Artículos (Nutrición y Bromatología, Toxicología y Medicina Legal)
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Artículo In vitro evaluation of interactions between cylindrospermopsin and water contaminants, arsenic and cadmium, in two human immune cell lines(Elsevier, 2024-11) Casas Rodríguez, Antonio; Šentjurc, Tjaša; Díez-Quijada Jiménez, Leticia; Pichardo Sánchez, Silvia; Žegura, Bojana; Jos Gallego, Ángeles Mencía; Cameán Fernández, Ana María; Nutrición y Bromatología, Toxicología y Medicina Legal; Ministerio de Ciencia, Innovación y Universidades (MICIU). España; Slovenian Research AgencyCylindrospermopsin (CYN), a cyanotoxin with worldwide distribution, is gaining increased attention due to its bioaccumulation potential and toxicological effects. Previous research suggests that CYN may interact with other environmental contaminants, potentially amplifying its toxicity. To address this concern, the present study investigated the combined effects of CYN with arsenic (As) and cadmium (Cd) on human immune cell lines, Jurkat and THP-1. Cytotoxicity tests showed that As and Cd significantly decreased the viability of both cell lines after 24 and 48 h of exposure. The EC50 (24 h) values for Jurkat cells were 13.15 ± 1.97 (As) and 36.92 ± 3.77 μM (Cd), respectively, while for THP-1, the EC50 (24 h) values were 46.48 ± 0.17 for As and 55.09 ± 4.98 μM for Cd. Furthermore, individual contaminants and their mixtures with CYN impaired monocyte differentiation into macrophages. The effect on mRNA expression of some cytokines (TNF-α, INF-γ, IL-2, IL-6 and IL-8) was also assessed. In the Jurkat cell line, As upregulated IL-8 expression while Cd increased the expression of all interleukins. Exposure to binary combinations (CYN + As, and CYN + Cd) increased IL-2 and INF-γ expression. In THP-1 cells, As elevated IL-8 and INF-γ expression, whereas Cd caused an increase in TNF-α and INF-γ expression. Exposure to CYN + As up-regulated IL-8 and INF-γ expression, while the CYN + Cd combination down-regulated TNF-α expression. These findings highlight the complex interactions between contaminants, emphasizing the need for evaluating combined effects in risk assessments.Artículo Acute study and the absorption, distribution, and metabolomic profile of the natural compound propyl-propane-thiosulfonate from allium in rats(Elsevier, 2024-12) Cascajosa Lira, Antonio; Pichardo Sánchez, Silvia; Baños, Alberto; Torre, José Manuel de la; Ayala-Soldado, Nahum; González-Pérez, José A.; Jiménez-Morillo, Nicasio T.; Jos Gallego, Ángeles Mencía; Cameán Fernández, Ana María; Nutrición y Bromatología, Toxicología y Medicina Legal; Junta de Andalucía; Ministerio de Ciencia, Innovación y Universidades (MICIU). EspañaPropyl-propane thiosulfonate (PTSO) is an organosulfur compound found in Allium spp., commonly used in animal nutrition and various agri-food applications. Extensive studies have demonstrated the safety of PTSO for feed use, including investigations into genotoxicity, mutagenicity, and subchronic toxicity in rats. However no kinetic or metabolic study has been previously performed. This study aimed to conduct an in vivo toxicokinetic assessment of PTSO in rats. For this purpose, eighteen Sprague Dawley rats received an oral dose of 175 mg/kg via gastric gavage. Plasma and tissue samples (brain, stomach, liver, lung, kidney, spleen, and testicle) were collected at specific intervals (10 min, 20 min, 30 min, 1h, 2h, 4h, 6h, 8h, and 24h) and analyzed using Gas Chromatography-High-Resolution Mass Spectrometry, Pyrolysis Gas Chromatography -High-Resolution Mass Spectrometry, and Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry to detect PTSO and its metabolites. PTSO was not detected in plasma or solid tissues throughout the sampling period; however, phase I and phase II metabolites were identified in both matrices. The toxicokinetic profile of s-propyl mercaptocysteine (CSSP), a significant metabolite, exhibited a well-correlated model. In the stomach, CSSP reached peak concentrations of 495.63 ± 6.53 ng/mL, while lower concentrations of 123.59 ± 8.35 ng/mL were observed in plasma. Furthermore, CSSP demonstrated high water solubility and rapid excretion, with a plasma half-life of 0.66 ± 0.05 h. Overall, these findings substantiate the safety profile of PTSO for specific agri-food applications under the conditions investigated.Artículo In vitro evaluation of the