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Abstract 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 also contains D‐lactose and its monomers, L‐fucose and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coli K‐12. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow‐on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population, except for food supplements for which the target population is individuals above 1 year of age. The anticipated daily intake of 3‐FL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of breastfed 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. In infants below 1 year of age, a possible exceedance of a natural intake was observed, but the degree of this exceedance is not considered of safety concern in view of the wide range of 3‐FL concentrations in human milk. Food supplements are not intended to be used if other foods with the added NF (as well as human milk for young children) are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.

Abstract 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 fruits of Synsepalum dulcificum as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is pitted and dried (by lyophilisation) fruits of S. dulcificum. The NF contains the glycoprotein miraculin (≤ 2.5%) which causes sour and acidic foods to taste sweet. The fruits have a documented history of consumption in Africa and products thereof can be found in different markets worldwide. Information on the production process and the composition of the NF is sufficient and does not raise safety concerns. The applicant proposes to use the NF as or in food supplements for the adult population, excluding pregnant and lactating women, at a maximum daily amount of 0.9 g. Taking into account these conditions of use, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The provided genotoxicity studies do not raise concerns for genotoxicity of the NF. The Panel concludes that the only dose tested in a 90‐day oral toxicity study of 2,000 mg/kg body weight (bw) per day was not associated with adverse effects. By applying an uncertainty factor of 200, the Panel concludes that the NF is safe at an intake level of 10 mg/kg bw per day, corresponding to a maximum daily intake of 0.7 g of the NF for the target population, rather than 0.9 g/day as proposed by the applicant.

Abstract The European Commission asked EFSA to evaluate the efficacy of an infant formula, containing a specific protein hydrolysate derived from whey protein isolate and concentrate and manufactured by Société des Produits Nestlé S.A., in reducing the risk of developing atopic dermatitis in infants with a family history of allergy. This was following the submission of a dossier by Société des Produits Nestlé S.A. to the European Commission, in the context of Regulation (EU) 2016/127. The protein hydrolysate from which the infant formula is produced is included in Annex I and II of Commission delegated Regulation (EU) 2016/127 as suitable protein source for the manufacture of infant and follow‐on formulae. This opinion does not cover the assessment of the nutritional safety and suitability of the infant formula or the safety of the food enzymes used in the manufacture of the protein hydrolysate. The Panel considers that, in relation to the effect that is claimed, the infant formula under evaluation is not sufficiently characterised with respect to the molecular weight distribution of peptides. From the human intervention studies submitted, no conclusions could be drawn on the efficacy of the infant formula in reducing the risk of developing atopic dermatitis. The Panel concludes that a cause‐and‐effect relationship has not been established between the consumption of the infant formula under evaluation and the reduction in the risk of developing atopic dermatitis in infants with a family history of allergy.

Abstract In 2014, the EFSA NDA Panel concluded that UV‐treated baker's yeast containing up to 3.5 Mio IU of vitamin D/100 g, is safe under the proposed conditions of use for yeast‐leavened breads, rolls and fine bakery wares, and food supplements. 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 an application for an extension of the use of UV‐treated baker's yeast as a novel food (NF) pursuant to Regulation (EU) 2015/2283. In this extension of use, the applicant proposed a broad range of food categories to which the NF can be added. On the basis of the proposed uses and maximum use levels, the Panel estimated the potential exposure to vitamin D from the NF and the potential combined exposure to vitamin D including also exposure from the background diet and food supplements. The Panel notes that the upper level (UL) for one age group, i.e. children aged 4–10 years, is exceeded by 4%, when summing up the highest P95 estimate for the background diet (including food supplements) and the highest P95 estimate for vitamin D from the NF under the proposed uses and maximum use levels. The Panel notes, however, the highly conservative approach for estimating the potential intake of vitamin D from the NF, given that the applicant has proposed 34 FoodEx2 level 2 food categories. Thus, the Panel considers that the UL for children aged between 4 and 10 years is highly unlikely to be exceeded. The Panel concludes that the NF is safe under the proposed conditions of use.

