EFSA Journal最新文献

{"title":"Assessment of genetically modified oilseed rape MON 88302 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21220)","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Giovanni Savoini,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Ana M. Camargo,&nbsp;Paolo Lenzi,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9378","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9378","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21220 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, 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 genetically modified oilseed rape MON 88302, 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 sequence of the event in oilseed rape MON 88302 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21220 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MON 88302.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9378","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939176","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":"Update of the Scientific Opinion on the risks for human health related to the presence of perchlorate in food","authors":"EFSA Panel on Contaminants in the Food Chain (CONTAM),&nbsp;Helle Katrine Knutsen,&nbsp;Agneta Åkesson,&nbsp;Vasileios Bampidis,&nbsp;Margherita Bignami,&nbsp;Laurent Bodin,&nbsp;Gisela Degen,&nbsp;Antonio Hernández-Jerez,&nbsp;Tim Hofer,&nbsp;Christer Hogstrand,&nbsp;Stefano Landi,&nbsp;Jean-Charles Leblanc,&nbsp;Kyriaki Machera,&nbsp;Evangelia Ntzani,&nbsp;Guido Rychen,&nbsp;Salomon Sand,&nbsp;Katharina Vejdovszky,&nbsp;Barbara Viviani,&nbsp;Aleksandra Buha Djordjevic,&nbsp;Thorhallur Halldorsson,&nbsp;Chantra Eskes,&nbsp;Olaf Mosbach-Schulz,&nbsp;Francesca Riolo,&nbsp;Elena Rovesti,&nbsp;Efisio Solazzo,&nbsp;Alexios Zormpas,&nbsp;Tuuli Tauriainen,&nbsp;James Kevin Chipman","doi":"10.2903/j.efsa.2025.9393","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9393","url":null,"abstract":"<p>The European Commission asked EFSA to update its 2014 risk assessment on perchlorate in food. Perchlorate is a contaminant of both natural and anthropogenic sources present in food and drinking water. It is a substrate for the sodium iodide symporter (NIS) and competitively inhibits the uptake of iodide into the thyroid. Experimental animal studies show that perchlorate exposure during pregnancy can result in neurodevelopmental toxicity. The CONTAM Panel established a tolerable daily intake of 1.4 μg/kg body weight per day, based on the inhibition of thyroid iodine uptake in healthy adults. The tolerable daily intake (TDI) takes into account the sensitivity of the fetus to maternal thyroid hormone disturbance and uncertainty around the impact of iodine deficiency on the effects of perchlorate during fetal development. This TDI is applicable for both a short-term (approximately 2-week period) and chronic exposures based on the mode of action of perchlorate, its toxicokinetic properties and the key study used to derive the TDI. An acute reference dose (ARfD) was not deemed necessary. EFSA received a total of 40,356 analytical results, between 2016 and 2022, which were considered for the dietary exposure assessments. A chronic dietary exposure assessment for all age groups and a short-term dietary exposure assessment for pregnant women were calculated. The CONTAM Panel concluded that chronic and short-term dietary exposure estimates to perchlorate were below the TDI for all age groups including pregnant women, with the exception at the upper bound of the P95 for infants, breastfed infants and formula-fed infants. Even if the limitations in analytical methods, leading to a large difference between lower bound (LB) and upper bound (UB) dietary exposure, reduces the certainty in this conclusion for infants, breastfed infants and formula-fed infants, the uncertainty analysis indicates a higher (above 50%) likelihood of ‘no concern’ for all scenarios.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9393","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143938960","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 pectinesterase from the genetically modified Trichoderma reesei strain RF6201","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;Jeroen Pasch,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9417","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9417","url":null,"abstract":"<p>The food enzyme pectinesterase (pectin pectylhydrolase, EC 3.1.1.11) is produced with the genetically modified <i>Trichoderma reesei</i> strain RF6201 by AB Enzymes GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant has requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed from or not carried into the final foods in three food manufacturing processes, the dietary exposure to the food enzyme–TOS was estimated only for the remaining four processes. The dietary exposure was calculated to be up to 0.488 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 2049. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9417","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939504","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 phospholipase A1 from the genetically modified Trichoderma reesei strain DP-Nzk98","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;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Natália Kovalkovičová,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9425","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9425","url":null,"abstract":"<p>The food enzyme phospholipase A1 (phosphatidylcholine 1-acylhydrolase; EC 3.1.1.32) is produced with the genetically modified <i>Trichoderma reesei</i> strain DP-Nzk98 by Genencor International B.V. 