EFSA Journal最新文献

{"title":"Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × GA21 and its subcombinations for renewal authorisation under Regulation (EC) No 1829/2003 (application GMFF-2025-35594).","authors":"Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M Epstein, Thomas Frenzel, Jean-Luc Gallois, Frits Koning, Antoine Messéan, F Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H Schulman, Christoph Tebbe, Eve Veromann, Ana M Camargo, Tilemachos Goumperis, Paolo Lenzi, Tommaso Raffaello, Martina Bonatti","doi":"10.2903/j.efsa.2026.10365","DOIUrl":"10.2903/j.efsa.2026.10365","url":null,"abstract":"<p><p>Following the submission of the application GMFF-2025-35594 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant and insect-resistant genetically modified maize Bt11 × MIR162 × MIR604 × GA21 and its subcombinations, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize Bt11 × MIR162 × MIR604 × GA21 and its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in this renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize Bt11 × MIR162 × MIR604 × GA21 and its subcombinations.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":"e10365"},"PeriodicalIF":3.8,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13674151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149215196","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 a food enzyme containing cellulase and endo-1,3(4)-β-glucanase activities from the non-genetically modified <i>Trichoderma reesei</i> strain DP-Nzc104.","authors":"Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L M Solano, Henk Van Loveren, Laurence Vernis, Cristina Andreoli, Andrea Terron, Andrey Yurkov, Ana Criado, Daniele Cavanna, Jaime Aguilera, Magdalena Andryszkiewicz, Yi Liu","doi":"10.2903/j.efsa.2026.10339","DOIUrl":"10.2903/j.efsa.2026.10339","url":null,"abstract":"<p><p>The food enzyme containing cellulase (4-(1,3;1,4)-β-d-glucan-4-glucanohydrolase, EC 3.2.1.4) and endo-1,3(4)-β-glucanase (3-(1,3;1,4)-β-d-glucan 3(4)-glucanohydrolase, EC 3.2.1.6) activities is produced with the non-genetically modified <i>Trichoderma reesei</i> strain DP-Nzc104 by Genencor International B.V. The food enzyme was considered free from viable cells of the production organism. The applicant proposed using the food enzyme in eight food manufacturing processes. Since the claimed activities have no function on the raw material proposed in one process and residual amounts of food enzyme-total organic solids (TOS) are removed in another process, dietary exposure was calculated for the remaining six food manufacturing processes. It was estimated to be up to 0.601 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, resulted in a margin of exposure of at least 1664. A search for the homology of the amino acid sequences of the food enzyme to known allergens was made and matches with two food allergens and one respiratory allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":"e10339"},"PeriodicalIF":3.8,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13674153/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149215253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of the food enzyme endo-polygalacturonase from the non-genetically modified <i>Rhizopus oryzae</i> strain MC3-3-9.","authors":"Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L M Solano, Henk Van Loveren, Laurence Vernis, Cristina Andreoli, Andrea Terron, Andrey Yurkov, Cristina Fernàndez-Fraguas, Jaime Aguilera, Natalia Kovalkovicova, Yi Liu","doi":"10.2903/j.efsa.2026.10333","DOIUrl":"10.2903/j.efsa.2026.10333","url":null,"abstract":"<p><p>The food enzyme endo-polygalacturonase (1,4-α-D-galacturonan glycanohydrolase, EC 3.2.1.15) is produced with the non-genetically modified <i>Rhizopus oryzae</i> strain MC3-3-9 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining four food manufacturing processes. It was estimated to be up to 0.385 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 872 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 2265. A search for the homology of the amino acid sequence of the endo-polygalacturonase to known allergens was made and matches with one food allergen and 12 respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure 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":"24 10","pages":"e10333"},"PeriodicalIF":3.8,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13670137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149215173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of genetically modified maize Bt11 × MIR162 × MON 89034 × NK603 (application GMFF-2025-33624).","authors":"Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M Epstein, Thomas Frenzel, Jean-Luc Gallois, Frits Koning, Antoine Messéan, F Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H Schulman, Christoph Tebbe, Eve Veromann, Elisabeth Waigmann, Michele Ardizzone, Giacomo De Sanctis, Antonio Fernandez Dumont, Andrea Gennaro, José Ángel Gómez Ruiz, Tilemachos Goumperis, Sara Jacchia, Dafni Maria Kagkli, Paolo Lenzi, Ana M Camargo, Franco Maria Neri, Tommaso Raffaello, Alice Branchi, Arianna Ferrari","doi":"10.2903/j.efsa.2026.10364","DOIUrl":"10.2903/j.efsa.2026.10364","url":null,"abstract":"<p><p>Genetically modified maize Bt11 × MIR162 × MON 89034 × NK603 was developed by crossing to combine four single events: Bt11, MIR162, MON 89034 and NK603. The maize Bt11 × MIR162 × MON 89034 × NK603 expresses the Cry1Ab, PAT, Vip3Aa20, PMI, Cry1A.105, Cry2Ab2, CP4 EPSPS and CP4 EPSPS L214P proteins to confer protection against certain lepidopteran pests, tolerance to glufosinate- and glyphosate-containing herbicides and to be used as a selectable marker. The GMO Panel previously assessed the four single maize events and seven of the sub-combinations and did not identify safety concerns. No new data on the single maize events or the assessed sub-combinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the four-event stack does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack, as described in this application, is as safe as the non-GM comparator and non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of release of processed four-event stack or accidental spillage of viable GM maize seeds into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in three of the maize sub-combinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed sub-combinations and the four-event stack. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack and of its sub-combinations. The GMO Panel concludes that maize Bt11 × MIR162 × MON 89034 × NK603 and its sub-combinations are as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":"e10364"},"PeriodicalIF":3.8,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13670140/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149215201","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 <i>Heyndrickxia faecalis</i>DSM 32016 (TechnoSpore50®) for calves for fattening/rearing, and other bovines, ovines, caprines, cervids and camelids at the corresponding developmental stage (Biochem Zusatzstoffe Handels- und Produktionsgesellschaft mbH).","authors":"Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Giovanna Martelli, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Katerina Theodoridou, Vasileios Bampidis, Montserrat Anguita, Matteo Lorenzo Innocenti, Jordi Ortuño, Maria Mountricha","doi":"10.2903/j.efsa.2026.10353","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10353","url":null,"abstract":"<p><p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of <i>Heyndrickxia faecalis</i> (formerly identified as <i>Weizmannia faecalis</i>) DSM 32016 (TechnoSpore50®) as a zootechnical feed additive (functional group: gut flora stabiliser) for calves for fattening/rearing, and other bovines, ovines, caprines, cervids and camelids at the corresponding developmental stage. The strain was earlier identified as belonging to <i>H. faecalis</i> species, showed no toxigenic potential, and harboured no acquired antimicrobial resistance genes. Therefore, based on previous assessments, the additive was considered safe for the target species, consumers and the environment. Regarding the user safety, the additive is not a skin/eye irritant but a skin and respiratory sensitizer. Inhalation and dermal exposure were considered a risk. The Panel concluded that the additive has the potential to be efficacious as a zootechnical feed additive for calves for fattening/rearing, other bovines, ovines, caprines, cervids and camelids at the corresponding developmental stage at 1 × 10⁹ colony forming unit (CFU)/kg complete feed and 5 × 10⁸ CFU/L water for drinking.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":"e10353"},"PeriodicalIF":3.8,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13655969/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149180192","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 benfotiamine as a Novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of benfotiamine as a source of thiamin in the context of Directive 2002/46/EC on food supplements.","authors":"Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Francesco Cubadda, Thomas Frenzel, Ursula Gundert-Remy, Francesca Marcon, Harry J McArdle, Monika Neuhäuser-Berthold, Miguel Prieto Maradona, Alexandros Siskos, Matthew Wright, Gabriela Precup, Silvia Valtueña Martinez, Hanna Schmierer, Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2026.10301","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10301","url":null,"abstract":"<p><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 benfotiamine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and on the bioavailability of benfotiamine as a source of thiamin in the context of Directive 2002/46/EC. The NF, which is produced by chemical synthesis, is proposed to be used in food supplements for adults at a maximum intake of 300 mg/day. The Panel notes that the identity of the NF has not been sufficiently demonstrated, including the possible presence of small particles and nanoparticles. The Panel also notes that the data provided were insufficient to demonstrate that the manufacturing process is reproducible and capable of consistently producing a product with the proposed characteristics. No conclusion could be drawn on the microbiological stability of the NF over the proposed shelf life. The information provided indicates that the bioavailability of thiamin from benfotiamine may be higher than that from water-soluble forms of thiamin and thus benfotiamine may be used as a source of thiamin. Owing to the insufficient characterisation of the NF, unresolved uncertainties regarding small particles, including nanoparticles, the lack of adequate information on its metabolic fate, bioaccumulation and long-term effects, and the limitations of the submitted toxicological data, the Panel concludes that the safety of benfotiamine as a NF cannot be established under the proposed conditions of use. The Panel also concludes that the higher bioavailability of benfotiamine compared with authorised or natural sources of thiamin has not been quantified to an extent that would allow the derivation of a conversion factor for labelling purposes.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":"e10301"},"PeriodicalIF":3.8,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13650730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149165341","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 feed additives consisting of tinctures derived from the roots or leaves and stems of Althaea officinalis L.: Marsh mallow root tincture for use in all animal species and marsh mallow leaf tincture for use in horses and dogs (FEFANA asbl)","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;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Maria de Lourdes Bastos,&nbsp;Emilio Benfenati,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2026.10346","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10346","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 two tinctures obtained from the roots (marsh mallow root tincture) or leaves and stems (marsh mallow leaf tincture) of <i>Althaea officinalis</i> L. when used as sensory additives. The additives are water/ethanol tinctures, with a specified dry matter content of 2%–3% (w/w) (marsh mallow root tincture) and not more than 25% (w/w) (marsh mallow leaf tincture). Marsh mallow root tincture is intended for use in feed or water for drinking