Abstract Following an application from Nestlé S.A. submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta‐glucans from oats and/or barley in a ready‐to‐eat cereal manufactured via pressure cooking and reduction of blood glucose rise after consumption. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed is ‘beta‐glucans from oats and/or barley incorporated into ready‐to‐eat breakfast cereals manufactured via pressure cooking’. The applicant proposed that at least 1.3 g of beta‐glucans/25 g of available carbohydrates in ready‐to‐eat breakfast cereals manufactured via pressure cooking should be consumed. Beta‐glucans from oats, barley or any combination thereof incorporated into ready‐to‐eat cereals manufactured by pressure cooking, are sufficiently characterised. The claimed effect proposed is ‘reduction of the blood glucose rise after the meal’. The reduction of post‐prandial glycaemic responses (as long as post‐prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect. One human intervention study showed an effect of beta‐glucans from oats and/or barley, incorporated into breakfast cereals manufactured via pressure cooking at a level of at least 1.2 g/25 g available carbohydrates, on decreasing post‐prandial glycaemic responses without disproportionally increasing insulinaemic responses. Dose–response relationships were not tested, and no evidence has been provided that beta‐glucans incorporated into cereals processed using pressure cooking would exert a higher effect on post‐prandial glucose responses than beta‐glucans added to other carbohydrate containing foods. Whereas the effect of beta‐glucans in reducing post‐prandial blood glucose responses is well established, the evidence provided is insufficient to establish such an effect at doses of 1.3 g beta‐glucans per 25 g of available carbohydrate incorporated into ready‐to‐eat breakfast cereals manufactured via pressure cooking (i.e. either batch cooking or extrusion).

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on vitamin D2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ingredient produced from Agaricus bisporus mushroom powder that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains concentrations of vitamin D provided by vitamin D2 in the ranges of 580–595 μg/g. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods and beverages, including food for special medical purposes and food supplements. The target population is the general population except for food supplements and Foods for Special Medical Purposes (FSMPs), for which the target population is individuals above 1 year of age. The Panel concludes that the NF, used as an ingredient, is safe for the general population at the proposed condition of use in foods and beverages and that the NF used as a food supplement, is safe for individuals above 1 year.

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to revise the Opinion on the essential composition of total diet replacements for weight control (TDRs) regarding the minimum content of linoleic acid (LA) and alpha‐linolenic acid (ALA) and the maximum content of magnesium (Mg). Through a comprehensive literature search, human studies were retrieved reporting on LA and ALA concentrations in adipose tissue (AT), on weight loss and gallstone formation following TDR consumption and on diarrhoea after supplemental Mg intake. The distribution of the amount of LA and ALA release from AT during weight loss when consuming TDRs was estimated using statistical simulations. Using the fifth percentile, the coverage of the adequate intake (AI) for both FA was estimated. For the risk of developing diarrhoea when consuming TDRs with an Mg content of 350 mg/day, four cross‐over studies using 360–368 mg Mg/day were reviewed. The Panel concludes that (1) there is no need to add LA to TDRs, as the amount released from AT during weight loss when consuming TDRs is sufficient to cover the AI for LA; (2) a minimum of 0.8 g/day ALA is needed in TDRs in order to meet the AI for ALA; (3) the minimum fat content of TDRs of 20 g/day as derived in the Panel's previous opinion is proposed to be maintained until the availability of further evidence, given the considerable uncertainty as to the amount of fat required for reducing the risk of gallstone formation; and (4) the likelihood that Mg‐induced diarrhoea occurs at a severity that may be considered of concern for overweight and obese individuals consuming TDRs is low when the total maximum Mg content in TDRs is 350 mg/day.

