EFSA Journal最新文献

{"title":"Safety evaluation of an extension of use of the food enzyme mannan endo-1,4-β-mannosidase from the non-genetically modified Aspergillus niger strain AE-HCM","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;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9489","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9489","url":null,"abstract":"<p>The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-<span>d</span>-mannan mannanohydrolase; EC 3.2.1.78) is produced with the non-genetically modified microorganism <i>Aspergillus niger</i> strain AE-HCM by Amano Enzyme Inc. 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 three food manufacturing processes. Subsequently, the applicant requested to extend its use to include ten additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of 13 food manufacturing processes. As the food enzyme–total organic solids (TOS) are not carried into the final foods in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated for the remaining 12 processes. The dietary exposure was calculated to be up to 0.586 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (728 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1242. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 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.2025.9489","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144308727","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":"Commodity risk assessment of Berberis thunbergii plants from the UK","authors":"EFSA Panel on Plant Health (PLH),&nbsp;Antonio Vicent Civera,&nbsp;Paula Baptista,&nbsp;Anna Berlin,&nbsp;Elisavet Chatzivassiliou,&nbsp;Jaime Cubero,&nbsp;Nik Cunniffe,&nbsp;Eduardo de la Peña,&nbsp;Nicolas Desneux,&nbsp;Francesco Di Serio,&nbsp;Anna Filipiak,&nbsp;Paolo Gonthier,&nbsp;Beata Hasiów-Jaroszewska,&nbsp;Hervé Jactel,&nbsp;Blanca B. Landa,&nbsp;Lara Maistrello,&nbsp;David Makowski,&nbsp;Panagiotis Milonas,&nbsp;Nikos T. Papadopoulos,&nbsp;Hanna Susi,&nbsp;Dirk Jan van der Gaag,&nbsp;Jane Debode,&nbsp;Christophe Lacomme,&nbsp;Charles Manceau,&nbsp;Christer Sven Magnusson,&nbsp;Juan A. Navas-Cortes,&nbsp;Christos Kritikos,&nbsp;Maria Kormpi,&nbsp;Dimitrios Papachristos,&nbsp;Chrysavgi Reppa,&nbsp;Antigoni Akrivou,&nbsp;Spyridon Antonatos,&nbsp;Despoina Beris,&nbsp;Olaf Mosbach Schulz,&nbsp;Monia Federica Lombardo,&nbsp;Ciro Gardi,&nbsp;Roel Potting","doi":"10.2903/j.efsa.2025.9496","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9496","url":null,"abstract":"<p>The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘high risk plants, plant products and other objects’. Taking into account the available scientific information, including the technical information provided by the applicant country, this Scientific Opinion covers the plant health risks posed by the following commodities: <i>Berberis thunbergii</i>, bare root plants (up to 3 years old), whips (up to 2 years old) and rooted plants in pots (up to 4 years old) imported into the EU from the UK. A list of pests potentially associated with the commodities was compiled. The relevance of each pest was assessed based on evidence following defined criteria. One EU quarantine pest (<i>Phytophthora ramorum</i> (non-EU isolates)), one protected zone quarantine pest (<i>Bemisia tabaci</i> (European populations)) and one non-quarantine pest (<i>Phytophthora kernoviae</i>) were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in the UK and specified in the technical dossier were evaluated taking into account the factors reducing their efficacy. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies between the pests evaluated, with <i>P. ramorum</i> being the pest most frequently expected on the evaluated imported commodities. Expert Knowledge Elicitation indicated, with 95% certainty, that between 9975 and 10,000 per 10,000 <i>B. thunbergii</i> rooted plants in pots would be free from <i>P. ramorum.</i></p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9496","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144292920","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":"Setting of import tolerances for difenoconazole 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.2025.9472","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9472","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted an application to the competent national authority in Spain (rapporteur Member State, RMS) to set import tolerances for the active substance difenoconazole in various crops imported from the United States and Brazil. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for citrus fruits, tree nuts, mangoes, papayas, dry peas and soya beans. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in the commodities under consideration, animal tissues and eggs at the validated limit of quantification (LOQ) of 0.01 mg/kg and in milk at the validated LOQ of 0.005 mg/kg. Quick, Easy, Cheap, Effective, Rugged, and Safe (QuECHERs) methods are also available for the determination of difenoconazole alcohol (CGA205375) in animal matrices at the validated LOQ of 0.012 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 difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9472","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144273507","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 25-hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 for salmonids, other fish species and all other animal species (except poultry, pigs and all ruminants) (DSM Nutritional Products Ltd.)","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;Vasileios Bampidis,&nbsp;Noël Dierick,&nbsp;Montserrat Anguita,&nbsp;Rosella Brozzi,&nbsp;Matteo L. Innocenti,&nbsp;Fabiola Pizzo,&nbsp;Jordi Tarrés-Call,&nbsp;Angelica Amaduzzi","doi":"10.2903/j.efsa.2025.9479","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9479","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 25-hydroxycholecalciferol as a nutritional feed additive for salmonids, other fish species and all other animal species (except poultry, pigs and all ruminants). The additive is currently authorised for use in pigs, poultry and ruminants. The additive is safe for salmonids, other fish species and all other animal species (other than pigs, poultry and ruminants) at the maximum recommended use levels (in mg 25-OH-D₃/kg complete feed): 0.8 for salmonids, 0.075 in other fish species and 0.05 for all other animal species (other than poultry, pigs and ruminants). The use of 25-OH-D₃ in feed for all animal species under the proposed conditions of use is considered safe for the consumers and the environment. With regard to the safety of users, the additive is not irritant to the skin or eyes. No conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to the absence of data. The FEEDAP Panel concludes that 25-OH-D₃, when used as a nutritional additive in feed, is efficacious for all animal species.