Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on the conditions of use of certain substances to be used in food supplements-4

Los complementos alimenticios son alimentos cuyo fin es complementar la dieta normal y que consisten en fuentes concentradas de nutrientes (vitaminas y minerales) o de otras sustancias que tienen un efecto nutricional o fisiológico, en forma simple o combinada. Los complementos se comercializan en forma dosificada, se entregan al consumidor final únicamente preenvasados. En ningún caso, deben sustituir al uso de medicamentos sin una supervisión médica adecuada. Sólo deben utilizarse para complementar la dieta y, de forma general, su uso no es necesario si se sigue una dieta variada y equilibrada, a la que no pueden reemplazar. En España los complementos alimenticios están regulados por el Real Decreto 1487/2009 que traspuso a la legislación española la Directiva 2002/46/CE relativa a la aproximación de las legislaciones de los estados miembros en materia de complementos alimenticios. Sin embargo, actualmente sólo está regulado el uso de vitaminas y minerales, por lo que se ha solicitado al Comité Científico que realice una valoración de la propuesta de autorización de la utilización de determinadas sustancias distintas de vitaminas y minerales en la fabricación de complementos alimenticios. Las sustancias propuestas por la Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (AECOSAN) son: ácido L-aspártico, L-citrulina, glicina, L-prolina, L-serina, L-arginina-L-aspartato, L-lisina-L-aspartato, L-lisina-L-glutamato, N-acetil-L-cisteína, N-acetil-L-metionina, hidroximetilbu- tirato, ácido lipoico, Monascus purpureus, carbón activo y lactulosa. El Comité Científico ha valorado cada propuesta, analizando las características y fuentes de cada sustancia, así como la nutrición, metabolismo y seguridad y ha concluido, en cada caso, si la presentada por la AECOSAN era aceptable desde el punto de vista de su seguridad en su uso como complemento alimenticio. En ningún caso, la evaluación realizada supone un aval de la eficacia biológica de las sustancias y dosis valoradas. El Comité Científico indica que, en todo caso es necesario que las personas que estén sometidas a tratamientos con medicamentos consulten con su médico la oportunidad o conveniencia de consumir complementos alimenticios dada la posibilidad de que existan interferencias en algunos casos.Food supplements are foods, the purpose of which is to supplement the normal diet and which consist of concentrated nutrient sources (vitamins and minerals) or other substances with a nutritional or physiological effect, alone or in combination. The supplements are marketed in dosage form and are only supplied to the end consumer prepacked. In no event should they replace the use of medicines without suitable medical supervision. They should only be used to supplement the diet and, on the whole, their usage is not required if the individual has a varied and balanced diet, which cannot be replaced. In Spain, food supplements are regulated by Royal Decree 1487/2009, which transposed Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements into Spanish law. However, only the use of vitamins and minerals is currently regulated. Therefore the Scientific Committee has been asked to make an assessment of the proposal to authorise certain substances other than vitamins and minerals in the manufacture of food supplements. The substances proposed by the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) are food supplements, L-aspartic acid, L-citrulline, glycine, L-proline, L-serine, L-arginine-L-aspar- tate, L-lysine L-aspartate, L-lysine-L-glutamate, N-acetyl-L-cysteine, N-acetyl-L-methionine, hidro- xymethylbutyrate, lipoic acid, Monascus purpureus, activated carbon and lactulose. The Scientific Committee has assessed each proposal, analysing the characteristics and sources of each substance, and the nutrition, metabolism and safety and has concluded, in each case, whether that submitted by the AECOSAN is acceptable from a safety viewpoint for use as a food supplement. In no event is the assessment intended as a guarantee of the biological efficiency of the substances and doses assessed. The Scientific Committee states that, in any case individuals undergoing medical treatment must seek medical advice as to the suitability of taking food supplements, given the possibility of interactions in certain cases

Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on the risk of Tribulus te- rrestris in food supplements

