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Background: Cross-sectional studies indicate an age-related decline in vitamin B6 status. Because longitudinal studies are lacking, the present study investigates the long-term association between age and vitamin B6 status in older adults by considering potential confounding factors.Methods: The study population consists of 249 women and 111 men aged ≥ 60 years, who had at least three follow-ups between 1996 and 2014 with complete data records on relevant parameters. Vitamin B6 status was assessed by serum pyridoxal 5'-phosphate (PLP) concentrations measured by high-performance liquid chromatography. Linear mixed models were used to analyze the influence of age, sex, body composition, supplements, diet, lifestyle, and serum creatinine on PLP concentrations.Results: At baseline, 37% of the subjects showed PLP concentrations < 30 nmol/L and more than half failed to meet the recommended dietary intake. Longitudinal analyses revealed that age, use of supplements and protein intake were positive determinants of PLP concentrations, whereas body fat showed a negative impact. No influence of sex, dietary vitamin B6 intake, lifestyle factors or serum creatinine on PLP concentrations was found.Conclusion: The present study provides no evidence that in the course of aging PLP concentrations decline between 60 and 90 years. However, age-related changes in body composition, such as an increased ratio of fat mass to fat-free mass may negatively affect vitamin B6 status. [ABSTRACT FROM AUTHOR]

Objective Emerging evidence indicates that vitamin D has anti-oxidative properties. The present study investigates whether serum 25‑hydroxyvitamin D [25(OH)D] is associated with biomarkers of anti-oxidative status in community-dwelling older adults using cross-sectional and longitudinal data. Methods A total of 302 subjects aged 62 to 92 years from Germany (50.6°N) were analysed via cross-sectional approach. For longitudinal analysis, data of 153 subjects were available. Fasting blood samples from 2004 and 2012 were analysed for 25(OH)D concentrations, total anti-oxidative status (TAOS) as well as anti-oxidative enzymes, such as catalase (CAT), glutathione peroxidase (GPx) and superoxide dismutase (SOD). Multiple regression analyses were performed to examine the associations between 25(OH)D and parameters of anti-oxidative status. Results In cross-sectional analyses, 25(OH)D was a significant predictor of CAT ( β  = −0.166; P  = 0.010), lg 10 GPx ( β  = 0.136; P  = 0.037) and TAOS ( β  = 0.121; P  = 0.048) after adjusting for age, sex, percentage total body fat (TBF), month of blood sampling, smoking behaviour and use of vitamin D supplements. Longitudinal change in 25(OH)D concentration positively predicted change in TAOS ( β  = 0.224; P  = 0.006) after adjusting for sex, baseline TAOS, age, smoking behaviour, use of vitamin D supplements and change in TBF, physical activity level, current time spent outdoors and dietary vitamin D intake. Conclusion The maintenance of an adequate vitamin D status may have a beneficial impact on the anti-oxidative defence system in older adults on a long-term perspective. [ABSTRACT FROM AUTHOR]

Background: Considering the suggested link between vitamin D insufficiency and several chronic diseases, attention should be given to approaches for improving vitamin D status. Elderly subjects are regarded as a high-risk group for developing an insufficient vitamin D status. Socioeconomic, dietary, lifestyle and environmental factors are considered as influencing factors, whereupon sex differences in predictors of vitamin D status are rarely investigated. The purpose of this study is to identify the main predictors of serum 25-hydroxyvitamin D3 [25(OH)D3] concentrations in elderly subjects by taking into account potential sex differences. Methods: This is a cross-sectional study in 162 independently living German elderly aged 66 to 96 years. Serum 25(OH)D3 concentrations were assessed by an electrochemiluminescence immunoassay. Multiple regression analyses were performed to identify predictors of 25(OH)D3 concentrations stratified by sex. Results: Median 25(OH)D3 concentration was 64 nmol/L and none of the subjects had 25(OH)D3 concentrations < 25 nmol/L. In women, intact parathyroid hormone (iPTH) (β = -0.323), % total body fat (β = -0.208), time spent outdoors (β = 0.328), month of blood sampling (β = 0.229) and intake of vitamin D supplements (β = 0.172) were the predominant predictors of 25(OH)D3, whereas in men, iPTH (β = -0.254), smoking (β = -0.282), physical activity (β = 0.336) and monthly household net income (β = 0.302) predicted 25 (OH)D3 concentrations. The final regression models accounted for 30% and 32% of the variance in 25(OH)D3 concentrations in women and men, respectively. Conclusion: The findings indicate that 25(OH)D3 concentrations are influenced by body composition, month of blood sampling, economic factors, lifestyle, supplement intake and iPTH, but may not be associated with age, sex, dietary factors, kidney function and presence of selected chronic diseases in community-dwelling elderly. Furthermore, our results provide evidence for sex-specific determinants of the vitamin D status, which ought to be considered for preventive strategies. [ABSTRACT FROM AUTHOR]