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9479","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264618","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 mannan endo-1,4-β-mannosidase from the non-genetically modified Aspergillus niger strain AE-HCM","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;Andrew Chesson,&nbsp;Lieve Heman,&nbsp;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Natalia Kovalkovicova,&nbsp;Giulio di Piazza,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9488","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9488","url":null,"abstract":"<p>The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-<span>d</span>-mannan mannanohydrolase; EC 3.2.1.78) is produced with the non-genetically modified microorganism <i>Aspergillus niger</i> strain AE-HCM by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in three food manufacturing processes. Dietary exposure was calculated to be up to 0.568 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 728 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 1282. A search for the homology of the amino acid sequence of the mannan endo-1,4-β-mannosidase to known allergens was made and a match with a respiratory allergen 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":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9488","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264620","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-1,4-β-xylanase from the genetically modified Trichoderma reesei strain DP-Nzd72","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;Daniele Cavanna,&nbsp;Ana Criado,&nbsp;Cristina Fernández-Fraguas,&nbsp;Simone Lunardi,&nbsp;Valentina Tokić,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9485","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9485","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>Trichoderma reesei</i> strain DP-Nzd72 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and 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 0.017 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 58,824. A search for the homology of the amino acid sequence of the endo-1,4-β-xylanase 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":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9485","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264619","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 glucan 1,4-α-maltohydrolase from the genetically modified Escherichia coli strain MLAVSC","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;Daniele Cavanna,&nbsp;Jaime Aguilera Entrena,&nbsp;Cristina Fernández-Fraguas,&nbsp;Silvia Peluso,&nbsp;Valentina Tokić,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9483","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9483","url":null,"abstract":"<p>The food enzyme glucan 1,4-α-maltohydrolase (4-α-<span>d</span>-glucan α-maltohydrolase, EC 3.2.1.133) is produced with the genetically modified <i>Escherichia coli</i> strain MLAVSC by Advanced Enzyme Technologies Ltd. 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 three food manufacturing processes. Since residual amounts of food enzyme total organic solids (TOS) are removed in one food manufacturing process, dietary exposure was calculated for the remaining two processes. It was estimated to be up to 0.172 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 5814. A search for the homology of the amino acid sequence of the glucan 1,4-α-maltohydrolase 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 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":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9483","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264543","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 triacylglycerol lipase from the genetically modified Komagatella phaffii strain LALL-LI2","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;Jaime Aguilera,&nbsp;Daniele Cavanna,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9486","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9486","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified <i>Komagatella phaffii</i> strain LALL-LI2 by Danstar Ferment AG. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.071 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 triacylglycerol lipase 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":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9486","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144264542","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 ponceau 4R for its use in baits for freshwater fish (GIFAP)","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;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Alberto Navarro-Villa,&nbsp;Maria Vittoria Vettori","doi":"10.2903/j.efsa.2025.9462","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9462","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of ponceau 4R. Ponceau 4R is intended to be used as a sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs) in baits for freshwater fish up to a maximum content of 15 mg/kg in complementary feed. Ponceau 4R is intended to be incorporated in fishing baits in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture. The characterisation of the additive, its safety and its efficacy were evaluated in a previous opinion of the Panel. In that opinion, the Panel concluded that the use of ponceau 4R in the preparation of baits for freshwater fish under the proposed conditions of use is of no concern for the target animals, for the consumer and the environment. Regarding the user safety, the additive is not skin irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. Finally, in the previous opinion, the Panel concluded that in absence of data no conclusion could be reached on the efficacy of ponceau 4R in freshwater fish baits. Based on the new data submitted by the applicant, the Panel concluded that ponceau 4R has the potential to be efficacious in colouring fishing baits under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9462","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244589","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 grain and flour from perennial intermediate wheatgrass (Thinopyrum intermedium) 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;Harry J. McArdle,&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;Helle Katrine Knutsen,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Ruth Roldán-Torres,&nbsp;Fabio Alfieri,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9467","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9467","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 grain and flour from perennial intermediate wheatgrass (IWG) (<i>Thinopyrum intermedium</i>) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, composed primarily of carbohydrates, proteins and water, is produced by cultivating the IWG plant and subsequently processing it to yield either grains or flour. The target population proposed by the applicant is the general population and the NF is proposed as a food ingredient in several food products. Considering the nutritional profile of the NF and the proposed conditions of use, its consumption is considered not nutritionally disadvantageous, and the Panel considers that no toxicological studies are required on this NF. The microbiological analyses for several batches of the NF revealed high microbial counts regarding total aerobic microbial count, Enterobacteriaceae, yeasts and moulds, highlighting excessive variability in the hygiene conditions along the production process. The NF has the same potential as wheat, barley and rye to trigger IgE-mediated allergic reactions in cereal-allergic individuals and/or adverse reactions in individuals with coeliac disease under the proposed conditions of use. The Panel notes that, due to the high microbial loads observed in both IWG grain and flour batches, the microbiological quality of the NF is compromised. The potential presence of Enterobacteriaceae and opportunistic pathogen <i>Pantoea</i> species, such as <i>P. agglomerans</i>, and further released compounds could pose safety concerns. Moreover, the provided stability data do not support a 12-month shelf-life for the NF. Based on the available data, the Panel concludes that the safety of the NF, grain and flour from perennial intermediate wheatgrass (<i>Thinopyrum intermedium</i>) cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9467","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144244960","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}