EFSA Journal最新文献

{"title":"Statement on the testing strategy and timelines for the assessment of developmental neurotoxicity and endocrine disruption properties of acetamiprid in the context of the review of the approval of the active substance","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9639","DOIUrl":"10.2903/j.efsa.2025.9639","url":null,"abstract":"<p>On 29 January 2021, the EFSA Panel on Plant Protection Products and their Residues adopted a Statement on acetamiprid in response to a mandate from the Commission following a notification under Article 69 of Regulation (EC) No 1107/2009 in which, among others, it was recommended to conduct an assessment of the endocrine disrupting (ED) properties of acetamiprid in line with the criteria established by Commission Regulation (EU) No 2018/605. On 27 March 2024, EFSA issued a Statement on the toxicological properties and maximum residue levels of acetamiprid and its metabolites, following a mandate from the Commission pursuant to Article 31 of Regulation (EC) No 178/2002. EFSA concluded that there are data gaps in the in vivo body of evidence, including the lack of an acceptable measurement of learning and memory, motor activity and morphometric evaluation in the available developmental neurotoxicity (DNT) studies. To account for the identified gaps, EFSA proposed to include an additional uncertainty factor of 5 in the derivation of the Health-Based Guidance Values: as a consequence, it could not be fully established that acetamiprid still meets the approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009 with respect to its DNT, as well as for the ED properties for which an assessment is not available. Therefore, the European Commission decided to launch a review of the existing approval in accordance with Article 21 of that Regulation and invited the applicant to submit a comprehensive list of existing or planned studies, along with any relevant information, for re-assessing the ED and DNT properties of acetamiprid. On 21 May 2025, pursuant to Article 21(2) of Regulation (EC) No 1107/2009, the Commission requested EFSA to assess the proposal, as submitted by the applicant, on the testing strategy and associated timelines for the generation of additional data for the assessment of the DNT and ED properties of acetamiprid. The current statement contains EFSA's considerations whether the proposed studies are considered sufficient and realistic to complete the assessment of the ED properties of the active substance in line with Commission Regulation (EU) 2018/605 and to conduct an evaluation of DNT properties in line with the recommendations given in the EFSA statement issued in 2024.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145206010","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 an extension of use of pasteurised Akkermansia muciniphila 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;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Margarita Aguilera-Gómez,&nbsp;Thomas Frenzel,&nbsp;Francesca Marcon,&nbsp;Harry J. McArdle,&nbsp;Peter Moldeus,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Henk van Loveren,&nbsp;Reinhard Ackerl,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9632","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9632","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 the safety of an extension of use of pasteurised <i>Akkermansia muciniphila</i> as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension pertains to the use of the NF in food supplements and Foods for Special Medical Purposes (FSMPs) for adolescents from 12 to &lt; 18 years of age and to pregnant and lactating women. The maximum proposed daily doses of the NF correspond to about 4.8 × 10⁸ cells/kg bodyweight per day, which was the safe dose as established for the NF by the Panel in 2021. The newly identified toxicological and human studies with <i>A. muciniphila</i> from various strains, including the strain to which the NF belongs, do not raise safety concerns in view of the extension of use of the NF for adolescents from 12 years of age. However, no evidence was provided for the safety of the NF in pregnant and lactating women. The Panel concludes that the NF, pasteurised <i>A. muciniphila</i>, is safe at doses up to 2.1 × 10¹⁰ cells/day for adolescents from 12 to &lt; 14 years and 3.0 × 10¹⁰ cells/day for adolescents from 14 years until &lt; 18 years. The safety of the NF in pregnant and lactating women has not been established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9632","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145146647","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 Pediococcus pentosaceus NCIMB 12674 for all animal species (Danstar Ferment AG)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño,&nbsp;Joana Revez,&nbsp;Yolanda García-Cazorla","doi":"10.2903/j.efsa.2025.9634","DOIUrl":"10.2903/j.efsa.2025.9634","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on <i>Pediococcus pentosaceus</i> NCIMB 12674 when used as a technological additive to improve ensiling of all fresh plant material for all animal species at a proposed minimum concentration of 1 × 10⁹ colony forming units (CFU)/kg fresh plant material. The bacterial species <i>P. pentosaceus</i> is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established, and no acquired antimicrobial resistance genes were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, inhalation and dermal exposure is considered a risk. No conclusions can be drawn on the eye irritancy potential of the additive. The FEEDAP Panel concluded that <i>P. pentosaceus</i> NCIMB 12674 at a minimum level of 1 × 10⁹ CFU/kg fresh plant material has the potential to improve the production and fermentation quality of silage made from moderately difficult to ensile fresh plant material, with DM content ranging from 21% to 38.5%.