Background: Considering the suggested link between vitamin D insufficiency and several chronic diseases, attention should be given to approaches for improving vitamin D status. Elderly subjects are regarded as a high-risk group for developing an insufficient vitamin D status. Socioeconomic, dietary, lifestyle and environmental factors are considered as influencing factors, whereupon sex differences in predictors of vitamin D status are rarely investigated. The purpose of this study is to identify the main predictors of serum 25-hydroxyvitamin D3 [25(OH)D3] concentrations in elderly subjects by taking into account potential sex differences. Methods: This is a cross-sectional study in 162 independently living German elderly aged 66 to 96 years. Serum 25(OH)D3 concentrations were assessed by an electrochemiluminescence immunoassay. Multiple regression analyses were performed to identify predictors of 25(OH)D3 concentrations stratified by sex. Results: Median 25(OH)D3 concentration was 64 nmol/L and none of the subjects had 25(OH)D3 concentrations < 25 nmol/L. In women, intact parathyroid hormone (iPTH) (β = −0.323), % total body fat (β = −0.208), time spent outdoors (β = 0.328), month of blood sampling (β = 0.229) and intake of vitamin D supplements (β = 0.172) were the predominant predictors of 25(OH)D3, whereas in men, iPTH (β = −0.254), smoking (β = −0.282), physical activity (β = 0.336) and monthly household net income (β = 0.302) predicted 25 (OH)D3 concentrations. The final regression models accounted for 30% and 32% of the variance in 25(OH)D3 concentrations in women and men, respectively. Conclusion: The findings indicate that 25(OH)D3 concentrations are influenced by body composition, month of blood sampling, economic factors, lifestyle, supplement intake and iPTH, but may not be associated with age, sex, dietary factors, kidney function and presence of selected chronic diseases in community-dwelling elderly. Furthermore, our results provide evidence for sex-specific determinants of the vitamin D status, which ought to be considered for preventive strategies. [ABSTRACT FROM AUTHOR]

Background: Considering the suggested link between vitamin D insufficiency and several chronic diseases, attention should be given to approaches for improving vitamin D status. Elderly subjects areregarded as a high-risk group for developing an insufficient vitamin D status. Socioeconomic, dietary, lifestyle and environmental factors are considered as influencing factors, whereuponsex differences in predictors of vitamin D status are rarely investigated. The purpose of thisstudy is to identify the main predictors of serum 25-hydroxyvitamin D3 [25(OH)D3]concentrations in elderly subjects by taking into account potential sex differences. Methods: This is a cross-sectional study in 162 independently living German elderly aged 66 to 96 years. Serum 25(OH)D3 concentrations were assessed by an electrochemiluminescence immunoassay. Multiple regression analyses were performed to identify predictors of 25(OH)D3 concentrations stratified by sex. Results: Median 25(OH)D3 concentration was 64 nmol/L and none of the subjects had 25(OH)D3 concentrations < 25 nmol/L. In women, intact parathyroid hormone (iPTH) (β = -0.323), % total body fat (β = -0.208), time spent outdoors (β = 0.328), month of blood sampling (β = 0.229) and intake of vitamin D supplements (β = 0.172) were the predominant predictors of 25(OH)D3, whereas in men, iPTH (β = -0.254), smoking (β = -0.282), physical activity (β = 0.336) and monthly household net income (β = 0.302) predicted 25(OH)D3 concentrations. The final regression models accounted for 30% and 32% of the variance in 25(OH)D3 concentrations in women and men, respectively. Conclusion: The findings indicate that 25(OH)D3 concentrations are influenced by body composition, month of blood sampling, economic factors, lifestyle, supplement intake and iPTH, but may not be associated with age, sex, dietary factors, kidney function and presence of selected chronic diseases in community-dwelling elderly. Furthermore, our results provide evidence for sex-specific determinants of the vitamin D status, which ought to be considered for preventive strategies. [ABSTRACT FROM AUTHOR]

Abstract: This cross-sectional study investigates whether serum 25-hydroxyvitamin D3 [25(OH)D3] and intact parathyroid hormone (iPTH) are affected by vitamin D, calcium, or phosphate intake in 140 independently living elderly subjects from Germany (99 women and 41 men; age, 66-96 years). We hypothesized that habitual dietary intakes of vitamin D, calcium, and phosphate are not associated with 25(OH)D3 or iPTH and that body mass index confounds these associations. Serum 25(OH)D3 and iPTH were measured by an electrochemiluminescence immunoassay. Dietary intake was determined using a 3-day estimated dietary record. The median dietary intake levels of vitamin D, calcium, and phosphate were 3 μg/d, 999 mg/d, and 1250 mg/d, respectively. Multiple regression analyses confirmed that dietary vitamin D and calcium did not affect 25(OH)D3 or iPTH; however, supplemental intakes of vitamin D and calcium were associated with 25(OH)D3 after adjustment for age, sex, body composition, sun exposure, physical activity, and smoking. In addition, phosphate intake and the calcium-to-phosphate ratio were associated with iPTH after multiple adjustments. In a subgroup analysis, calcium and vitamin D supplements, as well as phosphate intake, were associated with 25(OH)D3 and/or iPTH in normal-weight subjects only. Our results indicate that habitual dietary vitamin D and calcium intakes have no independent effects on 25(OH)D3 or iPTH in elderly subjects without vitamin D deficiency, whereas phosphate intake and the calcium-to-phosphate ratio affect iPTH. However, vitamin D and calcium supplements may increase 25(OH)D3 and decrease iPTH, even during the summer, but the impact of supplements may depend on body mass index. [Copyright &y& Elsevier]

Summary. Background: Evidence has accumulated that in both acutely ill and recovered patients with either anorexia or bulimia nervosa circulating leptin levels (LL) are lower than in controls matched for body mass index (BMI; kg/m[sup 2] ). It is unknown if these lower leptin levels represent a state or trait marker. Aim of the study: We aimed to confirm the lowered leptin levels in eating disordered females and to identify underlying mechanisms. Methods: We screened 181 female students of the nutritional sciences for eating disorders with the respective module of the M-Composite International Diagnostic Interview and the Cognitive Restraint scale of the Three Factor Eating Questionnaire. The physical assessment included determinations of BMI, body composition and LL. Each case fulfilling lifetime DSM-IV criteria for an eating disorder was BMI matched to two controls. We used a multivariate mixed regression model to evaluate if the observed difference in lg[sub 10] -leptin level between cases and controls is actually due to the influence of restrained eating and/or previous weight loss after adjustment for BMI and percent body fat. Results: In accordance with our hypothesis the 32 (17.7 %) cases had a lower serum lg[sub 10] -leptin level than the 64 BMI matched controls (one-sided p < 0.001). We were not able to detect an influence of restrained eating or previous weight loss. Conclusions: We confirm that females with a lifetime history of an eating disorder have lower LL. We were not able to identify an underlying mechanism. Similar to most previous studies we found a high rate of eating disorders among female students of nutritional sciences. [ABSTRACT FROM AUTHOR]