toxicity mechanisms of two functionalized reduced graphene oxide derivatives(Elsevier, 2025-01-25) Cebadero Domínguez, Óscar; Díez-Quijada Jiménez, Leticia; Puerto Rodríguez, María; Prieto, Alejandro; Cameán Fernández, Ana María; Jos Gallego, Ángeles Mencía; Nutrición y Bromatología, Toxicología y Medicina Legal; Junta de AndalucíaDodecyl amine functionalized reduced graphene oxide (DA-rGO) and [2-(methacryloyloxy) ethyl] trimethylammonium chloride functionalized rGO (MTAC-rGO) have been developed and characterised for their further use in the food packaging industry as food contact materials. But before their application, an authorization procedure is required in which their safety plays a key role. Therefore, the aim of this work was to evaluate their toxicity with focus on two different toxicity mechanisms: genotoxicity and immunotoxicity. Following the recommendations of the European Food Safety Authority, the mutagenicity and genotoxicity were evaluated by the mouse lymphoma assay and the micronucleus assay, respectively, in L5178Y TK cells. Both assays did not show any effect at the tested concentrations (up to 200 μg/mL). The potential immunotoxicity was evaluated on two human cell lines: THP-1 (monocytes) and Jurkat (lymphocytes). The results showed that the highest cytotoxicity was induced by MTAC-rGO in Jurkat cells. The two functionalized rGO compounds did not significantly affect the differentiation process of monocytes into macrophages. In general, both compounds altered the expression of different cytokines, with the most prominent changes observed with MTAC-rGO in THP-1 cells. Moreover, MTAC-rGO induced the most evident differences in markers of cell death mechanisms. Also, for this graphene derivative, increased levels of IL-1β and TNF-α in THP-1 cell supernatants were observed by ELISA. In conclusion, a case-by-case evaluation is necessary as both functionalized rGO compounds exhibit distinct toxicity profiles that warrant further investigation before their application in the food industry.Artículo Post-Fermentative Addition of Grape Seed Protein Hydrolysates and Their Impact on Wine Colour-Related Polyphenols(Mdpi, 2024-11-12) Mora Garrido, Ana Belén; Escudero Gilete, María Luisa; González-Miret Martín, María Lourdes; Heredia Mira, Francisco José; Cejudo Bastante, María Jesús; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalThis study evaluates the effect of protein hydrolysates, obtained from grape seed,meal (industrial waste), as colour stabilisers in red wines from warm climates. Protein,hydrolysates were added to the wine after fermentation and maceration. Assays were,performed using different types and doses of protein hydrolysates. Two grapevine-growing,seasons were monitored over 8 months. Attention was focused on different families of,polyphenolic compounds, copigmentation, and polymerisation, and colour changes were,assessed by differential tristimulus colourimetry. Regardless of doses and typology, wines,with protein hydrolysates suffered a decrease in the amount of phenolics and an increase,in % polymerisation. Only wines treated with 3 g/L of hydrolysates showed lower colour,intensity and greater clarity and hue after 8 months, while treatment with 0.5 g/L produced,brownish wines. The addition of hydrolysates from a low hydrolysis time did not affect the,copigmentation balances or produced negative visually perceptible colour differences over,time. These results indicate that the post-fermentation addition of protein hydrolysates,does not seem to significantly improve the stabilisation of the wine colour, in contrast to,the addition at other stages. This information is of great interest to wineries to consider the,application of this novel technique at the optimal time.Artículo Green optimization of microwave and ultrasound-assisted extraction of zeaxanthin from dehydrated goji berries using corn oil as a solvent(Elsevier, 2025-08) Stinco Scanarotti, Carla Maria; Benítez González, Ana; Escudero Gilete, María Luisa; Vicario Romero, Isabel; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; Universidad de SevillaThis research aimed to investigate and compare the extraction of zeaxanthin from lyophilised goji berries using ultrasonic-assisted extraction (UAE) and microwave-assisted extraction (MAE), employing food-grade corn oil as a green solvent. Optimisation of both processes was carried out using Response Surface