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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 (sodium salt), but it also contains sialic acid, d-glucose, d-lactose, 6'-sialyllactulose sodium salt, 3'-sialyllactose (3'-SL) sodium salt and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain ( Escherichia coli NEO6) 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 already assessed for 6'-SL sodium salt produced by fermentation by a genetically modified strain of E. coli K-12 DH1. Therefore, since the NF would be consumed at the same extent as the already assessed 6'-SL sodium salt, no new estimates of the intake have been carried out. Similarly, FS 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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, 3-fucosyllactulose and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain ( Escherichia coli K-12 DH1 MDO MAP1834) of E. coli K-12 DH1 (DSM 4235). 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 special medical purposes and food supplements (FS). 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. FS 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 UV-treated powder of whole yellow mealworm ( Tenebrio molitor larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow mealworm refers to the larval form of the insect species T. molitor . The NF is the UV-treated powder of the whole, thermally dried yellow mealworm. The NF consists mainly of crude protein, fat, digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF highly depend on the occurrence levels of these substances in the insect feed. The Panel notes furthermore 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 in the NF is overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen. The applicant proposed to use the NF as an ingredient in various food products, such as bakery products, pasta, compotes of fruit/vegetables and cheese. The target population is the general population. The Panel notes that considering the composition of the NF, the proposed conditions of use and that the NF will not be the sole source of dietary protein, the consumption of the NF is not nutritionally disadvantageous. Despite the UV treatment, the Panel notes that the NF is not a significant dietary contributor of vitamin D3. The submitted toxicity studies from the literature did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergies to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. With the exception of possible allergenicity, the Panel concludes that the NF is safe under the proposed uses and use levels., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 paramylon as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Paramylon is a linear, unbranched beta-1,3-ᴅ-glucan polymer that is isolated from the single-cell microalga Euglena gracilis . The NF consists of at least 95% beta-glucan and minor amounts of protein, fat, ash and moisture. The applicant proposed to use the NF in food supplements, as a food ingredient added to a number of food categories and in foods for total diet replacement for weight control. In 2019, E. gracilis was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only', which includes food products based on microbial biomass of the microalga. Based on the information provided, E. gracilis is not expected to survive the manufacturing process. The submitted toxicity studies did not raise safety concerns. No adverse effects were observed in the subchronic toxicity studies, up to the highest dose tested, i.e. 5,000 mg NF/kg body weight per day. In view of the QPS status of the source of the NF, supported by the manufacturing process, compositional data and lack of toxicity observed in the toxicity studies, the Panel has no safety concerns and concludes that the NF, i.e. paramylon, is safe under the proposed uses and use levels., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 vitamin B6. Systematic reviews of the literature were conducted by a contractor. The relationship between excess vitamin B6 intakes and the development of peripheral neuropathy is well established and is the critical effect on which the UL is based. A lowest-observed-effect-level (LOAEL) could not be established based on human data. A reference point (RP) of 50 mg/day is identified by the Panel from a case-control study, supported by data from case reports and vigilance data. An uncertainty factor (UF) of 4 is applied to the RP to account for the inverse relationship between dose and time to onset of symptoms and the limited data available. The latter covers uncertainties as to the level of intake that would represent a LOAEL. This leads to a UL of 12.5 mg/day. From a subchronic study in Beagle dogs, a LOAEL of 50 mg/kg body weight (bw) per day can be identified. Using an UF of 300, and a default bw of 70 kg, a UL of 11.7 mg/day can be calculated. From the midpoint of the range of these two ULs and rounding down, a UL of 12 mg/day is established by the Panel for vitamin B6 for adults (including pregnant and lactating women). ULs for infants and children are derived from the UL for adults using allometric scaling: 2.2-2.5 mg/day (4-11 months), 3.2-4.5 mg/day (1-6 years), 6.1-10.7 mg/day (7-17 years). Based on available intake data, EU populations are unlikely to exceed ULs, except for regular users of food supplements containing high doses of vitamin B6., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 CO 2 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Water lentil protein concentrate is produced from two water lentil species ( L. gibba and L. minor ) by separation of the protein fraction of the plant material from fibres, followed by pasteurisation and spray drying. The NF consists mainly of protein, fibre, fat and ash. The applicant proposed to use the NF as a food ingredient in a variety of food categories and as a food supplement. The target population is the general population when used as a food ingredient and exclusively adults when used as a food supplement. 