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Safety evaluation of the food enzyme prolyl oligopeptidase from the genetically modified Trichoderma reesei strain DP-Nyq99 转基因里氏木霉DP-Nyq99食品酶脯氨酰寡肽酶的安全性评价
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-05-07 DOI: 10.2903/j.efsa.2025.9418
EFSA Panel on Food Enzymes (FEZ), 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, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Jaime Aguilera, Daniele Cavanna, Cristina Fernàndez-Fraguas, Natalia Kovalkovicova, Simone Lunardi, Yi Liu
{"title":"Safety evaluation of the food enzyme prolyl oligopeptidase from the genetically modified Trichoderma reesei strain DP-Nyq99","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;Jaime Aguilera,&nbsp;Daniele Cavanna,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Natalia Kovalkovicova,&nbsp;Simone Lunardi,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9418","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9418","url":null,"abstract":"<p>The food enzyme prolyl oligopeptidase (EC 3.24.21.26) is produced with the genetically modified <i>Trichoderma reesei</i> strain DP-Nyq99 by Genencor international B.V. The genetic modifications do not give rise to safety concerns. The food enzyme was considered 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 brewed products. Dietary exposure was estimated to be up to 0.041 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 body weight (bw) per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 24,390. A search for the homology of the amino acid sequence of the prolyl oligopeptidase 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":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9418","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914455","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}
引用次数: 0
Safety evaluation of the food enzyme acetolactate decarboxylase from the genetically modified Bacillus subtilis strain DP-Ezz65 转基因枯草芽孢杆菌DP-Ezz65食品酶乙酰乳酸脱羧酶的安全性评价
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-05-07 DOI: 10.2903/j.efsa.2025.9419
EFSA Panel on Food Enzymes (FEZ), 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, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Magdalena Andryszkiewicz, Daniele Cavanna, Cristina Fernàndez-Fraguas, Silvia Peluso, Yi Liu
{"title":"Safety evaluation of the food enzyme acetolactate decarboxylase from the genetically modified Bacillus subtilis strain DP-Ezz65","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;Cristina Fernàndez-Fraguas,&nbsp;Silvia Peluso,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9419","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9419","url":null,"abstract":"<p>The food enzyme acetolactate decarboxylase (α-acetolactate decarboxylase; EC 4.1.1.5) is produced with the genetically modified <i>Bacillus subtilis</i> strain DP-Ezz65 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of brewed products. Dietary exposure was estimated to be up to 0.001 mg total organic solids/kg body weight 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, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the acetolactate decarboxylase 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":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9419","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914454","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}
引用次数: 0
Specific effects on kidneys relevant for performing a dietary cumulative risk assessment of pesticide residues 对肾脏的特定影响与进行农药残留的饮食累积风险评估有关
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-05-05 DOI: 10.2903/j.efsa.2025.9406
European Food Safety Authority (EFSA), Anna F. Castoldi, Tamara Coja, Anna Lanzoni, Kyriaki Machera, Luc Mohimont, Camilla Recordati, Federica Crivellente
{"title":"Specific effects on kidneys relevant for performing a dietary cumulative risk assessment of pesticide residues","authors":"European Food Safety Authority (EFSA),&nbsp;Anna F. Castoldi,&nbsp;Tamara Coja,&nbsp;Anna Lanzoni,&nbsp;Kyriaki Machera,&nbsp;Luc Mohimont,&nbsp;Camilla Recordati,&nbsp;Federica Crivellente","doi":"10.2903/j.efsa.2025.9406","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9406","url":null,"abstract":"<p>In consistency with the ‘EFSA-SANTE Action Plan on Cumulative Risk Assessment for pesticides residues’ EFSA initiated a retrospective cumulative risk assessment (CRA) of the effects of pesticide residues on the kidneys. EFSA identified the following specific effects on kidneys of relevance for cumulative risk assessment: glomerular injury, tubular injury, tubular crystals, papillary necrosis, interstitial nephritis, pelvis erosion/ulceration, pelvis calculi/crystals, renal preneoplastic and