EFSA Journal最新文献

{"title":"Safety and efficacy of a feed additive consisting of 4-hydroxy-2,5-dimethylfuran-3(2H)-one for all animal species other than dogs and cats (ADISSEO France SAS, ADM International Sàrl, Laboratoires Phodé S.A.S., LUCTA S.A., Norel, S.A.)","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;Maria Bastos,&nbsp;Thomas Poiger,&nbsp;Jaume Galobart,&nbsp;Paola Manini,&nbsp;Jordi Tarrès-Call,&nbsp;Maria Vittoria Vettori,&nbsp;Fabiola Pizzo","doi":"10.2903/j.efsa.2025.9538","DOIUrl":"10.2903/j.efsa.2025.9538","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the authorisation of a feed additive consisting of 4-hydroxy-2,5-dimethylfuran-3(2H)-one for all animal species other than dogs and cats. 4-Hydroxy-2,5-dimethylfuran-3(2H)-one is currently authorised for use as a sensory additive (functional group: flavouring compounds) for cats and dogs at a recommended maximum content of 18 and 25 mg/kg complete feed, respectively. The FEEDAP Panel concludes that the use of the additive 4-hydroxy-2,5-dimethylfuran-3(2H)-one at the maximum use level proposed by the applicants (10 mg/kg complete feed) is safe for all animal species other than cats and dogs. 4-Hydroxy-2,5-dimethylfuran-3(2H)-one is safe for consumer and environment, however, it is irritant to skin, eyes and is a dermal and respiratory sensitiser. It should be considered irritant to the respiratory tract. Any exposure is considered a risk. 4-Hydroxy-2,5-dimethylfuran-3(2H)-one is used in food as a flavouring and its function in feed is essentially the same as that in food. Moreover, the Panel notes that the additive is already authorised in feed for cats and dogs. Therefore, no further demonstration of efficacy is necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9538","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635426","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 endo-1,4-beta-xylanase EC 3.2.1.8 produced by Bacillus subtilis LMG S-15136 (Belfeed B MP/ML) for gestating sows (Puratos NV)","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;Giovanna Martelli,&nbsp;Baltasar Mayo,&nbsp;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Matteo L. Innocenti,&nbsp;Fabiola Pizzo,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2025.9552","DOIUrl":"10.2903/j.efsa.2025.9552","url":null,"abstract":"<p>Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Belfeed B MP/ML as a feed additive for gestating sows when used at 10 IU/kg feed. The additive contains endo-1,4-b-xylanase produced by a genetically modified strain of <i>Bacillus subtilis</i> (LMG S-15136). The FEEDAP Panel concluded that the additive is safe for the target species at the proposed use level and that there are no concerns regarding the use of Belfeed B MP/ML for the consumers and for the environment. The two formulations of the additive were considered skin and eye irritants and respiratory sensitisers. The Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in sows during the gestation period at 10 IU/kg feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9552","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635474","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 a feed additive consisting of folic acid for aquatic species (Chr. Olesen A/S and 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;Jürgen Gropp,&nbsp;Joana Firmino,&nbsp;Jaume Galobart,&nbsp;Fabiola Pizzo,&nbsp;Jordi Ortuño,&nbsp;Robin Ornsrud","doi":"10.2903/j.efsa.2025.9539","DOIUrl":"10.2903/j.efsa.2025.9539","url":null,"abstract":"<p>Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of a feed additive consisting of folic acid intended for use as a nutritional additive (functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effects) for aquatic species. The characterisation, safety and efficacy of the additive have been assessed previously, however the FEEDAP Panel, considering the narrow margin between the requirement and the tolerated levels seen in some aquatic animal species, could not set a maximum safe level for all fish and crustacean species and considered that supplementation should not exceed the requirements of the different aquatic animal species. In addition, the FEEDAP Panel recommended that further research is conducted to allow setting a maximum safe level of folic acid in aquatic animal species. In the present assessment, the applicant submitted new information retrieved with an extensive literature search. After the assessment of the data newly submitted, the FEEDAP Panel reiterates its previous conclusions that the use of folic acid in aquatic animal species to cover their nutritional needs is considered safe. However, the Panel is not in a position to set maximum safe levels for all fish, crustacean and molluscs species. Considering the narrow margin between the requirement and the tolerated levels seen in some aquatic animal species, the FEEDAP Panel considers that supplementation should not exceed the requirements of the different aquatic animal species recognised by International scientific organisations.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9539","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635427","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 maleic hydrazide","authors":"European Food Safety Authority (EFSA),&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Marija Blazevic,&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;Monica Fittipaldi Broussard,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Anna Lanzoni,&nbsp;Renata Leuschner,&nbsp;Jochem Louisse,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9522","DOIUrl":"10.2903/j.efsa.2025.9522","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Belgium for the pesticide active substance maleic hydrazide are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The purpose of this application was to lift the precaution to Member States to ensure, where appropriate, that the label of the treated crops includes the indication that the crops were treated with maleic hydrazide and the accompanying instructions to avoid exposure of the livestock. The conclusions were reached on the basis of the evaluation of the representative uses of maleic hydrazide as a plant growth regulator on onion, shallot, garlic, potato and carrot. A modification of existing maximum residue level (MRLs) for animal commodities is recommended. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Endpoints not relevant to the scope of the proposed amendment of approval conditions have not been addressed under this process. No additional missing information as required by the regulatory framework was identified in the scope of this review. No concerns were identified in the scope of this review.