Tribulus terrestris L. es una planta de la familia Zygophyllaceae cuyo uso en complementos alimenticios está autorizado en varios países de la Unión Europea y que contiene de manera natural varias sustancias activas, entre las que destacan saponósidos esteroídicos, alcaloides b-carbolínicos, favonoides y lignanamidas. La toxicidad de Tribulus terrestris en animales ha sido ampliamente documentada a lo largo de su historia como planta medicinal y se describen efectos negativos a nivel neuronal, muscular, hepático y renal. Algunos países consideran que utilizar partes de la planta de Tribulus terrestris en la elaboración de complementos alimenticios no es seguro, por lo que impiden su comercialización y lo comunican al sistema de alertas europeo RASFF (Rapid Alert System for Food and Feed). El Comité Científico ha realizado una evaluación del riesgo a fin de determinar si el consumo de frutos, partes aéreas de la planta y sus extractos de Tribulus terrestris en complementos alimenticios es seguro y ha concluido que no hay disponibles datos toxicológicos suficientes que permitan evaluar la seguridad del uso de partes de la planta de Tribulus terrestris en complementos alimenticios. En cualquier caso, se considera que las cantidades máximas diarias de Tribulus terrestris en complementos alimenticios no deberían superar las dosis de uso farmacológico y que en los complementos debería constar la parte de la planta empleada, y si se trata de un extracto u otra forma de preparación, así como el contenido en saponósidos.Tribulus terrestris L. is a plant from the Zygophyllaceae family whose use in food supplements is authorised in various European Union countries. In its natural form, it contains various active substances, the most notable of which are steroidal saponins, b-Carboline alkaloids, flavonoids and lignanamides. Tribulus terrestris’ toxicity to animals has been widely documented throughout its history as a medicinal plant and it has been reported to have negative neuronal, muscular, hepatic and renal effects. Some countries consider using parts of the Tribulus terrestris plant to produce food supplements to be unsafe so they do not allow such supplements to be sold. This is reported through the European Rapid Alert System for Food and Feed (RASFF). The Scientific Committee has conducted a risk assessment with the aim of determining whether consuming fruit, plant shoots and their extracts from Tribulus terrestris in food supplements is safe, concluding that there is insufficient toxicological data to assess how safe using parts of the Tribulus terrestris plant in food supplements is. In any case, the maximum daily quantity of Tribulus terrestris in food supplements should not exceed the dose used for pharmacological purposes and the part of the plant used, whether it was extracted or prepared in some other way and its saponin content should all be made clear on the supplement itself

Report of the Scientific Committee of the Spanish Agency for Consumers Affairs, Food Safety and Nutrition (AECOSAN) on the use of an aqueous solution of phosphoric acid and propylene glycol as a processing aid in the stabilization of the chlorine used to wash fresh cut vegetables and ready-toeat leafy vegetables

La empresa SmartWash Solutions, LLC ha solicitado una evaluación de la seguridad del uso como coadyuvante tecnológico de una solución acuosa de ácido fosfórico (18-25 %) y propilenglicol (5-10 %) en el procesado de vegetales frescos cortados y hortalizas de hoja de IV gama. Ambas sustancias se encuentran autorizadas en la Unión Europea como aditivos alimentarios en diversas categorías de alimentos. El uso propuesto para el coadyuvante tecnológico es como solución estabilizadora del pH para favorecer la actividad antimicrobiana del cloro utilizado para la desinfección del agua de lavado utilizada en el procesado de vegetales frescos cortados y hortalizas de hoja de IV gama. Con esta solución se pretende reducir el pH de las aguas de lavado a niveles de entre 5,5 a 6,5. La concentración de uso varía dependiendo de los requerimientos del producto y la composición química de las aguas de lavado, siendo la concentración máxima solicitada 0,1 %. El solicitante realizó análisis de residuos en muestras de lechugas y espinacas, no detectándose residuos de propilenglicol en ninguna de las muestras analizadas. En el caso de los fosfatos, las concentraciones detectadas en las muestras lavadas con el coadyuvante tecnológico no fueron significativamente distintas de las detectadas en las mismas muestras lavadas sin el coadyuvante. El Comité Científico concluye que, basándose en la información facilitada por el solicitante y teniendo en cuenta la composición y condiciones de uso propuestas, el uso del coadyuvante tecnológico no implica riesgo para la salud del consumidor.The company SmartWash Solutions, LLC has requested a safety assessment of the use of an aqueous solution of phosphoric acid (18-25 %) and propylene glycol (5-10 %) as a processing aid in the processing of fresh cut vegetables and ready-to-eat leafy vegetables. Both substances are authorised in the European Union as food additives in different food categories. The proposed use for the processing aid is as a pH stabilising solution in order to enhance the antimicrobial activity of the chlorine used for the washing water disinfection required in the processing of fresh cut vegetables and ready-to-eat leafy vegetables. The desired effect of this solution is to reduce the pH levels of the washing waters to levels between 5.5-6.5. The use concentration varies, depending on the requirements of the product and the chemical composition of the washing waters, with 0.1 % as the maximum concentration requested. The applicant analysed the residues on lettuce and spinach samples, and did not detect propylene glycol residues in any of the samples tested. In the case of phosphates, the detected concentrations in the samples washed with the processing aid were not significantly different from those detected in the same washed samples without the processing aid. The Scientific Committee concludes that, based on the information provided by the applicant and taking into account the proposed composition and conditions of use, the use of this processing aid does not involve a health risk for the consumer

Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on the programming of official controls on chemical hazards

La Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (AECOSAN) y las comuni dades autónomas han elaborado un Documento de priorización y distribución de muestras para control oficial de peligros químicos con el propósito de mejorar la calidad y homogeneidad de los controles oficiales en el marco del Plan Nacional de Control Oficial de la Cadena Alimentaria (PN COCA). Este Documento de priorización pretende distribuir la toma de muestras para control oficial en toda España, previa evaluación de los riesgos y de la capacidad analítica de los laboratorios. Ade más servirá de apoyo y orientación a las comunidades autónomas para que ejecuten sus progra mas de control oficial. El Documento de priorización define un modelo semicuantitativo, en el que se establecen las variables a las que se les asigna un valor numérico relativo para obtener una calificación final. La metodología de jerarquización se basa en aproximarse a la medida del riesgo dependiente de la presencia de un contaminante en un alimento, siendo el riesgo la suma de dos variables, el impacto en la salud de la población y la prevalencia en los productos de consumo. El Comité Científico concluye que el Documento de priorización y distribución de muestras de control oficial dirigidas a la determinación de peligros químicos es adecuado, en el momento actual, para el fin previsto. Este Documento deberá actualizarse periódicamente a la luz de la experiencia de su aplicación, el avance en los conocimientos científicos, los cambios en la legislación y las directrices y herramientas sobre priorización y muestreo que puedan desarrollarse a nivel nacional o de la Unión Europea.The Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) and the autonomous communities have prepared a Document for the prioritisation and distribution of samples for the official control of chemical hazards with the aim of improving the quality and uniformity of official controls in the framework of the National Food Chain Official Control Plan (PNCOCA). The prioritisation Document aims to distribute the sampling for official controls throughout Spain, following prior assessment of the risks and the analytical capacity of the laboratories. It will also serve to provide support and guidance to the autonomous communities in the implementation of their official control programmes. The prioritisation Document defines a semi-quantitative model which sets out the variables to which a relative numerical value is allocated in order to obtain a final qualification. The hierarchical methodology is based on estimating the extent of the risk depending on the presence of a contaminant in a food, where the risk is the sum of two variables, the impact on the health of the population and the prevalence in consumer products. The Scientific Committee concludes that the Document for the prioritisation and distribution of official control samples aimed at determining chemical hazards is adequate, at present, for the intended purpose. This Document should be regularly updated in light of the experience obtained from its application, progress in scientific knowledge, changes in the legislation and the directives and tools on prioritisation and sampling which may be developed at national or European Union level

Circulating carotenoids are associated with favorable lipid and fatty acid profiles in an older population at high cardiovascular risk