neoplastic lesions, and pelvis preneoplastic and neoplastic lesions. A list of histological indicators was defined and will be used to collect information on these specific effects, as reported in the assessment reports of the different active substances used as plant protections products. The criteria for inclusion of active substances/metabolites into cumulative assessment groups (CAGs) were also defined, together with the hazard characterisation methodology and the lines of evidence for assessing CAG-membership probabilities. Since no acute CAGs for kidney effects are considered appropriate, the cumulative dietary risk assessment will focus on chronic exposure only. The process of data extraction and establishment of the CAGs is beyond the scope of this report. This part of the CRA process was outsourced and will be the subject of a separate report.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9406","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143905095","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}
引用次数: 0
Specific effects on liver relevant for performing a dietary cumulative risk assessment of pesticide residues 对肝脏的特定影响与进行农药残留的膳食累积风险评估有关
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-05-05 DOI: 10.2903/j.efsa.2025.9409
European Food Safety Authority (EFSA), Anna F. Castoldi, Tamara Coja, Anna Lanzoni, Kyriaki Machera, Luc Mohimont, Monica Nepal, Camilla Recordati, Federica Crivellente
{"title":"Specific effects on liver relevant for performing a dietary cumulative risk assessment of pesticide residues","authors":"European Food Safety Authority (EFSA),&nbsp;Anna F. Castoldi,&nbsp;Tamara Coja,&nbsp;Anna Lanzoni,&nbsp;Kyriaki Machera,&nbsp;Luc Mohimont,&nbsp;Monica Nepal,&nbsp;Camilla Recordati,&nbsp;Federica Crivellente","doi":"10.2903/j.efsa.2025.9409","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9409","url":null,"abstract":"<p>According to the ‘EFSA-SANTE Action Plan on Cumulative Risk Assessment for pesticides residues’, EFSA initiated a retrospective cumulative risk assessment (CRA) of the effects of pesticide residues on the liver. For this CRA, EFSA identified the following liver-specific effects in accordance with the International Harmonisation of Nomenclature and Diagnostic Criteria (INHAND): (1) hypertrophy due to enzymatic induction, liver; (2) fatty change and/or phospholipidosis, hepatocellular; (3) degeneration/cell death, hepatocellular; (4) porphyria, hepatocellular, biliary duct; (5) cholestasis, hepatocellular, biliary duct; (6) preneoplastic and neoplastic changes, hepatocellular; (7) neoplastic changes, biliary duct. In addition, as gallbladder is part of the extrahepatic biliary system and can be affected by hepatic toxicity, the following specific effects in the gallbladder were defined: (1) erosion/ulceration, gallbladder (2) calculi, gallbladder and (3) neoplastic changes, gallbladder. Histopathology was considered as the most appropriate source of evidence together with the increase in relative liver weight, and a list of indicators was defined and will be used to collect information on these specific effects as included in the assessment reports of the different active substances used as plant protection products. The criteria for inclusion of active substances/metabolites into cumulative assessment groups (CAGs) were also defined, together with the hazard characterisation methodology and the lines of evidence for assessing CAG-membership probabilities. While primary indicators define the specific effect, secondary indicators and other endpoints (named ancillary endpoints) are considered not sufficiently informative to indicate a specific effect but are rather contributing to the overall evidence; these will be collected only for a limited number of substances (i.e. risk drivers based on hazard and exposure considerations) for determining the likelihood of the substances truly belonging to the CAGs (CAG-membership probabilities). Considering that it is not considered appropriate to establish CAGs for acute liver effects, CRAs on the liver will be only focused on chronic exposure. The process of data extraction and actual establishment of the CAGs is beyond the scope of this report. This part of the CRA process was outsourced and will be the subject of a separate report.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9409","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143905098","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}
引用次数: 0
Safety assessment of the substance N,N′-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide) for use in plastic food contact materials 用于塑料食品接触材料的物质N,N ' -(2-(4-(2-氨基苯甲氨基)丁基)戊烷-1,5-二基)双(2-氨基苯甲酰胺)的安全性评价
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-05-05 DOI: 10.2903/j.efsa.2025.9368