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 an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in protein products at a maximum use level of 1 g of docosahexaenoic acid (DHA) in 100 g of product. The Panel considers that the information provided on the composition and the production process is sufficiently described and does not raise safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided demonstrated the absence of viable cells in the NF. Under the proposed extension of use, the highest intake estimate (at the 95th percentile) of DHA from the NF in protein products is 6.3 mg DHA/kg bw per day for adolescents. The Panel notes that the exposure to DHA from the new intended use of the NF in protein products is very low compared to the exposure to DHA from the already authorised food categories (excluding food supplements). The Panel concludes that the NF (oil from S. limacinum (FCC‐3204)) is safe under the new intended use. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Older people are reported to be prone to imbalances between cobalamin and folate status with possible adverse effects on health. This longitudinal study investigates dynamics and interactions of cobalamin and folate status in a cohort of community-dwelling older adults by considering possible influencing factors.Methods: In total, 332 subjects ≥ 60 years were investigated over a mean observation period of 12 years. Data collection included serum cobalamin, folate and creatinine, dietary intakes of cobalamin, folate and alcohol, use of supplements, body composition, smoking behavior, and diseases. Linear mixed-effects models with repeated measurements were used to investigate the influence of variables on serum cobalamin and folate.Results: At baseline, median cobalamin intake exceeded the dietary reference value (DRV), while median folate intake was considerably below DRV. In most subjects, serum concentrations of both vitamins were within reference ranges. For serum cobalamin, apart from supplement use (Parameter estimate [95% confidence interval]: 130.17 [53.32, 207.01]), the main positive predictor was serum folate (4.63 [2.64, 6.62]). For serum folate, serum creatinine (10.85 [4.85, 16.86]), use of supplements (7.86 [5.05, 10.67]), serum cobalamin (0.01 [< 0.01, 0.01]), and dietary folate intake (0.02 [0.01, 0.03]) were positive predictors. No main effects of age, sex, body composition, alcohol intake or smoking were found after adjusting for simultaneous inference.Conclusions: Advancing age, per se, is no risk factor for a decline in serum concentrations of cobalamin or folate in subjects ≥ 60 years. Suboptimal folate intake may limit the function of folate regarding the supply of methyl groups for methylation of cobalamin and subsequent creatine biosynthesis. The positive association of serum creatinine with folate deserves further exploration with regard to its possible relevance for maintaining energy dependent functional integrity in the course of ageing. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA adopted scientific opinion on 'Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283', including its bioavailability as a metabolite of vitamin D3 when added for nutritional purposes to food supplements. On 5 July 2023, EFSA adopted the 'Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate'. This opinion concerns an updated exposure assessment for vitamin D and proposes a conversion factor for calcidiol monohydrate into vitamin D3 of 2.5 for labelling purposes. In addition, in reference to the EFSA opinion on the safety of calcidiol monohydrate, the Commission had received a letter from the pharmaceutical company EirGen Pharma Ltd requesting a revision of this opinion based on new data concerning calcidiol. Based on the information and data considered in this scientific technical report, EFSA concludes that the novel food calcidiol monohydrate proposed for use in food supplements is a bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25‐dihydroxyvitamin D, that a conversion factor of 2.5 reflects the relative bioavailability of calcidiol vs vitamin D3 under the proposed conditions of use and use levels, and that it is safe under the proposed conditions of use and use levels, i.e. up to 10 μg/day for children ≥ 11 years old and adults, including pregnant and lactating women, and up to 5 μg/day for children 3–10 years of age. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract: The impact of fat-free mass (FFM), fat mass (FM), body mass index (BMI), body mass and body height on calcaneal bone characteristics as measured with quantitative ultrasound (QUS) was investigated in 137 women and 85 men aged 62–92 years, considering age, smoking, waist-to-hip ratio (WHR) and physical activity level (PAL). In regression analyses using various models, in women, age was a negative predictor of speed of sound (SOS), broadband ultrasound attenuation (BUA) and stiffness index (SI) and smoking was a negative predictor of SOS; positive predictors of SOS, BUA, and SI were BMI, body mass and FFM. In men, smoking was a negative predictor and BMI, body mass and FFM were positive predictors of BUA and SI. In both sexes, PAL, body height, WHR and FM had no effect on QUS parameters. The influence of BMI on calcaneal bone characteristics in elderly people depends on FFM rather than on FM. [Copyright &y& Elsevier]

