EFSA Journal最新文献

{"title":"Safety of a feed additive consisting of xanthan gum (produced with Xanthomonas campestris strains ATCC SD-7012, DSM 23730, CNCM I-4861 and ■■■■■ for all animal species with the exception of cats and aquatic species (BIOPOLYMER International)","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;Rosella Brozzi,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Fabiola Pizzo,&nbsp;Maria Vittoria Vettori,&nbsp;Angelica Amaduzzi","doi":"10.2903/j.efsa.2025.9466","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9466","url":null,"abstract":"<p>Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the safety of xanthan gum as a technological feed additive for all animal species, with the exception of cats and aquatic species. Xanthan gum, produced with <i>Xanthomonas campestris</i> ATCC SD-7012, CNCM I-4861, DSM 23730 and ■■■■■, does not pose any safety concern associated with the production strains. The FEEDAP Panel concluded that the additive is safe for all target animal species under application. The use of xanthan gum in animal nutrition did not pose any concern for consumer safety. Additionally, the use of this additive was considered safe for the environment. Regarding the user safety, the additive is not a skin irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the eye irritation potential due to the lack of data.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9466","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144331953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme endo-polygalacturonase from the genetically modified Trichoderma reesei strain AR-414","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;D. Cavanna,&nbsp;A. Criado,&nbsp;Cristina Fernandez-Fraguas,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9484","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9484","url":null,"abstract":"<p>The food enzyme endo-polygalacturonase ((1–4)-α-<span>d</span>-galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified <i>Trichoderma reesei</i> strain AR-414 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in three food manufacturing processes, dietary exposure was calculated for the remaining five food processes. It was estimated to be up to 0.216 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 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 4630. A search for the homology of the amino acid sequence of the endo-polygalacturonase to known allergens was made and matches with one food allergen and 12 respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the 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":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9484","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144323407","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 maize NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21250)","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;Paolo Lenzi,&nbsp;Ana M. Camargo,&nbsp;Pietro Piffanelli,&nbsp;Tommasso Raffaelo","doi":"10.2903/j.efsa.2025.9505","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9505","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21250 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, 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 NK603, 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 NK603 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application GMFF-2023-21250 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9505","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144323408","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 pelargonic acid (nonanoic acid)","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;Alexandra Piti,&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.2025.9408","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9408","url":null,"abstract":"<p>The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co-rapporteur Member State Austria for the pesticide active substance pelargonic acid (nonanoic acid) and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 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 use of pelargonic acid as a herbicide on vineyards, potatoes, paths and places with woody plants, ornamental shrubs, ornamentals lawn, home gardens and allotments, paths and open areas with tree growth, woody ornamentals, decorative lawns, turf (field use). The conclusions reached in the renewal process were updated following the request from the European Commission via a specific mandate in accordance with Article 31 of Regulation (EC) No 178/2002, in conjunction with Regulation (EC) No 1107/2009, to further elaborate on certain aspects of the risk assessment for non-target arthropods for the representative home and garden uses of the plant protection product ‘MON 74134’. 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.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9408","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144315303","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 glucose oxidase from the non-genetically modified Penicillium rubens strain PGO 19–162","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Ana Criado,&nbsp;Jaime Aguilera,&nbsp;Cristina Fernández-Fraguas,&nbsp;Magdalena Andryszkiewicz,&nbsp;Laura Sanmartin,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9494","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9494","url":null,"abstract":"<p>The food enzyme glucose oxidase (β<i>-</i><span>d</span>-glucose: oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with the non-genetically modified <i>Penicillium rubens</i> strain PGO 19–162 by Shin Nihon Chemical Co. Ltd. The food enzyme was free from viable cells of the production organism. It is intended to be used in five food manufacturing processes. Dietary exposure was estimated to be up to 0.062 mg total organic solids (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 193 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 3113. A search for the homology of the amino acid sequence of the glucose oxidase to known allergens was made and matches with one food allergen and one contact allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the 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":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9494","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144315333","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 assessment of the process Gneuss 5 used to recycle post-consumer PET into food contact materials","authors":"EFSA Panel on Food Contact Materials (FCM),&nbsp;Claude Lambré,&nbsp;Riccardo Crebelli,&nbsp;Maria da Silva,&nbsp;Koni Grob,&nbsp;Maria Rosaria Milana,&nbsp;Marja Pronk,&nbsp;Gilles Rivière,&nbsp;Mario Ščetar,&nbsp;Georgios Theodoridis,&nbsp;Els Van Hoeck,&nbsp;Nadia Waegeneers,&nbsp;Vincent Dudler,&nbsp;Constantine Papaspyrides,&nbsp;Maria de Fátima Tavares Poças,&nbsp;Daniele Comandella,&nbsp;Evgenia Lampi","doi":"10.2903/j.efsa.2025.9492","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9492","url":null,"abstract":"<p>The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process Gneuss 5. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are melted in an extruder (step 2), decontaminated during a melt-state polycondensation (MSP) ■■■■■ (step 3) and finally pelletised. Having examined the challenge test provided, the Panel concluded that MSP (step 3) is critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency of step 3 are the pressure, the temperature, the residence time as well as the geometrical and operational characteristics of the reactor. It was demonstrated by the challenge test that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molecular mass of a contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature or below, with or without hot-fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9492","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144308711","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 pullulanase from the genetically modified Bacillus licheniformis strain DP-Dzp107","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Cristina Fernandez-Fraguas,&nbsp;Laura Sanmartín,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9481","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9481","url":null,"abstract":"<p>The food enzyme pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified <i>Bacillus licheniformis</i> strain DP-Dzp107 by Genencor International B.V. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism, but not its DNA. The food enzyme is intended to be used in three food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining food manufacturing process. It was estimated to be up to 0.053 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, the Panel considers toxicity tests unnecessary. A search for the homology of the amino acid sequence of the pullulanase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the 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":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9481","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144308725","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 sucrose:sucrose fructosyltransferase from the genetically modified Yarrowia lipolytica strain E4772","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9490","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9490","url":null,"abstract":"<p>The food enzyme sucrose:sucrose fructosyltransferase (sucrose:sucrose 1′-β-<span>d</span>-fructosyltransferase; EC 2.4.1.99) is produced with the genetically modified <i>Yarrowia lipolytica</i> strain E4772 by SEQENS. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is free from viable cells of the production organism, but not free from recombinant DNA. The food enzyme is intended to be used in the processing of sugars for the production of fructo-oligosaccharides. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.088 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the sucrose: sucrose fructosyltransferase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the 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":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9490","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144308722","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 endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 (Huvezym® neXo) for all porcine species and all poultry (Huvepharma EOOD)","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;Noël Dierick,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Marianna Kujawa,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2025.9460","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9460","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase (produced with <i>Trichoderma citrinoviride</i> DSM 33578) (Huvezym® neXo), intended to be used as a zootechnical feed additive (functional group: digestibility enhancers) for all <i>Suidae</i> and all poultry at the recommended application level 1500 endo-pentosanase units (EPU), 100 cellulase unit (CU) and 100 xyloglucanase unit (XGU)/kg of complete feed. The additive is available in granulated (Huvezym® neXo 100 G) and liquid (Huvezym® neXo100 L) forms, and it is authorised for use in reproductive sows and poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. In previous opinions, the FEEDAP Panel concluded that Huvezym® neXo is safe for the target species, consumers and the environment. Additionally, the FEEDAP Panel concluded that Huvezym® neXo in either form is not an irritant to the skin and eyes; the liquid form is not a skin sensitiser, but the solid form should be considered a potential skin sensitiser. Both forms of the additive are considered respiratory sensitisers. However, in the previous assessments, the Panel could not conclude on the efficacy of weaned piglets and laying hens. Considering the previously and newly submitted data the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for all porcine species and all poultry under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9460","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144308712","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 feed additive consisting of 6-phytase (produced with Trichoderma reesei CBS 126897) (Quantum® Blue) for the renewal of its authorisation for poultry, weaned piglets, pigs for fattening and sows (4a19), and its extension of use to other porcine species and ornamental birds (AB Enzymes Finland Oy)","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;Baltasar Mayo,&nbsp;Monsterrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Rosella Brozzi,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Elisa Pettenati,&nbsp;Fabiola Pizzo,&nbsp;Angelica Amaduzzi","doi":"10.2903/j.efsa.2025.9463","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9463","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 the feed additive consisting of 6-phytase produced with a genetically modified strain of <i>Trichoderma reesei</i> (CBS 126897) (Quantum® Blue) as a zootechnical feed additive for poultry, piglets, pigs for fattening and sows, other porcine species and ornamental birds. The additive is currently authorised for use in feed for laying birds, poultry other than laying birds, weaned piglets, pigs for fattening and sows. This scientific opinion concerns the request for the renewal of the authorisation of the additive for these species and the extension of use to suckling piglets and other porcine species and ornamental birds. The additive is available in two solid (Quantum® Blue 5 G and 40 P) and two liquid formulations (Quantum® Blue 5 and 10 L). Some changes in the composition of the product have been implemented since the first authorisation. The applicant provided evidence that the additive complies with the terms of the authorisation. The FEEDAP Panel concluded that all formulations of the additive remain safe for the target species, consumers and the environment, and that the extension of use to the new species would not affect these conclusions. Regarding user safety, all the forms of the additive should be considered as respiratory sensitisers. The solid forms of the additive are dust free; therefore, the exposure of users through inhalation is unlikely. No specific information was submitted for the four formulations of the additive under assessment regarding their potential to be skin and eye irritants and skin sensitisers. In the absence of data, the FEEDAP Panel is not in the position to conclude on the potential of the additive to be skin and eye irritants or skin sensitisers. There is no need for the assessment of efficacy in poultry, weaned piglets, pigs for fattening and sows in the context of the renewal of the authorisation. The FEEDAP Panel considers that the additive has the potential to be efficacious in ornamental birds at 250 FTU/kg complete feed and in suckling piglets and in suckling and weaned piglets of minor porcine species at 500 FTU/kg and in minor porcine species for fattening/reared for reproduction and reproductive animals at 250 FTU/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9463","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144308726","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}