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9522","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615439","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 AMP deaminase from the non-genetically modified Aspergillus pallidofulvus strain AE-DN","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;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Natália Kovalkovičová,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9530","DOIUrl":"10.2903/j.efsa.2025.9530","url":null,"abstract":"<p>The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the non-genetically modified <i>Aspergillus pallidofulvus</i> strain AE-DN by Amano Enzyme Inc. The food enzyme was free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.030 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 152 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 5067. A search for the homology of the amino acid sequence of the AMP deaminase 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 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9530","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615438","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 asparaginase from the non-genetically modified Saccharomyces cerevisiae strain ARY-1","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.2025.9533","DOIUrl":"10.2903/j.efsa.2025.9533","url":null,"abstract":"<p>The asparaginase (<span>l</span>-asparagine amidohydrolase, EC 3.5.1.1) is produced by the non-genetically modified <i>Saccharomyces cerevisiae</i> strain ARY-1 by Renaissance BioScience Corporation. The food enzyme is not separated from the yeast cells during the enzyme production. The food enzyme is intended to be used to reduce acrylamide formation during food processing at high temperature and low moisture conditions by hydrolysing asparagine. Dietary exposure was estimated to be up to 32.646 mg TOS/kg body weight per day in European populations. Toxicity tests were considered unnecessary by the Panel because the production strain was considered safe and no issues of concern resulting from the food enzyme manufacturing process were identified. A search for the homology of the amino acid sequence of the asparaginase 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. 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 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9533","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615444","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 Komagataella phaffii strain DSM 34125","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;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9546","DOIUrl":"10.2903/j.efsa.2025.9546","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified <i>Komagataella phaffii</i> strain DSM 34125 by Chr. Hansen. 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 four food manufacturing processes. Dietary exposure was estimated to be up to 0.039 mg total organic solids (TOS)/kg body weight per day in European populations. Given the qualified presumption of safety 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 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 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9546","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615443","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 aminopeptidase Y from the genetically modified Trichoderma reesei strain DP-Nyf80","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;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Natália Kovalkovičová,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9560","DOIUrl":"10.2903/j.efsa.2025.9560","url":null,"abstract":"<p>The food enzyme aminopeptidase Y (EC 3.4.11.15) is produced with the genetically modified <i>Trichoderma reesei</i> strain DP-Nyf80 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. Recombinant DNA was not detected under standard testing conditions. However, the absence of viable cells could not be excluded. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure was calculated to be up to 1.861 mg total organic solids (TOS)/kg body weight 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 537. A search for the homology of the amino acid sequence of the aminopeptidase Y 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 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9560","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144614959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme aspergillopepsin I from the non-genetically modified Aspergillus sp. strain AE-PRHF","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;Natália Kovalkovičová,&nbsp;Daniele Cavanna,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Simone Lunardi,&nbsp;Silvia Peluso,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9561","DOIUrl":"10.2903/j.efsa.2025.9561","url":null,"abstract":"<p>The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified <i>Aspergillus</i> sp. strain AE-PRHF by AMANO ENZYME INC. The food enzyme was free from viable cells of the production organism. It is intended to be used in 15 food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining 13 food manufacturing processes. It was estimated to be up to 2.172 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 2003 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 922. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and matches with three respiratory allergens and one injected allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to 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 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9561","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144614958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Surveillance of West Nile virus infections in humans and animals in Europe, monthly report","authors":"European Centre for Disease Prevention and Control (ECDC),&nbsp;European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9594","DOIUrl":"10.2903/j.efsa.2025.9594","url":null,"abstract":"<div>\u0000 \u0000 <p>In 2025, and as of 2 July 2025, no countries in Europe reported any locally acquired1 human cases of WNV infection with known place of infection.</p>\u0000 <p>In the previous five years, the first locally acquired cases of the WNV transmission season usually had symptom onset in June. However, the absence of notification of locally acquired cases of WNV in the EU/EEA and EU-neighbouring countries is not unexpected at this time of the year. This could either be due to the absence of WNV infections in humans or due to a delay in diagnosis and reporting of cases of WNV infection. Furthermore, a majority of WNV infections in humans remain asymptomatic or pauci-symptomatic.</p>\u0000 <p>From the veterinary perspective, 2 WNV outbreaks among equids and 3 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 12 June 2025 in Hungary and 11 June 2025 in Italy.</p>\u0000 <p>The number of outbreaks in birds and equids reported during this first period of 2025 is below the mean monthly outbreak count for the same time frame (calculated from 2015–2024). During the same period in 2024, 16 outbreaks were reported. In 2025, as of 2 July, this is the lowest number of outbreaks in birds and equids reported during the same period since 2022. All three countries (and their associated regions) reported WNV outbreaks in birds and/or equids in 2024 and in prior years, indicating endemic WNV activity in these regions.</p>\u0000 <p>In temperate regions like Europe, WNV transmission typically occurs from mid-June to mid-November, when mosquito activity is highest. Off-season reports of WNV outbreaks in birds and equids should be carefully evaluated as they raise questions about the timing of infection. The two early-season WNV outbreak reports (Germany's equid case in January and Italy's bird case in February) require cautious interpretation, as they may reflect residual detection (e.g. lingering antibodies or viral RNA from prior infections) rather than active transmission in 2025.</p>\u0000 <p>The absence of reported human West Nile virus infections in Europe as of 2 July 2025, alongside a notably lower number of outbreaks in birds and equids compared to 2024, suggests a reduced level of viral circulation in the environment during the early transmission season in 2025. Natural fluctuations in virus prevalence can occur year to year, influenced by immunity levels in bird populations and ecological conditions.</p>\u0000 <p>Human cases are expected to occur in the coming weeks.</p>\u0000 </div>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9594","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144598261","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}