EFSA Panel on Food Contact Materials (FCM), Claude Lambré, Riccardo Crebelli, Maria da Silva, Konrad Grob, Evgenia Lampi, Maria Rosaria Milana, Marja Pronk, Mario Ščetar, Georgios Theodoridis, Els Van Hoeck, Nadia Waegeneers, Ronan Cariou, Laurence Castle, Emma Di Consiglio, Roland Franz, Eric Barthélémy, Remigio Marano, Gilles Rivière
{"title":"Safety assessment of the substance N,N′-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide) for use in plastic food contact materials","authors":"EFSA Panel on Food Contact Materials (FCM),&nbsp;Claude Lambré,&nbsp;Riccardo Crebelli,&nbsp;Maria da Silva,&nbsp;Konrad Grob,&nbsp;Evgenia Lampi,&nbsp;Maria Rosaria Milana,&nbsp;Marja Pronk,&nbsp;Mario Ščetar,&nbsp;Georgios Theodoridis,&nbsp;Els Van Hoeck,&nbsp;Nadia Waegeneers,&nbsp;Ronan Cariou,&nbsp;Laurence Castle,&nbsp;Emma Di Consiglio,&nbsp;Roland Franz,&nbsp;Eric Barthélémy,&nbsp;Remigio Marano,&nbsp;Gilles Rivière","doi":"10.2903/j.efsa.2025.9368","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9368","url":null,"abstract":"<p>The EFSA Panel on Food Contact Materials assessed the safety of N,N′-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide) to be used at up to 650 mg/kg in polyethylene terephthalate (PET) to scavenge acetaldehyde (AA). Final articles are intended for contact with aqueous, acidic and low-alcoholic beverages for long-term storage at room temperature and below. The migration of the substance from PET bottles into 20% ethanol was 0.0038 mg/kg food. The Panel calculated the potential migration of the summed reaction products not to exceed 0.02 mg/kg food. From experimental studies, the Panel excluded genotoxicity concerns for the substance, for 2-aminobenzamide +1 formaldehyde and 2-aminobenzamide +1 AA, both with desaturation. In silico predictions, previous EFSA evaluations and the use of the threshold of toxicological concern (TTC) excluded genotoxicity concerns for 15 other impurities/reaction products. A tentatively identified by-product was predicted as possible DNA-reactive in vitro mutagen and clastogen, due to its aromatic hydroxylamine group. Its modelled migration would not exceed 0.14 μg/kg food, leading to a potential exposure below the TTC of 0.0025 μg/kg body weight per day. Non-identified reaction products are expected to be structurally related to the identified ones and, hence, not to raise concern for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer, if it is used as an additive at up to 650 mg/kg in PET intended for contact with foods simulated by simulants A, B and C, for storage above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70°C ≤ <i>T</i> ≤ 100°C for maximum <i>t</i> = 120/2<sup>((<i>T</i>−70)/10)</sup> minutes. The substance should not be used for infant formula (including water used for reconstitution) and human milk. The migration of the substance should not exceed 0.05 mg/kg food. The substance should not contain aromatic hydroxylamine derivatives at more than 0.15% w/w.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9368","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143905097","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}
引用次数: 0
Olive oil polyphenols and the maintenance of normal HDL-cholesterol concentrations: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 橄榄油多酚和维持正常高密度脂蛋白胆固醇浓度:根据法规(EC) No 1924/2006第13(5)条对健康声明的评估
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-05-02 DOI: 10.2903/j.efsa.2025.9372
EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan de Henauw, Karen-Ildico Hirsch-Ernst, Angeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Frank Thies, Ionut Craciun, Thibault Fiolet, Alfonso Siani
{"title":"Olive oil polyphenols and the maintenance of normal HDL-cholesterol concentrations: 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;Ionut Craciun,&nbsp;Thibault Fiolet,&nbsp;Alfonso Siani","doi":"10.2903/j.efsa.2025.9372","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9372","url":null,"abstract":"<p>Following an application from University of Bari Aldo Moro, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, 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 olive oil polyphenols and the maintenance of normal blood high-density lipoprotein cholesterol (HDL-c) concentrations. The Panel considers that the food constituent, olive oil polyphenols, is sufficiently characterised. The maintenance of HDL-c concentrations in the blood (without increasing low-density lipoprotein cholesterol concentrations) is a beneficial physiological effect for the general population. The applicant submitted a published systematic review and meta-analysis of 10 human intervention studies, along with the individual studies