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 3′‐sialyllactose (3′‐SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 3′‐SL (sodium salt), but it also contains sialic acid, d‐glucose, d‐lactose, 3′‐sialyllactulose and 6′‐sialyllactose sodium salts and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli NEO3) of E. coli W (ATCC 9637). 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 to a variety of foods, including infant formula and follow‐on formula, food for special medical purposes and food supplements (FS). The target population is the general population. The applicant applies for the same uses and use levels as already assessed for 3′‐SL sodium salt produced by a genetically modified strain of E. coli K‐12 DH1, with the exception for the use in FS, which is proposed to be higher (from 0.5 to 1.0 g/day) in individuals from 3 years of age. Since the NF as a food ingredient would be consumed at the same extent as the already assessed 3′‐SL sodium salt, no new estimates of the intakes have been carried out. The Panel notes that the maximum daily intake of 3′‐SL from the proposed use of the NF in FS for individuals from 3 years of age (1.0 g/day) is lower than the estimated highest mean daily intake of 3′‐SL in breastfed infants. FS are not intended to be used if other sources of 3′‐SL are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 an apple fruit cell culture biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and intended as an ingredient for food supplements in adults. The cells have been sourced from the callus grown on a piece of apple placed on a solid medium under sterile conditions. The de‐differentiated apple cells are then cultivated in liquid medium. The medium contains sucrose, vitamins, minerals, trace elements and the two synthetic plant hormone analogues, benzylaminopurine (< 0.1 mg/kg) and 2,4‐dichlorophenoxyacetic acid (< 0.25 mg/kg). These plant hormones are regulated under the EU pesticide legislation and their residue levels in the NF are in compliance with the EU maximum residue levels. The main components of the NF are carbohydrates (including sugars and non‐digestible carbohydrates), ash, proteins and smaller amounts of fatty acids and organic acids. Except for the amount of total fat and the organic acids (succinic and l‐malic acid), the quantities of the compositional parameters of the NF and apple have little in common. The Panel considers that a provided subchronic toxicity study was not needed to establish the safety of this NF, when taking into account the source of the NF, i.e. apples, the production process, the low intended use level and the composition of the NF, despite the noted differences to apple. The Panel considers that the NF contains proteins, which were not detected in apple and which may be allergenic. The Panel concludes that the NF, an apple fruit cell culture biomass, is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 whole seeds of oilseed rape as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of seeds of oilseed rape, in particular double low white flowering varieties of Brassica napus (oilseed rape Brassica napus L. emend. Metzg). The NF's oilseed rape is produced following drying, cleaning and storage procedures traditionally used for oilseed rape in oil production. The NF is proposed to be used as an ingredient in 'Bread and rolls with special ingredients added' and 'Gluten free bread'. The target population is the general population. The highest daily intake of the NF was estimated for young children as 92.6 mg/kg body weight (bw) per day. The Panel notes that intakes of the NF can result in considerably increased levels of glucosinolates consumption as compared to intakes of glucosinolates from background diets. The Panel asked the applicant for additional studies to support the safety of the NF, but these were not provided. The Panel concludes that the safety of whole seeds of oilseed rape under the proposed conditions of use has not been established. [ABSTRACT FROM AUTHOR]

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 2′‐fucosyllactose (2’‐FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 2’‐FL, but it also contains d‐lactose, l‐fucose, 3‐fucosyllactose, difucosyllactose, d‐glucose and d‐galactose. The NF is produced by fermentation with a genetically modified strain (APC199) of Corynebacterium glutamicum ATCC 13032. 2’‐FL, when chemically synthesised or produced by fermentation with derivative strains of Escherichia coli K‐12 DH1 or E. coli BL21 (DE3), is already authorised and included in the EU list of NFs. This application refers to a change in the production process and specifications, while target population, conditions of use and consequently, the anticipated intake remain unchanged. The information provided on the identity, production process, composition and specifications of the NF does not raise safety concerns. The intake of other carbohydrate‐type compounds structurally related to 2’‐FL is also considered of no safety concern. In line with other milk oligosaccharides that are natural components of human milk, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake as NF. Given that the NF would be consumed at the same extent as the already authorised 2’‐FL, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 6′‐sialyllactose (6’‐SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 6’‐SL, but it also contains d‐lactose, 6′‐sialyllactulose, sialic acid, N‐acetyl‐d‐glucosamine and a small fraction of other related oligosaccharides. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL21 (DE3), the production strain and the optional degradation strain. 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 to a variety of foods, including infant formula and follow‐on formula, food for special medical purposes and food supplements. The target population is the general population. In some scenarios at the maximum use levels, the estimated intakes per kg body weight were higher than the high average natural intake of 6’‐SL from human milk. However, given the intrinsic nature of human milk oligosaccharides (HMOs), the wide range of intakes from human milk, and considering that infants are naturally exposed to similar amounts of these substances, the Panel considers that the consumption of the NF at the proposed conditions of use does not raise safety concerns. The intake of 6’‐SL in breastfed infants on a body weight basis is also expected to be safe for other population groups. The intake of other carbohydrate‐type compounds structurally related to 6’‐SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 6’‐SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the impact of implant-prosthetic rehabilitation combined with nutritional counseling on the nutritional status of patients with severely reduced dentitions. Design: An explorative intervention study including an intra-individual comparison of 20 patients with severely reduced dentitions in terms of nutrition- and quality of life-related parameters recorded at baseline and at six and twelve months after implant-prosthetic rehabilitation. Participants: Twenty patients from the Department of Prosthetic Dentistry of Justus-Liebig University of Giessen, with an mean age of 63 years, who had fewer than ten pairs of antagonists. Measurements: The baseline data collection included dental status, a chewing ability test, laboratory parameters, anthropometric data (body mass index), energy supply, a 3-day dietary record, an analysis of the oral health-related quality of life (OHRQoL) with the OHIP-G14, the Mini-Mental Status (MMS) and Mini Nutritional Assessment (MNA). Six months after implantation and prosthetic rehabilitation, individual nutritional counseling was performed by a dietician. Data were again collected and analyzed. A final follow-up was conducted 12 months after prosthetic rehabilitation. Results: Despite the highly significant improvement in masticatory ability and OHRQoL after implant-prosthetic rehabilitation, no significant changes were observed regarding MNA, anthropometric data or energy supply. Except for cholinesterase (p = 0.012), ferritin (p = 0.003), folic acid (p = 0.019) and vitamin A (p = 0.004), no laboratory parameter changed significantly during the investigation period. In addition, no general significant differences were observed for nutrient intake or food choice. Conclusion: The present study does not confirm the assumption that the implant-prosthetic rehabilitation of patients with severely reduced residual dentitions with or without an individual nutritional counseling influences nutritional status. [ABSTRACT FROM AUTHOR]

