EFSA Journal最新文献

{"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}

{"title":"EFSA scientific report on dietary exposure to lead in the European population","authors":"European Food Safety Authority (EFSA),&nbsp;Petra Gergelová,&nbsp;Laura Martino,&nbsp;Elena Rovesti","doi":"10.2903/j.efsa.2025.9577","DOIUrl":"10.2903/j.efsa.2025.9577","url":null,"abstract":"<p>Following a request of the European Commission and the need for a joint assessment identified by the European Environmental Agency, the EFSA estimated the chronic dietary exposure to lead in the European population, updating the results of the 2012 assessment. The highest mean lead occurrence was observed for food category ‘Meat and meat products’, strongly affected by extreme lead concentrations found in game mammals' meat, the impact of which was assessed via two exposure scenarios including (A) an excluding (B) them. In the scenario A, the highest mean exposure upper bound (UB) and highest 95th percentile exposure UB were estimated respectively in toddlers (1.80 μg/kg body weight (bw) per day) and in infants (3.36 μg/kg body weight (bw) per day). Across the different age classes, the main contributors to the dietary exposure to lead in adults were the meat-based foods, mostly ‘Cured ripened raw sausages’, other types of sausages, game mammals' meat and ‘Bread and similar products’. Ad hoc exposure scenarios for high consumers of game animals’ meat showed ⁓six-fold higher exposure as compared to the total population when extreme lead levels were considered. The authority also investigated the time trend in the occurrence. A linear shape was considered appropriate to to describe the time trend. A random effect was used to account for similarity of measurements in the same country. The lead occurrence showed a slight decrease for most of the food categories with an increase observed for the ‘Legumes, nuts, oilseeds and spices’ (+0.32 μg/kg per month), ‘Vegetables and vegetable products’ (+0.17 μg/kg per month) and ‘Coffee, cocoa, tea and infusions’ (1.28 μg/kg per month). Uncertainties were identified and recommendations listed to improve future dietary exposure assessments to lead.</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://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9577","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145128957","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 levels for cyflufenamid in various crops","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.2025.9611","DOIUrl":"10.2903/j.efsa.2025.9611","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Belchim B.V. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance cyflufenamid in parsley, raspberries (red and yellow), blackberries, blueberries, cranberries, currants, gooseberries, rose hips, mulberries, azaroles/Mediterranean medlars, elderberries and other small fruits and berries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all the requested crops. Adequate analytical methods are available to control the residues of cyflufenamid according to the enforcement residue definition in plant matrices 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 cyflufenamid according to the reported 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":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12332501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816096","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":"Statement on the use and interpretation of the margin of exposure approach","authors":"EFSA Scientific Committee,&nbsp;Suzanne Hougaard Bennekou,&nbsp;Ana Allende,&nbsp;Angela Bearth,&nbsp;Josep Casacuberta,&nbsp;Laurence Castle,&nbsp;Tamara Coja,&nbsp;Amélie Crépet,&nbsp;Thorhallur Halldorsson,&nbsp;Laurentius (Ron) Hoogenboom,&nbsp;Helle Knutsen,&nbsp;Claude Lambré,&nbsp;Søren Nielsen,&nbsp;Dominique Turck,&nbsp;Antonio Vicent Civera,&nbsp;Roberto Villa,&nbsp;Pikka Jokelainen,&nbsp;Holger Zorn,&nbsp;Diane Benford,&nbsp;Rex Fitzgerald,&nbsp;Bette Meek,&nbsp;Alicja Mortensen,&nbsp;Salomon Sand,&nbsp;Emanuela Testai,&nbsp;Paola Manini,&nbsp;Alicia Paini,&nbsp;Dieter Schrenk","doi":"10.2903/j.efsa.2025.9606","DOIUrl":"10.2903/j.efsa.2025.9606","url":null,"abstract":"<p>The margin of exposure (MOE) is a risk assessment tool used to evaluate the safety of substances in food and feed. Adopted by the European Food Safety Authority (EFSA) in 2005, the MOE is calculated as the ratio between a Reference Point (RP) and the estimated exposure. While some regulatory bodies use ‘margin of safety’ (MOS) interchangeably with MOE, others define it differently, leading to inconsistencies in interpretation. To address this, EFSA has standardised its terminology, establishing MOE as a primary metric for safety assessments across human and animal health evaluations. In addition, the meaning and interpretation of terms used to qualify a ‘concern’ is elaborated. The EFSA definitions will come into force from when this statement is published. By refining these definitions and ensuring consistent terminology across sectors, EFSA aims to improve clarity and transparency in its risk assessments, facilitating effective communication.