that none of the studies retrieved by the literature search contained new hazards or risks not previously considered in EFSA scientific opinions.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9619","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144915240","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 of the active substance prothioconazole","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Angelo Colagiorgi,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Mark Egsmose,&nbsp;Gabriella Fait,&nbsp;Franco Ferilli,&nbsp;Monica Fittipaldi Broussard,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Roberto Lava,&nbsp;Renata Leuschner,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Christopher Lythgo,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Laura Padovani,&nbsp;Vincenzo Padricello,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Simone Rizzuto,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9593","DOIUrl":"10.2903/j.efsa.2025.9593","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom and Poland, after Brexit and co-rapporteur Member State, France, for the pesticide active substance prothioconazole are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of prothioconazole as a fungicide on barley, wheat, oats, spelt, rye and triticale field crops and seeds. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9593","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144910270","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 bacillolysin from the non-genetically modified Bacillus amyloliquefaciens strain AGS 430","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;Jeroen Pasch,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9620","DOIUrl":"10.2903/j.efsa.2025.9620","url":null,"abstract":"<p>The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified <i>Bacillus amyloliquefaciens</i> strain AGS 430 by Kerry Ingredients &amp; Flavours Ltd. 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 11 food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process. In the present assessment, EFSA has updated the safety evaluation of this food enzyme when used in a total of 12 food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed from the final foods in two food manufacturing processes, the dietary exposure to the food enzyme-TOS was estimated only for the remaining 10 processes. It was calculated to be up to 7.111 mg TOS/kg body weight per day in European populations. Based on the revised dietary exposure estimates 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 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9620","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144905378","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":"Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels in citrus fruits for imazalil","authors":"European Food Safety Authority (EFSA),&nbsp;Sofia Batista Leite,&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Marco Binaglia,&nbsp;Luis Carrasco Cabrera,&nbsp;Irene Castellan,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Monica Del Aguila,&nbsp;Lucien Ferreira,&nbsp;Luna Greco,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Anna Lanzoni,&nbsp;Renata Leuschner,&nbsp;Jochem Louisse,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Stefanie Nave,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Hermine Reich,&nbsp;Simone Rizzuto,&nbsp;Silvia Ruocco,&nbsp;Alessia Pia Scarlato,&nbsp;Andrea Simonati,&nbsp;Marta Szot,&nbsp;Olha Timofieieva,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani,&nbsp;Elena Zioga","doi":"10.2903/j.efsa.2025.9614","DOIUrl":"10.2903/j.efsa.2025.9614","url":null,"abstract":"<p>The applicant Janssen Pharmaceutica N.V. submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for imazalil in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005. In addition, a request for raising the MRL for citrus fruits was made. To address the data gaps additional information on the toxicity of the metabolites R014821, FK-722 and FK-284 and storage stability for imazalil and FK-772 in ruminant matrices were submitted. The data gaps implemented in the MRL legislation were considered satisfactorily addressed with the information submitted in this application and in a previous MRL application on courgettes. The available residue data support the intended post-harvest uses in citrus fruits and allow deriving an MRL proposal. The implementation of the Codex MRL for bananas and the maintenance of the existing tentative MRL for melons are proposed for risk management consideration. Based on the risk assessment results, noting that data on unit-to-unit variability of residues to refine the acute consumer risk assessment for citrus were provided, EFSA concluded that the short term and long-term intake of residues resulting from the uses of imazalil according to the intended agricultural practices is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9614","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144881107","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 2023 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU","authors":"European Food Safety Authority (EFSA),&nbsp;Antoine Messéan,&nbsp;Fernando Álvarez,&nbsp;Yann Devos,&nbsp;Elena Sánchez-Brunete,&nbsp;Ana M. Camargo","doi":"10.2903/j.efsa.2025.9613","DOIUrl":"10.2903/j.efsa.2025.9613","url":null,"abstract":"<p>At the request of the European Commission, the European Food Safety Authority (EFSA) assessed the 2023 post-market environmental monitoring (PMEM) report on the cultivation of the genetically modified maize event MON 810, which expresses the Cry1Ab protein. The report provides no evidence of adverse effects from maize MON 810 cultivation. It confirms high refuge compliance among farmers in Spain and Portugal. However, uncertainty remains on compliance in areas where clustered maize MON 810 fields exceed five hectares. No signs of practical resistance to Cry1Ab were found in corn borer populations sampled in north-eastern Spain in 2023, although reduced susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information collected through farmer questionnaires in Spain and scientific literature searches revealed no unanticipated adverse effects on human and animal health, or on the environment. However, EFSA remains concerned about the potential exposure of non-target lepidopteran species classified as ‘very highly’ or ‘extremely’ susceptible to Cry1Ab to harmful amounts of maize MON 810 pollen. Several recommendations from previous PMEM report assessments remain unaddressed and new shortcomings were identified. Particularly, EFSA emphasises the urgent need to: (1) increase the sensitivity of the insect resistance monitoring strategy; (2) implement mitigation measures to ensure exposure of non-target lepidoptera to maize MON 810 pollen remains at levels of no concern; (3) harmonise farmer questionnaires across Spain and Portugal; and (4) revise the remedial action plan. Finally, EFSA acknowledges the proactive initiatives undertaken by the Competent Authorities of Spain in support of the PMEM activities and encourages continued collaboration to strengthen monitoring and risk management measures.