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9634","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111177","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":"Beta-glucans from oats or barley and reduction of postprandial glycaemic responses: Modification of an authorised health claim pursuant to Article 13(1) of Regulation (EC) No 1924/2006 following a request in accordance with Article 19 of Regulation (EC) No 1924/2006","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;Karen-Ildico Hirsch-Ernst,&nbsp;Angeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Frank Thies,&nbsp;Ines Drenjančević,&nbsp;Ionut Craciun,&nbsp;Thibault Fiolet,&nbsp;Alfonso Siani","doi":"10.2903/j.efsa.2025.9630","DOIUrl":"10.2903/j.efsa.2025.9630","url":null,"abstract":"<p>Following an application from PepsiCo International, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the modification of an authorised health claim related to beta-glucans from oats or barley and reduction of postprandial glycaemic responses. The proposed modification concerns a reduction of the lowest effective dose from 4 g to 2 g of beta-glucans (BG) per 30 g of available carbohydrates (avCHO). Beta-glucans from oat and barley, which are the subject of the health claim, have been sufficiently characterised. A reduction of postprandial glycaemic responses is a beneficial physiological effect in the context of the food/constituent and the target population for this claim. The applicant submitted 21 pertinent published human intervention studies (59 trial comparisons) investigating the effect of beta-glucans from oat or barley on the postprandial incremental area under the curve (iAUC) for glucose using matched comparators and conducted a dose–response meta-regression analysis. Four published systematic reviews and dose–response meta-regression analyses were also provided. In weighing the evidence, the Panel considered that the human intervention studies did not consistently show a significant effect of beta-glucans from oats or barley on postprandial glucose iAUC at doses between 2 and &lt; 4 g BG/30 g avCHO, and that dose–response data suggest a lowest effective dose above the 2 g/30 g avCHO proposed by the applicant. The Panel concludes that a consistent effect of beta-glucans from oats or barley on the reduction of postprandial glycaemic responses has not been demonstrated under the conditions of use proposed by the applicant of at least 2 g BG/30 g avCHO consumed with a meal.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9630","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102100","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 rapeseed protein–fibre concentrate 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;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Alfonso Siani,&nbsp;Frank Thies,&nbsp;Margarita Aguilera-Gómez,&nbsp;Thomas Frenzel,&nbsp;Harry J. McArdle,&nbsp;Peter Moldeus,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Henk van Loveren,&nbsp;Marcello Laganaro,&nbsp;Emanuela Turla,&nbsp;Anna-Maria Pieger,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9631","DOIUrl":"10.2903/j.efsa.2025.9631","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 the safety of rapeseed protein-fibre concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powder mainly composed of protein and fibre, which is obtained after aqueous and organic solvent extraction applied to cold-pressed rapeseed cake. The source rape plants are non-genetically modified double low (00) cultivars of <i>Brassica rapa</i> L. and <i>Brassica napus</i> L., which are bred to obtain low erucic acid and glucosinolate content. The information provided on the production process, composition and specifications of the NF, when accounting for recommendations proposed by the Panel, does not raise safety concerns. The NF is proposed to be used as a food ingredient in several foods (for the general population), and in food supplements and in food for special medical purposes for individuals above 10 years of age. Considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous when consumed within a mixed diet. There is a potential concern related to manganese when consuming the NF as a food ingredient and supplement on the same day. Taking into account the nature of the NF, the production process, the composition of the NF and the toxicological profile of similar rapeseed powders already assessed, the Panel considers that no toxicological studies are required with the NF. The Panel concludes that the NF, rapeseed protein–fibre concentrate, is safe under the proposed conditions of use, provided that individuals above 10 years of age do not consume foods containing the NF and food supplements containing the NF on the same day.