Background: Evidence points to adverse effects of trans fatty acids (TFA) on health. The aim of this study was to estimate total TFA intake, evaluate major food contributors and its effect on dyslipidemia. Methods: A total of 3537 adults (48.3% males) were included. Total TFA intake was assessed using two 24-hour dietary recalls. Foods were categorized into specific food groups. Adjusted Logistic Regression analysis was performed to assess the likelihood of dyslipidemia by tertile of TFA aand Saturated Fatty Acid (SFA) level. Results: Median TFA intake was 0.53% of energy (from 0.34 to 0.81) ranging from 0.27 (Q1) to 0.95 (Q3) (p < 0.001, for trend), and 16% of individuals consumed TFA above 1% of their total energy. Cheese was the main contributor to TFA intake, with processed/refined grains and fried fish following. The latter was the main contributor in older adults (51+ years). Adjusted logistic regression analysis showed that individuals at the highest tertile of trans consumption were 30% more likely to have dyslipidemia compared to the lowest (OR(Q⁢3-Q⁢1): 1.3; 95% CI: 1.02–1.66 and OR(Q⁢2-Q⁢1): 1.3; 95% CI:1.01–1.66, respectively). This increased by 10% when stratified by SFA intake (OR: 1.4; 95% CI: 1.061–1.942) and remained significant only in individuals at the highest tertile and with higher than recommended SFA intake. Conclusions: A high intake of TFA combined with high SFA intakes further increase the likelihood of dyslipidemia and should be accounted for in public health prevention programs. Monitoring and evaluation of the recent EU legislative measures on TFA levels in foods is also necessary.

Abstract Endorsement date 21 January 2021 Implementation date 27 March 2021 Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well‐structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use. This guidance was originally adopted in 2016.It has beenrevised to informapplicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.

Abstract Endorsement date 21 January 2021 Implementation date 27 March 2021 Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well‐structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.It is applicable to allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.

Abstract Endorsement date 21 January 2021 Implementation date 27 March 2021 Following a request from the European Commission, EFSA was asked to provide scientific and technical guidance for the preparation and presentation of a dossierfor evaluation of an infant and/or follow‐on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow‐on formulae manufactured from protein hydrolysates with respect to the nutritional safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specificdossiers, and in the light of applicable Unionguidelines and legislation. The guidance was adopted by the Panel on Dietetic Products, Nutrition and Allergies on 5 April 2017.Upon request from the European Commission in 2020, it has been revised to inform food business operators of the new provisions in the pre‐submission phase and in the procedure set out in the General Food Law, as amended by the Transparency Regulation. This revised guidance applies to all dossiers submitted as of 27 March 2021 and shall be consulted for the preparation of dossiers intended to be submitted from that date onwards. For dossiers submitted prior to 27 March 2021, the previous guidance, published in May 2017 remains applicable.

Abstract 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. Schizochytrium sp. is a single‐cell microalga. The strain FCC‐3204, used by the applicant (Fermentalg), belongs to the species Schizochytrium limacinum. The NF, an oil rich in docosahexaenoic acid (DHA), is obtained from microalgae after enzymatic lysis. The applicant proposed to increase the use level of the NF as a food supplement, from 250 mg DHA/day (currently authorised for the general population, excluding pregnant and lactating women) to 3 g DHA/day for adults, excluding pregnant and lactating women. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel considers that the data provided by the applicant are not sufficient to conclude on the safety of the NF at the proposed uses (3 g DHA/day as a food supplement) in adults. However, in 2012, the Panel concluded that supplemental intakes of DHA alone up to about 1 g/day do not raise safety concerns for the general population. The Panel concludes that the NF is safe for the use in food supplements at the maximum intake level of 1 g DHA/day for the target population (adults, excluding pregnant and lactating women).

