EFSA Journal最新文献

{"title":"Revised safety evaluation of the food enzyme aqualysin 1 from the genetically modified Bacillus subtilis strain LMG S-25520 produced by a modified process","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;Silvia Peluso,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Roos Anna de Nijs,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9288","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9288","url":null,"abstract":"<p>The food enzyme aqualysin 1 (EC 3.4.21.111) is produced with the genetically modified Bacillus subtilis strain LMG S-25520 by Puratos N.V. In a previous evaluation, the Panel could not exclude safety concerns due to an insufficient margin of exposure and noted the presence of recombinant DNA in all food enzyme batches tested. As a follow-up, the applicant changed the manufacturing process and provided new data. These data established that the production strain meets the requirements for qualified presumption of safety (QPS) status, and no concerns arose from the modified food enzyme manufacturing process; hence, toxicological tests were not considered necessary. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure is estimated to be up to 0.385 mg TOS/kg body weight per day in European populations. A new search for the homology of the amino acid sequence of the aqualysin 1 to known allergens was made, and matches with one food allergen, 20 respiratory allergens and three contact allergens were found. Based on the new data provided, the Panel concluded that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. The Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9288","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143595397","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 pullulan (E 1204) as a food additive and new application for its extension of use","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald Fitzgerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;José Manuel Barat Baviera,&nbsp;Gisela Degen,&nbsp;David Gott,&nbsp;Jean-Charles Leblanc,&nbsp;Peter Moldeus,&nbsp;Ine Waalkens-Berendsen,&nbsp;Detlef Wölfle,&nbsp;Jaime Aguilera Entrena,&nbsp;Gabriele Gagliardi,&nbsp;Agnieszka Mech,&nbsp;Concepción Medrano-Padial,&nbsp;Simone Lunardi,&nbsp;Ana Maria Rincon,&nbsp;Camilla Smeraldi,&nbsp;Alexandra Tard,&nbsp;Laura Ruggeri","doi":"10.2903/j.efsa.2025.9267","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9267","url":null,"abstract":"<p>The present opinion deals with the re-evaluation of pullulan (E 1204) when used as a food additive and with the new application on the extension of use to several food categories. Pullulan (E 1204) is obtained by fermentation of a food-grade hydrolysed starch with non-genetically modified <i>Aureobasidium pullulans</i> ■■■■■. Based on the available information, the Panel considered that the manufacturing process of pullulan (E 1204) using this microorganism does not raise a safety concern. The Panel confirmed that pullulan (E 1204) is of no concern for genotoxicity. In vitro, pullulan (E 1204) is broken down by salivary and pancreatic amylase and intestinal iso-amylase and it is further metabolised to short chain fatty acids in the colon by fermentation. Human adult volunteer studies suggested that effects of pullulan (E 1204) are similar to the effects of other poorly digestible carbohydrate polymers including modified celluloses and that mild undesirable gastrointestinal symptoms (i.e. abdominal fullness, flatulence, bloating and cramping) may occur at doses of 10 g pullulan per day and greater. The Panel compared the dose of 10 g pullulan per day with the dietary exposure estimates to pullulan (E 1204) in its currently permitted uses and considering the proposed changes to the currently permitted uses. The Panel concluded that there is no need for a numerical ADI for pullulan (E 1204) and there is no safety concern for the currently reported uses and use levels. Additionally, the Panel concluded that the exposure estimates considering the proposed changes to the currently permitted uses and use levels of pullulan (E 1204) are of no safety concern. The estimates for dietary exposure to pullulan (E 1204) indicate that individuals with a high level of exposure, principally coming from food supplements, may experience mild gastrointestinal symptoms at the currently reported uses and use levels.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9267","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143595396","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 β-fructofuranosidase from the genetically modified Trichoderma reesei strain AR-996","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;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Giulio di Piazza,&nbsp;Cristina Fernández-Fraguas,&nbsp;Eleonora Marini,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9287","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9287","url":null,"abstract":"<p>The food enzyme β-fructofuranosidase (β-<span>d</span>-fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the genetically modified <i>Trichoderma reesei</i> strain AR-996 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 three food manufacturing processes. Dietary exposure was estimated to be up to 0.605 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 