Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283.

The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use.

Safety of glucosyl hesperidin as a Novel food pursuant to Regulation (EU) 2015/2283.

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 glucosyl hesperidin (GH) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is produced from hesperidin and dextrin by enzymatic reactions, is a powder consisting mainly of monoglucosyl hesperidin (MGH) and unreacted hesperidin (flavonoid), which account in total for up to 92.8% (on dry basis) of the product. The applicant proposed to use the NF in specific drinks and food supplements leading to a maximum intake of up to 364 mg per day for adults. The target population is the general population, except for food supplements for which the proposed target population is children from 1 year onwards and adults. Taking into consideration the composition of the NF and the proposed uses, the consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day oral toxicity study conducted with the NF, the Panel considers the NOAEL at the mid-dose group, i.e. ~ 1000 mg/kg body weight (bw) per day. By applying an uncertainty factor of 200, the resulting intake providing sufficient margin of exposure for humans would be 5 mg/kg bw per day. The available human intervention studies did not report clinically relevant changes in haematological or clinical chemistry parameters following the administration of GH/MGH at supplemental doses of up to 3 g/day for 12 weeks. Overall, the Panel considers that the margin of exposure (~ 200) between the intake of the NF at the proposed uses and use levels and the NOAEL from the 90-day study is sufficient. The Panel concludes that the NF, glucosyl hesperidin, is safe for the target population at the proposed uses and use levels.

Safety of Acheta domesticus powder as a Novel food pursuant to Regulation (EU) 2015/2283.

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 Acheta (A.) domesticus powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The main components of the NF are protein, fat and dietary fibre (chitin). The Panel notes that the concentration of contaminants in the NF depends on the occurrence levels of these substances in the insect feed. The Panel further notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf-life. The NF has a high protein content, although the true protein content is overestimated when using the nitrogen-to-protein conversion factor of 6.25 due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF as food ingredient in a number of food products. The target population proposed by the applicant is the general population. Considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The panel notes that no safety concerns arise from the toxicological information of A. domesticus. The panel considers that the consumption of the NF might trigger primary sensitisation to A. domesticus proteins and may cause allergic reactions in subjects allergic to crustaceans, mites and molluscs. Additionally, allergens from the feed may end up in the NF. The panel concludes that the NF is safe under the proposed uses and use levels.

Prior knowledge of students: essential aspects that a nursing expert professor identifies, interprets, and organizes to foster learning.

Objective: To analyze the essential aspects that the nursing expert professor identifies, interprets, and organizes during classroom dialogic processes with students to foster their learning. Methods: Qualitative study, part of a multicenter study, which used ethnography of communication specifically from a micro-ethnographic approach. An expert professor from the Faculty of Nursing at a public university in Medellín, Colombia, was selected for the study. The fieldwork was done in three stages: 1:non-participant observations in two in-person classes of the Morphophysiology course recorded on video from two different perspectives (one focusing on the professor and another on the students); 2:think-aloud interviews with the professor and five students (three from the first class and two from the second) who spontaneously started more than two communicative interactions with the professor during the classes; and 3:parallel transcriptions, organized in didactic sequences (videos). The analysis was supported by the unit Student-Professor (identification-evaluation-answer) Student [S-P(i-e-a)S'], and by continuous comparisons of the data. Results: Four categories were identified: 1: Identification of essential aspects: importance of prior knowledge, 2: Interpretation: connection between essential aspects and students' mental processes, 3: Organization of the answer: connection between prior knowledge and new knowledge, and: 4: Synchronization with the learning needs of the students, which were grouped in a meta-category: Prior knowledge of the students: essential aspects for learning. Conclusion: Students' experiential prior knowledge constitutes the essential aspects identified, interpreted, and organized by the expert professor to achieve significant learning.