Abstract 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 change in the conditions of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of GOS, consisting of different galactosyl residues (two to nine) linked to a terminal glucose by a β‐glycosidic bond but also contains lactose and its monomers (galactose and glucose). The NF is a syrup containing ≥ 55% GOS (w/w dry matter) and is produced enzymatically by two β‐galactosidases. GOS produced by β‐galactosidases according to the same production process is already authorised and included in the EU Union list of novel foods. This application is limited to an assessment of the proposed increase of the use level as food supplement. The proposed change in the conditions of use increases the maximum level in food supplements from 0.333 kg GOS/kg food supplement (33.3%) to 0.450 kg GOS/kg food supplement (45.0%). Since it is recommended that individuals consume no more than 3 servings of 12 g/day, the maximum recommended daily intake would be no more than 16.2 g GOS. No new food uses or other increases to the already approved use levels are being proposed. The information provided on the proposed use levels and anticipated intake do not raise safety concerns. The Panel concludes that the proposed increase in the maximum level of galacto‐oligosaccharides as a NF in food supplements is safe under the proposed changes in conditions of use.

Abstract 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 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 Tenebrio molitor. The NF is the thermally dried yellow mealworm, either as whole dried insect or in the form of powder. The main components of the NF are protein, fat and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the occurrence levels of these substances in the insect feed. The Panel 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 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 as whole, dried insect in the form of snacks, and as a 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 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 allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels.

Abstract 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. Schizochytrium sp. is a single‐cell microalga. The strain FCC‐ 3204, used by the applicant (Fermentalg), belongs to the species Schizochytrium limacinum. The NF, an oil rich in docosahexaenoic acid (DHA), is obtained from microalgae after enzymatic lysis. The applicant proposed to use the NF in infant formulae (IF) and follow‐on formulae (FOF). The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.

Abstract 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 extract of Cistanche tubulosa stems as a novel food (NF) for its use in food supplements (FS) and foods for special medical purposes (FSMP). The target population is the general adult population excluding pregnant and lactating women. The applicant proposes a maximum daily intake of 2 g for FS and a maximum use level of 10% in FSMP. The characteristic components of the extract are phenylethanoid glycosides (at least 70% of the NF), in particular, echinacoside (25–45% of the NF). The NF has been authorised as a prescription drug in China in 2005 for the treatment of vascular dementia. The Panel notes that an integrated analysis of three studies covering 1,076 patients with vascular dementia treated with the proposed NF at a daily dose of 1,800 mg, reported that 12 adverse events (AEs) were classified to be ‘definitely’, ‘probably’ or ‘possibly related’ to the exposure to the NF. Two of these AE were classified as severe (cerebral haemorrhage and epilepsy). The Panel considers that the reported AEs raise safety concerns. The Panel also notes the limitations of the provided toxicological studies, in particular the non‐compliance with the EFSA approach on the genotoxicity testing strategy and the non‐compliance with good laboratory practice (GLP) and the respective OECD Guidance documents of the repeated dose toxicity studies. In view of the AEs in the human studies, the Panel considers that additional toxicological studies, following testing guidelines would not be able to overcome the concerns raised from the human studies. The Panel concludes that the safety of the NF has not been established.

Recent advances in the field of nutrigenetics have provided evidence on how genetic variations can impact the individuals' response to dietary intakes. An objective and reliable assessment of dietary exposures should rely on combinations of methodologies including frequency questionnaires, short-term recalls or records, together with biological samples to evaluate markers of intake or status and to identify genetic susceptibilities. In an attempt to present current knowledge on how genetic fingerprints contribute to an individual's nutritional status, we present a review of current literature describing associations between genetic variants and levels of well-established biomarkers of vitamin status in free-living and generally healthy individuals. Based on the outcomes of candidate gene, genome-wide-association studies and meta-analyses thereof, we have identified several single nucleotide polymorphisms (SNPs) involved in the vitamins' metabolic pathways. Polymorphisms in genes encoding proteins involved in vitamin metabolism and transport are reported to have an impact on vitamin D status; while genetic variants of vitamin D receptor were most frequently associated with health outcomes. Genetic variations that can influence vitamin E status include SNPs involved in its uptake and transport, such as in SCAR-B1 gene, and in lipoprotein metabolism. Variants of the genes encoding the sodium-dependent vitamin C transport proteins are greatly associated with the body's status on vitamin C. Regarding the vitamins of the B-complex, special reference is made to the widely studied variant in the MTHFR gene. Methodological attributes of genetic studies that may limit the comparability and interpretability of the findings are also discussed. Our understanding of how genes affect our responses to nutritional triggers will enhance our capacity to evaluate dietary exposure and design personalized nutrition programs to sustain health and prevent disease.