Methodology (RSM). The selected combinations of variables studied were the ultrasonic amplitude and treatment time for UAE and microwave power and treatment time for MAE. The zeaxanthin-enriched corn oils and the commercial corn oil were characterised for carotenoids content, colour and oxidative stability. The highest extraction yields were obtained for UAE (68 %; 151.8 mg zeaxanthin/kg oil), while for MAE (54.5 %; 116.88 ± 1.77 mg zeaxanthin/kg oil). Both extraction methods result in enriched oils with darker, deeper, and more vivid orange colours than the original corn oil, with oxidation stability like that of the no enriched corn oil. In terms of environmental impact, MAE had lower energy consumption and CO2 emissions than UAE, but the latter achieved the highest oil enrichment. Compared to conventional organic solvent-based methods, the proposed solvent-free approach using edible oil minimizes toxicity, eliminates the need for post-extraction solvent removal, and allows direct application of the enriched product in food systems. Although the extraction condition providing maximum yield was not the greenest, MAE represented a more sustainable alternative. These findings highlight the need to balance extraction efficiency and environmental impact when designing green extraction processes. The resulting zeaxanthin-enriched corn oil could be used as a functional ingredient and natural colourant for the food industry.Artículo Safety of a change of specifications of phytosterols/phytostanols as a novel food pursuant to Regulation (EU)2015/2283(Wiley, 2025-01-27) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; Henauw, Stefaan de; Hirsch-Ernst, Karen Ildico; Jos Gallego, Ángeles Mencía; McArdle, Harry J.; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalFollowing a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to provide an opinion on thesafety of a change of the specifications of the authorised NF ‘phytosterols/phyto-stanols’ as a novel food (NF) pursuant to Regulation (EU) 2015/2283. This author-ised NF concerns phytosterols extracted from plants and which may be presentedas free sterols and stanols or esterified with food grade fatty acids. It has to con-tain less than 81% β-sitosterol, less than 35% β-sitostanol, less than 40% camp-esterol, less than 15% campestanol, less than 30% stigmasterol and less than 3%brassicasterol. Regarding the maximum limit of the specification parameter ‘othersterols/stanols’, the applicant asks for an increase from currently less than 3% toless than 7% to better reflect and cover the natural composition and proportionsof sunflower-based phytosterols/phytostanols, noting that the existing specifica-tions have been established largely based on the NF when sourced from soy. Noevidence was found from the literature for the genotoxicity, subchronic toxicity,chronic toxicity and carcinogenicity, and reproductive toxicity of four phytosterolswhich have been identified by the applicant in the NF when produced from sun-flower oil. These four phytosterols, albeit at lower concentrations, are also foundin the NF if produced from soy. The Panel also notes the history of multiple safetyassessments of phytosterols performed by Member States and EFSA, in addition tothe group ADI established by JECFA. The Panel also considers that an increase fromless than 3 to less than 7% for the maximum specification limit for ‘other phytos-terols’ is of no relevance regarding nutritional considerations. The Panel concludesthat the NF is safe under the proposed change of the specifications.Artículo Pacran®, a powder obtained from cranberries, and defence against bacterial pathogens in the lower urinary tract: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006(Wiley, 2025-04) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; Henauw, Stefaan de; Hirsch-Ernst, Karen Ildico; Jos Gallego, Ángeles Mencía; Siani, Alfonso; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalFollowing an application from Givaudan, submitted for authorisation of a healthclaim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the CompetentAuthority 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 healthclaim related to Pacran® and defence against bacterial pathogens in the lowerurinary tract. The Panel considers that the food Pacran®, a powder obtained fromcranberries, is sufficiently characterised. Defence against bacterial pathogens inthe