Prior knowledge of students: essential aspects that a nursing expert professor identifies, interprets, and organizes to foster learning / Saberes previos de los estudiantes: aspectos esenciales que un docente experto en enfermería identifica, interpreta y organiza para favorecer el aprendizaje / Conhecimento prévio dos alunos: aspectos essenciais que um professor especialista em enfermagem identifica, interpreta e organiza para promover a aprendizagem

Objective. To analyze the essential aspects that the nursing expert professor identifies, interprets, and organizes during classroom dialogic processes with students to foster their learning. Methods. Qualitative study, part of a multicenter study, which used ethnography of communication specifically from a micro-ethnographic approach. An expert professor from the Faculty of Nursing at a public university in Medellín, Colombia, was selected for the study. The fieldwork was done in three stages: 1)non-participant observations in two in-person classes of the Morphophysiology course recorded on video from two different perspectives (one focusing on the professor and another on the students); 2)think-aloud interviews with the professor and five students (three from the first class and two from the second) who spontaneously started more than two communicative interactions with the professor during the classes; and 3)parallel transcriptions, organized in didactic sequences (videos). The analysis was supported by the unit Student-Professor (identification-evaluation-answer) Student [S-P(i-e-a)S ́], and by continuous comparisons of the data. Results. Four categories were identified: 1) Identification of essential aspects: importance of prior knowledge, 2) Interpretation: connection between essential aspects and students' mental processes, 3) Organization of the answer: connection between prior knowledge and new knowledge, and: 4) Synchronization with the learning needs of the students, which were grouped in a meta-category: Prior knowledge of the students: essential aspects for learning. Conclusion. Students' experiential prior knowledge constitutes the essential aspects identified, interpreted, and organized by the expert professor to achieve significant learning.

Objetivo. Analizar los aspectos esenciales que el docente experto en enfermería identifica, interpreta y organiza durante los procesos dialógicos con los estudiantes en el aula para favorecer su aprendizaje. Métodos. Estudio cualitativo, parte de un estudio multicéntrico, que utilizó la etnografía de la comunicación desde un abordaje micro-etnográfico. Se seleccionó un docente experto de una Facultad de Enfermería de una universidad pública de Medellín, Colombia. El trabajo de campo se desarrolló en tres momentos: 1) observaciones no participantes en dos clases presenciales del curso de morfofisiología grabadas en video en dos planos (uno enfocando al profesor, y el otro, a los estudiantes); 2) entrevistas Think-Aloud Protocol (método de pensamiento en voz alta) al docente y a cinco estudiantes (tres de la primera clase y dos de la segunda) que iniciaron espontáneamente más de dos interacciones con el docente durante las clases; y 3) transcripciones paralelas, organizadas en secuencias didácticas (videos). El análisis se apoyó en la unidad [E-P(i-e-r)E ́] (Estudiante-Profesor (identificación-evaluación-respuesta) Estudiante ́) y en comparaciones constantes de los datos. Resultados. Emergieron cuatro categorías: 1) Identificación de aspectos esenciales: importancia de los saberes previos, 2) Interpretación: articulación de los aspectos esenciales y los procesos mentales del estudiantado, 3) Organización de la respuesta: conexión entre saberes previos y el nuevo conocimiento, y: 4) Sintonización con las necesidades de aprendizaje del estudiantado; las que fueron agrupadas en una meta-categoría: Saberes previos del estudiante: aspectos esenciales para el aprendizaje. Conclusión.Los saberes previos experienciales de los estudiantes se constituyen en los aspectos esenciales identificados, interpretados y organizados por el profesor experto, para el logro de aprendizajes significativos.