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 the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.972 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1029. A search for the homology of the amino acid sequence of the phospholipase A1 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 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9425","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143938999","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 sugar beet KWS20-1 (application GMFF-2023-14732)","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Giovanni Savoini,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Michele Ardizzone,&nbsp;Giacomo De Sanctis,&nbsp;Antonio Fernandez Dumont,&nbsp;Arianna Ferrari,&nbsp;Andrea Gennaro,&nbsp;José Ángel Gómez Ruiz,&nbsp;Tilemachos Goumperis,&nbsp;Dafni Maria Kagkli,&nbsp;Aleksandra Lewandowska,&nbsp;Ana M. Camargo,&nbsp;Maria Neri Franco,&nbsp;Pietro Piffanelli,&nbsp;Tommaso Raffaello,&nbsp;Marta Rodrigues,&nbsp;Elena Sánchez-Brunete","doi":"10.2903/j.efsa.2025.9381","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9381","url":null,"abstract":"<p>Genetically modified sugar beet KWS20-1 was developed to confer tolerance to glyphosate-, dicamba- and glufosinate-ammonium-based herbicides. These properties were achieved by introducing the <i>cp4 epsps</i>, <i>dmo</i> and <i>pat</i> expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring further safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between sugar beet KWS20-1 and its conventional counterpart need further assessment, except for pectin in roots, which underwent additional evaluation and was found not to raise any safety or nutritional concerns. The GMO Panel does not identify safety concerns regarding the potential toxicity and allergenicity of the CP4 EPSPS, DMO and PAT proteins as expressed in sugar beet KWS20-1, and finds no evidence that the genetic modification would change the overall safety of sugar beet KWS20-1 as food and feed. In the context of this application, the consumption of food and feed from sugar beet KWS20-1 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that sugar beet KWS20-1 is as safe as the conventional counterpart and non-GM sugar beet reference varieties tested, and no post-market monitoring of food/feed is considered necessary. The scope of the application does not include cultivation and import of viable materials in the EU and the products would be expected to only contain residual amounts of DNA and protein. The environmental risk assessment was limited to the possible plant-to-bacteria horizontal gene transfer and the evaluation of potential interactions of KWS20-1 sugar beet products with biogeochemical cycles, and neither of them indicates a safety concern. The GMO Panel concludes that the sugar beet KWS20-1 is as safe as its conventional counterpart and the tested non-GM reference sugar beet varieties with respect to potential effects on human and animal health and the environment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9381","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939025","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":"Pest categorisation of Selenaspidus articulatus","authors":"EFSA Panel on Plant Health (PLH),&nbsp;Antonio Vicent Civera,&nbsp;Paula Baptista,&nbsp;Anna Berlin,&nbsp;Elisavet Chatzivassiliou,&nbsp;Jaime Cubero,&nbsp;Nik Cunniffe,&nbsp;Eduardo de la Peña,&nbsp;Nicolas Desneux,&nbsp;Francesco Di Serio,&nbsp;Anna Filipiak,&nbsp;Paolo Gonthier,&nbsp;Beata Hasiów-Jaroszewska,&nbsp;Hervé Jactel,&nbsp;Blanca B. Landa,&nbsp;Lara Maistrello,&nbsp;David Makowski,&nbsp;Panagiotis Milonas,&nbsp;Nikos Papadopoulos,&nbsp;Roel Potting,&nbsp;Hanna Susi,&nbsp;Dirk Jan van der Gaag,&nbsp;Vasiliki Evangelou,&nbsp;Alex Gobbi,&nbsp;Virag Kertesz,&nbsp;Andrea Maiorano,&nbsp;Dimitrios Papachristos,&nbsp;Oresteia Sfyra","doi":"10.2903/j.efsa.2025.9382","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9382","url":null,"abstract":"<p>Following the commodity risk assessment of <i>Jasminum polyanthum</i> unrooted cuttings from Uganda, in which <i>Selenaspidus articulatus</i> (Hemiptera: Diaspididae) was identified as a pest of possible concern, the European Commission requested the EFSA Panel on Plant Health to conduct a pest categorisation of <i>S. articulatus</i> for the territory of the European Union (EU). <i>S. articulatus</i> originates probably from sub-Saharan Africa. It is present in Africa, North and South America, as well as in parts of Asia and Oceania. Within the EU, the pest has been recorded in the Netherlands in greenhouses on ornamental plants, however, it appears not to be able to establish outside of a greenhouse under the environmental conditions of the Netherlands. <i>S. articulatus</i> is polyphagous, feeding on plants assigned to 158 genera in 68 plant families. Important crops of the EU that may be affected by this insect are avocado, citrus, grape and olive. Host availability and climate suitability would support its establishment in the southern EU countries. Indoor establishment in greenhouses can occur in colder areas of the EU. Reintroduction and spread of this scale insect would likely have an economic impact in the EU as it feeds on plant leaves and fruit, injects toxic saliva, reduces photosynthesis, and overall may cause yield loss and even death of entire plants. <i>S. articulatus</i> is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. Phytosanitary measures are available to reduce the likelihood of entry, establishment and spread of the pest into the EU. All criteria assessed by EFSA for consideration as a potential quarantine pest are met.