lower urinary tract is a beneficial physiological effect. The applicant identi-fied two human intervention studies which investigated the effect of Pacran® onthe incidence of urinary tract infections (UTI) as being pertinent to the claim. Inweighing the evidence, the Panel took into account that one human interventionstudy showed a beneficial effect of Pacran® consumed daily at doses of 500 mg for6 months on the incidence of symptomatic, culture-confirmed UTI in women witha history of recurrent UTI, whereas such an effect was not consistently observedin another study under similar conditions. The Panel also took into account thatlimited evidence has been provided for a mechanism by which Pacran® could exertthe claimed effect. The Panel concludes that the evidence provided is insufficientto establish a cause and effect relationship between the consumption of Pacran®and the defence against bacterial pathogens in the lower urinary tract.Artículo Nutritional safety and suitability of a specific protein hydrolysate manufactured by Fonterra Co-operative Group Ltd derived from a whey protein concentrate and used in infant formula and follow-on formula(Wiley, 2025-01-22) Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; Henauw, Stefaan de; Hirsch-Ernst, Karen Ildico; Jos Gallego, Ángeles Mencía; Turck, Dominique; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalThe European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability for use in infant and follow-on formula of a specific protein hydrolysate from whey protein concentrate manufactured by Fonterra Co-operative Group Ltd. Fonterra Co-operative Group Ltd. submitted a dossier to the European Commission to request an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in the manufacture of infant and/or follow-on formula. The protein hydrolysate under evaluation is sufficiently characterised with respect to the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.0 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to a growth similar to a formula manufactured from intact cow's milk with the same protein content. Data on gastrointestinal tolerance of the formula did not raise any concerns. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. Given that follow-on formula is consumed with complementary foods and the protein source is nutritionally safe and suitable in an infant formula that is the sole source of nutrition of young infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 2.0 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.Artículo Deciphering the synthesis in Saccharomyces cerevisiae of the bioactives melatonin, serotonin, indoleacetic acid, hydroxytyrosol and tyrosol from glucose by using 13C labelling precursors and UHPLC-MS(Elsevier, 2025-09) González Ramírez, Marina; Masuero, Domenico; Cerezo López, Ana Belén; Troncoso González, Ana María; Vrhovšek, Urška; García Parrilla, María del Carmen; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; Ministerio de Ciencia, Innovación y Universidades (MICIU). España; Junta de AndalucíaSaccharomyces cerevisiae produces bioactive compounds such as melatonin (MEL), serotonin (SER), indoleacetic acid (IAA), hydroxytyrosol (HT), and tyrosol during alcoholic fermentation. Previous research shows that tryptophan and tyrosine are precursors. This study aimed to investigate whether S. cerevisiae can synthetize these bioactives from glucose. Using [U13C]-glucose as the fermentation substrate and UHPLC-MS for analysis, the research traced unequivocally the formation of these compounds. Results confirmed that MEL, SER, IAA, tyrosol, and HT are partly derived from glucose. Different 13C-labelled forms of HT, tyrosol, and tyrosine were identified which allows to propose a biosynthetic pathway leading to the formation of HT through reactions between intermediates from the pentose phosphate pathway, glycolysis, additionally to the Erlich pathway. The proposed pathway includes L-DOPA and catechol which were detected in their 13C-labelled forms. Understanding HT synthesis opens opportunities to enhance the bioactive potential of fermented beverages.Artículo Bioactive and agroindustrial potential of Amazonian fruit species: a review(Taylor and Francis, 2025-01-15) Cuéllar Álvarez, Liceth Natalia; García-Chacón, Juliana María; Heredia Mira, Francisco José; González-Miret Martín, María Lourdes; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; Junta