Objetivo. Analisar os aspectos essenciais que o professor especialista em enfermagem identifica, interpreta e organiza durante os processos dialógicos com os alunos em sala de aula para promover sua aprendizagem. Métodos. Estudo qualitativo, parte de um estudo multicêntrico, que utilizou a etnografia da comunicação a partir de uma abordagem microetnográfica. Foi selecionada uma professora especialista da Faculdade de Enfermagem de uma universidade pública de Medellín, Colômbia. O trabalho de campo foi desenvolvido em três momentos: 1) observações não participantes em duas aulas presenciais do curso de morfofisiologia gravadas em vídeo em dois planos (um focado no professor, e outro, nos alunos); 2) Entrevistas do Protocolo Think-Aloud com a professora e cinco alunos (três da primeira turma e dois da segunda) que iniciaram espontaneamente mais de duas interações com a professora durante as aulas; e 3) transcrições paralelas, organizadas em sequências didáticas (vídeos). A análise baseou-se na unidade [E-P(i-e-r)E ́] (Aluno-Professor (identificação-avaliação-resposta) Aluno ́) e em comparações constantes dos dados. Resultados. Emergiram quatro categorias: 1) Identificação dos aspectos essenciais: importância do conhecimento prévio, 2) Interpretação: articulação dos aspectos essenciais e dos processos mentais do aluno, 3) Organização da resposta: conexão entre conhecimentos prévios e novos conhecimentos, e: 4) Sintonia com as necessidades de aprendizagem do corpo discente; que foram agrupados em uma metacategoria: Conhecimentos prévios do aluno: aspectos essenciais para a aprendizagem. Conclusão. O conhecimento experiencial prévio dos alunos constitui os aspectos essenciais identificados, interpretados e organizados pelo professor especialista, para a obtenção de uma aprendizagem significativa.

Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2020/2226).

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 vitamin D2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from Agaricus bisporus mushroom powder that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains concentrations of vitamin D in the form of vitamin D2 in the range of 245-460 µg/g. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF as an ingredient in a variety of foods and beverages in amounts that result in either 1.2 or 2.4 µg vitamin D2 per 100 g or 100 mL of the food as consumed. The applicant also intends to add the NF in food supplements at a maximum of 15 µg vitamin D2/day for individuals above 1 year of age, as well as in foods for special medical purposes (FSMPs). The estimates for combined intake of vitamin D from the NF, the background diet and fortified foods, were below the ULs for vitamin D as established previously by the NDA Panel for children, adolescents and adults, i.e. 50 and 100 µg/day. The estimated combined vitamin D intake in infants (6-12 months) is also below the UL for vitamin D of 35 µg/day. The Panel considers that taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous for the proposed target population. The Panel concludes that the NF is safe under the proposed conditions of use.

[Clinical case of anaphylaxis due to eye drops]. / Caso clínico de anafilaxia por gotas oftálmicas.

BACKGROUND: Anaphylaxis is a severe systemic allergic reaction that can be life-threatening, timely diagnosis and treatment is required in these patients, one of the most frequent triggers is pharmacological. OBJECTIVE: To report the case of a patient who presented anaphylaxis due to eye drops. CASE REPORT: A 7-year-old male with a history of rhinitis and asthma with good control. It started with itchy eyes, ophthalmic drops were administered, composition: Polyethylene glycol 400, 0.4%, Propylene glycol 3 mg, polyquad 0.001%, presenting at 15 minutes an episode of anaphylaxis initially characterized by pruritus and intense conjunctival erythema, later nausea, vomiting, sweating, weakness, urticaria/facial angioedema and dyspnea were added, this episode was controlled opportunely with Levocetirizine 5 mg sublingual and Betametasona 4 mg intramuscular, progressively improving over the next 2 hours. The patient was evaluated by the Allergist, written recommendations were given to the mother in case this reaction occurred again, the use of the drops was prohibited, and the performance of skin test and a probable conjunctival provocation protocolized with the ophthalmic drops were pending. Accidentally 2 months later the patient was re-exposed with the same eye drops, presenting a similar reaction 15 minutes after the administration of the medication, they went to the emergency room where he received antihistamine and corticosteroid intravenous treatment, after this re-exposure is confirmed to the ophthalmic drops mentioned above as a trigger of anaphylaxis in this patient. CONCLUSIONS: We present a case of conjunctival anaphylaxis after application of eye drops, confirmed by re-exposure to the drug. It is essential to give diagnoses, recommendations with treatments and avoidance of the probable triggering agent of the reaction. The administration of immediate medication when the allergic episode begins in these patients can be vital, even more so when they live far from a health center, as was the case in this patient.

