Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I) 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 rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a high molecular weight polysaccharide derived from carrot pomace. The Panel considers that the production process is sufficiently described and does not raise safety concerns.

Negative impact of soluble, gel-forming dietary fibres on the bioaccessibility of β-carotene, lutein, and lycopene.

Carotenoids, including β-carotene, lutein and lycopene, the 3 main carotenoids present in our body, are lipophilic phytochemicals associated with several health benefits. Dietary fibre may influence the bioavailability of carotenoids by altering their release from the food matrix and their solubilisation into mixed micelles during digestion and thus their subsequent absorption by enterocytes. We examined the dose-dependent influence of major soluble (pectin, guar, alginate, fructooligosaccharides,) and insoluble dietary fibres (cellulose, type-2 resistant starch) at nutritional relevant doses (0, 30 and 90 mg per 26 ml) added for digestion, containing also pure β-carotene, lutein or lycopene (at 75 μg) solubilized in peanut oil.

Individual Genomic Loci, Transcript Levels, and Serum Profiles of Immune and Antioxidant Markers Associated with Bacteria-Induced Abortion in Sheep ().

Aboudeleik sheep are a prominent native breed in desert and semi-desert areas, known for their adaptability to harsh climates and their utility in both milk and meat production [...

Safety of lacto-N-tetraose (LNT) produced by a derivative strain ( K-12 MG1655 INB_LNT_01) of K-12 MG1655 (ATCC 700926) as a novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on lacto-N-tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) LNT, but it also contains lacto-N-triose II, d-lactose, LNT-fructose isomer and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain ( K-12 MG1655 INB_LNT_01) of K-12 MG1655 (ATCC 700926).

Safety of synthetic cannabidiol 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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is -cannabidiol (CBD), produced by chemical synthesis and proposed to be used in food supplements at a level of 30 mg/day. The target population is the general population, excluding pregnant and lactating women.

Vitamin A5: Evidence, Definitions, Gaps, and Future Directions.

With the emergence of a new vitamin concept-vitamin A5-it is essential to first clarify the basic definition of vitamins, particularly vitamin A. This article summarizes the foundational concepts and definitions of vitamins with particular relevance to the discovery, establishment, and categorization of new vitamin concepts. Vitamin A5 was discovered 80 years after the last vitamin was identified.

Designing and Developing a Population/Literature-Based Westernized Diet Index (WDI) and Its Relevance for Cardiometabolic Health.

: Recent research indicates a global transition from healthy and balanced diets to unhealthy Westernized dietary patterns (WDPs). This transition is linked to increased rates of non-communicable diseases (NCDs), e.g.

Safety of inulin-propionate ester 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 inulin-propionate ester as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is the subject of the application, is a compound constituted by a natural polymer composed mainly of fructose moieties, polysaccharide inulin (65%-95% w/w), esterified with a short-chain fatty acid (SCFA) moiety, propionic acid (5%-35% w/w). The NF is synthesised by the chemical reaction of inulin with propionic anhydride, under alkaline conditions and controlled temperature.

Safety of magnesium orotate dihydrate 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 orotate dihydrate 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 is produced by chemical synthesis and is proposed to be used in food supplements at a maximum intake level of 6100 mg per day by adults. This intake level corresponds to around 5000 mg/day orotic acid and 400 mg/day magnesium.

Safety of grain and flour from perennial intermediate wheatgrass () 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 grain and flour from perennial intermediate wheatgrass (IWG) () as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, composed primarily of carbohydrates, proteins and water, is produced by cultivating the IWG plant and subsequently processing it to yield either grains or flour. The target population proposed by the applicant is the general population and the NF is proposed as a food ingredient in several food products.

Safety of D-allulose 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 D-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant.

Phenolic compounds naturally present in olive oil and lowering of blood LDL-cholesterol and systolic blood pressure, therefore reducing the risk of coronary heart disease: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006.

Following an application from QvExtra! Internacional pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to phenolic compounds naturally present in olive oil and lowering of blood LDL-cholesterol (LDL-c) and systolic blood pressure (SBP), therefore reducing the risk of coronary heart disease (CHD). The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The Panel considers that the food/constituent, phenolic compounds naturally present in olive oil, is sufficiently characterised, and that lowering of blood LDL-c and SBP are beneficial effects by reducing the risk of CHD.

Longitudinal effects of diet quality on healthy aging - Focus on cardiometabolic health: findings from the Canadian longitudinal study on aging (CLSA).