de Andalucíaits high biodiversity makes the Amazon rainforest a strategic place to carry out bioprospectingof fruit and plant species with nutritional, biofunctional, and technological value. This reviewhighlights some Amazonian fruits such as açaí (Euterpe oleracea), arazá (Eugenia stipitata),camu-camu (Myrciaria dubia), canangucha (Mauritia flexuosa), cocona (Solanum sessiliflorum),and uva caimarona (Pourouma cecropiifolia), which deserve and need further and deeperexploration of their chemical composition, bioactive properties, and potential applicationswithin the food industry, especially those grown in the colombian Amazon region. Therefore,this article aims to contribute to the obtention and formulation of new and innovative foodproducts that can increase the shelf life of fruits and preserve their bioactive properties, andin some cases, improve their sensory acceptance. Additionally, it identifies the challenges inthe production and marketing chain as a strategy to promote the consumption andcommercialization of these Amazonian fruits, offering opportunities for research anddevelopment.Artículo Assessment of the Chemical Diversity and Functional Properties of Secondary Metabolites from the Marine Fungus Asteromyces cruciatus(Multidisciplinary Digital Publishing Institute (MDPI), 2024-12-24) González Troncoso, María Paz; Landeta-Salgado, Catalina; Munizaga, Javiera; Hornedo Ortega, Ruth; García Parrilla, María del Carmen; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; Centre for Biotechnology and Bioengineering-CeBiBNatural compounds derived from microorganisms, especially those with antioxidant and anticancer properties, are gaining attention for their potential applications in biomedical, cosmetic, and food industries. Marine fungi, such as Asteromyces cruciatus, are particularly promising due to their ability to produce bioactive metabolites through the degradation of marine algal polysaccharides. This study investigates the metabolic diversity of A. cruciatus grown on different carbon sources: glucose, Durvillaea spp., and Macrocystis pyrifera. Crude extracts of fungal biomass were analyzed for total phenolic content (TPC), antioxidant capacity (TAC), toxicity, and phenolic compound identification using ultra-high-performance liquid chromatography coupled with high-resolution electrospray ionization mass spectrometry (UHPLC-MS/MS). The analysis revealed the presence of anthraquinone compounds, including emodin (0.36 ± 0.08 mg/g DW biomass) and citrereosein in glucose medium and citrereosein and endocrocin in M. pyrifera medium. No such compounds were detected in Durvillaea spp. medium. The glucose-grown extract exhibited the highest TPC (3.09 ± 0.04 mg GAE/g DW) and TAC (39.70 ± 1.0 µmol TEq/g biomass). Additionally, no detrimental effects were observed on a neuronal cell line. These findings highlight the influence of carbon sources on the production of bioactive metabolites and their functional properties, providing valuable insights into the biotechnological potential of A. cruciatus.Artículo Safety of oil from Schizochytrium limacinum (strain ATCC-20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283(Wiley, 2025-01-22) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; Henauw, Stefaan, de ; Jos Gallego, Ángeles Mencía; Hirsch-Ernst, Karen Ildico; McArdle, Harry J.; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalFollowing a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on thesafety of an oil derived from the microalga Schizochytrium sp. (strain ATCC-20889)as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixtureof triglycerides in which docosahexaenoic acid (DHA) represents 40%–43% offatty acids. The available evidence indicates that the source organism (strain ATCC-20889) belongs to the species Schizochytrium limacinum. The applicant intendsto market the NF as an ingredient in infant formulae (IF) and follow-on formulae(FOF). The use levels proposed by the applicant were derived from Regulation (EU)2016/127, which states the mandatory presence of DHA to IF and FOF at the levelsof 20–50 mg/100 kcal. Schizochytrium limacinum was attributed the qualified pre-sumption of safety (QPS) status with the qualification ‘for production purposesonly’. Data provided by the applicant demonstrated the absence of viable cells inthe NF. No toxicological studies were performed with the NF. However, based onthe