included therein, investigating the effect of olive oil polyphenols on blood HDL-c concentrations. In weighing the evidence, the Panel took into account that, whereas one human intervention study in adult males showed a dose-dependent increase in HDL-c following daily consumption of olive oil polyphenols for 3 weeks, these results are not supported by other studies and have not been replicated in other population groups or settings. The Panel also took into account that no evidence was available on the sustainability of the effect with continuous consumption of olive oil polyphenols over longer periods of time (e.g. ≥ 8 weeks), and that no evidence for a plausible mechanism by which olive oil polyphenols could exert the claimed effect was provided. The Panel concludes that the evidence provided is insufficient to establish a cause-and-effect relationship between the consumption of olive oil polyphenols and the maintenance of normal HDL-c concentrations.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9372","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143896904","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}
引用次数: 0
Safety of Clostridium butyricum TO-A as a novel food pursuant to Regulation (EU) 2015/2283 根据法规(EU) 2015/2283,丁酸梭菌to - a作为新型食品的安全性
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-05-02 DOI: 10.2903/j.efsa.2025.9371
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), 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, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Reinhard Ackerl, Dafni Maria Kagkli, Karen Ildico Hirsch-Ernst
{"title":"Safety of Clostridium butyricum TO-A 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;Monika Neuhäuser-Berthold,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Reinhard Ackerl,&nbsp;Dafni Maria Kagkli,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9371","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9371","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 <i>Clostridium butyricum</i> TO-A as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is proposed by the applicant to be used as a food supplement, 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, and considering an uncertainty factor of 200, the Panel estimated a safe dose in humans of 4.5 × 10<sup>6</sup> colony forming unit (CFU)/kg body weight (bw) per day. However, considering that appropriate initial bacteria colonisation of the gastrointestinal tract in humans, in particular during the first 3 years of life, profoundly affects health during infancy and childhood, that disruptions to the microbiota early in life can have lasting health effects into adulthood, and taking into account that the 90-day oral toxicity study was conducted in adult rats, the Panel considers that the target population for the NF should be restricted to children above 3 years of age, adolescents and adults, excluding pregnant and lactating women. The Panel concludes that the NF, <i>C. butyricum</i> TO-A, is safe at 1.0 × 10<sup>8</sup> CFU/day for other children (3 to &lt; 10 years), 2.0 × 10<sup>8</sup> CFU/day for adolescents from 10 to &lt; 14 years, 2.8 × 10<sup>8</sup> CFU/day for adolescents from 14 to &lt; 18 years and 3.2 × 10<sup>8</sup> CFU/day for adults, excluding pregnant and lactating women.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9371","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143896903","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}
引用次数: 0
Commodity risk assessment of Alnus cordata and Alnus glutinosa specimen trees from the UK 英国秋桤木和秋桤木样品树的商品风险评估
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-30 DOI: 10.2903/j.efsa.2025.9383
EFSA Panel on Plant Health (PLH), Antonio Vicent Civera, Paula Baptista, Anna Berlin, Elisavet Chatzivassiliou, Jaime Cubero, Nik Cunniffe, Eduardo de la Peña, Nicolas Desneux, Francesco Di Serio, Anna Filipiak, Paolo Gonthier, Beata Hasiów-Jaroszewska, Hervé Jactel, Blanca B. Landa, Lara Maistrello, David Makowski, Panagiotis Milonas, Nikos T. Papadopoulos, Hanna Susi, Dirk Jan van der Gaag, Jane Debode, Charles Manceau, Christer Sven Magnusson, Juan A. Navas-Cortes, Christos Kritikos, Maria Kormpi, Dimitrios Papachristos, Chrysavgi Reppa, Olaf Mosbach Schulz, Ciro Gardi, Monia Federica Lombardo, Antigoni Akrivou, Spyridon Antonatos, Despoina Beris, Roel Potting
