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.

Safety of yellow/orange 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/orange 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/orange tomato containing predominantly phytoene and phytofluene, as well as a lesser amount of beta-carotene, zeta-carotene and lycopene. The NF is produced from the tomato pulp using supercritical CO2 extraction. The applicant proposes the use of the NF in cereal bars, functional drinks and as a food supplement in individuals above 15 years of age. For the use of the NF in cereal bars and functional drinks, the Panel considers, the target population is the general population. According to EFSA's latest exposure assessment for lycopene as a food additive (EFSA ANS Panel, 2017), the highest P95 intakes for children (< 10 and 10-17 years) and adults when combined to the use of lycopene as a food colour from natural occurrence would exceed the established acceptable daily intake (ADI) for lycopene (0.5 mg/kg body weight (bw) day). The estimated intakes of the NF would lead to an exceedance of the ADI when considering natural occurrence and exposure to lycopene when used as a food additive. Due to the absence of safety data regarding phytoene and phytofluene intake from the NF, and the contribution of the NF to the estimated high daily intakes of lycopene, the Panel considers that it cannot be established whether or not the consumption of the NF is nutritionally disadvantageous. The Panel concludes that the safety of the NF has not been established under the proposed conditions of use.

Safety of the extension of use of partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content 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 partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content as a novel food (NF) pursuant to Regulation (EU) 2015/2283. 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 of the NF as a food ingredient in several food categories with a high moisture content that are subject to thermal processing. The target population for the extension of use is the general population. The information provided on the formation of process contaminants (acrylamide, furan and methylfurans) in a selected food category with added NF (bread) subjected to heat treatment is sufficient for this assessment and does not raise safety concerns. Noting that no safety concerns were identified from the information available on the production process, composition, specifications and proposed uses of the NF, the Panel considers that intake estimates for the NF are not needed for this assessment. The Panel concludes that the NF, partially defatted chia seeds powder with a high fibre content, is safe under the proposed conditions of use.

Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2019/1471).

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.

Nicotinamide and heat preconditioning - Effects on hepatic HSP70, carbohydrate and oxidative disturbances in STZ-induced diabetic rats.

OBJECTIVE: Nicotinamide (NA) is known to have antioxidant potential and partially to protect insulin-secreting cells against diabetogenic agent STZ (streptozotocin). In a combination to heat stress (HS), NA is also known to induce heat-shock proteins (HSPs) production. Heat preconditioning (HP) and HSPs have cytoprotective effects against development of cellular injury caused by application of subsequent stressor. We aimed to determine if pretreatment with NA and HP (as HSP70 -inducers) can affect STZ-induced diabetic disturbances in rats. METHODS: NA-pretreatment (250 mg/kg b.w., 7 days) and heat preconditioning (41 ± 1 °C, 45 min) of diabetic rats was performed. The changes in hepatic carbohydrate- and antioxidative-related enzymes and substrates were investigated. RESULTS: NA-pretreatment, alone or in combination with HS, resulted in significant increase of HSP70 concentration in the liver of control and diabetic rats. Compared to diabetic controls, pretreatment with NA, in combination with HP, resulted in decrease of blood and liver glucose, increase of glycogen and glucose-6-phosphate level, increase of glycogenolytic/glycolytic enzymes, decrease of gluconeogenic enzymes, as well as an increase of glutathione content and glutathione peroxidase, decrease of glutathione reductase and catalase activities. CONCLUSIONS: NA is a potent HSP70 coinducer, alone or in a combination with HS in the liver of both control and diabetic rats. Pretreatment with NA, accompanied by HP, has a pronounced corrective effect on STZ-induced diabetes disturbances in the key hepatic carbohydrate- and antioxidative-related parameters. It seems that this corrective effect is based on the increased production of hepatic HSP70.

Heat-Shock Protein 70-Mediated Heat Preconditioning Attenuates Hepatic Carbohydrate and Oxidative Disturbances in Rats With Type 1 Diabetes.

OBJECTIVES: Heat preconditioning and heat-shock protein (HSP) synthesis have significant cytoprotective effects against the development of cellular injury caused by the application of a subsequent stressor, which were found to depend on the time period between the stressors. We aimed to determine the most efficient recovery time (6 h or 24 h) following heat-stress exposure and prior application of diabetic streptozotocin (STZ) on the moderation of carbohydrate and oxidative metabolic disturbances caused by diabetes. METHODS: Experiment animals (Wistar rats) were exposed to acute heat stress at 41±1°C for 45 min, followed by 6-h or 24-h recovery times at room temperature before sacrifice or STZ administration. RESULTS: Our findings indicate that acute heat stress with 6-h or 24-h recovery periods results in a significant rise in the hepatic heat-shock protein 70 (HSP70) levels (even more so after 24 h), glycogen breakdown and stable glycemia, followed by reduced glycolytic and gluconeogenic activity (after 24 h) (glucose-6-phosphatase, fructose-1,6-bisphosphatase); stimulates antioxidative activity (glutathione peroxidase, glutathione reductase) (after 6 h); and decreases glutathione and catalase activity (after 24 h). Heat preconditioning (with 6-h and 24-h recovery periods) prior to STZ-induced diabetes increases HSP70 levels and causes lower serum glucose levels, higher glycogen and glucose-6-phosphate levels, lower glucose-6-phosphatase levels and glycogen phosphorylase and hexokinase levels but also elevates glutathione reductase and glutathione peroxidase activity compared to untreated STZ animals. CONCLUSIONS: Based on our findings, heat preconditioning and HSP70 induction in rats with type 1 diabetes attenuates STZ-induced metabolic alterations in hepatic carbohydrate metabolism and oxidative states. These changes are more evident at 24 h recovery post-acute heat stress, based on the most evident accumulation of HSP70 in this time frame.