for all animal species, while marsh mallow leaf tincture is proposed for use in feed for horses and dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that marsh mallow root tincture is safe at the maximum proposed use level of 250 mg/kg complete feed for all animal species. Marsh mallow leaf tincture is safe at the maximum proposed use level of 1000 mg/kg complete feed for horses and 325 mg/kg complete feed for dogs. No safety concern would arise for the consumer and the environment from the use of marsh mallow tinctures in animal feed. The additives under assessment should be considered as irritant to skin and eyes, and as dermal and respiratory sensitisers. Exposure of users by any route is considered a risk. Since the roots of <i>A. officinalis</i> are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy for marsh mallow root tincture was considered necessary. The same conclusions are extended to marsh mallow leaf tincture.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10346","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149146279","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 an extension of use of the food enzyme non-reducing end α-l-arabinofuranosidase from the genetically modified Trichoderma reesei strain NZYM-GV","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;Daniele Cavanna,&nbsp;Yi Liu,&nbsp;Valentina Tokić","doi":"10.2903/j.efsa.2026.10340","DOIUrl":"10.2903/j.efsa.2026.10340","url":null,"abstract":"<p>The food enzyme non-reducing end α-<span>l</span>-arabinofuranosidase (α-<span>l</span>-arabinofuranoside non-reducing end α-<span>l</span>-arabinofuranosidase; EC 3.2.1.55) is produced with the genetically modified <i>Trichoderma reesei</i> strain NZYM-GV by Novozymes A/S. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of two food manufacturing processes. As the food enzyme–Total Organic Solids (TOS) are removed in one process, the dietary exposure to the food enzyme–TOS was estimated for the remaining food manufacturing process. It was calculated to be up to 0.009 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1116 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure (MOE) of at least 124,000. Based on the new data, the revised MOE 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":"24 10","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13647195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135388","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 containing endo-polygalacturonase, pectinesterase, pectin lyase and arabinan endo-1,5-α-l-arabinanase activities from the non-genetically modified Aspergillus sp. strain ASNSC","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;Cristina Andreoli,&nbsp;Andrea Terron,&nbsp;Andrey Yurkov,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Ana Criado,&nbsp;Simone Lunardi,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2026.10330","DOIUrl":"10.2903/j.efsa.2026.10330","url":null,"abstract":"<p>The food enzyme containing endo-polygalacturonase (1,4-α-<span>d</span>-galacturonan glycanohydrolase; EC 3.2.1.15), pectinesterase (pectin pectylhydrolase; EC 3.1.1.11), pectin lyase (1,4-6-<i>O</i>-methyl-α-<span>d</span>-galacturonan lyase; EC 4.2.2.10) and arabinan endo-1,5-α-<span>l</span>-arabinanase (5-α-<span>l</span>-arabinan 5-α-<span>l</span>-arabinanohydrolase; EC 3.2.1.99) activities is produced with the non-genetically modified <i>Aspergillus</i> sp. strain ASNSC by Advanced Enzyme Technologies Ltd. The food enzyme was considered free from viable cells of the production strain. The applicant proposed the use of the food enzyme in four food manufacturing processes. Since one activity is not allowed in fruit juice production in the European Union and residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining two food manufacturing processes. It was estimated to be up to 2.179 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 708 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 325. A search for the homology of the amino acid sequences of pectinesterase and pectin lyase to known allergens was made and no match was found. No information was provided for the two other declared activities; however, considering that the production strain belongs to an <i>Aspergillus</i> species, matches with allergenic polygalacturonases are expected. The Panel considered that, under the intended conditions of use, a risk of allergic reactions upon dietary exposure 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, in three food manufacturing processes (excluding the use in the production of juices).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13647196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149135383","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 application for modification of the terms of authorisation of the feed additive consisting of Heyndrickxia faecalis DSM 32016 (TechnoSpore50®) (Biochem Zusatzstoffe Handels- und Produktionsges. mbH)","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;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Rosella Brozzi,&nbsp;Matteo L. Innocenti,&nbsp;Jaume Galobart,&nbsp;Alberto Navarro Villa,&nbsp;Sofia Sandalli","doi":"10.2903/j.efsa.2026.10350","DOIUrl":"10.2903/j.efsa.2026.10350","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the modification of the terms of authorisation of <i>Heyndrickxia faecalis</i> (formerly identified as <i>Weizmannia faecalis</i>) DSM 32016 (TechnoSpore50®), as a zootechnical feed additive authorised for use in all poultry species for fattening, reared for laying/breeding, ornamental birds and suckling and weaned Suidae piglets. The applicant sought a modification of such authorisation for all poultry species and ornamental birds to allow the simultaneous use of the additive with the coccidiostats decoquinate, nicarbazin, lasalocid sodium and narasin. The Panel concluded that TechnoSpore50® is compatible with the coccidiostats decoquinate, nicarbazin, lasalocid sodium and narasin at the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 10","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13647204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134676","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}