available toxicological data on oils derived from Schizochytrium sp., the QPSstatus of the source of the NF, the production process, the composition of the NF,the absence of marine biotoxins and viable cells in the NF, the Panel considers thatthere are no concerns with regard to the toxicity of the NF. The Panel concludesthat the NF is safe under the proposed conditions of use.Artículo In silico and in vitro evaluation of potential agonistic and antagonistic estrogenic and androgenic activities of pure cyanotoxins, microcystin-LR and cylindrospermopsin(Elsevier, 2025) Casas Rodríguez, Antonio; Cascajosa Lira, Antonio; Puerto Rodríguez, María; Cameán Fernández, Ana María; Jos Gallego, Ángeles Mencía; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; Ministerio de Ciencia, Innovación y Universidades (MICINN). España; Agencia Estatal de Investigación. España; European Union (UE)The potential endocrine disruption activity of cyanotoxins, particularly their effects on estrogen and androgen receptors (ER, AR), remains poorly understood. In the present study, the potential agonistic/antagonistic estrogenic and androgenic activities of MC-LR and CYN have been determined for the first time with validated OECD Test Guidelines No. 455 and 458, respectively. The data show that only MC-LR demonstrated weak estrogenic agonistic effects (LogPC10 value of − 9.85 M), while both toxins displayed antagonistic effects on the ER, with LogIC30 values of − 4.4 and − 6.4 for MC-LR and CYN, respectively. In addition, neither MC-LR nor CYN exhibited agonistic/antagonistic activities in AR. Docking studies revealed potential interactions between both toxins and AR, with CYN showing a higher predicted affinity for this receptor. In vivo studies, particularly those investigating androgen disruption, are warranted to confirm the endocrine disrupting potential of MC-LR and CYN.Artículo Safety of mineral salt containing(Wiley, 2025) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; de Henauw, Stefaan; Jos Gallego, Ángeles Mencía; Hirsch-Ernst, Karen Ildico; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalFollowing a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on amineral salt, containing potassium and magnesium, as a novel food (NF) pursu-ant to Regulation (EU) 2015/2283. The NF is a mineral salt that consists mainly ofmagnesium potassium trichloride hexahydrate. The information provided on thecomposition is sufficient for characterising the NF and does not raise safety con-cerns. The production process is sufficiently described and does not raise safetyconcerns. The NF is intended to be added to meat, sausages and dishes based onpasta, rice and other cereals. Taking into account the composition of the NF andthe proposed use and use levels, the Panel considers that the consumption of theNF is not nutritionally disadvantageous. Regarding the presence of bromide in theNF, the Panel notes that the combined daily intake of bromide from the NF andthe background diet does not exceed the tolerable daily intake of bromide of 0.4mg/kg body weight (bw) per day. Based on its physicochemical characteristics andsolubility data, the NF is expected to be dissociated in the gastrointestinal tract.Taking into account the composition and the nature of the NF, the Panel considersthat no toxicological studies with the NF are required. The Panel concludes thatthe NF (i.e. a mineral salt containing potassium and magnesium) is safe under theproposed conditions of use.Artículo Safety of Tiger Nuts (Cyperus Esculentus) Oil as a Novel food Pursuant to Regulation (EU) 2015/2283(Wiley-Blackwell, 2024) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; de Henauw, Stefaan; Hirsch-Ernst, Karen Ildico; Jos Gallego, Ángeles Mencía; Maciuk, Alexandre; Mangelsdorf, Inge; McNulty, Breige; McArdle, Harry J.; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalFollowing a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Tiger nuts (Cyperus esculentus) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Tiger nuts (C. esculentus) is an edible tuber with history of consumption as food. The NF is the oil obtained from the nuts through cold pressing of the seeds flour. Oleic acid is the major component, representing 65%–69% of the oil's total fatty acids. The applicant proposed to use the NF as an ingredient in several food categories, and as a cooking oil or added as a condiment. The Panel notes