</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/PMC12332500/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816097","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 cotton GHB614 × LLCotton25 for renewal authorisation under regulation (EC) No 1829/2003 (dossier GMFF-2024-21890)","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;Ana M. Camargo,&nbsp;Paolo Lenzi,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9572","DOIUrl":"10.2903/j.efsa.2025.9572","url":null,"abstract":"<p>Following the submission of dossier GMFF-2024-21890 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seeds 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 cotton GHB614 × LLCotton25, 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 sequences of the events in cotton GHB614 × LLCotton25 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2024-21890 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton GHB614 x LLCotton25.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12329425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798528","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 oxygen (E 948) and hydrogen (E 949) as food additives","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;Josef Daniel Rasinger,&nbsp;Camilla Smeraldi,&nbsp;Samuele Di Ciano,&nbsp;Borana Dino,&nbsp;Elena Mazzoli,&nbsp;Ana Maria Rincon","doi":"10.2903/j.efsa.2025.9595","DOIUrl":"10.2903/j.efsa.2025.9595","url":null,"abstract":"<p>The Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of oxygen (E 948) and hydrogen (E 949) as food additives. Their currently permitted use in food in the European Union (EU) is in all food categories, including in foods for infants and young children at quantum satis (QS). They can also be used in food additive preparations, food enzymes and nutrients also at QS. No interested business operators (IBOs) provided information in response to the call for data published by EFSA to support their re-evaluation. The original evaluation by the EU in 1990 indicated their use as packaging gases, and in the case of oxygen (E 948), also as propellant. The Panel considered the two gases to be of low toxicological concern when used as food additives and their dietary exposure very low. The Panel concluded that the use of oxygen (E 948) and hydrogen (E 949) as food additives does not raise a safety concern. The Panel made some recommendations for amending existing EU specifications for both oxygen (E 948) and hydrogen (E 949).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12329423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798529","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 and efficacy of a feed additive consisting of L-arginine produced with Escherichia coli CCTCC M 20231961 for all animal species (Kempex Holland B.V.)","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;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Matteo L. Innocenti,&nbsp;Maria Kolona,&nbsp;Jordi Tarrés Call","doi":"10.2903/j.efsa.2025.9609","DOIUrl":"10.2903/j.efsa.2025.9609","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 L-arginine produced with a genetically modified strain of <i>Escherichia coli</i> (CCTCC M 20231961) as a nutritional feed additive for all animal species and categories. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the production strain <i>E. coli</i> CCTCC M 20231961 does not raise safety concerns. No viable cells or DNA of the production strain are detected in the final product. Therefore, the FEEDAP Panel concludes that the additive does not pose any safety concern regarding the production strain. The use of L-arginine produced by fermentation with <i>E. coli</i> CCTCC M 20231961 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of L-arginine in water for drinking. The use of L-arginine produced by fermentation with <i>E. coli</i> CCTCC M 20231961 in animal nutrition is considered safe for the consumers and for the environment. The FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes and to be a potential dermal sensitiser. The feed additive consisting of L-arginine produced by fermentation with <i>E. coli</i> CCTCC M 20231961 is regarded as an efficacious source of the amino acid L-arginine for all non-ruminant species. For the supplemental L-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9609","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144782700","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":"Efficacy of a feed additive consisting of 6-phytase produced by (Komagataella phaffii CGMCC 7.370) (VTR-phytase) for all pigs and growing poultry species (Victory Enzymes GmbH)","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;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Marianna Kujawa,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2025.9556","DOIUrl":"10.2903/j.efsa.2025.9556","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6-phytase produced by <i>Komagataella phaffii</i> CGMCC 7.370 (VTR-phytase) as a zootechnical feed additive for all pigs and growing poultry species. The additive is intended to be commercialised