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.

Scientific opinion on the tolerable upper intake level for iron.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for iron. Systematic reviews were conducted to identify evidence regarding high iron intakes and risk of chronic diseases, adverse gastrointestinal effects and adverse effects of iron supplementation in infancy, young childhood and pregnancy. It is established that systemic iron overload leads to organ toxicity, but no UL could be established. The only indicator for which a dose-response could be established was black stools, which reflect the presence of large amounts of unabsorbed iron in the gut. This is a conservative endpoint among the chain of events that may lead to systemic iron overload but is not adverse per se. Based on interventions in which black stools did not occur at supplemental iron intakes of 20-25 mg/day (added to a background intake of 15 mg/day), a safe level of intake for iron of 40 mg/day for adults (including pregnant and lactating women) was established. Using allometric scaling (body weight0.75), this value was scaled down to children and adolescents and safe levels of intakes between 10 mg/day (1-3 years) and 35 mg/day (15-17 years) were derived. For infants 7-11 months of age who have a higher iron requirement than young children, allometric scaling was applied to the supplemental iron intakes (i.e. 25 mg/day) and resulted in a safe level of supplemental iron intake of 5 mg/day. This value was extended to 4-6 month-old infants and refers to iron intakes from fortified foods and food supplements, not from infant and follow-on formulae. The application of the safe level of intake is more limited than a UL because the intake level at which the risk of adverse effects starts to increase is not defined.

Biomarkers of food intake and their relevance to metabolic syndrome.

Metabolic syndrome (MetS) constitutes a prevalent risk factor associated with non communicable diseases such as cardiovascular disease and type 2 diabetes. A major factor impacting the etiology of MetS is diet. Dietary patterns and several individual food constituents have been related to the risk of developing MetS or have been proposed as adjuvant treatment. However, traditional methods of dietary assessment such as 24 h recalls rely greatly on intensive user-interaction and are subject to bias. Hence, more objective methods are required for unbiased dietary assessment and efficient prevention. While it is accepted that some dietary-derived constituents in blood plasma are indicators for certain dietary patterns, these may be too unstable (such as vitamin C as a marker for fruits/vegetables) or too broad (e.g. polyphenols for plant-based diets) or reflect too short-term intake only to allow for strong associations with prolonged intake of individual food groups. In the present manuscript, commonly employed biomarkers of intake including those related to specific food items (e.g. genistein for soybean or astaxanthin and EPA for fish intake) and novel emerging ones (e.g. stable isotopes for meat intake or microRNA for plant foods) are emphasized and their suitability as biomarker for food intake discussed. Promising alternatives to plasma measures (e.g. ethyl glucuronide in hair for ethanol intake) are also emphasized. As many biomarkers (i.e. secondary plant metabolites) are not limited to dietary assessment but are also capable of regulating e.g. anti-inflammatory and antioxidant pathways, special attention will be given to biomarkers presenting a double function to assess both dietary patterns and MetS risk.

Scientific opinion on the tolerable upper intake level for preformed vitamin A and ß-carotene.

Following two requests from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for preformed vitamin A and ß-carotene. Systematic reviews of the literature were conducted for priority adverse health effects of excess vitamin A intake, namely teratogenicity, hepatotoxicity and endpoints related to bone health. Available data did not allow to address whether ß-carotene could potentiate preformed vitamin A toxicity. Teratogenicity was selected as the critical effect on which to base the UL for preformed vitamin A. The Panel proposes to retain the UL for preformed vitamin A of 3000 µg RE/day for adults. This UL applies to men and women, including women of child-bearing age, pregnant and lactating women and post-menopausal women. This value was scaled down to other population groups using allometric scaling (body weight0.75), leading to ULs between 600 µg RE/day (infants 4-11 months) and 2600 µg RE/day (adolescents 15-17 years). Based on available intake data, European populations are unlikely to exceed the UL for preformed vitamin A if consumption of liver, offal and products thereof is limited to once per month or less. Women who are planning to become pregnant or who are pregnant are advised not to consume liver products. Lung cancer risk was selected as the critical effect of excess supplemental ß-carotene. The available data were not sufficient and suitable to characterise a dose-response relationship and identify a reference point; therefore, no UL could be established. There is no indication that ß-carotene intake from the background diet is associated with adverse health effects. Smokers should avoid consuming food supplements containing ß-carotene. The use of supplemental ß-carotene by the general population should be limited to the purpose of meeting vitamin A requirements.