Background: Hypertension, a major concern for older adults, contributes to morbidity and mortality by increasing the risk of cardiovascular disease, stroke, kidney dysfunction, and cognitive decline. A healthy diet plays a vital role in limiting chronic disease progression in aging populations.

Aim: This study investigated the association between diet quality and healthy aging, focusing on blood pressure measurements (BPMs), using the Canadian Longitudinal Study on Aging (CLSA).

Safety of yellow tomato extract 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 yellow tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid-rich extract from the yellow tomato containing predominantly phytoene plus phytofluene (PE/PF) at up to 10% of the NF, as well as a lesser amount of zeta-carotene (≤ 5%), beta-carotene (≤ 0.5%) and lycopene (≤ 0.

Olive oil polyphenols and the maintenance of normal HDL-cholesterol concentrations: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from University of Bari Aldo Moro, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to olive oil polyphenols and the maintenance of normal blood high-density lipoprotein cholesterol (HDL-c) concentrations. The Panel considers that the food constituent, olive oil polyphenols, is sufficiently characterised. The maintenance of HDL-c concentrations in the blood (without increasing low-density lipoprotein cholesterol concentrations) is a beneficial physiological effect for the general population.

Safety of TO-A 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 TO-A as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is proposed by the applicant to be used as a food supplement, is sufficiently characterised. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns.

Safety of dried biomass powder of THN 6 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 dried biomass powder of THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant.

Safety of the extension of use of 3-fucosyllactose (3-FL) 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 the extension of use of 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, produced with a genetically modified strain ( BL21 (DE3) JBT-3FL) of BL21 (DE3), is already authorised as ingredient in several food categories, including infant formula (IF) and follow-on formula (FOF). The applicant proposed to increase the maximum use levels of the NF in IF, FOF, food for special medical purposes (FSMP) and food supplements (FS).

Neighbourhood exposure to fast-food and sit-down restaurants and estimated 24-hour urinary sodium excretion: a cross-sectional analysis of urban adults from the ORISCAV-LUX 2 study.

Objective: Increased out-of-home consumption may elevate sodium (Na) intake, but self-reported dietary assessments limit evidence. This study explored associations between neighbourhood exposure to fast-food and sit-down restaurants and estimated 24-hour urinary Na excretion.

Design: A cross-sectional analysis from the ORISCAV-LUX 2 study (2016-2017).

Pacran®, a powder obtained from cranberries, and defence against bacterial pathogens in the lower urinary tract: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Givaudan, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Pacran® and defence against bacterial pathogens in the lower urinary tract. The Panel considers that the food Pacran®, a powder obtained from cranberries, is sufficiently characterised. Defence against bacterial pathogens in the lower urinary tract is a beneficial physiological effect.

A protocol for microRNA extraction from gastrointestinal digesta.

MicroRNAs (miRNAs) are non-coding RNAs that influence gene-expression via post-transcriptional regulation of target protein-coding RNAs. With literature reports indicating survival of diet-derived miRNAs following their ingestion, it is important to study their stability and concentration during gastrointestinal digestion. The unique combination of chemicals and elevated RNAse content present in the gastrointestinal matrix may be a limiting factor for studying diet-derived miRNAs.

Nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk and whey protein concentrates and used in infant and follow-on formula manufactured from hydrolysed protein by Healthcare Reckitt B.V.

The European Commission (EC) requested the European Food Safety Authority to evaluate the nutritional safety and suitability of a specific protein hydrolysate derived from sources of skimmed cow's milk (including non-fat) and whey protein concentrates for use in infant and follow-on formula manufactured by Healthcare Reckitt B.V. Healthcare Reckitt B.

Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice 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 monacolins from red yeast rice (RYR), 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, which included analytical data on the composition of RYR supplements, the intake of monacolins from other dietary sources, in vitro bioaccessibility and cytotoxicity data of monacolins vs. other statins, nutrivigilance/post-marketing data, case reports and clinical studies.

Safety of a change of specifications of phytosterols/phytostanols 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 provide an opinion on the safety of a change of the specifications of the authorised NF 'phytosterols/phytostanols' as a novel food (NF) pursuant to Regulation (EU) 2015/2283. This authorised NF concerns phytosterols extracted from plants and which may be presented as free sterols and stanols or esterified with food grade fatty acids. It has to contain less than 81% β-sitosterol, less than 35% β-sitostanol, less than 40% campesterol, less than 15% campestanol, less than 30% stigmasterol and less than 3% brassicasterol.

Safety of oil from (strain ATCC-20889) 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 an oil derived from the microalga sp. (strain ATCC-20889) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 40%-43% of fatty acids.