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. There are no concerns regarding genotoxicity of the NF. The Panel considers that the risk of the NF triggering allergic reactions is low. The Panel concludes that the NF, water lentil protein concentrate from a mixture of L. gibba and L. minor , is safe under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 selenium. Systematic reviews of the literature were conducted to identify evidence regarding excess selenium intake and clinical effects and potential biomarkers of effect, risk of chronic diseases and impaired neuropsychological development in humans. Alopecia, as an early observable feature and a well-established adverse effect of excess selenium exposure, is selected as the critical endpoint on which to base a UL for selenium. A lowest-observed-adverse-effect-level (LOAEL) of 330 μg/day is identified from a large randomised controlled trial in humans (the Selenium and Vitamin E Cancer Prevention Trial (SELECT)), to which an uncertainty factor of 1.3 is applied. A UL of 255 μg/day is established for adult men and women (including pregnant and lactating women). ULs for children are derived from the UL for adults using allometric scaling (body weight 0.75 ). Based on available intake data, adult consumers are unlikely to exceed the UL, except for regular users of food supplements containing high daily doses of selenium or regular consumers of Brazil nuts. No risk has been reported with the current levels of selenium intake in European countries from food (excluding food supplements) in toddlers and children, and selenium intake arising from the natural content of foods does not raise reasons for concern. Selenium-containing supplements in toddlers and children should be used with caution, based on individual needs., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 Lemna minor and Lemna gibba whole plant material as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Lemna minor and Lemna gibba are aquatic plants commonly named water lentils. The NF is produced by cultivation of Lemna minor and Lemna gibba plants, washing with water and heat treatment. The main constituents of the NF are water, protein and fibre. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is intended to be used as a vegetable, similar to other leafy vegetables. The target population is the general population. The Panel considers that, with the exception of concerns related to the manganese intake, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel considers that the risk that the consumption of the NF may trigger allergic reactions in humans is low. The Panel concludes that the NF, in consideration of its proposed uses and the concentration of manganese as compared to the normally present concentration of manganese in other leafy vegetables, may be of safety concern, therefore, the safety of the NF cannot currently be established., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Objective: While maternal fish consumption in pregnancy has consistently been linked to better cognitive and emotional outcomes in children, fish is also a primary source of exposure to methyl mercury (MeHg), which has been linked to poorer child cognitive outcomes. The aim of this study was to evaluate the associations between MeHg exposure, using calculated MeHg exposure from maternal diet and total mercury (Hg) concentration in maternal blood during pregnancy, and child internalising and externalising behaviours at 3 and 5 years of age., Design and Participants: The study sample comprised 51 238 mother-child pairs in the Norwegian Mother, Father and Child Cohort Study. Data on maternal blood Hg concentration in gestational week 18 were available for a sub-sample of 2936 women. Maternal MeHg exposure from diet was calculated from a validated Food Frequency Questionnaire answered in mid-pregnancy. Mothers reported children's emotional behaviour at age 3 and 5 years by questionnaires including twenty items from the Child Behaviour Checklist. Longitudinal associations were examined using generalised estimating equations, adjusted for potential confounders and stratified by maternal fish intake., Results: Maternal blood Hg concentration (median=1.02 µg/L, 90th percentile=2.22, range=0-13.8) was not associated with emotional behaviour in children. Increasing dietary MeHg intake (median 0.15 µg/kg body weight/week, 90th percentiles=0.31, range=0-1.86) was significantly associated with lower internalising β=-0.03 (95% CI -0.05 to -0.00) and externalising child behaviours β=-0.04 (95% CI -0.07 to -0.02) in adjusted models. The inverse associations were also apparent when stratifying by low/high maternal fish intake (<400 and ≥400 g/week)., Conclusions: The results indicated that prenatal MeHg exposure, well below the weekly tolerable intake established by European Food Safety Authority (1.3 µg/kg bw), did not adversely affect child emotional regulation. Children of mothers consuming fish regularly were less likely to show signs of emotional behavioural problems., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 aqueous extract of Labisia pumila as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a standardised hydroalcoholic extract from a dried whole plant (including roots) of L. pumila , mixed with maltodextrin (as a drying aid), and proposed by the applicant to be used as a food supplement in amounts up to 750 mg/day. The target population is the general adult population, except pregnant and lactating women. The major constituents of this NF are carbohydrates (up to 85.5%), with a smaller amount of proteins (up to 6.5%), gallic acid (up to 3.7%) and fats (up to 1.6%). 