Background: Several studies have reported positive correlations between thyroid-stimulating hormone (TSH) and body mass index (BMI) in euthyroid subjects. As impaired thyroid function is known to affect the metabolic rate, this study investigated whether TSH is associated with resting energy expenditure (REE) in euthyroid elderly subjects, independent of age, anthropometric data and body composition. Methods: Cross-sectional data of 77 women (66-96 years, BMI 18-36 kg/m2) and 55 men (66-86 years, BMI 20-39 kg/m2) were analyzed. REE was measured using indirect calorimetry, body composition by bioelectrical impedance analysis and serum TSH using an electrochemiluminescence immunoassay. Results: REE, fat-free mass (FFM) and waist circumference (WC) were significantly lower, whereas TSH and fat mass (FM) were significantly higher in women than in men. In multiple stepwise regression analysis, with age-adjusted REE (REEadj) as the dependent variable and FFM, FM and WC as independent variables, FFM and WC explained 40.7% in women and FFM 32.8% in men of the variability in REEadj. Including TSH in the model led to a significant rise of the adjusted R-squared value in women only, and explained an additional 2.8% of the variability in REEadj. Conclusions: TSH is independently and negatively associated with REE in euthyroid elderly women. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

ObjectiveAlthough emerging evidence indicates an association between vitamin D and serum lipids, the data are still inconsistent. The purpose of the present study was to investigate whether 25-hydroxycholecalciferol (25-hydroxyvitamin D3; 25(OH)D3) or intact parathyroid hormone (iPTH) was independently related to serum lipids in elderly women and men.DesignCross-sectional study. Fasting serum levels of 25(OH)D3, iPTH, TAG, total cholesterol (TC), HDL cholesterol (HDL-C) and LDL cholesterol (LDL-C) were assessed. Body composition was measured by bioelectrical impedance analysis. Lifestyle factors, such as nutrient intake, time spent outdoors, physical activity, smoking, supplement intake and medication, were assessed by questionnaires. Multiple regression analyses were performed to examine associations of 25(OH)D3 and iPTH with serum lipids.SettingGiessen, Germany.SubjectsOne hundred and ninety-three well-functioning German elderly aged 66–96 years.ResultsAfter adjusting for age, body fat, physical activity, smoking, alcohol intake, lipid-modifying drugs and either iPTH or 25(OH)D3, 25(OH)D3 was a predictor of TAG (standardised coefficient beta (β)=–0·180), HDL-C (β=0·197), LDL-C:HDL-C (β=−0·298) and TC:HDL-C (β=−0·302) in women, whereas iPTH was a predictor of HDL-C (β=−0·297) in men. In sub-analysis, associations between 25(OH)D3 and TC (β=−0·252), HDL-C (β=0·230), LDL-C (β=−0·324), LDL-C:HDL-C (β=−0·412) and TC:HDL-C (β=−0·380) were found in women with 25(OH)D3 concentrations above or equal the median vitamin D status (62·3 nmol/l), but not in women with lower 25(OH)D3 concentrations.ConclusionsIn the elderly, associations of 25(OH)D3 and iPTH with serum lipids may differ by sex and may require a vitamin D status above 62 nmol/l. [ABSTRACT FROM AUTHOR]

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 freeze‐dried mycelia of Antrodia camphorata as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced by solid‐state cultivation from tissue cultures derived from the fungus Antrodia camphorata. The applicant intends to market the NF in food supplements at a maximum dose of 990 mg per day. The target population is the general population. The NF mainly consists of carbohydrates, proteins and fats, and it contains numerous constituents, such as β‐glucans, antroquinonol and triterpenoids. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day repeated dose toxicity study and a prenatal developmental toxicity study performed with the NF, the Panel derives a safe level of 16.5 mg/kg body weight per day. The Panel concludes that the NF, freeze‐dried mycelia of Antrodia camphorata, is safe at the proposed use level for individuals aged 14 years and above. [ABSTRACT FROM AUTHOR]

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 zinc l‐carnosine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of zinc for use in food supplements. The NF is produced by chemical synthesis and is proposed to be used in food supplements as a source of zinc. The target population proposed by the applicant is individuals above the age of 12, excluding pregnant and lactating women. The NF which is the subject of the application is a chelate‐complex, formed between Zn2+ and l‐carnosine and is present as a mixture of a monomer and a dimer. The material is a powder with particulate nature and is insoluble in water at neutral pH. No relevant data using an existing zinc source as comparator have been made available by the applicant and the actual bioavailability of the zinc provided by the NF at the proposed use levels remains uncharacterised. Owing to the lack of a correct characterisation of the fraction of small particles, including nanoparticles of the NF, the Panel is not in the position to evaluate specification limits for the size of the constituent particles in the NF. Owing to the lack of information on the size distribution and the physico‐chemical properties of the particles constituting the NF, the Panel is not in the position to confirm whether the ADME studies and the toxicological studies provided by the applicant are appropriate to assess the safety of the NF. The Panel concludes that the NF is absorbed and provides zinc, but as it is in an insufficiently characterised particulate form, its safety has not been established and the bioavailability has not been determined. [ABSTRACT FROM AUTHOR]