that there are no safety concerns regarding stability if the NF complies with the proposed specification limits during its entire shelf-life. Taking into consideration the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel considers that, based on the production process, composition of the NF, history of use of and composition of the source, no toxicological studies are required on the NF. The Panel concludes that the NF is safe under the proposed conditions of use.Artículo Safety of an Extension of Use of Oil from Schizochytrium Limacinum (strain FCC-3204) as a Novel Food Pursuant to Regulation (EU) 2015/2283(Wiley-Blackwell, 2024) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; de Henauw, Stefaan; Hirsch-Ernst, Karen Ildico; Jos Gallego, Ángeles Mencía; Maciuk, Alexandre; Mangelsdorf, Inge; McNulty, Breige; Knutsen, Helle Katrine; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalFollowing a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an extension of use of oil from Schizochytrium limacinum (strain FCC-3204) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in protein products at a maximum use level of 1 g of docosahexaenoic acid (DHA) in 100 g of product. The Panel considers that the information provided on the composition and the production process is sufficiently described and does not raise safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided demonstrated the absence of viable cells in the NF. Under the proposed extension of use, the highest intake estimate (at the 95th percentile) of DHA from the NF in protein products is 6.3 mg DHA/kg bw per day for adolescents. The Panel notes that the exposure to DHA from the new intended use of the NF in protein products is very low compared to the exposure to DHA from the already authorised food categories (excluding food supplements). The Panel concludes that the NF (oil from S. limacinum (FCC-3204)) is safe under the new intended use.Artículo Guidance for Establishing and Applying Tolerable Upper Intake Levels for Vitamins and Essential Minerals(Wiley-Blackwell, 2024) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; de Henauw, Stefaan; Hirsch-Ernst, Karen Ildico; Jos Gallego, Ángeles Mencía; Maciuk, Alexandre; Mangelsdorf, Inge; McNulty, Breige; Naska, Androniki; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina LegalVitamins and essential minerals are micronutrients that are required for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. A tolerable upper intake level (UL) is a science-based reference value that supports policy-makers and other relevant actors in managing the risks of excess nutrient intake. EFSA's principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework for UL assessments. A draft was published in 2022 and underwent a 2-year piloting period. The present document incorporates revisions based on the experience gained through its practical implementation. It covers aspects related to the planning of the risk assessment (problem formulation and definition of methods) and its implementation (evidence retrieval, appraisal, synthesis, integration, uncertainty analysis). As in the previous framework, the general principles developed for the risk assessment of chemicals in food are applied, i.e. hazard identification, hazard characterisation, intake assessment, risk characterisation. Specific to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homeostasis and accumulation of the nutrient in the body. Such considerations must also be taken into account when conducting risk assessments of nutrients.Artículo Effects of a Diet of Allium Extract on Growth, Biochemistry, Metabolism, and Gut Microbiota of Rabbits (Oryctolagus cuniculus)(Multidisciplinary Digital Publishing Institute (MDPI), 2024-12-09) Cascajosa Lira, Antonio; Pichardo Sánchez, Silvia; Baños, Alberto; Aguinaga-Casañas, María Arántzazu; Ricci, Andrea; Frabetti, Andrea; Barausse, Andrea; Jos Gallego, Ángeles Mencía; Cameán Fernández, Ana María; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; Junta de AndalucíaThe rabbit farming industry is growing due to the rising demand for healthy, sustainable meat. Rabbit meat’s nutritional benefits and low environmental impact appeal to health-conscious consumers. To enhance economic sustainability, efforts focus on reducing disease susceptibility and antibiotic use through improved biosecurity and natural additives, such as organosulphur