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. The provided genotoxicity studies do not raise concerns about the genotoxicity of the NF. Based on the available toxicological data, the Panel considers an intake of up to 5 mg/kg body weight per day as safe. For the target population, this level corresponds to 350 mg/day, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population up to 350 mg/day., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 cellobiose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of two glucose monomers linked by a β-(1-4) glucosidic bond. The applicant intends to add the NF to a variety of foods, and to food supplements aimed at the general population 3 years and older. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. The applicant provided a subchronic toxicological study which did not raise safety concerns. The applicant provided a human dose-escalation study from which the Panel concludes that the consumption of 20 g per day of cellobiose (equivalent to 290 mg/kg body weight (bw) per day in a 70-kg adult) does not raise concern regarding gastrointestinal tolerability. The maximum anticipated daily intake of cellobiose from the proposed uses is below 290 mg/kg bw per day in the target population. Considering the nature, source, compositional characterisation, and production process of the NF, as well as the toxicological data provided, the Panel considers that the NF does not raise safety concerns under the proposed conditions of use., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 β-hydroxybutyrate (BHB) salts as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of sodium, magnesium and calcium BHB salts, and is proposed to be used by adults as a food ingredient in a number of food categories and as food supplement. The data provided by the applicant about the identity, the production process and the compositional data of the NF over the course of the risk assessment period were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the test item used in the subchronic toxicity study and human studies 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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 iron milk proteinate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of iron from this source in the context of Directive 2002/46/EC. The NF is a complex of iron, casein and phosphate, which is produced from iron salts (i.e. ferric chloride or ferric sulfate), sodium caseinate and potassium orthophosphate. The NF is proposed by the applicant to be used as a source of iron, of which the NF contains 2-4%. The applicant intends to market the NF as an ingredient in a number of food categories; in food supplements, in total diet replacement for weight control and in foods for special medical purposes. 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. The studies provided for ADME and bioavailability indicate that iron from the NF is bioavailable. Overall, the evidence indicates that upon ingestion the NF undergoes digestion into small peptides to yield iron-bound caseinophosphopeptides that are normal constituents of the human diet, and that the iron from the NF does not bypass the homeostatic control of iron as a nutrient. The Panel concludes that the NF, iron milk proteinate, is safe under the proposed conditions of use. The Panel also concludes that the NF is a source from which iron is bioavailable., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 conversion of calcium-l-methylfolate and ( 6S )-5-methyltetrahydrofolic acid glucosamine salt (collectively called 5-MTHF hereafter) into dietary folate equivalents (DFE). Following a systematic review, the conclusions of the opinion are based on one intervention study in adults for intakes < 400 μg/day and three intervention studies in adults for intakes ≥ 400 μg/day. At intakes below 400 μg/day, folic acid (FA) is assumed to be linearly related to responses of biomarkers of intake and status and is an appropriate comparator for deriving a DFE conversion factor for 5-MTHF. It is proposed to use the same factor as for folic acid for conversion of 5-MTHF into DFE for intakes < 400 μg/day. As such intake levels are unlikely to be exceeded through fortified food consumption, the conversion factor of 1.7 relative to natural food folate (NF) could be applied to 5-MTHF added to foods and to food supplements providing < 400 μg/day. At 400 μg/day, 5-MTHF was found to be more bioavailable than folic acid and a conversion factor of 2 is proposed for this intake level and for higher intakes. The derived DFE equations are DFE = NF + 1.7 × FA + 1.7 × 5-MTHF