Protective effect of provitamin A dietary carotenoid intake on overweight/obesity and their relation to inflammatory and oxidative stress biomarkers - a case-control study.

This investigation assessed associations between dietary carotenoid intake and the odds of overweight/obesity, as well as inflammatory/oxidative stress biomarkers, in 851 participants with overweight/obesity (BMI ≥25 kg m-2) and 754 normal-weight controls. A 124-item food-frequency-questionnaire (FFQ) and food composition databases were employed to estimate carotenoid intake. Binary logistic regressions assessed the association of carotenoid intake with the odds of overweight/obesity, adjusting for several potential confounders. Multiple linear regression models revealed associations between carotenoid intake and biomarkers (anthropometrics, blood lipids, inflammation, antioxidant status). Logistic regression models adjusted for various confounders and fruits and vegetables showed protective associations for provitamin A carotenoids (i.e., ß-carotene + α-carotene + ß-cryptoxanthin; odds ratio (OR): 0.655, p = 0.041) and astaxanthin (OR: 0.859, p = 0.017). Similarly adjusted multiple linear regressions revealed significant associations between several carotenoids and lower levels of interleukin (IL)-6, IL-1ß, and TNF-α and increased IL-10 and total antioxidant capacity. Further analysis revealed that lycopene was significantly associated with increased odds of overweight/obesity (OR: 1.595, p = 0.032) in a model adjusted for various confounders and vegetables (i.e., unadjusted for fruits). A protective association between the sum of provitamin A carotenoid and astaxanthin dietary intake and the odds of having overweight/obesity was found. The findings that carotenoids other than lycopene were not or inversely associated with the odds of overweight/obesity may point toward differentiating effects of various carotenoids or their associations with different food groups. Provitamin A rich food items including fruits and vegetables appear to be a prudent strategy to reduce inflammation and the odds of having overweight/obesity.

Scientific Opinion on additional scientific data related to the safety of preparations of Rheum palmatum L., Rheum officinale Baill. and their hybrids, Rhamnus purshiana DC., Rhamnus frangula L. and Cassia senna L., submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006.

The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of plant preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baill. and their hybrids, from the bark of Rhamnus frangula L. and Rhamnus purshiana DC. and from the leaf or fruit of Cassia senna L., which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925/2006. The NDA Panel reviewed the additional scientific data submitted during the period of scrutiny and the public consultation by interested parties. The pertinent scientific data were in vitro and in vivo genotoxicity studies on the plant preparations under consideration. All the results of the genotoxicity studies on plant preparations were negative. However, the plant preparations that were tested in the submitted studies were not sufficiently characterised with respect to the content of total and individual hydroxyanthracene derivatives (HADs) and components other than HADs. The studies confirmed the presence of ■■■■■, known to be genotoxic in vivo, and ■■■■■, shown to be genotoxic in vitro. In line with the EFSA Scientific Committee statement on genotoxicity assessment of chemical mixtures, considering the presence of an in vivo genotoxic compound, the plant preparations used in these studies have to be considered of concern for genotoxicity. Thus, the safety of preparations containing HADs from the root or rhizome of Rheum palmatum L., Rheum officinale Baill. and their hybrids, from the leaf or fruit of Cassia senna L. and from the bark of Rhamnus frangula L. and Rhamnus purshiana DC. cannot be established based on the submitted studies.

Longitudinal study of changes in greenness exposure, physical activity and sedentary behavior in the ORISCAV-LUX cohort study.