ANTECEDENTES: La anafilaxia es una reacción alérgica sistémica severa que puede llegar a comprometer la vida. Se requiere de un diagnóstico y tratamiento oportuno en estos pacientes, uno de los desencadenantes más frecuente es el farmacológico. OBJETIVO: Reportar el caso de un paciente que presentó anafilaxia a gotas oftálmicas. REPORTE DE CASO: Varón de siete años de edad con antecedentes de rinitis y asma con buen control. Inició con picor ocular, se le administraron gotas oftálmicas, composición: Polietilenglicol 400, 0,4%, Propilenglicol 3 mg, polyquad 0,001%, y a los 15 minutos presentó un episodio de anafilaxia caracterizado, inicialmente, por prurito y eritema conjuntival intenso; posteriormente, presentó náuseas, vómito, sudoración, debilidad, urticaria/angioedema facial y disnea. Este episodio fue controlado en el momento, con tratamiento de Levoceterizina 5 mg s.l. y Betametasona 4 mg i.m., con mejoría progresiva en las siguientes dos horas. El paciente fue evaluado por la especialidad de alergología. A su madre se dieron recomendaciones por escrito, por si se presentaba nuevamente la reacción. Se prohibió la utilización de las gotas, y quedó pendiente la realización de las pruebas cutáneas y una probable provocación conjuntival protocolizada con las gotas oftálmicas. Accidentalmente, dos meses después se reexpuso al paciente con las mismas gotas oftálmicas, y a los 15 minutos de la administración del medicamento, presentó una reacción similar, por lo que acudieron a emergencias donde recibió tratamiento antihistamínico y corticoides vía i.m.; tras esta reexposición, se confirma a las gotas oftálmicas mencionadas anteriomente, como desencadenantes de anafilaxia en el paciente. CONCLUSIONES: Presentamos un caso sobre anafilaxia por vía conjuntival tras aplicación de gotas oftálmicas, confirmado por la reexposición al fármaco. Es esencial dar diagnósticos, recomendaciones con tratamientos y evitar el probable agente desencadenante de la reacción. La administración de medicación inmediata cuando inicia el episodio alérgico en estos pacientes, puede ser vital, más aún cuando viven lejos de un centro de salud, como era el caso referenciado.

[Registry of Members of the Association of Patients with Hereditary Angioedema of Perú]. / Registro de miembros de la Asociación de Pacientes con Angioedema Hereditario de Perú.

OBJECTIVE: To report the registry of the HAE Peruvian patient's association. METHODS: We used the questionnaire of the Latin American HAE committee. Consent was requested from the patient's association to report the data. RESULTS: We report data of 63 patients, 51 Female, 12 Male, range age between 6 to 74 years. Nine under 18 years old, 5/9 between 6 to 13 years. Forty-five HAE C1-INH type I, 12 HAE-FXII, 5 HAE UNK, 1 AAE. Symptoms onset average age in 56/62 HAE patients was 16.8. In a group of 50/62 adult HAE patients, the average diagnostic delay approximately was 19.3 years. Laboratory tests: we can perform C4 complement C1-inhibitor antigenic and functional tests. Treatments: The patients have access to tranexamic acid (TA) and attenuated androgens. We do not have registered specific long-term prophylaxis treatments. We used moderate/high doses of TA, in most patients up to 6 gr i.v./in 24 hours, we start with the treatment immediately the HAE acute crisis is beginning, it helps to the HAE attacks are less symptomatic, resolves in a few days and decrease the frequency. CONCLUSIONS: We present 63 members of the Association of Patients with Hereditary Angioedema of Perú. We have improved blood tests for HAE diagnosis. Moderate and high doses of Tranexamic Acid are used for prophylaxis and acute crisis respectively, with acceptable response. No deaths have been reported due to HAE crisis in the patient's association.