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 that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains levels of vitamin D in the form of vitamin D2 in the range of 125–375 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 1.125 or 2.25 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, for infants from 7 to 11 months at a maximum of 10 µg vitamin D2/day and of 15 µg vitamin D2/day for individuals aged 1 year or older, as well as in foods for special medical purposes (FSMPs) and total and meal diet replacement for weight control. For the adult population, the maximum intended use level in FSMPs is 15 µg vitamin D2/day and 5 µg vitamin D2/meal in total and meal diet replacement for weight control. The Panel concludes that the NF is safe under the proposed conditions of use. The Panel notes uncertainty regarding the calculated combined exposures to vitamin D for the general population, given the fact that the range of foods fortified with vitamin D has increased over the years, as well as the marketing of high‐dose vitamin D supplements. [ABSTRACT FROM AUTHOR]

The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns. Many human studies have been carried out with Epidyolex®, a CBD drug authorised to treat refractory epilepsies. In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect. This is, however, not acceptable when considering CBD as a NF. Furthermore, most of the human data referred to in the CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses. No NOAEL could be identified from these studies. Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a NF. The effects on drug metabolism need to be clarified. Toxicokinetics in different matrices, the half‐life and accumulation need to be examined. The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child‐bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established. [ABSTRACT FROM AUTHOR]

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 3‐fucosyllactose (3‐FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 3‐FL, but it also contains d‐lactose, l‐fucose, d‐glucose and d‐galactose, and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coli BL21 (DE3). The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow‐on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3‐FL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3‐FL from human milk in infants on a body weight basis. The intake of 3‐FL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate‐type compounds structurally related to 3‐FL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 3‐FL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 3'‐sialyllactose (3'‐SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 3'‐SL, but it also contains d‐lactose, 3'‐sialyllactulose, sialic acid, N‐acetyl‐d‐glucosamine and a small fraction of other related oligosaccharides. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL21 (DE3), the production strain and the optional degradation strain. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow‐on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3'‐SL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3'‐SL from human milk in infants on a body weight basis. The intake of 3'‐SL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate‐type compounds structurally related to 3'‐SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 3'‐SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 defatted house cricket (Acheta domesticus) powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is proposed as dry powder. The main components of the NF are protein, fat and 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 levels are 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. The Panel notes that, 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 genotoxicity and no subchronic toxicity studies with the NF were provided by the applicant. Considering that no safety concerns arise from the history of use of the source of the NF (A. domesticus), and the limited difference between the whole insect and the partially defatted NF, the Panel identified no other safety concerns than allergenicity. 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. That aside, the Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

