Browsing by Subject "ingredient"

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  • Perttila, Sini; Jalava, Taina; Rinne, Marketta; Viana, Gabriel Da Silva; Valaja, Jarmo (2021)
    The apparent (AID) and standardised (SID) ileal amino acid digestibilities in wheat, soybean meal and rapeseed meal were determined with Ross 308 broiler chicken (n = 64) using the slaughter technique with chromium mordanted straw as an indigestible marker. The recovery of endogenous amino acids at the distal ileum was determined with protein-free diet and it was used to calculate the SID digestibilities of the studied feed ingredients. The mean amino acid AID and SID were higher in soybean meal and wheat than in rapeseed meal (p
  • EFSA Panel Dietetic Prod Nutr (2017)
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on alginate-konjac- xanthan polysaccharide complex (PGX) as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The NF is an off-white granular powder composed of three non- starch polysaccharides: konjac glucomannan, xanthan gum and sodium alginate. The information provided on the composition, the specifications, the batch-to-batch variability and the stability of the NF is sufficient and does not raise safety concerns. The production process is sufficiently described and does not raise concerns about the safety of the NF. The applicant intends to add the NF to a variety of foods as well as to market the NF in capsules. The recommended maximum daily intake of the NF from fortified foods and food supplements is 15 g. The target population proposed by the applicant is adults from 18 to 64 years of age. Considering the no observed adverse effect level of 1.8 g/kg body weight (bw) per day in a subchronic toxicity study with PGX and the highest mean and 95th percentile anticipated daily intake of NF from fortified foods, the margin of exposure (MoE) is 12 and 6, respectively, whereas the MoE for the NF from food supplements is 9. The Panel concludes that the safety of the novel food, PGX, for the intended uses and use levels as proposed by the applicant, has not been established. (C) 2017 European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr; Heinonen, Marina (2017)
    Following a request from the European Commission, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on betaine as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is proposed to be used in foods intended to meet additional requirements for intense muscular effort with a maximum intake of 2.5 g/day of betaine for sports people above 10 years of age. Based on the lowest BMDL05, which was derived from a chronic toxicity study in rats in which a dose-related increase in platelet counts was observed, and the anticipated daily intake of the NF in the target population, the Margins of Exposure are 3.6 and 5, which are generally regarded as not sufficient. However, the total exposure to betaine from the diet (about 830 mg/day) is not known to be associated with adverse effects. Moreover, no adverse effects on platelet counts were noted in human intervention studies with exposure levels of 4 g/day of betaine for up to 6 months. A significant increase in total and low-density lipoprotein (LDL)-cholesterol concentrations was noted at intakes of 4 g/day of betaine in overweight subjects with metabolic syndrome but not in healthy subjects, nor at intakes of 3 g/day. Thus, considering 4 g/day of betaine as a reference point and applying an uncertainty factor of 10 to account for interindividual variability, an amount of 400 mg/day of betaine in addition to the background exposure is considered as safe. The Panelconsiders that the NF is safe to be used at maximum intake of 400 mg/day in the target population. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr; Heinonen, Marina (2017)
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 'cranberry extract powder' as a novel food (NF)submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The NF contains about 55-60% proanthocyanidins ( PACs). The Panel considers that the information provided on the composition, the specifications, batch-to-batch variability and stability of the NF is sufficient and does not raise safety concerns. Cranberry extract powder is produced from cranberry juice concentrate through an ethanolic extraction using an adsorptive resin column to retain the phenolic components. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food. The NF is intended to be added to beverages and yogurts to provide 80 mg PACs per serving. The target population is the adult general population. The mean and 95th percentile estimates for the all-user intakes from all proposed food-uses are 68 and 192 mg/day, respectively, for female adults, and 74 mg/day and 219 mg/day, respectively, for male adults. Taking into account the composition of the novel food and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. While no animal toxicological studies have been conducted on the NF, a number of human clinical studies have been conducted with cranberry products. Considering the composition, manufacturing process, intake, history of consumption of the source and human data, the Panel considers that the data provided do not give reasons for safety concerns. The Panel concludes that the cranberry extract powder is safe as a food ingredient at the proposed uses and use levels. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr Al (2018)
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on D-ribose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant intends to market the NF as ingredient in a variety of foods, food supplements and in certain foods for specific groups. The NF is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis and marketed as Bioenergy Ribose (TM). The information provided on the batch-to-batch variability, specifications, stability, production process and history of the organism used as a source of the NF is sufficient and does not raise safety concerns. The Panel considers that the effects observed in a subchronic toxicity study in rats could be the consequence of nutritional imbalances, but toxicological effects could not be ruled out; from this study, the Panel derived a No observed adverse effect level (NOAEL) of 3.6 g/kg body weight (bw) per day. From the human studies indicating a potential decrease in glucose levels and/or the occurrence of transient symptomatic hypoglycaemia at intakes of 10 g of D-ribose, the Panel defined 70 mg/kg bw per day as the NOAEL with respect to hypoglycaemia that can be considered applicable for adults. For children, the Panel acknowledges the lack of human data directly relevant for this population group. Based on the NOAEL derived from the subchronic toxicity study in rats, an acceptable level of intake of 36 mg/kg bw per day was defined that would also take into account the potentially increased sensitivity of certain population groups to hypoglycaemia. The Panel concludes that the NF is safe for the general population at intake levels up to 36 mg/kg bw per day and considers that the safety of the NF at the intended uses and use levels as proposed by the applicant has not been established. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Nutr Novel Foods Food A; Turck, Dominique; Heinonen, Marina (2019)