OBJETIVO: Reportar el registro de pacientes de la Asociación de Pacientes con Angioedema Hereditario de Perú, AEH. MÉTODOS: Se utilizó el cuestionario del Comité de AEH, de la Sociedad Latinoamericana de Alergia, Asma e Inmunología (SLAAI). Se solicitó el consentimiento a la Asociación de Pacientes para reportar los datos. RESULTADOS: Se reportan datos de 63 pacientes, 51 mujeres y 12 hombres, en un rango de edad entre 6 y 74 años. Nueve menores de 18 años, 5/9, entre 6 y 13 años. 45 con AEH-C1-INH tipo I, 12 AEH-FXII, 5 AEH-D, 1 AEA. La edad promedio de inicio de síntomas en 56/62 pacientes fue de 16,8. En 50/62 pacientes adultos con AEH, el promedio de tiempo de espera en el diagnóstico fue de 19,3 años. Laboratorio: Se puede desarrollar C4 complemento, C1-Inhibidor antigénico y funcional. Tratamientos: Se cuenta con acceso al ácido tranexámico (AT) y andrógenos atenuados. No se cuenta con tratamientos específicos para profilaxis de largo plazo. Se utilizaron dosis moderadas/altas de (AT), hasta 6 g por I V/ en 24 horas, inmediatamente, al inicio de las crisis de AEH, ayuda a que los ataques no sean tan intensos y tengan menor duración y frecuencia. CONCLUSIONES: Se presentan 63 miembros de la Asociación de Pacientes con Angioedema Hereditario de Perú. Se han mejorado los exámenes sanguíneos para el diagnóstico del AEH. Se utilizaron dosis moderadas/altas de ácido tranexámico con aceptable respuesta en los pacientes. No se han presentado decesos por crisis de AEH en los miembros de la Asociación.

Shift from Pro- to Anti-Inflammatory Phase in Pelvic Floor Muscles at Postpartum Matches Histological Signs of Regeneration in Multiparous Rabbits.

Background and Objectives: Pelvic floor muscles (PFM) play a core role in defecation and micturition. Weakening of PFM underlies urogynecological disorders such as pelvic organ prolapse and stress urinary incontinence. Vaginal delivery damages PFM. Muscle trauma implies an inflammatory response mediated by myeloid cells, essential for subsequent recovery. Molecular signaling characterizing the pro-inflammatory phase shifts M1 macrophages to M2 macrophages, which modulate muscle repair. The present study aimed to evaluate histological characteristics and the presence of M1 and M2 macrophages in bulbospongiosus (Bsm) and pubococcygeus muscles (Pcm). Materials and Methods: Muscles from young nulliparous (N) and multiparous rabbits on postpartum days three (M3) and twenty (M20) were excised and histologically processed to measure the myofiber cross-sectional area (CSA) and count the centralized myonuclei in hematoxylin-eosinstained sections. Using immunohistochemistry, M1 and M2 macrophages were estimated in muscle sections. Kruskal-Wallis or one-way ANOVA testing, followed by post hoc tests, were conducted to identify significant differences (p < 0.05). Results: The myofiber CSA of both the Bsm and Pcm of the M3 group were more extensive than those of the N and M20 groups. Centralized myonuclei estimated in sections from both muscles of M20 rabbits were higher than those of N rabbits. Such histological outcomes matched significant increases in HLA-DR immunostaining in M3 rabbits with the CD206 immunostaining in muscle sections from M20 rabbits. Conclusions: A shift from the pro- to anti-inflammatory phase in the bulbospongiosus and pubococcygeus muscles of multiparous rabbits matches with centralized myonuclei, suggesting the ongoing regeneration of muscles.

Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283.

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 ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%-2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day.

Safety of magnesium l-threonate as a novel food pursuant to regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC.

