Artículos (Nutrición y Bromatología, Toxicología y Medicina Legal)

URI permanente para esta colecciónhttps://hdl.handle.net/11441/26073

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Safety of Dried Biomass Powder of Chlamydomonas ReinhardtiiTHN 6 as a Novel Food Pursuant to Regulation (EU) 2015/2283
(Wiley, 2025) Turck, Dominique; Cámara, Montaña; Bohn, Torsten; Castenmiller, Jacqueline; de Henauw, Stefaan; Jos Gallego, Ángeles Mencía; Maciuk, Alexandre; Mangelsdorf, Inge; McNulty, Breige; Naska, Androniki; Hirsch-Ernst, Karen Ildico; Nutrición y Bromatología, Toxicología y Medicina Legal
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 driedbiomass powder of Chlamydomonas reinhardtii THN 6 as a novel food (NF) pur-suant to Regulation (EU) 2015/2283. During the risk assessment, the Panel iden-tified 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, composi-tion, specifications, history of use, proposed uses and use levels, nutritional infor-mation, genotoxicity and allergenicity of the NF. Despite being contacted severaltimes, the applicant did not reply to EFSA's requests for additional data. The Panelconcludes that, based on the available data, the safety of the NF, i.e. dried biomasspowder of C. reinhardtii THN 6, cannot be established.
Safety of D-allulose as a Novel Food Pursuant to Regulation (EU) 2015/2283
(Wiley, 2025) Turck, D.; Cámara, M.; Bohn, T.; Castenmiller, J.; de Henauw, S.; Jos Gallego, Ángeles Mencía; Maciuk, A.; Mangelsdorf, I.; McNulty, B.; Naska, A.; Hirsch-Ernst, K. I.; EFSA Panel on Nutrition; Nutrición y Bromatología, Toxicología y Medicina Legal
Following a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to deliver an opinion onD-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During therisk assessment, the Panel identified a number of data gaps, which needed to beaddressed by the applicant. Therefore, an EFSA request for additional informationwas sent to the applicant. The requested data concerned the identity, the produc-tion process, proposed uses and use levels, genotoxicity and human data of theNF. Despite being contacted several times, the applicant did not reply to EFSA'srequests for additional data. Based on the available data, the Panel concludes thatthe safety of the NF, i.e. D-allulose, cannot be established.
Safety of Clostridium Butyricum TO-A as a Novel Food Pursuantto Regulation (EU) 2015/2283
(Wiley, 2025) Turck, Dominique; Bohn, Torsten; Cámara, Montaña; Castenmiller, Jacqueline; de Henauw, Stefaan; Jos Gallego, Ángeles Mencía; Maciuk, Alexandre; Mangelsdorf, Inge; McNulty, Breige; Naska, Androniki; Hirsch-Ernst, Karen Ildico; Nutrición y Bromatología, Toxicología y Medicina Legal
Following a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to deliver an opinion onClostridium butyricum 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 sup-plement, is sufficiently characterised. The information provided on the produc-tion process, composition, stability and specifications of the NF is sufficient anddoes not raise safety concerns. Based on the findings of a repeated dose 90- dayoral toxicity study in rats, and considering an uncertainty factor of 200, the Panelestimated a safe dose in humans of 4.5 × 10 6 colony forming unit (CFU)/kg bodyweight (bw) per day. However, considering that appropriate initial bacteria coloni-sation of the gastrointestinal tract in humans, in particular during the first 3 yearsof life, profoundly affects health during infancy and childhood, that disruptionsto the microbiota early in life can have lasting health effects into adulthood, andtaking 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 tochildren above 3 years of age, adolescents and adults, excluding pregnant andlactating women. The Panel concludes that the NF, C. butyricum TO-A, is safe at1.0 × 10 8 CFU/day for other children (3 to < 10 years), 2.0 × 10 8 CFU/day for adoles-cents from 10 to < 14 years, 2.8 × 10 8 CFU/day for adolescents from 14 to < 18 yearsand 3.2 × 10 8 CFU/day for adults, excluding pregnant and lactating women.