    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 heat-killed Mycobacterium setense manresensis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an encapsulated ingredient composed of 200 mg mannitol and
  • EFSA Panel Nutr Novel Foods Food A; Turck, Dominique; Heinonen, Marina (2020)
    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 'Hovenia dulcis fruit extract' as a novel food (NF) for its use in food supplements. The NF concerns a hot water extract of sliced and dried fruits and peduncles of Hovenia dulcis Thun. The production process is described in sufficient detail but contains contradictory information regarding the mixing with another ingredient of the NF. The NF is comprised of mostly carbohydrates (about 90%), about 2% proteins, 5% moisture, less than 1% fat and about 2% ash. In addition, the NF contains small amounts of flavonoids such as dihydromyricetin, myricetin and quercetin. The Panel notes limitations of the data provided from the batch testing regarding proximate analyses and plant secondary metabolites. Given these limitations, the Panel considers that the data provided by the applicant do not demonstrate that different batches produced with the described production process meet the proposed specifications. The target population is the general adult population excluding pregnant and lactating women and people with a chronic disease, such as liver malfunction. Limited information was provided on a history of consumption of Hovenia dulcis fruits and on an extract approved in South Korea. A number of toxicological studies were performed. However, the study reports did not allow to verify that the test item was representative of the NF. The same applied to a human study provided by the applicant. The Panel concludes that the safety of the NF has not been established. (c) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Nutr Novel Foods Food A; Amundsen, Mathias (2019)
    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 phenylcapsaicin as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Phenylcapsaicin is a chemically synthesised analogue of capsaicin intended to be marketed in food supplements and in foods for special medical purposes to the general population above the age of 11 years old at a maximum level of 2.5 mg/day. The highest intake of the NF is 2.5 mg/day which corresponds to 36 mu g/kg body weight (bw) per day for adults, and 58 mu g/kg bw per day for adolescents (10-14 years). The Panel considers that there is no concern with respect to genotoxicity of the NF. The reference point derived based on a 13-week rat study was the lowest of the model averaged BMDL20 values of 37.2 mg/kg bw per day in females for increased plasma alanine aminotransferase (ALAT) levels. The Panel concludes that the NF, phenylcapsaicin, is safe under the proposed uses and use levels. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr (2017)
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on proline-specific oligopeptidase (Tolerase (R) G) as a novel food ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is an enzyme preparation of prolyl-oligopeptidase produced with a genetically modified Aspergillus niger self clone strain. The target population is the general adult population. The results from a bacterial reverse mutation test and of an in vitro chromosome aberration test did not indicate genotoxicity. The Panel considers that the reported effects observed in a 90-day rat study are treatment-related effects and can be attributed to the higher energy consumption by these animals. Taking into account the intended maximum use level for Tolerase (R) G, its daily consumption would correspond to 2,746 mg TOS/person or to 39.2 mg TOS/kg body weight (bw) per day, when considering a default body weight of 70 kg for an adult person. The margin between this value and the dose in the rats, which caused effects attributable to the excess energy intake, is approximately 45. Noting this margin, the Panel considers that it is unlikely that such effects would occur in human at the intended use levels. The Panel concludes that the NF, Tolerase (R) G, is safe for the intended use at the intended use level. (C) 2017 European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr; Heinonen, Marina (2017)
    Following a request from the European Commission, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on pyrroloquinoline quinone disodium salt (PQQ), trade name BioPQQ, as a novel food pursuant to Regulation (EC) No 258/97. PQQ is produced by fermentation using Hyphomicrobiumdenitrificans CK-275 and purification process. PQQ has a minimum purity of 99.0%. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of PQQ is sufficient and does not raise safety concerns. The applicant intends to market PQQ for use in food supplements for healthy adults, except pregnant and lactating women, at a maximum proposed level of consumption of 20 mg/day (corresponding to 0.29 mg/kg bw per day for a 70-kg person). The proposed level of consumption is at least 250 times higher than the estimated background intake of PQQ occurring naturally in foods. Information on the absorption, distribution, metabolism and excretion of PQQ in animals and humans is limited. Considering the no-observed-adverse-effect-level (NOAEL) of 100mg/kg bw per day from a 90-day repeated dose oral toxicity study with BioPQQ, and the maximum proposed level of consumption, the Panelconcludes that the margin of exposure (of 344) is sufficient. The Panelconcludes that the novel food, pyrroloquinoline quinone disodium salt (BioPQQ (TM)), is safe under the intended conditions of use as specified by the applicant. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr (2016)