in two formulations: liquid and powder. In a previous opinion the FEEDAP Panel concluded that the additive is safe for target species, consumers and environment. The FEEDAP Panel deemed that both formulations of the additive are not skin and eyes irritant but should be considered skin and respiratory sensitisers. The FEEDAP Panel concluded that VTR-phytase has potential to be efficacious in laying hens at 1000 U phytase/kg complete feed, and this conclusion was extended to all laying and reproductive poultry. However, due to the lack of sufficient data, the Panel was not in a position to conclude on the efficacy for poultry for fattening or reared for laying/breeding, and in any porcine species. The applicant provided new trials to support the efficacy of the additive on those target species. Based on the data provided in the previous and current application, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for all poultry for fattening and reared for laying/breeding and reproductive porcine species at 500 U phytase/kg complete feed and all porcine species for fattening and reared for reproduction at 750 U phytase/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9556","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144782775","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":"Updated peer review of the pesticide risk assessment of the active substance fosetyl","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.2025.9513","DOIUrl":"10.2903/j.efsa.2025.9513","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, France, and co-rapporteur Member State, Estonia, for the pesticide active substance fosetyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of fosetyl as a fungicide on grapes, citrus and pome fruits. The conclusions from 2018 were updated with regard to the endocrine-disrupting properties following a mandate received from the European Commission in October 2019. 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 identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9513","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144782701","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":"Current practice, challenges and future opportunities in the safety assessment of newly expressed proteins in genetically modified plants","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;Luca Belmonte,&nbsp;Martina Bonatti,&nbsp;Ian Dewhurst,&nbsp;Ivan Dimitrov,&nbsp;Arianna Ferrari,&nbsp;Tilemachos Goumperis,&nbsp;Kevin Hogeveen,&nbsp;Aleksandra Lewandowska,&nbsp;Robin Ornsrud,&nbsp;Nikoletta Papadopoulou,&nbsp;Konstantinos Paraskevopoulos,&nbsp;Tommaso Raffaello,&nbsp;Reinhilde Schoonjans,&nbsp;Elisabeth Waigmann,&nbsp;Elena Sánchez-Brunete,&nbsp;Antonio Fernandez Dumont","doi":"10.2903/j.efsa.2025.9568","DOIUrl":"10.2903/j.efsa.2025.9568","url":null,"abstract":"<p>Current risk assessment strategies for protein safety of newly expressed proteins (NEPs) in genetically modified (GM) plants are based on chemical risk assessment principles and Codex Alimentarius guidelines for biotech-derived foods, initially published in 2003. These guidelines were designed for proteins with multiple testing options and for GMOs expressing a low number of NEPs. However, two decades of experience in assessing GMO and biotech products, along with recent advances in the field, underscore the need to update best practices for protein safety assessment. Furthermore, new types of products challenge the application of the current international guidelines, as assessments become more complex due to NEPs that are difficult to test using existing approaches or products with numerous NEPs. This document outlines a strategy that strengthens the stepwise, weight-of-evidence approach, incorporating new methodologies as complementary or alternative studies. An improved strategy for protein safety assessment could include: (1) considering history of safe use (HoSU), read-across and phylogeny defining the type of data required and remove the need for specific in vitro or in vivo studies; (2) applying advanced in silico tools, including predictive computational models and improved phylogenetic analysis to enable more accurate comparisons with known allergens, toxins or ‘safe’ proteins; (3) using standardised in vitro gastrointestinal models that replicate physiological conditions; (4) developing targeted in vivo studies; (5) evaluating the role of exposure in the safety assessment; and, where necessary, (6) considering post-market monitoring for risk characterisation. Consensus on the definition of HoSU and the effective integration of novel methodologies into the current NEP safety assessment will be essential to meet society's demand for safer, healthier and more sustainable food/feed in a growing world. This calls for revisiting and refining the goals of protein safety risk assessment to ensure that NEPs in biotech products are evaluated appropriately, consistently and proportionately.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9568","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144773927","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}