Phenolic Compounds Naturally Present in Olive Oil and Lowering of Blood LDL-cholesterol and Systolic Blood Pressure, therefore Reducing the Risk of Coronary heart disease: Evaluation of a Health Claim Pursuant to Article 14 of Regulation (EC) No 1924/2006
(Wiley, 2025) Turck, D.; Bohn, T.; Cámara, M.; Castenmiller, J.; de Henauw, S.; Hirsch-Ernst, Karen Ildico; Jos Gallego, Ángeles Mencía; Maciuk, A.; Mangelsdorf, I.; McNulty, B.; EFSA Panel on Nutrition; Nutrición y Bromatología, Toxicología y Medicina Legal
Following an application from QvExtra! Internacional pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, 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 phenolic compounds naturally present in olive oil and lowering of blood LDL-cholesterol (LDL-c) and systolic blood pressure (SBP), therefore reducing the risk of coronary heart disease (CHD). The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The Panel considers that the food/constituent, phenolic compounds naturally present in olive oil, is sufficiently characterised, and that lowering of blood LDL-c and SBP are beneficial effects by reducing the risk of CHD. The applicant identified seven pertinent human intervention studies investigating the effect of olive oil polyphenols on LDL-c and/or SBP. In weighing the evidence with regard to blood LDL-c, the Panel considered that, although one human intervention study in hypercholesteraemic individuals showed a reduction in LDL-c following daily consumption of olive oil polyphenols for 3 weeks, these results are not supported by other studies. The Panel also considered that no evidence was available for the sustainability of the effect over longer periods of time (e.g. ≥ 8 weeks), or for a plausible mechanism of action. In weighing the evidence with regard to SBP, the Panel took into account that, although some evidence for a plausible mechanism by which phenolic compounds in olive oil could exert the claimed effect has been provided, the studies submitted did not show an effect of olive oil polyphenols on SBP. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of phenolic compounds naturally present in olive oil and the reduction of blood LDL-c or SBP.
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
(Willey, 2025) 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; Siani, Alfonso; Nutrición y Bromatología, Toxicología y Medicina Legal
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.
¹H-NMR Spectroscopy and Chemometric Fingerprinting for the Authentication of Organic Extra Virgin Olive Oils
(MDPI, 2025) Azcarate, S. M.; Segura Borrego, María del Pilar; Ríos-Reina, Rocío; Callejón Fernández, Raquel María; Nutrición y Bromatología, Toxicología y Medicina Legal; Junta de Andalucía; European Commission (EC). Fondo Europeo de Desarrollo Regional (FEDER)
The authentication of organic extra virgin olive oils (OEVOOs) is crucial for quality control and fraud prevention. This study applies proton-nuclear magnetic resonance (1H-NMR) spectroscopy combined with chemometric analysis as a non-destructive, untargeted approach to differentiate EVOOs based on cultivation method (organic vs. conventional) and variety (Hojiblanca vs. Picual). Principal component analysis (PCA) and partial least squares-discriminant analysis (PLS-DA) demonstrated well-defined sample differentiation, while the variable importance in projection (VIP) selection and Tukey’s test identified key spectral regions responsible for classification. The results showed that sterols and lipid-related compounds played a major role in distinguishing organic from conventional oils, whereas fatty acids and phenolic compounds were more relevant for cultivar differentiation. These findings align with known metabolic differences, where Picual oils generally exhibit higher polyphenol content, and a distinct fatty acid composition compared to Hojiblanca. The agreement between chemometric classification models and statistical tests supports the potential of 1H-NMR for OEVOO authentication. This method provides a comprehensive and reproducible metabolic fingerprint, enabling differentiation based on both agronomic practices and genetic factors. These findings suggest that 1H-NMR spectroscopy, coupled with multivariate analysis, could be a valuable tool for quality control and fraud detection in the olive oil industry.
Potential Application of a Synthetic Organo-funtionalized High Load Expandable Mica as Drug Carrier for Controlled Release.