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‐tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed of the human‐identical milk oligosaccharide (HiMO) LNT, but it also contains d‐lactose, lacto‐N‐triose II and para‐lacto‐N‐hexaose, and a small fraction of other related saccharides. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL21 (DE3), the production strain and the optional degradation strain. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant and follow‐on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of LNT from the NF at the maximum proposed use levels does not exceed the intake level of naturally occurring LNT in breastfed infants on a body weight basis. The intake of LNT in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate‐type compounds structurally related to LNT is also considered of no safety concern. Food supplements are not intended to be used if other foods with added LNT or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 the extensions of use of the authorised novel foods (NFs) 2'‐fucosyllactose (2'‐FL) and lacto‐N‐neotetraose (LNnT) in food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K‐12 and already included in the EU list of NFs. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2'‐FL in FS intended for infants (< 1 year), at a maximum use level of 1.2 g/day. The applicant also proposes an extension of use of LNnT in FS intended for infants, at a maximum use level of 0.6 g/day. The intake of 2'‐FL per kg body weight from the proposed maximum use levels in FS for infants is lower than the lowest estimated mean intake of naturally occurring 2'‐FL from human milk. Similarly, the intake of LNnT per kg body weight is lower than the highest estimated mean intake of naturally occurring 2'‐FL from human milk. Furthermore, the Panel notes that the proposed uses of 2'‐FL in FS for infants are lower than the estimated intake from the already authorised uses of the NF for the same population group. The Panel also notes that the proposed uses of LNnT in FS for infants are similar to the estimated intake from the already authorised uses of the NF for the same population group. The Panel concludes that the use of the NFs containing 2'‐FL or LNnT in FS for infants is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 pea and rice protein fermented by Shiitake mushroom (Lentinula edodes) mycelia as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixture of fermented pea and rice protein concentrates (65% and 35%, respectively). The NF is proposed to be used as a food ingredient in specific food categories. The target population is the general population. The major constituent of this NF is protein (≥ 75% dry weight), which is well digestible and provides sufficient amounts of essential amino acids. Although a tolerable upper intake level (UL) has not been derived for protein, the protein intake from the NF may nevertheless further contribute to an already high dietary protein intake in Europe. The Panel notes that the cumulative exposure to the nutrients and contaminants analysed does not raise concern. The reported values for the levels of antinutritional factors in the NF are comparable to those in other foodstuffs. The Panel considers that taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. No toxicological studies with the NF were provided by the applicant; however, the Panel considers that no toxicological studies are required for this NF. The NF has the potential capacity to sensitise individuals or to induce allergic reactions in individuals allergic to pea, rice and Shiitake mushroom. However, this risk is expected not to be higher than that resulting from the normal consumption of pea, rice or the fruiting body of the Shiitake mushroom. The Panel considers that the NF is safe at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 beta‐lactoglobulin (BLG) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF (≥ 90% w/w dry matter protein) consists of BLG as primary component (≥ 90% of total protein), which is equivalent to BLG present in bovine milk and whey protein isolate (WPI). The NF is produced from bovine whey by crystallisation under acidic or neutral conditions. The NF is proposed to be used as a food ingredient in isotonic and sport drinks, whey powder and milk‐based drinks and similar products, and in food for special medical purposes as defined in Regulation (EU) No 609/2013. The target population is the general population. The highest daily intake of the NF was estimated for children of 3 to < 10 years of age as 667 mg/kg body weight (bw) per day. The NF presents proximate composition and content of essential amino acids similar to those in WPI. The Panel notes that the highest mean and highest 95th percentile daily protein intakes from the NF are below the protein population reference intakes for all population groups. Although a tolerable upper intake level has not been derived for protein, the protein intake from the NF may nevertheless further contribute to an already high dietary protein intake in Europe. The exposure to the reported minerals does not raise concerns. The Panel considers that the consumption of the NF is not nutritionally disadvantageous. No genotoxic concerns were identified from the standard in vitro test battery. No adverse effects were observed in the subchronic toxicity study, up to the highest dose tested, i.e. 1,000 mg NF/kg bw per day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF (β‐GOS) is produced from milk lactose using a β‐galactosidase derived from Bifidobacterium bifidum and it is proposed to be used in food for special medical purposes (FSMP). The target population is the general population from 4 years of age onwards. GOS produced according to the same production process are already authorised and included in the EU Union list of novel foods. The applicant stated that the maximum daily intake from the use in FSMP is 8.25 g GOS. GOS are already authorised for use in food supplements up to a daily dose of 16.2 g. FSMP containing GOS are not intended to be used if food supplements containing GOS are consumed on the same day. The information provided on the proposed use levels and anticipated intake does not raise safety concerns. The Panel concludes that the proposed extension of use of GOS in FSMP is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 the extensions of use of the authorised novel foods (NFs) 2'‐fucosyllactose/difucosyllactose (2'‐FL/DFL) mixture and lacto‐N‐tetraose (LNT) in food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K‐12 DH1 and already included in the EU list of NF. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2'‐FL/DFL mixture in FS intended for infants (< 1 year), at a maximum use level of 1.6 g/day for infants ≤ 6 months and up to 1.2 g/day for infants > 6 months. The applicant also proposes an extension of use of LNT in FS intended for infants (< 1 year), at a maximum use level of 0.8 g/day for infants ≤ 6 months and up to 0.6 g/day for infants > 6 months. The intake per kg body weight of 2'‐FL/DFL and LNT from the proposed maximum use levels of the respective NFs in FS for infants does not exceed the lowest estimated mean intake of naturally occurring 2'‐FL/DFL and it is similar to the highest estimated mean intake of LNT by breastfed infants. In addition, the Panel notes that the proposed uses of the NFs in FS for infants result in lower maximum daily intakes than those from the already authorised uses of the NFs for the same population group. The Panel concludes that the uses of the NFs containing either 2'‐FL/DFL or LNT in FS for infants are safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Background: Emerging evidence indicates that there is an association between vitamin D and obesity. The aim of this study was to investigate whether the level of serum 25-hydroxyvitamin D3 [25(OH)D3] in the elderly is influenced by parameters of anthropometry and body composition independent of potential confounding lifestyle factors and the level of serum intact parathyroid hormone (iPTH). Methods: Cross-sectional data of 131 independently living participants (90 women, 41 men; aged 66-96 years) of the longitudinal study on nutrition and health status in senior citizens of Giessen, Germany were analysed. Concentrations of 25(OH)D3 and iPTH were ascertained by an electrochemiluminescence immunoassay. Body composition was measured by a bioelectrical impedance analysis. We performed univariate and multiple regression analyses to examine the influence of body composition on 25(OH)D3 with adjustments for age, iPTH and lifestyle factors. Results: In univariate regression analyses, 25(OH)D3 was associated with body mass index (BMI), hip circumference and total body fat (TBF) in women, but not in men. Using multiple regression analyses, TBF was shown to be a negative predictor of 25(OH)D3 levels in women even after controlling for age, lifestyle and iPTH (β = -0.247; P = 0.016), whereas the associations between BMI, hip circumference and 25(OH)D3 lost statistical significance after adjusting for iPTH. In men, 25(OH)D3 was not affected by anthropometric or body composition variables. Conclusions: The results indicate that 25(OH)D3 levels are affected by TBF, especially in elderly women, independent of lifestyle factors and iPTH. [ABSTRACT FROM AUTHOR]

Abstract: The ability of spinal dual x-ray absorptiometry (DXA), calcaneal quantitative ultrasound (QUS) and spinal quantitative computed tomography (QCT) to identify women with osteoporosis within the GISELA study was evaluated in 43 women, aged 62–87 years. Osteoporosis was defined as a T-score below or equal to –2.5 using DXA (femoral neck). To determine the performance of each method, the sensitivity, specificity and area under the curve (by means of a receiver operating characteristic [ROC] analysis) were calculated. The median T-scores from the measurements differed significantly (p < 0.0001). DXA (spine) identified 75% of women with osteoporosis; QUS and QCT identified 100%. The specificity was 89% for DXA (spine), 66% for QUS and 29% for QCT. ROC analysis showed that all three methods are qualified to identify women with osteoporosis; however, the different sensitivities and specificities of the methods, as well as the thresholds used for diagnosing osteoporosis have to be considered. (E-mail: monika.neuhaeuser-berthold@ernaehrung.uni-giessen.de) [Copyright &y& Elsevier]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on dried coffee husk (cascara) from Coffea arabica L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF comprises the skin (exocarp), pulp (mesocarp), mucilage (pectin), parchment (endocarp) and a portion of the silver skin of the coffee fruit, and consists mainly of digestible carbohydrates, dietary fibre and water. The Panel considers 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 as such will not be consumed, instead, beverages produced with the infusion of the NF in water will be available to consumers. Considering an 100% extraction of caffeine from the NF to the beverage, the specification limit set for caffeine and the proposed use levels, the maximum concentration of caffeine in infusions produced using the NF could be up to 600 mg/L of drink, a concentration comparable to those in coffee beverages. The Panel notes that consumption of beverages produced using the NF will add significantly to the total dietary intake of caffeine of the general population. The consumption of beverages containing caffeine is not recommended for children, pregnant or breast‐feeding women if the caffeine content exceeds 150 mg/L. Taking into account the nature of the NF, the history of use of the NF as food and the proposed uses and use levels, the Panel considers that no toxicological studies are required on the NF. The risk of allergic reactions to the NF is considered low. The Panel concludes that the NF, dried husk of the fruit of Coffea arabica L., is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is the subject of the application is an oil rich in docosahexaenoic acid (DHA) that is produced by the microalgae Schizochytrium sp. (strain ATCC‐20889). The applicant proposed to add the NF in infant formulae (IF) and follow‐on formulae (FOF) at use levels in accordance with Regulation (EU) No 609/2013. The evidence provided by the applicant does not demonstrate to which species the strain Schizochytrium sp. ATCC 20889 belongs. As the source organism of the NF is not characterised at species level, no assessment for inclusion in the Qualified Presumption of Safety (QPS) list can be performed by EFSA. Marine biotoxins (including cyanotoxins) in the NF were below their limits of quantification. However, since it is unknown to which species the strain Schizochytrium sp. ATCC 20889 belongs, the concern that this strain has the potential to produce other toxins remains. No toxicological studies with the NF were provided by the applicant. Toxicological studies are available with DHA‐rich algal oils produced from other strains of Schizochytrium sp. However, the Panel considers that those toxicological studies cannot be used to establish the safety of the oil produced by the strain which is under assessment in this application (Schizochytrium sp. ATCC 20889). Therefore, based on the information provided by the applicant, the Panel concludes that the safety of the NF has not been established. [ABSTRACT FROM AUTHOR]