BACKGROUND: Greenness exposure has been associated with many health benefits, for example through the pathway of providing opportunities for physical activity (PA). Beside the limited body of longitudinal research, most studies overlook to what extent different types of greenness exposures may be associated with varying levels of PA and sedentary behavior (SB). In this study, we investigated associations of greenness characterized by density, diversity and vegetation type with self-reported PA and SB over a 9-year period, using data from the ORISCAV-LUX study (2007-2017, n = 628). METHODS: The International Physical Activity Questionnaire (IPAQ) short form was used to collect PA and SB outcomes. PA was expressed as MET-minutes/week and log-transformed, and SB was expressed as sitting time in minutes/day. Geographic Information Systems (ArcGIS Pro, ArcMap) were used to collect the following exposure variables: Tree Cover Density (TCD), Soil-adjusted Vegetation Index (SAVI), and Green Land Use Mix (GLUM). The exposure variables were derived from publicly available sources using remote sensing and cartographic resources. Greenness exposure was calculated within 1000m street network buffers around participants' exact residential address. RESULTS: Using Random Effects Within-Between (REWB) models, we found evidence of negative within-individual associations of TCD with PA (ß = - 2.60, 95% CI - 4.75; - 0.44), and negative between-individual associations of GLUM and PA (ß = - 2.02, 95% CI - 3.73; - 0.32). There was no evidence for significant associations between greenness exposure and SB. Significant interaction effects by sex were present for the associations between TCD and both PA and SB. Neighborhood socioeconomic status (NSES) did not modify the effect of greenness exposure on PA and SB in the 1000 m buffer. DISCUSSION: Our results showed that the relationship between greenness exposure and PA depended on the type of greenness measure used, which stresses the need for the use of more diverse and complementary greenness measures in future research. Tree vegetation and greenness diversity, and changes therein, appeared to relate to PA, with distinct effects among men and women. Replication studies are needed to confirm the relevance of using different greenness measures to understand its' different associations with PA and SB.

Local retail food environment exposure and diet quality in rural and urban adults: A longitudinal analysis of the ORISCAV-LUX cohort study.

Despite growing interest in understanding how food environments shape dietary behaviors, European longitudinal evidence is scarce. We aimed to investigate the associations of 9-year average and change in exposure to local retail food environments with the diet quality of residents in Luxembourg. We used data from 566 adults enrolled in both waves of the nationwide ORISCAV-LUX study (2007-2017). Dietary quality was assessed by the Diet Quality Index-International (DQI-I). Exposure to "healthy" and "less healthy" food outlets was assessed by both absolute and relative GIS-based measurements. The results showed a 56.3% increase in less healthy food outlets over the period. In adjusted linear mixed models, high (vs. low) 9-year average exposure to less healthy food outlets was associated with lower DQI-I, when examining spatial access (ß = -1.25, 95% CI: -2.29, -0.22) and proportions (ß = -1.24, 95% CI: -2.15, -0.33). Stratified analyses showed these associations to be significant only among urban residents. There was no association between change in exposure to less healthy food outlets and DQI-I. Increased exposure to healthy outlets in rural areas, using absolute measurements, was associated with worsened DQI-I. Neighborhood socioeconomic status did not moderate the above associations. Findings suggest that the proliferation of less healthy food outlets may have contributed to the deterioration of the diet quality of urban residents, and support the use of relative measurements to fully capture the healthiness of food environments.

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.

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.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol.

INTRODUCTION: Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers. METHODS AND ANALYSIS: PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed. ETHICS AND DISSEMINATION: Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

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.

Effect of Digested Selected Food Items on Markers of Oxidative Stress and Inflammation in a Caco-2-Based Human Gut Epithelial Model.

The human gut epithelium presents a crucial interface between ingested food items and the host. Understanding how different food items influence oxidative stress and inflammation in the gut is of great importance. This study assessed the impact of various digested food items on oxidative stress, inflammation, and DNA/RNA damage in human gut epithelial cells. Differentiated Caco-2 cells were exposed to food items and their combinations (n = 22) selected from a previous study, including sausage, white chocolate, soda, coffee, orange juice, and curcumin. Following stimulation with TNF-α/IFN-1ß/LPS and H2O2 for 4 h, the cells were exposed to digested food items or appropriate controls (empty digesta and medium) for a further 16 h. Cell viability, antioxidant capacity (ABTS, FRAP), IL-6, IL-8, F2-isoprostanes, lipid peroxidation (MDA), and DNA/RNA oxidative damage were assessed (3 independent triplicates). The ABTS assay revealed that cells treated with "white chocolate" and "sausage + coffee" exhibited significantly reduced antioxidant capacity compared to stimulated control cells (ABTS = 52.3%, 54.8%, respectively, p < 0.05). Similar results were observed for FRAP (sausage = 34.9%; white chocolate + sausage = 35.1%). IL-6 levels increased in cells treated with "white chocolate + sausage" digesta (by 101%, p < 0.05). Moreover, MDA levels were significantly elevated in cells treated with digested "sausage" or sausage in combination with other food items. DNA/RNA oxidative damage was found to be higher in digesta containing sausage or white chocolate (up to 550%, p < 0.05) compared to stimulated control cells. This investigation provides insights into how different food items may affect gut health and underscores the complex interplay between food components and the epithelium at this critical interface of absorption.

