EFSA Journal最新文献

{"title":"The 2023 European Union report on pesticide residues in food","authors":"European Food Safety Authority (EFSA),&nbsp;Luis Carrasco Cabrera,&nbsp;Giulio Di Piazza,&nbsp;Bruno Dujardin,&nbsp;Emanuela Marchese,&nbsp;Paula Medina Pastor","doi":"10.2903/j.efsa.2025.9398","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9398","url":null,"abstract":"<p>Under European Union legislation (Article 32, Regulation (EC) No 396/2005), the European Food Safety Authority publishes an annual report assessing the pesticide residue levels in food. In 2023, as part of the EU-coordinated multiannual control programme subset, 13,246 samples placed on the European market were analysed, with a 1.0% found to be non-compliant. Risk-based sampling procedures were used for the remaining 132,793 samples with a 2.0% non-compliant rate. Both dietary acute and chronic risk to consumers' health were estimated providing the probabilities of exceedance of the health-based guidance values (HBGV) for the pesticides in food by the different subpopulation of European consumers. This meant dropping the deterministic assessment used in the past. Overall, the dietary risk was found to be very low for most of the EU subpopulation groups. Recommendations were provided to risk managers to increase the effectiveness of European control systems and to ensure a high level of consumer protection throughout the EU.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9398","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944656","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 yellow tomato extract 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;Harry J. McArdle,&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;Monika Neuhäuser-Berthold,&nbsp;Helle Katrine Knutsen,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Ruth Roldán-Torres,&nbsp;Wolfgang Gelbmann,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9373","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9373","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 yellow tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid-rich extract from the yellow tomato containing predominantly phytoene plus phytofluene (PE/PF) at up to 10% of the NF, as well as a lesser amount of zeta-carotene (≤ 5%), beta-carotene (≤ 0.5%) and lycopene (≤ 0.4%). The NF is produced from the tomato pulp using supercritical CO₂ extraction. The applicant proposes to use the NF in food supplements (FS) for adults only at a maximum daily dose of 100 mg. The intake of lycopene from such FS would correspond to 0.4 mg/day which corresponds to 5.7 μg/kg body weight and day for an adult weighing 70 kg. This is approximately 1.1% of the acceptable daily intake (ADI) for lycopene established by EFSA (i.e. 0.5 mg/kg body weight), which does not raise safety concerns. According to the exposure assessment performed by EFSA, which included all population age groups, the highest mean and highest P95 intakes/kg bw estimates for PE/PF from the background diet of infants and toddlers are higher than the combined exposure of adults from the background diet and the NF under its proposed use and use levels in food supplements. Noting that the main sources for PE/PF are commonly and regularly consumed also by the youngest age groups and that PE/PF exposure from the background diet does not raise safety concern, the Panel considers that the NF is nutritionally not disadvantageous at the proposed intake of the NF of up to 100 mg/day used in FS in adults. The Panel concludes that the NF, yellow tomato extract, is safe under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9373","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944658","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":"Revised safety evaluation of the food enzyme leucyl aminopeptidase from the non-genetically modified Aspergillus sp. strain AE-MB","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;Eleonora Marini,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9422","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9422","url":null,"abstract":"<p>The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non-genetically modified <i>Aspergillus</i> sp. strain AE-MB by Amano Enzyme Inc. In a previous evaluation, the Panel concluded that the food enzyme could not be considered safe when used in five food manufacturing processes, due to insufficient margins of exposure estimated for all age groups. Subsequently, the applicant requested to withdraw one use, to include three additional food manufacturing processes, and to revise the use levels. In the present assessment, EFSA revised the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.367 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level reported in the previous opinion (183 mg TOS/kg bw per day, the lowest dose tested), the revised margin of exposure was at least 499. Having integrated new data into 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":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9422","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944659","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 cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21234)","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.2025.9377","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9377","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21234 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 cotton MON 88913, 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 cotton MON 88913 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-2023-21234 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton MON 88913.</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.2025.9377","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939564","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 soybean MON 87708 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21237)","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.2025.9379","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9379","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21237 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 soybean MON 87708, 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 soybean MON 87708 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-2023-21237 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87708.</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.2025.9379","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939174","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 MON 87427 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21254)","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.2025.9380","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9380","url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21254 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 of tissue-selective herbicide-tolerant genetically modified maize MON 87427, 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 maize MON 87427 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-2023-21254 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 87427.</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.2025.9380","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143939175","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 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}