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9613","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144869951","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 lacto-N-tetraose (LNT) produced by a derivative strain (Escherichia coli K-12 MG1655 INB_LNT_01) of E. coli K-12 MG1655 (ATCC 700926) 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;Francesco Cubadda,&nbsp;Thomas Frenzel,&nbsp;Marina Heinonen,&nbsp;Rosangela Marchelli,&nbsp;Harry J. McArdle,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Paolo Colombo,&nbsp;Pablo Rodríguez Fernández,&nbsp;Estefanía Noriega Fernández,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9610","DOIUrl":"10.2903/j.efsa.2025.9610","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 lacto-N-tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) LNT, but it also contains lacto-N-triose II, <span>d</span>-lactose, LNT-fructose isomer and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain (<i>Escherichia coli</i> K-12 MG1655 INB_LNT_01) of <i>E. coli</i> K-12 MG1655 (ATCC 700926). LNT when produced by fermentation with genetically modified strains of <i>E. coli</i> K-12 DH1 or <i>E. coli</i> BL21 is already authorised and included in the EU list of NFs. This application refers to a change in the production process and specifications, while the target population, conditions of use and consequently the anticipated intake remain unchanged. The information provided on the identity, production process, composition and specifications of the NF does not raise safety concerns. The intake of other carbohydrate-type compounds structurally related to LNT is also considered of no safety concern. In line with other HiMOs, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake of the NF. Given that the NF would be consumed to the same extent as the already authorised LNT, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns. The Panel concludes that the NF is safe under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9610","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144832572","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 as regards the specifications of the food additives acetic, lactic, tartaric, mono- and diacetyltartaric, mixed acetic and tartaric acids esters of mono- and diglycerides of fatty acids (E 472a,b,d,e,f)","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;Sabina Passamonti,&nbsp;Peter Fürst,&nbsp;Cheyns Karlien,&nbsp;Manuela Mirat,&nbsp;Alexandra Tard,&nbsp;Ana Maria Rincon","doi":"10.2903/j.efsa.2025.9602","DOIUrl":"10.2903/j.efsa.2025.9602","url":null,"abstract":"<p>Acetic, lactic, tartaric, mono- and diacetyltartaric, mixed acetic and tartaric acids esters of mono- and diglycerides of fatty acids (E 472a,b,d,e,f) were re-evaluated in 2020 by the Food Additives and Flavourings (FAF) Panel. The Panel issued several recommendations to amend the specifications of these food additives in Commission Regulation (EU) No 231/2012. The present opinion deals with the assessment of the data provided by interested business operators (IBOs) in support of an amendment of the EU specifications for these food additives. It also includes an assessment of dietary exposure to E 472d, E 472e and E 472f. The Panel concluded that the technical data provided by an IBO support amendments to the specifications for E 472a, E 472b and E 472e in Commission Regulation (EU) No 231/2012. However, regarding E 472d and E 472f, the Panel was unable to confirm that technical data provided by IBOs adequately support an amendment of the specifications as no supporting technical data were provided for these food additives. Dietary exposure estimates for E 472d, E 472e and E 472f, across all population groups and exposure scenarios, were found to be below the acceptable daily intake (ADI) of 480 mg/kg body weight (bw) per day for E 472d and 600 mg/kg bw per day for E 472e and E 472f, based on the food categories included in the assessment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9602","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811204","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 d-α-tocopheryl polyethylene glycol-1000 succinate (Vitamin E TPGS) 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;Gisela Degen,&nbsp;David Gott,&nbsp;Jean-Charles Leblanc,&nbsp;Peter Moldeus,&nbsp;Ine Waalkens-Berendsen,&nbsp;Detlef Wölfle,&nbsp;Civitella Consuelo,&nbsp;Agnieszka Mech,&nbsp;Concepción Medrano-Padial,&nbsp;Ana Maria Rincon,&nbsp;Camilla Smeraldi,&nbsp;Alexandra Tard,&nbsp;Laura Ruggeri","doi":"10.2903/j.efsa.2025.9605","DOIUrl":"10.2903/j.efsa.2025.9605","url":null,"abstract":"<p>The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of <span>d</span>-α-tocopheryl polyethylene glycol-1000 succinate (Vitamin E TPGS) as a new food additive to be used in several food categories as emulsifier. In 2007, the EFSA AFC Panel assessed TPGS as a source of tocopherol intended to be used in foods for particular nutritional uses. The Panel considered the AFC Panel assessment relevant for the present new food additive. Compositional data showed that the proposed food additive is composed of Vitamin E TPGS monoesters (&gt; 82% w/w of the whole preparation) and diesters (&lt; 20% w/w of the whole preparation). Data on the hydrolysis of Vitamin E TPGS showed that the ester bond between <span>d</span>-α-tocopherol and succinic acid is stable under the tested conditions, as no increase in free <span>d</span>-α-tocopherol was observed. Vitamin E TPGS is poorly absorbed and does not represent a source of Vitamin E in the healthy population. Vitamin E TPGS does not raise a concern with respect to genotoxicity and no adverse effects on reproductive and developmental parameters were observed up to 1000 mg TPGS/kg bw per day, the highest dose tested and identified as a reference point. Due to the limitations in the available data (e.g. in reporting), the Panel decided to use an MOE approach instead of deriving an ADI. The Panel considered the calculated MOEs sufficient. Based on the available data, the Panel concluded that the use of Vitamin E TPGS as a new food additive does not raise a safety concern at the proposed use and use levels.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9605","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811205","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 T25 maize for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2024-22651)","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;Tilemachos Goumperis,&nbsp;Paolo Lenzi,&nbsp;Ana M. Camargo,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9570","DOIUrl":"10.2903/j.efsa.2025.9570","url":null,"abstract":"<p>Following the submission of dossier GMFF-2024-22651 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified maize T25, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize T25 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2024-22651 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize T25.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12332502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816095","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}