1653. A search for the homology of the amino acid sequence of the β-fructofuranosidase 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 the likelihood is low. Based on the data provided and the derived margin of exposure, 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 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9287","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143595257","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 level for metalaxyl-M in honey","authors":"European Food Safety Authority (EFSA),&nbsp;G. Bellisai,&nbsp;G. Bernasconi,&nbsp;L. Carrasco Cabrera,&nbsp;I. Castellan,&nbsp;M. del Aguila,&nbsp;L. Ferreira,&nbsp;L. Greco,&nbsp;S. Jarrah,&nbsp;R. Leuschner,&nbsp;A. Mioč,&nbsp;S. Nave,&nbsp;H. Reich,&nbsp;S. Ruocco,&nbsp;A. P. Scarlato,&nbsp;A. Simonati,&nbsp;M. Szot,&nbsp;A. Theobald,&nbsp;O. Timofieieva,&nbsp;M. Tiramani,&nbsp;A. Verani,&nbsp;E. Zioga","doi":"10.2903/j.efsa.2025.9296","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9296","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Ascenza Agro S.A. submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance metalaxyl-M in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposal for honey. Adequate analytical methods for enforcement are available to control the residues of metalaxyl-M in honey matrix 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 expected in honey resulting from the existing uses of metalaxyl-M on melliferous crops reported by the Applicant is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9296","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143595067","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 maltodextrin","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;Silvia Mazzega,&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;Anamarija Romac,&nbsp;Agnès Rortais,&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.2025.9294","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9294","url":null,"abstract":"<p>The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Ireland, and co-rapporteur Member State, France, for the pesticide active substance maltodextrin 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 2020/103. The conclusions were reached on the basis of the evaluation of the representative uses of maltodextrin as an insecticide and acaricide on all edible and non-edible crops. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9294","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143595256","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 luchuensis strain APTC 3C-290","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;Simone Lunardi,&nbsp;Magdalena Andryszkiewicz,&nbsp;Natalia Kovalkovicova,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9286","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9286","url":null,"abstract":"<p>The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified <i>Aspergillus luchuensis</i> strain APTC 3C-290 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. 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 two processes, dietary exposure was calculated only for the remaining six food manufacturing processes. It was estimated to be up to 1.699 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 two repeated dose 90-day oral toxicity studies in rats. The two test items have been obtained by submerged culture and by solid state fermentation, respectively. The Panel used the lowest of the two no observed adverse effect levels (1600 mg TOS/kg bw per day, the highest dose tested of the batch obtained by submerged culture), which when compared with the estimated dietary exposure, results in a margin of exposure of at least 942. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and three matches with respiratory allergens and one match with a dermal allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but 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 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9286","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143581944","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 pea fibre concentrate (FIPEA) as food additive","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;José Manuel Barat Baviera,&nbsp;Gisela Degen,&nbsp;David Gott,&nbsp;Jean-Charles Leblanc,&nbsp;Peter Moldeus,&nbsp;Ine Waalkens-Berendsen,&nbsp;Detlef Wölfle,&nbsp;Gabriele Gagliardi,&nbsp;Agnieszka Mech,&nbsp;Camilla Smeraldi,&nbsp;Alexandra Tard,&nbsp;Panagiota Zakidou,&nbsp;Laura Ruggeri","doi":"10.2903/j.efsa.2025.9255","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9255","url":null,"abstract":"<p>The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pea fibre concentrate (FIPEA) as a food additive. FIPEA is a powder consisting mainly of dietary fibres (i.e. pectin and hemicellulose), and low amounts of protein, derived from yellow pea (<i>P. sativum</i>). The manufacturing process includes extensive heat treatments, (e.g. &gt; 100°C for more than 40 min), conditions which lead to inactivation of lectins, that in FIPEA do not pose a safety concern. A specific α-amylase is used in the manufacturing, and this should be included in the definition of the proposed specifications. The Panel considered that the additional contribution of FIPEA to the total fibre