(Bentham Science Publishers, 2021) Orta Cuevas, María del Mar; Maisanaba Hernández, Sara; Medina Carrasco, Santiago; Jos Gallego, Ángeles Mencía; Química Analítica; Nutrición y Bromatología, Toxicología y Medicina Legal
Background: In this work the cytotoxicity and gastric and gastrointestinal resistance of a high-load synthetic expandable mica, Na-mica-4, is studied for the first time. The hydrophilic character of this clay mineral can be modified by ion exchange reaction between Na+ inorganic cations housed in the interlayer space, and surfactant molecules, resulting in the formation of an organophilic material. This adsorption capability of organic compounds makes them very useful for a wide range of applications, such as their use as drug carriers. Previous studies have shown the high adsorption capacity of organofunctionalized Na-mica-4 of different types of drugs. Objetive: To carry out initial trials aimed at testing the cytotoxicity of a synthetic organofunctional expandable mica and evaluating its resistance to gastric and gastrointestinal digestion. Methods: A highly charged sodium mica (Na-mica-4) was synthesized and organofunctional by cationic exchange with an alkylamine, primary amine of 18 carbon atoms (C18-mica-4). Both were characterized by X-ray diffraction, field transmission electron microscopy, surface-specific analysis, differential scanning calorimetry, and thermal gravimetric analysis. In addition, screening cytotoxicity trials were conducted on the human intestinal cell line Caco-2 with C18-mica-4 (0-125 μg/ml). Results: Only one of the endpoints evaluated (the reduction of tetrazolium MTS salt by dehydrogenase enzymes) showed a significant decrease in cellular viability after 48h at the highest concentration tested. C18-mica-4 shows structural resistance to both, gastric and gastrointestinal, digestion. Conclusion: A successful development of a functionalized mica has been made with a promising potential application as a carrier to the drug.
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 Agency
Cylindrospermopsin (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.
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). España
Propyl-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.
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 Andalucía
Dodecyl 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.
In vitro toxicity of two functionalized reduced graphene oxide materials with potential application in food packaging
(Elsevier, 2025-01) Cebadero Domínguez, Óscar; Díez-Quijada Jiménez, Leticia; López Martín, Sergio; Prieto, Alejandro; Puerto Rodríguez, María; Cameán Fernández, Ana María; Jos Gallego, Ángeles Mencía; Nutrición y Bromatología, Toxicología y Medicina Legal; Biología Celular; Junta de Andalucía
Functionalized graphene materials have been proposed as nanofillers in food packaging applications as they improve the characteristics of the resulting nanocomposites. But food contact materials require a toxicity evaluation previous their authorization and use. In this sense, reduced graphene oxide functionalized with dodecyl amine (DA-rGO), and [2-(methacryloyloxy) ethyl] trimethylammonium chloride (MTAC-rGO) were characterized and their internalization and cytotoxicity in Caco-2 and HepG2 cultures evaluated. Cell viability decreased from 100 μg/mL in all experimental trials, and oxidative stress by means of a reduction in glutathione levels was evidenced as one of the potential toxicity mechanisms involved. Moreover, both materials were subjected to an in vitro digestion process to investigate their potential changes along the gastrointestinal tract. Digested samples were characterized, and the cytotoxicity also evaluated showing an exacerbation. These results raise concerns about the impact of these materials after oral exposure, and therefore further research is necessary.
Feasibility Assessment on the Use of Near Infrared Hyperspectral Imaging for the Screening of Vitamin C Content and Total Soluble Solids in Strawberries
(Elsevier, 2025) Baca Bocanegra, Berta; Espinar García, Ana Isabel; Hernández Hierro, José Miguel; Escudero Gilete, María Luisa; Nogales Bueno, Julio; Universidad de Sevilla. Departamento de Química Analítica; Universidad de Sevilla. Departamento de Nutrición y Bromatología, Toxicología y Medicina Legal
At market, strawberries are usually picked based on their external attributes, basically surface color. However, internal parameters are also important for the final quality of the fruit and, therefore, can strongly influence acceptance by consumers. The development of analytical methods that allow the evaluation of the strawberry internal quality in a rapid, cost-effective and environmentally friendly way will improve competitiveness in the fruit industry and profitability at markets. In this study, a feasibility assessment on the use of near infrared hyperspectral imaging for the control of the internal quality of strawberries from Huelva (an important strawberry exporting region) has been carried out. For it, modified partial least square regressions have been performed for the screening of vitamin C and total soluble solids. The standard errors of prediction in external validation (4.71 mg/100 g and 1.28 °Brix respectively) demonstrate the potential of the analyzed technique for the proposed objective.