© 2022 Marhuenda-Muñoz, Domínguez-López, Langohr, Tresserra Rimbau, Martínez González, Salas-Salvadó, Corella, Zomeño, Martínez, Alonso-Gómez, Wärnberg, Vioque, Romaguera, López-Miranda, Estruch, Tinahones, Lapetra, Serra-Majem, Bueno-Cavanillas, Tur, MartínSánchez, Pintó, Delgado-Rodríguez, Matía-Martín, Vidal, Vázquez, Daimiel, Ros, Toledo, Fernández de la Puente Cervera, Barragán, Fitó, Tojal-Sierra, Gómez-Gracia, Zazo, Morey, García-Ríos, Casas, GómezPérez, Santos-Lozano, Vázquez-Ruiz, Atzeni, Asensio, Gili-Riu, Bullon, Moreno-Rodriguez, Lecea, Babio, Peñas Lopez, Gómez Melis and Lamuela-Raventós. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY).Carotenoid intake has been reported to be associated with improved cardiovascular health, but there is little information on actual plasma concentrations of these compounds as biomarkers of cardiometabolic risk. The objective was to investigate the association between circulating plasma carotenoids and different cardiometabolic risk factors and the plasma fatty acid profile. This is a cross-sectional evaluation of baseline data conducted in a subcohort (106 women and 124 men) of an ongoing multi-factorial lifestyle trial for primary cardiovascular prevention. Plasma concentrations of carotenoids were quantified by liquid chromatography coupled to mass spectrometry. The associations between carotenoid concentrations and cardiometabolic risk factors were assessed using regression models adapted for interval-censored variables. Carotenoid concentrations were cross-sectionally inversely associated with serum triglyceride concentrations [-2.79 mg/dl (95% CI: -4.25, -1.34) and -5.15 mg/dl (95% CI: -7.38, -2.93), p-values = 0.0002 and <0.00001 in women and men, respectively], lower levels of plasma saturated fatty acids [-0.09% (95% CI: -0.14, -0.03) and -0.15 % (95% CI: -0.23, -0.08), p-values = 0.001 and 0.0001 in women and men, respectively], and higher levels of plasma polyunsaturated fatty acids [(0.12 % (95% CI: -0.01, 0.25) and 0.39 % (95% CI: 0.19, 0.59), p-values = 0.065 and 0.0001 in women and men, respectively] in the whole population. Plasma carotenoid concentrations were also associated with higher plasma HDL-cholesterol in women [0.47 mg/dl (95% CI: 0.23, 0.72), p-value: 0.0002], and lower fasting plasma glucose in men [-1.35 mg/dl (95% CI: -2.12, -0.59), p-value: 0.001].Peer ReviewedArticle signat per 51 autors/es: María Marhuenda-Muñoz, Inés Domínguez-López, Klaus Langohr, Anna Tresserra-Rimbau, Miguel Ángel Martínez González1,4, Jordi Salas-Salvadó, Dolores Corella, María Dolores Zomeño, J. Alfredo Martínez, Angel M. Alonso-Gómez, Julia Wärnberg, Jesús Vioque, Dora Romaguera, José López-Miranda, Ramón Estruch, Francisco J. Tinahones, José Lapetra, Ll. Serra-Majem, Aurora Bueno-Cavanillas, Josep A. Tur, Vicente Martín-Sánchez, Xavier Pintó, Miguel Delgado-Rodríguez, Pilar Matía-Martín, Josep Vidal, Clotilde Vázquez, Lidia Daimiel, Emilio Ros, Estefanía Toledo, María Fernández de la Puente Cervera, Rocío Barragán, Montse Fitó, Lucas Tojal-Sierra, Enrique Gómez-Gracia, Juan Manuel Zazo, Marga Morey, Antonio García-Ríos, Rosa Casas, Ana M. Gómez-Pérez, José Manuel Santos-Lozano, Zenaida Vázquez-Ruiz, Alessandro Atzeni, Eva M. Asensio, M. Mar Gili-Riu, Vanessa Bullon, Anai Moreno-Rodriguez, Oscar Lecea, Nancy Babio, Francesca Peñas Lopez, Guadalupe Gómez Melis and Rosa M. Lamuela-Raventós.Postprint (published version

Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on a request for initial assessment for marketing of chia ( Salvia hispanica ) seeds in sterilized ready to serve meals based on cereal, pseudocereals and/or pulse grains under Regulation (EC) No 258/97 on novel foods and novel food ingredients

La empresa Herba Ricemills S.L.U. ha solicitado la autorización de la comercialización en la Unión Europea de semillas de chía (Salvia hispanica) como ingrediente de platos preparados esterilizados elaborados a base de granos de cereales, pseudocereales y/o legumbres. Se trataría de una extensión de los usos autorizados para este nuevo alimento en 2009, 2013 y 2015. El Comité Científico considera que de la información aportada no se deduce que el consumo de las semillas de chía (Salvia hispanica) en platos preparados esterilizados basados en granos de cereales, pseudocereales y/o legumbres, en las condiciones propuestas por el solicitante, pueda producir efectos negativos para la salud, concluyendo que el nuevo alimento cumple los criterios de aceptación establecidos por el Reglamento (CE) Nº 258/97 sobre nuevos alimentos y nuevos ingredientes alimentarios (UE, 1997a).The company Herba Ricemills S.L.U. requested authorization to market chia (Salvia hispanica) seeds in sterilized ready to serve meals based on cereal, pseudocereals and/or pulse grains in the European Union. This would be an extension of use of the novel food authorized in 2009, 2013 and 2015. The AECOSAN Scientific Committee takes the view that, according to the information provided, there is no indication that consumption of chia (Salvia hispanica) seeds in ready to serve meals based on cereal, pseudocereals and/or pulse grains, under the conditions proposed by the applicant, can produce adverse effects on health. The Committee concludes that the novel food presented for assessment meets the criteria for acceptance laid down by Regulation (EC) No 258/97 concerning novel foods and novel food ingredients (UE, 1997a)

Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on a request for initial assessment for marketing of chia (Salvia hispanica) in chocolate bars under Regulation (EC) No 258/97 on novel foods and novel food ingredients