Abstract 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 change in the production process and specifications of lacto‐N‐neotetraose (LNnT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) LNnT but also contains lactose, lacto‐N‐triose II (LNT II), para‐lacto‐N‐neo‐hexaose (para‐LNnH) and other related carbohydrates. The NF is produced by fermentation with two genetically modified strains of Escherichia coliBL21. LNnT when chemically synthesised or produced by microbial fermentation using another E. coli strain (K‐12) is already authorised and included in the EU list of NFs. This application is limited to a change in the manufacturing process and specifications while target population, uses and use levels and consequently the anticipated intake do not change. The information provided on the manufacturing process, including the absence of DNA from the producing microorganisms, composition, identity and specifications of the NF do not raise safety concerns. Particularly, the proposed changes in the specifications are limited to a slightly higher ash content and limits for the presence of yeast and moulds, while specifications for methanol and LNnT fructose isomer have been removed. Food supplements are not intended to be used if other foods with the added NF or breast milk for young children are consumed on the same day. The Panel concludes that lacto‐N‐neotetraose (LNnT) as a NF when produced by fermentation with two genetically modified strains of E. coliBL21 is safe under the proposed conditions of use.

Abstract The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in an infant and follow‐on formula by Danone Trading ELN B.V, which submitted a dossier to the European Commission to request an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in the manufacture of infant and/or follow‐on formula. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.3 g/100 kcal and consumed as the sole source of nutrition by infants for 3.5 months led to growth equivalent to a formula manufactured from intact cow's milk protein (2 g protein/100 kcal). No experimental data have been provided on the nutritional safety and suitability of this protein source in follow‐on formula. However, given that it is consumed with complementary foods and the protein source is considered nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow‐on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow‐on formula, as long as the formula in which it is used contains a minimum of 2.3 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.

Abstract 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. Schizochytrium sp. is a single‐cell microalga. The strain WZU477, used by the applicant (Progress Biotech bv), was found to belong to the species Schizochytrium limacinum and was obtained in a marine environment from rotted mangrove forest leaves. The NF, an oil rich in docosahexaenoic acid (DHA), is isolated from the microalgae by mechanical extraction. The applicant proposed to use the NF in infant formulae (IF) and follow‐on formulae (FOF). The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns. The composition of the NF indicates the absence of marine biotoxins in the NF. Furthermore, Schizochytrium limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Based on the information provided, the microalga is not expected to survive the manufacturing process. Toxicological tests conducted with the NF were not performed. However, based on the available toxicological data on various forms of oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process and the composition of the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.

Abstract Following an application from Anxiofit Ltd., submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Hungary, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Anxiofit‐1 and reduction of subthreshold and mild anxiety. The food, Anxiofit‐1, Echinacea angustifolia root extract, standardised for the content of echinacoside (at least 3%) and the profile of alkamides, which is the subject of the health claim, is sufficiently characterised. The Panel considers that reduction of subthreshold and mild anxiety is a beneficial physiological effect. Subthreshold and mild anxiety are risk factors for anxiety and depressive disorders. One human intervention study showed an effect of Anxiofit‐1 (80 mg/day given for 7 days) on the state anxiety and not on the trait subscale in subjects with subthreshold or mild anxiety. These results are supported by two human intervention studies conducted with Anxiofit‐1 at 40 mg/day for 7 days and 6 weeks, respectively, which, on their own, cannot be used for the substantiation of the claim either because of methodological limitations or because the results cannot be extrapolated to the target population for the claim. All the human intervention studies submitted have been conducted in a similar setting, the results of the study with Anxiofit‐1 given at 80 mg/day have not been confirmed by other research groups. The information submitted by the applicant does not provide evidence for a plausible mechanism by which Anxiofit‐1 could exert the claimed effect. The Panel concludes that the scientific evidence is insufficient to establish a cause and effect relationship between the consumption of Anxiofit‐1 and reduction of subthreshold and mild anxiety.