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 Legal
This 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.
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 Sevilla
This 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.
Safety of frozen and dried forms of whole yellow mealworm (Tenebrio molitor larva) as a novel food pursuant to Regulation (EU) 2015/2283
(Wiley, 2024-01-16) 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 Legal
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 the safetyof frozen, dried and powder forms of whole yellow mealworm (Tenebrio molitor larva)as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow meal-worm refers to the larval form of the insect species T. molitor. The NF consists of thefrozen and dried forms of the whole yellow mealworm. The frozen form mainly con-sists of water, crude protein, carbohydrates and fat, whereas the dried forms consistof crude protein, fat and carbohydrates. The Panel notes that the levels of contami-nants in the NF highly depend on the occurrence levels of these substances in theinsect feed. The Panel notes that there are no safety concerns regarding the stabilityof the NF if the NF complies with the proposed specification limits during its entireshelf life. The NF has a protein content that ranges between 13 and 48 g/100 g. ThePanel acknowledges that the true protein content is overestimated when using thenitrogen-to-protein conversion factor of 6.25 due to the presence of non-protein ni-trogen from chitin. The applicant proposed to use the NF as food ingredient in vari-ous food products. The target population proposed by the applicant is the generalpopulation. Considering the composition of the NF and the proposed conditionsof use, the consumption of the NF is not nutritionally disadvantageous. The Panelnotes that no safety concerns arise from the toxicological information of the NF. ThePanel considers that the consumption of the NF might trigger primary sensitisationto yellow mealworm proteins and may cause allergic reactions in subjects allergic tocrustaceans, dust mites and molluscs. Additionally, allergens from the feed may endup in the NF. The Panel notes that allergic reactions may occur upon consumption.The Panel concludes that the NF is safe under the proposed uses and use levels.
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 Legal
Following 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.
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 Legal
Following 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.
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 Legal
The 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.
Nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk andwhey protein concentrates and used in infant and follow-onformula manufactured from hydrolysed protein by Healthcare Reckitt B.V.
(Wiley, 2025-01-29) 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 Legal
The European Commission (EC) requested the European Food Safety Authority toevaluate the nutritional safety and suitability of a specific protein hydrolysate de-rived from sources of skimmed cow's milk (including non-fat) and whey proteinconcentrates for use in infant and follow-on formula manufactured by HealthcareReckitt B.V. Healthcare Reckitt B.V. submitted a dossier to the EC seeking an amend-ment to Regulation (EU) 2016/127 regarding the protein sources permissible in themanufacture of infant and/or follow-on formula. The protein hydrolysate underevaluation is sufficiently characterised with respect to the hydrolysed protein. Inthe pertinent intervention study provided, an infant formula manufactured fromthe protein hydrolysate with a protein content of 2.3 g/100 kcal and consumed asthe sole source of nutrition for 3 months led to growth that is similar to an infantformula manufactured from intact cow's milk protein with a protein content of1.9 g/100 kcal. Data on adverse events and tolerance of the formula did not raiseany concerns. No experimental data have been provided on the nutritional safetyand suitability of this protein source in follow-on formula. Given that follow-onformula is consumed with complementary foods and the protein source is nutri-tionally safe and suitable in an infant formula that can be the sole source of nu-trition of young infants, the Panel considers that the protein hydrolysate is alsoa nutritionally safe and suitable protein source for use in follow-on formula. ThePanel concludes that the protein hydrolysate under evaluation is a nutritionallysafe and suitable protein source for use in infant and follow-on formula, as longas the formula in which it is used contains a minimum of 2.3 g/100 kcal proteinand complies with the compositional criteria of Regulation (EU) 2016/127 and theamino acid pattern in its Annex IIIA.
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 Andalucía
Saccharomyces 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.

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