La empresa Sanchis Mira S.A. ha solicitado la autorización de la comercialización en la Unión Europea de semillas de chía (Salvia hispanica) en chocolate en tabletas. Se trataría de una extensión de los usos autorizados para este nuevo alimento en 2009, 2013 y 2015. El Comité Científico considera que de la información aportada no se deduce que el consumo de las semillas de chía (Salvia hispanica) en chocolate en tabletas, en las condiciones propuestas por el solicitante, pueda producir efectos negativos para la salud, concluyendo que el nuevo alimento cumple los criterios de aceptación establecidos por el Reglamento (CE) Nº 258/97 sobre nuevos alimentos y nuevos ingredientes alimentarios (UE, 1997a).The company Sanchis Mira S.A requested authorization to market chia (Salvia hispanica) seeds in chocolate bars in the European Union. This would be an extension of use of the novel food authorized in 2009, 2013 and 2015. The AECOSAN Scientific Committee takes the view that, according to the information provided, there is no indication that consumption of chia (Salvia hispanica) in chocolate bars, under the conditions proposed by the applicant, can produce adverse effects on health. The Committee concludes that the novel food presented for assessment meets the criteria for acceptance laid down by Regulation (EC) No 258/97 concerning novel foods and novel food ingredients (UE, 1997a)

Mediterranean diet as a lifestyle and dynamic food pattern

This Supplement of the European Journal of Clinical Nutrition includes the proceedings of conferences presented at the XI International Mediterranean Diet Conference entitled Mediterranean Diet as a Lifestyle and Dynamic Food Pattern, which was held in Barcelona on April 2016 in the framework of the International Food and Beverage Exhibition, Alimentaria 2016 [1]. This year was the 20th anniversary of the Mediterranean Diet Foundation (MDF), the institution that has been devoted to spreading the advances of this food pattern and way of life since 1996, date in which the first International Congress on the Mediterranean Diet was held and the Barcelona Declaration on the Mediterranean Diet enacted. The MDF has been involved in the definition of the Mediterranean diet and its representation as a pyramid

Mediterranean diet and cardiodiabesity: A review

Cardiodiabesity has been used to define and describe the well-known relationship between type 2 Diabetes Mellitus (T2DM), obesity, the metabolic syndrome (MetS) and cardiovascular disease (CVD). The objective of this study was to perform a scientific literature review with a systematic search to examine all the cardiovascular risk factors combined and their relationship with adherence to the Mediterranean Diet (MedDiet) pattern as primary prevention against cardiodiabesity in a holistic approach. Research was conducted using the PubMed database including clinical trials, cross-sectional and prospective cohort studies. Thirty-seven studies were reviewed: fourteen related to obesity, ten to CVD, nine to MetS, and four to T2DM. Indeed 33 provided strong evidence on the association between adherence to a MedDiet and a reduced incidence of collective cardiodiabesity risk in epidemiological studies. This scientific evidence makes the MedDiet pattern very useful for preventive strategies directed at the general population and also highlights the need to consider all these diet-related risk factors and health outcomes together in daily primary care

Worldwide adherence to Mediterranean diet between 1960 and 2011

Background: From the 1960s to the early 21st-century adherence to the Mediterranean diet (MD) declined around the world. This was partly due to the westernization of eating habits. However, in the last decade a new variable came into play, the economic crisis, which may have affected dietary patterns. Objective: We analyzed worldwide trends of adherence to the MD between the periods 1961-1965, 2000-2003 and 2004-2011. Methods: Data was obtained from the Food and Agriculture Organization Food Balance Sheets in three study periods: 1961-1965, 2000-2003 and 2004-2011. The Mediterranean Adequacy Index (MAI) was calculated for 41 selected countries using the averages of available energy intake for different food groups. Changes in MAI indicated the trends in adherence in the different periods. Results: In many countries, MAI deteriorated from 1961 to 1965 and 2004 to 2011, yet an increase was observed in 16 countries. Between the last two observation periods, MAI values stabilized in 16 of the 41 selected countries. Regional rankings for the three study periods based on descending MAI scores were: Southern Mediterranean, Mediterranean Europe, Central Europe and Northern Europe. Discussion and Conclusions: Adherence to the MD significantly decreased between 1961-65 and 2000-03, whereas from 2004-2011 there was a stabilization of MAI values and even an increase among 16 countries. Efforts are needed to preserve the dietary traditions and lifestyle habits within the Mediterranean region in order to counteract increasing rates of chronic disease