Nutri-Score 2023 update.

In 2023, the algorithm underlying the Nutri-Score front-of-pack label was updated to better align with food-based dietary guidelines (FBDGs) across countries engaged in the system. On the basis of a comparison of FBDGs and literature reviews with the current Nutri-Score classification, modification scenarios were developed and tested in nutritional composition databases of branded products in four countries. The updated Nutri-Score nutrient profile model allows a better discrimination between products, in closer alignment with FBDGs, while the updated algorithm adopts a stricter approach for products that are high in components of concern (including non-nutritive sweeteners) and low in favourable dietary components. The updated Nutri-Score algorithm increases the alignment between the front-of-pack label system and FBDGs, strengthening its potential as a complementary public health tool in an international perspective.

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.

Relationship between multimorbidity, functional limitation, and quality of life among middle-aged and older adults: findings from the longitudinal analysis of the 2013-2020 Survey of Health, Ageing, and Retirement in Europe (SHARE).

PURPOSE: The increased burden of multimorbidity is restricting individuals' ability to live autonomously, leading to a poorer quality of life. This study estimated trajectories of functional limitation and quality of life among middle-aged (ages 50 to 64 years) and older (aged 65 years and older) individuals with and without multimorbidity. We also assessed differences in the relationship between these two trajectories by multimorbidity status and separately for each age cohort. METHODS: Data originated from the Survey of Health, Ageing, and Retirement in Europe (SHARE). In Luxembourg, data were obtained between 2013 and 2020, involving 1,585 respondents ≥ 50 years of age. Multimorbidity was defined as a self-reported diagnosis of two or more out of 16 chronic conditions; functional limitation was assessed by a combined (Instrumental) Activities of Daily Living (ADL/IADLI) scale; and to measure quality of life, we used the Control, Autonomy, Self-Realization, and Pleasure (CASP-12) scale. Latent growth curve modelling techniques were used to conduct the analysis where repeated measures of quality of life and functional limitation were treated as continuous and zero-inflated count variables, respectively. The model was assessed separately in each age cohort, controlling for the baseline covariates, and the estimates from the two cohorts were presented as components of a synthetic cohort covering the life course from the age of 50. RESULTS: Middle-aged and older adults living with multimorbidity experienced poorer quality of life throughout the life course and were at a higher risk of functional limitation than those without multimorbidity. At baseline, functional limitation had a negative impact on quality of life. Furthermore, among middle-aged adults without multimorbidity and older adults with multimorbidity, an increase in the number of functional limitations led to a decline in quality of life. These results imply that the impact of multimorbidity on functional limitation and quality of life may vary across the life course. CONCLUSION: Using novel methodological techniques, this study contributes to a better understanding of the longitudinal relationship between functional limitation and quality of life among individuals with and without multimorbidity and how this relationship changes across the life course. Our findings suggest that lowering the risk of having multimorbidity can decrease functional limitation and increase quality of life.

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.

Scientific opinion on the tolerable upper intake level for manganese.

Following a request from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for manganese. Systematic reviews of the literature of human and animal data were conducted to assess evidence regarding excess manganese intake (including authorised manganese salts) and the priority adverse health effect, i.e. manganese-induced neurotoxicity. Available human and animal studies support neurotoxicity as a critical effect, however, data are not sufficient and suitable to characterise a dose-response relationship and identify a reference point for manganese-induced neurotoxicity. In the absence of adequate data to establish an UL, estimated background dietary intakes (i.e. manganese intakes from natural dietary sources only) observed among high consumers (95th percentile) were used to provide an indication of the highest level of intake where there is reasonable confidence on the absence of adverse effects. A safe level of intake of 8 mg/day was established for adults ≥ 18 years (including pregnant and lactating women) and ranged between 2 and 7 mg/day for other population groups. The application of the safe level of intake is more limited than an UL because the intake level at which the risk of adverse effects starts to increase is not defined.

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.