Abstract 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 chia seeds in foods subject to thermal processing which may result in the formation of process contaminants. The safety assessment of this novel food (NF) is based on previous assessments of chia seeds by the EFSA NDA Panel, information received from a public call for data by EFSA and information retrieved from an extensive literature search performed by EFSA. In 2019, during the overall safety assessment of chia seeds, the NDA panel retrieved one reference which, among others, investigated the formation of process contaminants, i.e. acrylamide, hydroxymethylfurfural and furfural, in wheat flour‐based biscuits with added chia seeds flour. Based on this study, the Panel considers that there is a potential for substantial acrylamide formation in biscuits with 10–20% added chia seeds flour with low residual moisture contents (≤ 2%). The Panel is not aware of further scientific evidence corroborating these findings. The extensive new literature searches performed by EFSA did not show any relevant articles regarding either asparagine content or formation of process contaminants in chia seeds and products thereof. Information received from the call for data were either limited or inconclusive. The available evidence does not provide a basis to conclude whether or not the addition of chia seeds to foods undergoing heat treatment (at temperatures above 120°C) results in increased formation of acrylamide as compared to these foods without chia seeds. Reported concentrations of hydroxymethylfurfural and furfural in heat‐treated chia seeds do not pose a safety concern. No information on other process contaminants in chia seeds was found.

Background: Cadmium is a toxic heavy metal that has been implicated in breast cancer etiology, albeit with inconsistent results. Objective: To investigate the shape of the relation between cadmium exposure and breast cancer incidence and mortality in cohort studies. Data sources: Following a literature search through April 14, 2020, we carried out a systematic review and dose-response meta-analysis to investigate the shape of the relation between cadmium exposure (assessed either through diet or urine excretion) and disease incidence and mortality. Study eligibility criteria: For inclusion, a study had to report incidence or mortality for breast cancer according to baseline cadmium exposure category; be a prospective cohort, case-cohort or nested case-control study with a minimum one-year follow-up, and reporting effect estimates for all exposure categories. Study appraisal and synthesis methods: Studies were evaluated using the ROBINS-E risk of bias tool. The effects in humans were assessed quantitatively using one-stage dose-response meta-analysis in a random effects meta-analytical model. Results: We identified 10 studies eligible for inclusion in the dose-response meta-analysis, six based on cadmium dietary intake, and four on urinary excretion levels. We found a marginal and imprecise positive relation between dietary cadmium intake and breast cancer, and no association when urinary cadmium excretion was used for exposure assessment. Compared to no exposure, at 20 µg/day of cadmium intake the summary risk ratio was 1.12 (95% confidence interval 0.80–1.56), while at 2 µg/g creatinine of cadmium excretion the summary risk ratio was 0.89 (95% confidence interval 0.38–2.14). Analysis restricted to post-menopausal women showed no association between either dietary or urinary cadmium and subsequent breast cancer incidence and mortality. Limitations and conclusions: Overall, we found scant evidence of a positive association between cadmium and breast cancer. Available data were too limited to carry out stratified analyses according to age, smoking and hormone receptor status. Therefore, possible associations between cadmium exposure and breast cancer in selected subgroups cannot be entirely ruled out.