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 hydrothermally treated kernels from edible Jatropha curcas (Chuta) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Although Jatropha curcas is generally considered a toxic plant due to the presence of phorbol esters (PEs), edible varieties exist in Central America. The applicant has developed a breeding programme for an edible cultivar and proposes the kernels from this cultivar as an NF as whole kernels or fragments thereof to be used as a snack or as a food ingredient. Procedures are in place to avoid commingling with non‐edible kernels, with the last steps being the analytical control of PEs concentrations in all produced batches. The Panel considers that the production process of the NF is sufficiently described and that the information provided on the composition of the NF is sufficient for its characterisation. Components of the NF were tested for genotoxicity applying the standard in vitro test battery and no genotoxic concerns have been identified. In a conservative scenario for exposure to PEs from the NF, it was assumed that all kernels contain PEs at the level of detection of the analytical method. When comparing the estimated maximum exposure to PEs with a reference point from a subchronic study in pigs, a margin of exposure ≥ 900 is obtained, which is considered sufficiently large. The presence of anti‐nutritional factors does not pose safety concerns as they are within the ranges found in vegetables. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Tetrahydrocurcuminoids are derivatives of curcuminoids, produced chemically by hydrogenation of curcuminoids extracted from the rhizomes of C. longa L. The NF consists of more than 95% of tetrahydrocurcuminoids. The applicant proposed to use the NF in food supplements at a maximum dose of 300 mg/day for adults excluding pregnant and lactating women. Taking into account the composition of the NF and the proposed conditions of use, 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 and a reproduction/developmental toxicity screening test performed with the NF, the Panel derives a safe level of 2 mg/kg body weight per day. For the target population this level corresponds to 140 mg/day, which is lower than the use level as proposed by the applicant. The Panel concludes that the NF, tetrahydrocurcuminoids from turmeric (C. longa L.), is safe for the target population at 140 mg/day. [ABSTRACT FROM AUTHOR]

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 galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a syrup containing ≥ 57% w/w GOS (w/w dry matter), consisting of different galactosyl residues linked to a terminal glucose by a β‐glycosidic bond and also containing lactose and the constituent monomers of lactose (galactose and glucose). The NF is already authorised and included in the Union list of NFs and is produced according to the same production process. This application is limited to an assessment of the extension of use as a food ingredient in dairy confectionary, cheese and processed cheese, butter and spreads. There is a 10–30% increase in total GOS intake from the requested extension of use compared to the currently authorised uses at the highest 95th percentile. It is noted that the total intake at the highest mean (8.7–22.0 g/day) is below the adequate intake (AI) of 25 g/day for dietary fibre set to ensure a normal laxation in adults, while the highest 95th percentile (27.2–41.6 g/day) is higher than the AI. When the maximum use as a food supplement is added to the highest 95th percentile combined intake from all proposed and authorised food categories a total intake up to 58 g GOS/day is estimated. This highest intake level would exceed the AI for dietary fibre; however, no tolerable upper intake level for dietary fibre has been set and only transient gastrointestinal symptoms may be related to high intake of fibre. The Panel concludes that the NF, that is composed of ≥ 57% GOS dry matter, lactose and related saccharides, is safe under the proposed extension of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Food and Food Allergens (NDA) was asked to deliver an opinion on the safety of frozen and dried formulations from house crickets (Acheta domesticus) as a novel food pursuant to Regulation (EU) 2015/2283. The NF is proposed in three formulations: (i) frozen, (ii) dried, (iii) ground. The main components of the NF are protein, fat and fibre (chitin) in the dried form of the NF, and water, protein, fat and fibre (chitin) in the frozen form of the NF. The Panel notes that the concentrations of contaminants in the NF depend 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 levels in the NF are 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 in the form of a snack, and as a food ingredient in a number of food products. The target population proposed by the applicant is the general population. The Panel notes that, 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 genotoxicity and no subchronic toxicity studies with the NF were provided by the applicant. Considering that no safety concerns arise from the history of use of A. domesticus or from the compositional data of the NF, the Panel identified no other safety concerns than allergenicity. 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. [ABSTRACT FROM AUTHOR]