compounds from Allium plants, which have shown promise in studies for boosting productivity and health. This study aimed to investigate the effects of PTSO supplementation on farm rabbits. Over and after a 76-day period, various parameters were assessed to measure the impacts on rabbit growth, health, biochemical parameters, muscle metabolism, and intestinal microbiota. The rabbit groups received either a control diet or a diet supplemented with Allium extract. The results showed significant improvements in growth performance for rabbits fed with Allium extract, including higher final weights, increased average daily gain (ADG), and lower mortality rates. A biochemical analysis revealed normal values for the parameters measured in the treated group. A muscle analysis evidenced the presence of a few metabolites of PTSO. A gut microbiota analysis indicated distinct differences between the control and treated groups, increasing the presence of some strains that can influence positively the growth of rabbits. This study highlights the potential benefits of PTSO supplementation for improving growth performance, health parameters, and gut microbiota composition in farm rabbits, suggesting its efficacy as a dietary additive.Artículo Effect of the Addition of Protein Hydrolysates from Grape Seed Meal Residue to Red Wines in Warm Regions in the Stabilization Stage(Academic Press, 2024) Mora Garrido, Ana Belén; Escudero Gilete, María Luisa; González-Miret Martín, María Lourdes; Heredia Mira, Francisco José; Cejudo Bastante, María Jesús; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; European Commission (EC). Fondo Europeo de Desarrollo Regional (FEDER)The effect of adding protein hydrolysates from defatted grape seed meals, a residue of the grape pomace industry, on the improvement of color stabilization of Syrah wines in warm climates was evaluated. Factors such as the type of raw material, the hydrolysis time, and the doses of protein hydrolysate were assessed. Hydrolysates were added to the wines at the stabilization stage and scrutinized over five months focusing on the polyphenolic composition, copigmentation and polymerization, as well as color by differential tristimulus colorimetry. The addition of 3 g/L protein hydrolysates from 1-h hydrolysis depicted a color stabilization effect, leading to higher values of chroma (C*ab), phenolic compounds (benzoic acids and flavan-3-ols), and copigmentation, although assuming a slightly more aged-related tonality. These data obtained provide an interesting insight, not reported so far, on the use of this oenological alternative to avoid common color losses of red wines elaborated in warm climate.Artículo Assessment of the Effects of Anatoxin-a In Vitro: Cytotoxicity and Uptake(Multidisciplinary Digital Publishing Institute (MDPI), 2024-12-13) Plata Calzado, Cristina; Prieto Ortega, Ana Isabel; Cameán Fernández, Ana María; Jos Gallego, Ángeles Mencía; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal; Ministerio de Ciencia, Innovación y Universidades (MICINN). EspañaAnatoxin-a (ATX-a) is a cyanotoxin whose toxicological profile has been underinvestigated in comparison to other cyanotoxins such as microcystins (MCs) or cylindrospermopsin (CYN). However, its wide distribution, occurrence, and toxic episodes justify more attention. It is classified as a neurotoxin, but it has also been reported to affect other organs and systems. Thus, the aim of this study was to establish, as a first tier in its toxicological evaluation, its cytotoxicity in a wide range of cell lines representative of potential target organs (N2a, SH-SY5Y, HepG2, Caco2, L5178Y Tk+/−, THP-1 and Jurkat). As limited effects were observed after exposure to up to 200 µg/mL of ATX-a for 24 h (only Jurkat and THP-1 cells showed reduced cell viability), cell uptake experiments were performed by ultra-high performance liquid chromatography–tandem mass spectrometry (UHPLC-MS/MS). The results showed that the immune system cells had the highest percentage of ATX-a in the intracellular fraction, followed by neuronal cells and finally Caco-2 and HepG2 cells. Moreover, the expression of genes related to cell death mechanisms in THP-1 cells was also analyzed by polymerase chain reaction (PCR) and showed no changes under the conditions tested. Further research is required on ATX-a’s toxic effects and toxicokinetics to contribute to its risk assessment.