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of ‘Hovenia dulcis fruit extract’ as a novel food (NF) for its use in food supplements. The NF concerns a hot water extract of sliced and dried fruits and peduncles of Hovenia dulcis Thun. The production process is described in sufficient detail but contains contradictory information regarding the mixing with another ingredient of the NF. The NF is comprised of mostly carbohydrates (about 90%), about 2% proteins, 5% moisture, less than 1% fat and about 2% ash. In addition, the NF contains small amounts of flavonoids such as dihydromyricetin, myricetin and quercetin. The Panel notes limitations of the data provided from the batch testing regarding proximate analyses and plant secondary metabolites. Given these limitations, the Panel considers that the data provided by the applicant do not demonstrate that different batches produced with the described production process meet the proposed specifications. The target population is the general adult population excluding pregnant and lactating women and people with a chronic disease, such as liver malfunction. Limited information was provided on a history of consumption of Hovenia dulcis fruits and on an extract approved in South Korea. A number of toxicological studies were performed. However, the study reports did not allow to verify that the test item was representative of the NF. The same applied to a human study provided by the applicant. The Panel concludes that the safety of the NF has not been established.

Abstract Following an application from DuPont Nutrition Biosciences ApS submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Bifidobacterium animalis subsp. lactis Bi‐07 (Bi‐07) and contribution to increasing lactose digestion. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Bi‐07. The Panel considers that Bi‐07 is sufficiently characterised. The claimed effect proposed by the applicant is ‘improvement of lactose digestion’. The Panel considers that increasing lactose digestion is a beneficial physiological effect for individuals with lactose maldigestion provided that the symptoms of lactose maldigestion are improved. Two human intervention studies which investigated a single dose effect of Bi‐07 on lactose digestion using the hydrogen breath test, as well as on gastrointestinal symptoms were submitted. These studies show that consumption of Bi‐07 (1012 CFU) increases lactose digestion in individuals with lactose maldigestion and that Bi‐07 exhibits lactase activity in vitro. However, these studies provide no evidence that increasing lactose digestion through the consumption of Bi‐07 (1012 CFU) improves gastrointestinal symptoms of lactose maldigestion, which is considered a beneficial physiological effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium animalis subsp. lactis Bi‐07 and a beneficial physiological effect (i.e. the improvement of symptoms of lactose maldigestion) in individuals with lactose maldigestion.

Abstract 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 rapeseed powder from Brassica rapa L. and Brassica napus L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Rapeseed powder will be produced from the seeds of non‐genetically modified double low (00) cultivars that are varieties with a low content of erucic acid and reduced content of glucosinolates compared to older varieties. The applicant developed a production process designed to further reduce the content of glucosinolates and other undesirable compounds such as phytates. The NF will be used as a food ingredient added to a number of food products. The target population is the general population from 1 year of age. The maximum estimated intake of the NF is 18–21 g/day in adolescents, adults and elderly (corresponding to 0.35, 0.23 and 0.25 g/kg body weight (bw) per day, respectively). The levels of undesirable compounds in this NF, such as erucic acid, glucosinolates and phytates, are below levels which would raise concerns. The EFSA NDA Panel has previously assessed the safety of similar products for human consumption and there is extensive experience on the use of rapeseed in animal feed. The applicant provided a human study on the safety and tolerability of the NF and no safety concerns were identified. The Panel considers that the NF, i.e. rapeseed powder from Brassica rapa L. and Brassica napus L., is safe at the proposed conditions of use.

Abstract 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 ‘plant sterol esters’ when added to vegetable fat spreads and to liquid vegetable fat‐based emulsions for cooking and baking purposes pursuant to Regulation (EU) 2015/2283. Member States expressed concerns in relation to plant sterol oxidation products (POP) and consumption by non‐target population groups. The median (0.5%) and P90 (2.28%) value of the oxidation rates of plant sterols determined by a wide range of cooking experiments were used together with exposure estimates for plant sterol when added and cooked with vegetable fat spreads and liquids. The no‐observed adverse effect level (NOAEL) of a subchronic rat study and an applied default uncertainty factor of 200 served to derive levels (i.e. 0.64 mg POP/kg body weight (bw) per day) considered safe for humans. This safe level of exposure would be exceeded at the P95 by all age groups when considering the P90 oxidation rate and using EFSA's comprehensive food consumption database for assessing the potential exposure. When considering the median oxidation rate, the safe level of 0.64 mg POP/kg bw per day would be exceeded at the highest P95 intake estimates in children below 9 years of age. When considering an intake of the maximum authorised use level of 3 g plant sterols/person per day and oxidation rates of 0.5% and 2.28%, the resulting daily POP intakes per kg bw by an adult weighing 70 kg would be 0.21 and 0.98 mg/kg bw per day, respectively, the latter value exceeding 0.64 mg/kg bw per day. The Panel concludes that the safety of the intended extension of use of plant sterol esters under the proposed conditions of use has not been established.

