EFSA Journal最新文献

{"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}

{"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}

{"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^{((<i>T</i>−70)/10)} 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}

{"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}

{"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 × 10⁶ 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 × 10⁸ CFU/day for other children (3 to &lt; 10 years), 2.0 × 10⁸ CFU/day for adolescents from 10 to &lt; 14 years, 2.8 × 10⁸ CFU/day for adolescents from 14 to &lt; 18 years and 3.2 × 10⁸ 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}

{"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}

{"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}

{"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}

{"title":"Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 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;Montaña Cámara,&nbsp;Torsten Bohn,&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;Harry J. McArdle,&nbsp;Morten Poulsen,&nbsp;Miguel Prieto Maradona,&nbsp;Josef Rudolf Schlatter,&nbsp;Alexandros Siskos,&nbsp;Henk van Loveren,&nbsp;Reinhard Ackerl,&nbsp;Maria Glymenaki,&nbsp;Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9413","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9413","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 dried biomass powder of <i>Chlamydomonas reinhardtii</i> THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of <i>C. reinhardtii</i> THN 6, cannot be established.</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.2025.9413","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889023","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":"Re-evaluation of acesulfame K (E 950) as food additive","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;Monika Batke,&nbsp;Ellen Bruzell,&nbsp;James Chipman,&nbsp;Karlien Cheyns,&nbsp;Riccardo Crebelli,&nbsp;Cristina Fortes,&nbsp;Peter Fürst,&nbsp;Thorhallur Halldorsson,&nbsp;Jean-Charles Leblanc,&nbsp;Manuela Mirat,&nbsp;Oliver Lindtner,&nbsp;Alicja Mortensen,&nbsp;Matthew Wright,&nbsp;Stefania Barmaz,&nbsp;Consuelo Civitella,&nbsp;Pauline Le Gall,&nbsp;Elena Mazzoli,&nbsp;Josef Daniel Rasinger,&nbsp;Ana Rincon,&nbsp;Alexandra Tard,&nbsp;Federica Lodi","doi":"10.2903/j.efsa.2025.9317","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9317","url":null,"abstract":"<p>The present opinion deals with the re-evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5-chloro-acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).</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.2025.9317","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889037","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}