for fortified foods and food supplements providing intakes < 400 μg/day; and DFE = NF + 1.7 × FA + 2.0 × 5-MTHF for food supplements providing intakes ≥ 400 μg/day. Although this assessment applies to calcium-L-methylfolate and 5-MTHF glucosamine salt, it is considered that the influence of the cation on bioavailability is likely to be within the margin of error of the proposed DFE equations. Therefore, the proposed equations can also be applied to 5-MTHF associated with other cations., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 for Yarrowia lipolytica yeast biomass 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 single meal replacement products for weight reduction for adults at a maximum amount of 6 g NF per day, which is the same amount of NF as already authorised in food supplements for this population group. According to the applicant, food supplements with Yarrowia lipolytica biomass (as already authorised) should not be consumed concomitantly with the meal replacement products in order not to exceed the 6 g NF per day. The Panel considers that the consumption of the NF is not nutritionally disadvantageous under the proposed conditions of use. The Panel concludes that the NF, Yarrowia lipolytica yeast biomass, is safe under the proposed conditions of use., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 frozen and dried formulations from whole lesser mealworm ( Alphitobius diaperinus larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term lesser mealworm refers to the larval form of the insect species Alphitobius diaperinus . The NF comprises the frozen and freeze-dried formulations of the lesser mealworm as whole or in the form of a paste or powder. Apart from water in the frozen formulations (whole, paste), the main components of the NF are crude protein and fat, besides smaller amounts of digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the concentration of such substances in the insect feed. The Panel notes furthermore that 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 formulations added as an ingredient to various food products such as cereal bars, pasta, meat imitates and bakery products. The target population is the general population. Additionally, the applicant proposed to use the NF as a food supplement in adults. The Panel notes that, considering that the NF will not be the sole source of dietary protein, and the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted subchronic 90-day toxicity study with the NF as testing material did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to lesser mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. Allergenicity aside, the Panel concludes that the NF is safe under the proposed uses and use levels., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 Zn 2+ 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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 D 2 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 D 2 (ergosterol) to vitamin D 2 (ergocalciferol). The NF contains levels of vitamin D in the form of vitamin D 2 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 D 2 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 D 2 /day and of 15 µg vitamin D 2 /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 D 2 /day and 5 µg vitamin D 2 /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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Objectives: The aim of this study was to identify dietary patterns in a Czech pregnancy cohort established in the early postcommunist era and investigate associations between dietary patterns, maternal characteristics and birth outcomes., Methods: Pregnant women were recruited for the Czech part of the European Longitudinal Study of Pregnancy and Childhood. A self-reported questionnaire answered in late pregnancy was used to assess information about the weekly intake of 43 food items. Information about birth outcomes (birth weight, height, ponderal index, head circumference, cephalisation index, gestational length and Apgar score) was obtained from the National Registry of Newborns. Complete details on diet and birth outcomes were available for 4320 mother-infant pairs., Results and Conclusion: The food items were aggregated into 28 variables and used for extraction of two dietary patterns by principal component factor analysis. The patterns were denoted 'unhealthy' and 'healthy/traditional' based on the food items with the highest factor loadings on each pattern. The 'unhealthy' pattern had high positive loadings on meat, processed food and confectionaries. In contrast, the 'healthy/traditional' pattern had high positive loadings on vegetables, dairy, fruits and wholemeal bread. Following adjustment for covariates, we found that high adherence to the unhealthy pattern (expressed as beta for 1 unit increase in pattern score), that is, the higher consumption of less healthy foods, was associated with lower birth weight: -23.8 g (95% CI -44.4 to -3.2) and length: -0.10 cm (95% CI -0.19 to -0.01) and increased cephalisation index: 0.91 μm/g (95% CI 0.23 to 1.60). The 'healthy/traditional' pattern was not associated with any birth outcomes. This study supports the recommendation to eat a healthy and balanced diet during pregnancy., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 bovine milk osteopontin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow-on formula (FoF) and ready-to-eat