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 safety of magnesium l-threonate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF, produced by chemical synthesis, is intended to be used as new source for magnesium in food supplements at a maximum intake level of 3000 mg per day by adults, except for pregnant and lactating women. This dose corresponds to ~ 2730 mg l-threonate and 250 mg magnesium, which also corresponds to the UL for supplemental magnesium from readily dissociable magnesium salts. Based on results obtained from a dissociation study, two rat studies and one human trial, the Panel considers that magnesium is bioavailable from the NF. The NF may contain up to 1% oxalic acid. The Panel considers that an additional exposure to oxalic acid, that is up to 30 mg daily from the NF, is not to be of safety concern. The Panel concludes that the NF is not nutritionally disadvantageous. In 2008, the EFSA ANS Panel concluded that a human intake of l-threonate of 2700 mg per day is safe. This intake is similar to the maximum intake of l-threonate from the NF under the maximum proposed uses, and the NDA Panel concurs with the ANS Panel that this intake is safe. The Panel considers that there are no concerns regarding the genotoxicity of the NF. The Panel concludes that the NF, Mg l-threonate, is safe under the proposed conditions of use. The Panel concludes that the NF is a source from which magnesium is bioavailable.

Extension of use of isomalto-oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283.

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 extension of use of isomalto-oligosaccharide (IMO) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of glucose oligomers with degrees of polymerisation of 3-9, along with various amounts of mono- and disaccharides. The NF comes in both syrup and powder form. The applicant intends to extend the current uses of the NF as an ingredient in several foods, and use the NF in food supplements aimed at the general population older than 10 years of age. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. Along with literature data, the applicant carried out a tolerability study in adult volunteers with the NF at doses up to 120 g/day. The Panel concludes that this study provides reassurance that the NF is tolerable at doses of 120 g/day. Conservative intake estimates resulting from the use of the NF as an ingredient according to the currently authorised uses and new proposed uses result in a highest intake estimate in adolescents of 112 g/day at the 95th percentile, and reach 142 g/day in adolescents when the use as a food supplement is included. The Panel notes this amount is higher than the dose of 120 g/day for which tolerability has been demonstrated. However, considering the source, compositional characterisation, production process and nature of the NF, as well as the available nutritional and toxicological data on the NF, the Panel considers that the NF does not present safety concerns under the proposed conditions of use.

Safety of isomaltulose syrup (dried) as a novel food pursuant to Regulation (EU) 2015/2283.

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 isomaltulose syrup (dried) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of a mixture of mono- and disaccharides in powder form, mainly composed of isomaltulose (≥ 75%) and trehalulose (< 13%). The applicant intends to use the NF as a replacement for sucrose already on the market. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. No absorption, distribution, metabolism and excretion (ADME) or toxicological data were provided for the NF. Instead, the safety of the NF was assessed based on literature data available on isomaltulose and mixtures of isomaltulose and trehalulose. In addition, considering the nature, compositional characterisation and production process of the NF, the Panel considered that such data were sufficient to conclude that the NF is as safe as sucrose.

Safety of HelixComplex snail mucus (HSM) as a novel food pursuant to Regulation (EU) 2015/2283.

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 HelixComplex Snail Mucus (HSM) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of snail mucus collected from Helix aspersa maxima and is proposed to be used by adults as a food supplement. The data provided by the applicant about the composition and stability of the NF together with the report of the subchronic toxicity study were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the certificates of analysis and of the data on the subchronic toxicity provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established.

Sucrose consumption modifies the urethrogenital reflex and histological organization of the bulbospongiosus muscle in the male rat.