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on synthetic L-ergothioneine, marketed as Ergoneine (R), as a novel food submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The novel food, synthetic L-ergothioneine, is produced by a one-pot patented manufacturing process. Chemically, L-ergothioneine is a derivative of thiolhistidine, and it is naturally present in a number of foodstuffs such as mushrooms, some varieties of black and red beans, offal and cereals. The production process for the novel food is sufficiently described and does not raise concerns about the safety of the novel food. The information on the composition, specifications, batch-to-batch variability and stability of the novel food is sufficient and does not raise safety concerns. The applicant intends to use the novel food in quantities of up to 5 mg per serving in alcohol-free beverages, cereal bars, milk, fresh dairy products and chocolate. The applicant also proposes to provide the novel food as a food supplement, with a daily dose of up to 30 mg/day for adults and 20 mg/day for children. The target population is children above 3 years of age and the general adult population, except pregnant and breastfeeding women. Considering the NOAEL of 800 mg/kg bw per day, which was based on two subchronic toxicity studies in rats, and the maximum estimated intake levels for L-ergothioneine from all sources, the Panel concludes that the margins of safety of 470 for adults (except pregnant and breastfeeding women) and of 216 for children above 3 years of age are sufficient. The Panel concludes that the novel food, synthetic L-ergothioneine (marketed as Ergoneine (R)), is safe under the intended conditions of use as specified by the applicant. (C) 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); Turck, Dominique; Heinonen, Marina (2021)
    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 vitamin D-2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ingredient produced from Agaricus bisporus mushroom powder that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D-2 (ergosterol) to vitamin D-2 (ergocalciferol). The NF contains concentrations of vitamin D provided by vitamin D-2 in the ranges of 580-595 mu g/g. 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 in a variety of foods and beverages, including food for special medical purposes and food supplements. The target population is the general population except for food supplements and Foods for Special Medical Purposes (FSMPs), for which the target population is individuals above 1 year of age. The Panel concludes that the NF, used as an ingredient, is safe for the general population at the proposed condition of use in foods and beverages and that the NF used as a food supplement, is safe for individuals above 1 year. (c) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Nutr Novel Foods Food A; Turck, Dominique; Heinonen, Marina (2020)
    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 vitamin D-2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ingredient produced from Agaricus bisporus mushrooms that have been exposed to ultraviolet (UV) light to induce the conversion of provitamin D-2 (ergosterol) to vitamin D-2 (ergocalciferol). The NF contains concentrations of vitamin D provided by vitamin D-2 in the ranges of 1,000-1,300 mu g/g. 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 in a variety of foods and beverages, including food for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above seven months of age. The Panel concludes that the NF, used as an ingredient, is safe for the general population at the proposed condition of use in foods and beverages and that the NF used as a food supplement, is safe for individuals above 1 year. The Panel, however, notes that the UL for infants aged 0-6 months may be exceeded in high consumers of infant formula (IF) and/or follow-on formula (FoF) that may also be high consumers of foods fortified with the NF and for infants aged 7-12 months consuming a daily vitamin D oral supplementation of 10 mu g. However, the Panel considers this scenario unlikely as complementary feeding in high consumers of IF and/or FoF may be limited. Furthermore, the combined consumption of vitamin D via fortified foods and supplements does not specifically concern this NF application. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations. (C) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Dietetic Products Nutr (2018)
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on whey basic protein isolate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained by ion exchange chromatography of skimmed cow's milk. The applicant intends to market the NF in infant and follow-on formulae and meal replacement beverages, dietary foods for special medical purposes and as food supplements. The highest estimated intake of the NF based on the proposed uses and use levels would be 24.8 mg/kg body weight (bw) per day in infants and 27.8 in toddlers. The information provided on composition, specifications, production process and stability of the NF do not raise safety concerns. Taking into account the composition of the NF and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The Panel considers that there is no concern with respect to genotoxicity. The no observed adverse effect level (NOAEL) of a subchronic 13-week rat study was 2000 mg/kg bw per day. Considering the source, the production process and nature of the NF, the Panel considers the margin of exposure (MOE) of 154 to be sufficient for the adult population (on a high-estimated intake of 13 mg/kg bw). For infants and toddlers, the MOE would be at least 81 and 72, respectively. Taking into account the composition of the NF, its source, the history of consumption of the main components of the NF, the production process and that the NOAEL in a subchronic rat study was the highest dose tested the Panel considers that also the MOE for infants and toddlers are sufficient. The Panel concludes that the novel food ingredient, whey basic protein isolate, is safe under the proposed uses and use levels. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.