dairy-based meals for children up to 35 months of age. As compared to the concentrations naturally present in cow's milk and concentrations found in IF on the market reported in the literature, the proposed use level of the NF represents an about 10-fold higher concentration of bmOPN. The intended use levels of the NF would provide bmOPN at a concentration within the range of human milk (hm) OPN. In a 6-month study, 14, 72 and 140 mg bmOPN/L in reconstituted (as consumed) IF were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inconsistencies and limitations were noted in the study report, the Panel considers that the results obtained from this study do not raise safety concerns. Considering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure (i.e. 36) between the NOAEL of the subchronic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel concludes that the NF is safe under the proposed conditions of use., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver scientific advice related to nutrient profiling for the development of harmonised mandatory front-of-pack nutrition labelling and the setting of nutrient profiles for restricting nutrition and health claims on foods. This Opinion is based on systematic reviews and meta-analyses of human studies on nutritionally adequate diets, data from the Global Burden of Disease framework, clinical practice guidelines, previous EFSA opinions and the priorities set by EU Member States in the context of their Food-Based Dietary Guidelines and associated nutrient/food intake recommendations. Relevant publications were retrieved through comprehensive searches in PubMed. The nutrients included in the assessment are those likely to be consumed in excess or in inadequate amounts in a majority of European countries. Food groups with important roles in European diets have been considered. The Panel concludes that dietary intakes of saturated fatty acids (SFA), sodium and added/free sugars are above, and intakes of dietary fibre and potassium below, current dietary recommendations in a majority of European populations. As excess intakes of SFAs, sodium and added/free sugars and inadequate intakes of dietary fibre and potassium are associated with adverse health effects, they could be included in nutrient profiling models. Energy could be included because a reduction in energy intake is of public health importance for European populations. In food group/category-based nutrient profiling models, total fat could replace energy in most food groups owing to its high-energy density, while the energy density of food groups with low or no fat content may be well accounted for by the inclusion of (added/free) sugars. Some nutrients may be included in nutrient profiling models for reasons other than their public health importance, e.g. as a proxy for other nutrients of public health importance, or to allow for a better discrimination of foods within the same food category., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from five European Nordic countries, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was tasked to provide scientific advice on a tolerable upper intake level (UL) or a safe level of intake for dietary (total/added/free) sugars based on available data on chronic metabolic diseases, pregnancy-related endpoints and dental caries. Specific sugar types (fructose) and sources of sugars were also addressed. The intake of dietary sugars is a well-established hazard in relation to dental caries in humans. Based on a systematic review of the literature, prospective cohort studies do not support a positive relationship between the intake of dietary sugars, in isocaloric exchange with other macronutrients, and any of the chronic metabolic diseases or pregnancy-related endpoints assessed. Based on randomised control trials on surrogate disease endpoints, there is evidence for a positive and causal relationship between the intake of added/free sugars and risk of some chronic metabolic diseases: The level of certainty is moderate for obesity and dyslipidaemia (> 50-75% probability), low for non-alcoholic fatty liver disease and type 2 diabetes (> 15-50% probability) and very low for hypertension (0-15% probability). Health effects of added vs. free sugars could not be compared. A level of sugars intake at which the risk of dental caries/chronic metabolic diseases is not increased could not be identified over the range of observed intakes, and thus, a UL or a safe level of intake could not be set. Based on available data and related uncertainties, the intake of added and free sugars should be as low as possible in the context of a nutritionally adequate diet. Decreasing the intake of added and free sugars would decrease the intake of total sugars to a similar extent. This opinion can assist EU Member States in setting national goals/recommendations., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Vitamins and essential minerals are micronutrients that are essential for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. The concept of a tolerable upper intake level (UL) is a science-based reference value, which was introduced to support policy-makers and other relevant actors in managing the risks of excess nutrient intake. EFSA's principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. Since then, experience has been gained and the scientific field developed. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework to support EFSA's UL assessments. It covers aspects related to the planning of the risk assessment (problem formulation and definition of methods) and its implementation (evidence retrieval, appraisal, synthesis, integration, uncertainty analysis). As in the previous framework, the general principles developed for the risk assessment of chemicals in food are applied (hazard identification, hazard characterisation, intake assessment, risk characterisation). Peculiar to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homoeostasis and body burden of the nutrient. These must be considered when conducting a risk assessment of nutrients. This document constitutes a draft guidance that will be applied in EFSA's assessments during a 1-year pilot phase and be revised and complemented as necessary. Before finalisation of the guidance, a public consultation will be launched., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 Eurycoma longifolia (Tongkat Ali) root extract as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is standardised water extract prepared from the dried ground root chips of Tongkat Ali ( Eurycoma longifolia Jack) and proposed by the applicant to be used as food supplement in amounts up to 200 mg/day. The target population is the adult population, except pregnant and lactating women. The characteristic components of the NF are glycosaponins (40-65%) and eurycomanone (0.8-1.5%). It can also contain canthin-6-one alkaloids and isoscopoletin (coumarin). The NF has been present in various international markets since 2009. The Panel notes positive results from the submitted in vitro chromosome aberration test, which indicates clastogenic properties of the NF. In the requested follow-up in vivo mammalian alkaline comet assay, the NF induced positive results at the highest dose tested (2,000 mg/kg body weight (bw)) at the tissues of the first site of contact (stomach and duodenum). Histopathological evaluation of the tested tissues indicated that the positive results of the comet assay were rather due to genotoxicity than cytotoxicity. Taken together, the Panel concludes that the NF has the potential to induce DNA damage, which is of concern, particularly locally for tissues that represent first sites of contact. The Panel concludes that the safety of NF has not been established under any condition of use., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 Wolffia globosa powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Wolffia globosa is an aquatic plant, one out of the 38 species of the water lentil family which is composed by five genera (i.e. Spirodela , Landoltia , Lemna , Wolffiella and Wolffia ). The NF is produced by cultivation of Wolffia globosa plants under controlled conditions, washing with hot water and drying. The main constituents of the NF are protein, fibre and fat. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is intended to be used as food ingredient in a variety of food categories and as food supplement. The target population is the general population except for food supplements which are intended to be consumed exclusively by adults. The Panel considers that with the exception of concerns related to the manganese intake, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The subchronic toxicity study provided with the NF revealed a number of significant findings and the Panel considers the middle dose (6.5 g/kg body weight (bw) per day) as the no observed adverse effect level (NOAEL). Based on the protein concentration, the Panel considers that the consumption of the NF may trigger allergic reactions. The Panel concluded that an increase in manganese intake from the NF used as food ingredient or food supplements is of safety concern and the safety of the NF cannot be established., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 iron hydroxide adipate tartrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC. The NF is intended to be used in food supplements up to a maximum dose of 100 mg per day, corresponding to a maximum daily intake of iron of 36 mg. The target population proposed by the applicant is the general population above 3 years of age. The NF which is the subject of the application is an engineered nanomaterial having primary particles, of almost spherical morphology, with a diameter typically smaller than 5 nm. The studies provided for absorption, distribution, metabolism and excretion (ADME) and bioavailability indicate that iron, once taken up into the epithelial cells of the gut, is subject to the same mechanisms of regulation and absorption as that of other forms of iron. Further studies provided in the context of the toxicological assessment indicate that the NF does not lead to iron bioaccumulation in tissues and organs at the doses tested. The Panel notes that the NF contains nickel at concentrations that may increase the risk of flare-up reactions in nickel-sensitised young individuals up to 10 years of age. In the 90-day toxicity study, findings related to haematology, clinical biochemistry and organ weights were observed and the Panel defined a no observed adverse effect level (NOAEL) of 231 mg/kg body weight (bw) per day, that is, the mid-dose used in the study. The Panel considers that the NF is a source from which iron is bioavailable and it is safe under the proposed conditions of use., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The Fusarium mycotoxin