Disorders of the bulbospongiosus muscle (Bsm) are associated with male sexual dysfunction, such as premature ejaculation. We determined the effect of sucrose-water consumption during pregnancy-lactation and postnatal on reflex responses and morphology of Bsm fibers in adult male Wistar rat offspring. Female rats were mated and grouped into consumed tap water mothers and sucrose-water (5 %) mothers during pregnancy-lactation to obtain experimental groups. Male pups were weaned and assigned into four groups (n = 12; each group). Those from control mothers who continued drinking tap water (CM-CO group) or sucrose water (CM-SO group), and those from sucrose mothers who drank tap water (SM-CO group) or continued drinking sucrose water (SM-SO group) until adult life. In male rat offspring (n = 6 per group) was recorded the electrical activity of Bsm was recorded during penile stimulation and urethrogenital reflex (UGR). Other male rat offspring were designated for histological analysis (n = 6 per group). Sucrose consumption during prenatal stages increased the frequency of the Bsm during UGR, while pre and postnatal consumption modified muscle fiber cross-sectional area and increased the collagen content, suggesting that a combination of a diet with pre- and postnatal sucrose changes the Bsm morphophysiology possibly causing male sexual dysfunctions.

Safety of lacto-N-fucopentaose I/2'-fucosyllactose (LNFP-I/2'-FL) mixture as a novel food pursuant to Regulation (EU) 2015/2283.

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 lacto-N-fucopentaose I (LNFP-I)/2'-fucosyllactose (2'-FL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharides (HiMO) LNFP-I and 2'-FL, but it also contains d-lactose, lacto-N-tetraose, difucosyllactose, 3-fucosyllactose, LNFP-I fructose isomer, 2'-fucosyl-d-lactulose, l-fucose and 2'-fucosyl-d-lactitol, and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli K-12 DH1 MDO MP2173b) of E. coli K-12 DH1 (DSM 4235). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant formula (IF) and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements (FS). The target population is the general population. The anticipated daily intake of LNFP-I from use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. Overall, the anticipated daily intake of LNFP-I from the NF as a food ingredient at the maximum proposed use levels is unlikely to exceed the intake level of breastfed infants on a body weight basis. The intake in breastfed infants on a body weight basis is expected to be safe also for other population groups. The anticipated 2'-FL intake is generally rather low. The use of the NF in FS is not intended if other foods with added NF components or human milk (for infants and young children) are consumed on the same day. The Panel concludes that the NF, a mixture of LNFP-I and 2'-FL, is safe under the proposed conditions of use.

Safety of oil from Schizochytrium limacinum (strain TKD-1) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283.

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 safety of Schizochytrium sp. (TKD-1) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single-cell microalga. The strain TKD-1, used by the applicant (ATK Biotech Co. Ltd.), belongs to the species Schizochytrium limacinum. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 53%-61% of fatty acids. The applicant proposed to use the NF 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 addition of DHA to IF and FOF at the level of 20-50 mg/100 kcal. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.

Safety of oil from Schizochytrium sp. (strain CABIO-A-2) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283.

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 safety of Schizochytrium sp. (strain CABIO-A-2) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. S. sp. is a single-cell microalga. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 38%-44% of fatty acids. The applicant proposed to use the NF 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 addition of DHA to IF and FOF at the level of 20-50 mg/100 kcal. The evidence provided demonstrated that the strain S. sp. CABIO-A-2 is phylogenetically closely related to the strain S. sp. ATCC 20888. The assessment of some already authorised S. sp. oils in the Union list were also based on similarities with the strain ATCC 20888. The applicant provided a 90-day repeated dose toxicity study in rats with the NF. No adverse effects were observed up to the highest dose tested, i.e. 10.2 g/kg body weight (bw) per day. Taking into account the toxicity studies performed with the NF and with DHA-oils derived from strains belonging to the genus Schizochytrium, its phylogenetical profile, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.