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9382","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939503","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 endo-polygalacturonase from the genetically modified Trichoderma reesei strain RF6197","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;Jeroen Pasch,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9416","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9416","url":null,"abstract":"<p>The food enzyme endo-polygalacturonase ((1-4)-α-<span>d</span>-galacturonan glycanohydrolase, EC 3.2.1.15) is produced with the genetically modified <i>Trichoderma reesei</i> strain RF6197 by AB Enzymes GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant has requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed from or not carried into the final foods in three food manufacturing processes, the dietary exposure to the food enzyme–TOS was estimated only for the remaining four processes. The dietary exposure was calculated to be up to 0.137 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 7299. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9416","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939502","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 Duddingtonia flagrans NCIMB 30336 (BioWorma®) for all grazing animals (International Animal Health Products Pty 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;Montserrat Anguita,&nbsp;Rosella Brozzi,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Fabiola Pizzo,&nbsp;Jordi Ortuño","doi":"10.2903/j.efsa.2025.9366","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9366","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 <i>Duddingtonia flagrans</i> NCIMB 30336 (BioWorma®) for all grazing animals other than dairy bovines, ovines and caprines (namely, grazing animals from the following species: pigs (all categories), rabbits (all categories), horses (all categories) and calves/kids of species in the family Cervidae (deer, etc.) and Camelidae (alpacas, etc)). The safety and efficacy of the additive have already been assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the grazing animals other than dairy bovines, ovines and caprines due to the limitations in the dataset provided. For the current assessment, the applicant referred to the sub-chronic oral toxicity study provided in the previous application. The Panel considered that, since the microorganism is provided in the form of chlamydospores and is very unlikely to germinate during the gastrointestinal passage, the results from the sub-chronic oral toxicity study can be used to support the safety of the additive for the target species. Based on the NOAEL derived from the sub-chronic oral toxicity study, the maximum safe levels calculated are higher than the intake levels, resulting from the recommended use level for all the species. Therefore, the Panel concludes that the additive is safe for all grazing bovines, ovines, caprines, rabbits, horses, cervids, camelids and porcine species at the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9366","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143926059","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 chymotrypsin from the genetically modified Bacillus licheniformis strain NZYM-RH","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;Pier Sandro Cocconcelli,&nbsp;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9421","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9421","url":null,"abstract":"<p>The food enzyme chymotrypsin (EC 3.4.21.1) is produced with the genetically modified microorganism <i>Bacillus licheniformis</i> strain NZYM-RH by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 1.945 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, the toxicological studies provided were considered not necessary according to the current guidance but evaluated as supportive evidence. A search for the homology of the amino acid sequence of the chymotrypsin 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 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9421","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143919334","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 vermiculite for all poultry and ornamental birds, all porcine species, equines, leporids, camelids, pets and other non-food-producing animals (Regal B.V.)","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;Secundino López Puente,&nbsp;Jaume Galobart,&nbsp;Maria Vittoria Vettori,&nbsp;Orsolya Holczknecht,&nbsp;Fabiola Pizzo,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño,&nbsp;Piera Valeri","doi":"10.2903/j.efsa.2025.9362","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9362","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 vermiculite as a technological feed additive for all poultry and ornamental birds, all porcine species, equines, leporids, camelids, pets and other non-food-producing animals. The FEEDAP Panel concluded that vermiculite is considered safe at 10,000 mg/kg complete feed for the use in feed for chickens for fattening and reared for laying/breeding and laying hens, and at 5000 mg/kg complete feed for piglets and pigs for fattening. No conclusion can be drawn on the safety of the product for ornamental birds, equines, leporids, camelids, pets and other non-food-producing animals. The Panel concluded that the use of vermiculite is safe for consumer and the environment. The additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. Due to the lack of data, the Panel could not conclude on the potential of the additive to be an eye irritant. The FEEDAP Panel concluded that vermiculite is efficacious as anticaking agent in feed, when used at 10,000 mg/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9362","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143919861","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}