intake in adults and toddlers would be acceptable considering the levels that are considered adequate by the NDA Panel. The Panel recommended to lower the specification limits proposed for the toxic elements. The solubility test indicates that the material does not require specific assessment at the nanoscale. No toxicological data have been submitted on FIPEA. The Panel considered that, similarly to water-soluble soybean polysaccharides, FIPEA is not absorbed intact but undergoes extensive fermentation by the intestinal microbiota in humans and is not of genotoxic concern. Dry peas (raw material) are a staple food, with a very long history of safe use in the EU. FIPEA is extracted with hot water from the insoluble fibrous material of dehulled yellow peas, therefore the structure of the fibres is not chemically modified, and no new by-products or components of toxicological concern are expected from the manufacturing process. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that pea fibre concentrate (FIPEA) as a new food additive does not raise a safety concern at the proposed use and use levels.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9255","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143581860","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 fall-back MRLs for revoked CXLs previously implemented in the EU legislation","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9299","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9299","url":null,"abstract":"<p>In the 55th meeting of the Codex Committee on Pesticide Residues (CCPR meeting) held in June 2024 and the subsequent 47th meeting of the Codex Alimentarius Commission (CAC) (November 2024), in total 111 Codex MRLs (CXLs) for 16 active substances (a.s.) were revoked. In accordance with Article 43 of Regulation (EC) 396/2005, EFSA was requested by the European Commission to identify the revoked CXLs which had been previously taken over in the EU MRL legislation (Regulation (EC) No 396/2005) and, if possible, propose fall-back maximum residue levels (MRLs) to replace the revoked CXLs. Based on the detailed assessment and taking into account the information provided by Member States, EFSA proposed fall-back MRLs for carbofuran in cotton seed and fluopyram/wheat. Risk management discussions are recommended to decide on the appropriate fall-back option for cyantraniliprole in soya beans. For difenoconazole, EFSA proposed to postpone the decision on a possible fall-back MRL, pending the outcome of the ongoing review of EU MRLs. For imazapyr/wheat and cyantraniliprole/beans and eggs, the existing MRLs will be replaced by new CXLs. The revocation of the other CXLs does not trigger a modification of the existing EU MRLs.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9299","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143581933","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 efficacy of a feed additive consisting of Bifidobacterium longum CNCM I-5642 (PP102I) for dogs (Nestlé Enterprises 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;Giovanna Martelli,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2025.9254","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9254","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of <i>Bifidobacterium longum</i> CNCM I-5642 (PP102I) as a zootechnical feed additive (functional group: physiological condition stabiliser) for dogs. In a previous opinion, the FEEDAP Panel concluded that PP102I was safe for dogs and the environment. Regarding the safety for the users, the Panel concluded that the additive should be considered a skin and respiratory sensitiser. Due to the lack of data, no conclusions could be drawn on the potential for skin/eye irritancy of the additive. Due to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for dogs at the proposed conditions of use. The applicant submitted in vitro eye and skin irritation tests and one efficacy trial in dogs to address the inconclusive aspects of the previous assessment. Based on the data provided, the Panel considers that the additive is irritant to the eyes but not to the skin. The additive has the potential to be efficacious when included in feed for dogs at 1 × 10⁹ colony forming unit (CFU)/dog per day (which would correspond approximately to 3.5 × 10⁹ CFU/kg complete feed).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9254","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143581945","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 pyraclostrobin","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;Anamarija Romac,&nbsp;Agnès Rortais,&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.2025.9257","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9257","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 Germany and co-rapporteur Member State Hungary for the pesticide active substance pyraclostrobin and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of pyraclostrobin as a fungicide and plant growth regulator on cereals (wheat, barley, oats, rye, triticale), maize (forage and grain) and potatoes. MRLs were assessed in sweet corn and fish. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9257","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143554760","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}