Comunicación interpersonal de médicos-docentes en las prácticas formativas de un pregrado de medicina

Introducción: La comunicación es una competencia esencial en los currículos médicos, y es fundamental en modelos de atención centrados en el paciente. Las prácticas clínicas, eje en la formación médica, son escenarios de interacciones docente-estudiantes-pacientes; en ellas, los estudiantes aprenden a comunicarse con el paciente de la mano de sus profesores. El objetivo del estudio fue comprender la comunicación de médicos-docentes en prácticas clínicas de un pregrado de medicina. Metodología: Investigación cualitativa desde el marco interpretativo del interaccionismo simbólico y el análisis bajo los lineamientos de la teoría fundamentada. Se entrevistaron quince médicos docentes de cursos clínicos. Las entrevistas se grabaron, transcribieron y codificaron por unidades de sentido. Resultados: Del análisis emergen diferentes visiones del estudiante e interés por los elementos comunicativos con este y el paciente y la reflexión de la práctica docente. Los docentes son conscientes del rol de modelaje para el aprendizaje de los estudiantes; consideran a los pacientes como seres vulnerables, generosos, agradecidos, que representan el recurso más valioso para la enseñanza; con ellos desarrollan su doble misión de resolver problemas de salud y enseñar. Conclusiones: Los docentes, en la interacción con los estudiantes y pacientes, transforman una práctica más instruccional y disciplinar a una centrada en los sujetos y sus necesidades. La regulación del currículo y la normativa de las instituciones de salud genera tensiones a los docentes entre el quehacer médico y el deseo de enseñar.

Introduction: Communication is an essential skill in medical curricula and crucial in patient-centered care models. Resident experience is fundamental in medical training. These experiences offer teacher-student-patient interactions where students learn about doctor-patient communication directly from their preceptors. The objective of the study was to understand doctor-teacher communication during clinical practices in an undergraduate medical program. Methodology: Qualitative research undertaken from the interpretive framework of Symbolic Interactionism andanalysis under Grounded Theory guidelines. Fifteen (15) clinical-course medical doctors were interviewed. The interviews were recorded, transcribed, and coded by meaning units. Results: Different student views emerged, including student interest in student-patient communicative aspects as well as their own thoughts on teaching. Teachers are aware of their role as models in student learning; they see patients as vulnerable, generous, grateful people that represent the most valuable asset in their teaching endeavor; with them, teachers develop their dual mission, that is, solving health-related problems and teaching. Discussion and conclusions: During their interaction with students and patients, teachers transform an essentially instructional and disciplined practice into one centered on the patient and their needs. The stress doctors face when addressing the medical task itself versus their desire to teach is compounded by curriculum guidelines and health agency norms. This is, in fact, part of the hidden curriculum that influences student learning

Safety of a change in specifications of the novel food oleoresin from Haematococcus pluvialis containing astaxanthin pursuant to Regulation (EU) 2015/2283.

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 safety of a change of specifications of the novel food (NF) oleoresin from Haematococcus pluvialis containing astaxanthin (ATX) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient for the use in food supplements as defined in Directive 2002/46EC in accordance to Regulation (EU) 2017/2470. The NF concerns an oleoresin which contains ~ 10% ATX, obtained by supercritical CO2 extraction of the homogenised and dried biomass of cultivated H. pluvialis. This NF has been assessed by the Panel in 2014. With the present dossier, the applicant proposed to lower the minimum specification limits for protein and ATX monoesters for the NF, and to increase the maximum specification limit for the relative amount of ATX diesters in total ATX. An increase of the maximum specification limit for the 9-cis isomer is also applied for. Although the data are limited regarding bioavailability and distribution in humans of these three naturally occurring ATX isomers, the available in vitro and in vivo data suggest that the 13-cis rather than the 9-cis ATX is selectively absorbed, i.e. has a higher bioavailability and/or possibly emerges from isomerisation of all-trans ATX. The Panel notes that the toxicity of the individual ATX isomers has not been studied individually. However, the ADI of 0.2 mg/kg, which was established for synthetic ATX and ATX from H. pluvialis, applies also for ATX in the oleoresin from H. pluvialis with the proposed changes of specifications. The Panel concludes that the NF, oleoresin from H. pluvialis containing ATX, is safe with the proposed specification limits.