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9631","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145062548","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 – data submitted up to 3 September 2025","authors":"European Centre for Disease Prevention and Control (ECDC),&nbsp;European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9662","DOIUrl":"10.2903/j.efsa.2025.9662","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Epidemiological summary&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;In 2025, and as of 3 September 2025, 9 countries in Europe reported 652 locally acquired&lt;sup&gt;1&lt;/sup&gt; human cases of WNV infection with known place of infection. The earliest and latest date of onset were respectively on 2 June 2025 and 31 August 2025. Locally acquired cases were reported by &lt;b&gt;Italy&lt;/b&gt; (500), &lt;b&gt;Greece&lt;/b&gt; (69, of which 1 with unknown place of infection), &lt;b&gt;Serbia&lt;/b&gt; (33), &lt;b&gt;France&lt;/b&gt; (20), &lt;b&gt;Romania&lt;/b&gt; (15), &lt;b&gt;Hungary&lt;/b&gt; (6), &lt;b&gt;Spain&lt;/b&gt; (5), &lt;b&gt;Albania&lt;/b&gt; (3) and &lt;b&gt;Bulgaria&lt;/b&gt; (1). In Europe, 38 deaths were reported.&lt;/p&gt;\u0000 \u0000 &lt;p&gt;Case numbers reported so far this year are above the average for the past decade in the same period (514). However, these figures remain lower than those seen in 2018, 2022, and 2024 – years when virus circulation was particularly intense, with over 1000 cases reported by this point in the year. As the latter figures are based on consolidated data, while the current year's data remain delayed and incomplete, direct comparisons should be made with caution.&lt;/p&gt;\u0000 \u0000 &lt;p&gt;Italy is currently experiencing a large outbreak, with 500 confirmed human infections, including 32 fatalities (case fatality rate of 6.4%, which is within the expected range). This is the highest number of human WNV infections reported by Italy at this time of the year. The cases are mainly reported from the Lazio region (Latina, Roma and Frosinone), with a total of 218 cases, and the Campania region (Napoli, Caserta, Salerno and Avellino), with a total 106 cases. Other regions are reporting similar numbers as in previous years.&lt;/p&gt;\u0000 \u0000 &lt;p&gt;As of 3 September 2025, locally acquired human cases of WNV infection have been reported in 100 regions across nine countries. This compares with 174 regions (16 countries) during the same period in 2024, and 129 regions (12 countries) in 2018 (based on consolidated data). All nine countries have previously reported human cases of WNV.&lt;/p&gt;\u0000 \u0000 &lt;p&gt;During the current transmission season, the following regions reported human cases of WNV infection for the first time ever: by Italy in Genova (ITC33), Sondrio (ITC44), Avellino (ITF34), Catanzaro (ITF63), Reggio di Calabria (ITF65), Palermo (ITG12), Messina (ITG13), Nuoro (ITG2E), Arezzo (ITI18), Latina (ITI44) and Frosinone (ITI45), by France in Seine-Saint-Denis (FR106), Puy-de-Dôme (FRK14) and Vaucluse (FRL06), and by Romania in Sălaj (RO116).&lt;/p&gt;\u0000 \u0000 &lt;p&gt;As observed in previous years, most cases are among males aged 65 years and older. The hospitalisation rate is similar to previous years, with 91% of cases hospitalised this year compared to 92% in the past decade. The high hospitalisation rate is due to the nature of WNV surveillance, which tends to predominantly capture the most severe cases. The case fatality rate so far","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9662","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145057732","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":"Calcium sulphate and reduction in body weight: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006","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;Karen-Ildico Hirsch-Ernst,&nbsp;Angeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Frank Thies,&nbsp;Ines Drenjančević,&nbsp;Ionut Craciun,&nbsp;Thibault Fiolet,&nbsp;Alfonso Siani","doi":"10.2903/j.efsa.2025.9633","DOIUrl":"10.2903/j.efsa.2025.9633","url":null,"abstract":"<p>Following an application from Mediconomics APS, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Denmark, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to calcium sulphate and reduction in body weight. The Panel considers that the food constituent, calcium sulphate, is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight adults. The applicant submitted two human intervention studies investigating the effect of calcium sulphate on body weight. The Panel notes that no conclusions can be drawn from any of the human intervention studies submitted for the scientific substantiation of the claim and that no convincing evidence has been provided for a mechanism by which calcium sulphate could exert the claimed effect in vivo in humans. The Panel concludes that a cause and effect relationship has not been established between the consumption of calcium sulphate and a beneficial physiological effect on body weight under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9633","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145037740","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 for the active substance pinoxaden in light of confirmatory data submitted","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Angelo Colagiorgi,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Mark Egsmose,&nbsp;Gabriella Fait,&nbsp;Franco Ferilli,&nbsp;Monica Fittipaldi Broussard,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Roberto Lava,&nbsp;Renata Leuschner,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Christopher Lythgo,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Laura Padovani,&nbsp;Vincenzo Padricello,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Simone Rizzuto,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9622","DOIUrl":"10.2903/j.efsa.2025.9622","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 Austria, for the pesticide active substance pinoxaden are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information in the areas of environmental fate, mammalian toxicology and residues. The conclusions were reached on the basis of the evaluation of the representative uses of pinoxaden as a herbicide in winter and spring cereals. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and/or literature in the dossier peer reviewed, are presented. Concerns are identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9622","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145007987","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 the fungal biomass from Fusarium species strain flavolapis as a novel food pursuant to Article 10 of 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;Peter Moldeus,&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;Henk van Loveren,&nbsp;Océane Albert,&nbsp;Rossi Annamaria,&nbsp;Hanna Schmierer,&nbsp;Ruth Roldán-Torres,&nbsp;Gabriela Precup,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9536","DOIUrl":"10.2903/j.efsa.2025.9536","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 the safety of the fungal biomass from <i>Fusarium</i> species strain <i>flavolapis</i> as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF as the frozen form of the <i>Fusarium</i> sp. str. <i>flavolapis</i> (named by the applicant), which is proposed by the applicant to be used as an ingredient in several food categories, is sufficiently characterised. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Based on the findings of a repeated dose 90-day oral toxicity study in rats conducted with the dehydrated NF, and considering the evidence for thyroidal effects along with the lack of robustness of other findings at the low dose tested, the Panel considers the lowest dose tested as the no observed adverse effect level (NOAEL), i.e. 2744 mg/kg bw per day of the NF in a dehydrated form, corresponding to approximately 10,400 mg/kg bw per day NF. Under the proposed conditions of use, the highest intake estimates of the NF range from 189 to 556 mg/kg bw per day. Applying a default uncertainty factor of 200 to the NOAEL, the Panel considers that the margins of exposure (i.e. 55 in adolescents and 19 in infants) between the intake of the NF at the proposed use and use levels and the NOAEL from the 90-day study are insufficient. The Panel considers that it is likely that the NF may trigger allergic reactions in allergic subjects. The Panel concludes that, based on the available data, the safety of the NF, i.e. biomass of <i>Fusarium</i> strain <i>flavolapis</i> (F. sp. strain flavolapis) fungus, cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 9","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9536","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145012254","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 rhamnogalacturonan-I enriched carrot fibre (cRG-I) 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;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;Harry J. McArdle,&nbsp;Monika Neuhäuser-Berthold,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Annamaria Rossi,&nbsp;Wolfgang Gelbmann,&nbsp;Ruth Roldán-Torres,&nbsp;Domenico Azzollini,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9537","DOIUrl":"10.2903/j.efsa.2025.9537","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 rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a high molecular weight polysaccharide derived from carrot pomace. The Panel considers that the production process is sufficiently described and does not raise safety concerns. The novel food is intended for use as ingredient in various food products targeting the general population, in food for special medical purposes, meal replacement for weight control and food supplements targeting the general population excluding infants, and in total diet replacement for weight control targeting the adult population. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. Based on the data provided the Panel considers that there are no concerns regarding genotoxicity. Results from the 90-day study did not show effects of toxicological relevance for humans up to the highest dose tested (7753 mg/kg bw per day). The NF may retain the allergenic potential of carrots and allergic reactions to the NF may occur, but they will not be dissimilar from those triggered by the consumption of carrots. The Panel considers the margins of exposure to be sufficient considering that the source (i.e. carrots), nature, composition and production of the NF do not raise safety concerns. The Panel concludes that the NF, cRG-I, a rhamnogalacturonan-rich polysaccharide fraction derived from carrot pomace, is safe under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 8","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9537","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144915239","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}