{"title":"Commodity risk assessment of Alnus cordata and Alnus glutinosa specimen trees from the UK","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 T. Papadopoulos,&nbsp;Hanna Susi,&nbsp;Dirk Jan van der Gaag,&nbsp;Jane Debode,&nbsp;Charles Manceau,&nbsp;Christer Sven Magnusson,&nbsp;Juan A. Navas-Cortes,&nbsp;Christos Kritikos,&nbsp;Maria Kormpi,&nbsp;Dimitrios Papachristos,&nbsp;Chrysavgi Reppa,&nbsp;Olaf Mosbach Schulz,&nbsp;Ciro Gardi,&nbsp;Monia Federica Lombardo,&nbsp;Antigoni Akrivou,&nbsp;Spyridon Antonatos,&nbsp;Despoina Beris,&nbsp;Roel Potting","doi":"10.2903/j.efsa.2025.9383","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9383","url":null,"abstract":"<p>The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘high risk plants, plant products and other objects’. This Scientific Opinion covers the plant health risks posed by the following commodities: <i>Alnus cordata</i> and <i>A. glutinosa</i> as specimen trees (from 7 to 25 years old) in pots imported into the EU from the UK. A list of pests potentially associated with the commodities was compiled. The relevance of each pest was assessed based on evidence following defined criteria. Three pests were selected for further evaluation: one EU-protected zone quarantine pest (<i>Entoleuca mammata</i>), one EU quarantine pest (<i>Phytophthora ramorum</i> (non-EU isolates)) and one non-quarantine pest (<i>Phytophthora siskiyouensis</i>). For the selected pests, the risk mitigation measures implemented in the UK and specified in the technical dossier were evaluated. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, as larger trees are more likely to be infested mainly due to longer time grown in the field. In addition, large canopies and root systems are more difficult to inspect, thereby making the detection of pests more challenging on large trees. The degree of pest freedom varies between the pests evaluated, with <i>E. mammata</i> being the pest most frequently expected on imported <i>Alnus</i> spp. specimen trees. Expert Knowledge Elicitation indicated, with 95% certainty, that between 9905 and 10,000 per 10,000 <i>Alnus</i> spp. specimen trees would be free from <i>E. mammata.</i></p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9383","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889024","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}
引用次数: 0
Plain Language Summary of the Re-evaluation of acesulfame K (E 950) as food additive 安赛蜜K (e950)作为食品添加剂的再评价综述
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-30 DOI: 10.2903/j.efsa.2025.p230401
{"title":"Plain Language Summary of the Re-evaluation of acesulfame K (E 950) as food additive","authors":"","doi":"10.2903/j.efsa.2025.p230401","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.p230401","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.p230401","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889201","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}
引用次数: 0
Peer review of the pesticide risk assessment for the active substance etoxazole in light of confirmatory data on the endocrine disruption assessment 根据内分泌干扰评估的确认性数据对原料药乙恶唑农药风险评估进行同行评议
IF 3.3 3区 农林科学
EFSA Journal Pub Date : 2025-04-30 DOI: 10.2903/j.efsa.2025.9407
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Franco Ferilli, German Giner Santonja, Katrin Halling, Alessio Ippolito, Frederique Istace, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Alberto Linguadoca, Jochem Louisse, Iris Mangas, Tunde Molnar, Martina Panzarea, Juan Manuel Parra Morte, Alexandra Piti, Simone Rizzuto, Rachel Sharp, Csaba Szentes, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
{"title":"Peer review of the pesticide risk assessment for the active substance etoxazole in light of confirmatory data on the endocrine disruption assessment","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;Franco Ferilli,&nbsp;German Giner Santonja,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Iris Mangas,&nbsp;Tunde Molnar,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Alexandra Piti,&nbsp;Simone Rizzuto,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9407","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9407","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 Greece for the pesticide active substance etoxazole are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the endocrine disruption potential of the substance. The conclusions were reached on the basis of the evaluation of the representative uses of etoxazole as an acaricide on pome fruits, plums, peaches, nectarines, apricots, cherries, citrus, grapes, strawberries, tomatoes/eggplants, cucurbits inedible peel, cotton seeds and ornamental plants. Assessments not finalised, together with the missing information identified as being required by the regulatory framework, are listed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 4","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9407","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889036","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}
引用次数: 0
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