deoxynivalenol (DON) and its modified forms are present in most samples of grain and grain-based products. Due to the widespread presence of DON in these highly consumed food commodities, nearly all individuals are exposed to DON. Previous estimates of the dietary DON intake in Norway indicated that children's dietary intake is close to or exceed the TDI of 1 µg/kg bw/day for the sum of DON and three modified forms. One aim of the current study was to determine whether the concentrations of DON in morning urine differ between population groups like men, women, children, vegetarians, and pregnant women. An additional aim was to compare a set of models for estimating the dietary intake of DON based on urinary DON concentrations and also compare these models with DON-intakes estimated using food consumption data. DON and metabolites were detected in the morning urine from 256 out of 257 individuals and with concentrations in similar range as reported from other countries. Children have higher urinary DON-concentration than adults and elderly. The urinary DON-concentration in pregnant women and vegetarians did not differ from other adults. The estimated intake of DON was higher for children than for other age groups on a body weight basis. The correlations between different models for estimating DON-intake based on urinary concentration as well as based on individual food consumption were good (0.79-0.99), but with some outliers. We conclude that Norwegians are exposed to DON in the same range as reported from other countries and that children have a higher exposure than adults. Furthermore, we conclude that intake estimates based on urinary DON concentration is a useful tool for evaluation of the exposure at population level, but due to outliers, the estimates for individuals are uncertain. There are also uncertainties in intake estimates both from food consumption and from urinary DON concentration, and we could not conclude on which approach provides the most accurate exposure estimate., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

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 water lentil powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Water lentils refer to aquatic plants belonging to the Araceae family and represented by five genera ( Lemna , Wolffia , Wolffiella , Landoltia and Spirodela ). The NF is thermally washed and dried water lentils, which are produced as a polyculture crop consisting of species from the Lemna genus (70-100%) and the Wolffia genus (0-30%). The main constituents of the NF are protein, fibre and fat. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is expected to be stable and to comply with the specifications during the suggested shelf life. The NF is intended for human consumption as a food ingredient in herbs, spices and seasonings, sauces, soups and broths, protein products, dietary food for weight control and as a food supplement. The target population is the general population, except for food supplements which are exclusively intended for consumption by adults. The Panel considers that based on the composition of the NF and the proposed intended uses, the NF is not nutritionally disadvantageous, except for the concerns regarding intake of manganese from the NF. No adverse effect was observed in the submitted 90-day subchronic study, at the highest dose, 1,000 mg/kg body weight (bw) per day of NF. The Panel considers that, based on the protein concentration, the consumption of the NF may trigger allergic reactions. The Panel concluded that an increase in manganese intake from the NF used as food ingredient or food supplements is of safety concern and the safety of the NF cannot be established., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 the novel food (NF) nicotinamide riboside chloride (NRC) pursuant to Regulation (EU) 2015/2283. The assessment addresses the use of NRC in 'meal replacement products' and 'nutritional drink mixes' at levels up to 300 mg/day for the general population, and in food for special medical purposes (FSMP) and total diet replacement for weight control (TDRWC) (as per Regulation (EU) No 609/2013) at levels up to 500 mg/day in adults. Benchmark dose modelling was carried out on data from the 90-day oral toxicity studies in rats relevant to the safety assessment. Considering the lack of tolerable upper intake level (UL) for nicotinamide in infants and the narrow margin of exposure between the estimated intake in infants and the lower confidence bound of the benchmark doses (BMDL 05 ) estimated by the models, the Panel concludes that the safety of the NF has not been established for use in 'meal replacement products' and 'nutritional drink mixes' under the proposed conditions of use. For FSMP and TDRWC, the proposed maximum use level corresponds to an intake of 210 mg nicotinamide per day, which is below the current UL for nicotinamide of 900 mg/day for adults. The Panel considers that the NF is as safe as pure nicotinamide for use in FSMP and TDRWC. The Panel, however, notes experimental data which indicate several pathways by which intakes of nicotinamide (or its precursors), at levels that are substantially higher than the physiological requirement, might cause adverse effects. The Panel considers that further investigations are required and that a re-evaluation of the UL for nicotinamide may be warranted., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)