Abstract 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 selenite triglycerides as a novel food (NF) pursuant to Regulation (EU) 2015/2283, their safety when added for nutritional purposes to food supplements as a source of selenium and the bioavailability of selenium from this source, in the context of Directive 2002/46/EC. The proposed NF is the first lipophilic organic form of selenium so far described in the literature. It is composed by a mixture of individual Se‐containing lipids which do not occur in nature. The Panel considers that the information provided on the composition of the NF does not allow a complete characterisation of the product. From the data provided to characterise the absorption, distribution, metabolism and excretion of the NF, it cannot be established in which chemical form Se is systemically available and if it can enter the functional Se body pool to fulfil Se physiological functions. The Panel considers that, since it is not demonstrated that the NF is converted to a known form of Se following ingestion and absorption, the NF is to be treated as a xenobiotic with unknown properties in the body. From a subchronic toxicity study in rats, the Panel derives a lowest observed adverse effect level (LOAEL) for general toxicity of 2 mg Se/kg body weight (bw) per day based on findings indicating liver as a target organ, as it has been shown for other studies on dietary Se. The Panel concludes that the NF is absorbed and provides Se, but in an unknown form of which the bioavailability has not been determined. The Panel also concludes that the safety of the NF under the intended conditions of use cannot be established.

Background Epidemiologic studies, including trials, suggest an association between potassium intake and blood pressure (BP). However, the strength and shape of this relationship is uncertain. Methods and Results We performed a meta‐analysis to explore the dose‐response relationship between potassium supplementation and BP in randomized‐controlled trials with a duration ≥4 weeks using the recently developed 1‐stage cubic spline regression model. This model allows use of trials with at least 2 exposure categories. We identified 32 eligible trials. Most were conducted in adults with hypertension using a crossover design and potassium supplementation doses that ranged from 30 to 140 mmol/d. We observed a U‐shaped relationship between 24‐hour active and control arm differences in potassium excretion and BP levels, with weakening of the BP reduction effect above differences of 30 mmol/d and a BP increase above differences ≈80 mmol/d. Achieved potassium excretion analysis also identified a U‐shaped relationship. The BP‐lowering effects of potassium supplementation were stronger in participants with hypertension and at higher levels of sodium intake. The BP increase with high potassium excretion was noted in participants with antihypertensive drug‐treated hypertension but not in their untreated counterparts. Conclusions We identified a nonlinear relationship between potassium intake and both systolic and diastolic BP, although estimates for BP effects of high potassium intakes should be interpreted with caution because of limited availability of trials. Our findings indicate an adequate intake of potassium is desirable to achieve a lower BP level but suggest excessive potassium supplementation should be avoided, particularly in specific subgroups.

Abstract 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 also containing D‐lactose, sialic acid and a small fraction of other related oligosaccharides resulting in a fully characterised mixture of carbohydrates. The NF is produced by fermentation with a genetically modified strain of Escherichia coli K‐12 DH1. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow‐on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3’‐SL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of naturally occurring 3’‐SL in breastfed 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 NF (as well as breast milk, milk, fermented milk‐based products and selected cheeses retaining milk sugar (e.g. curd cheese) for infants and young children) are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations.

Abstract 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 a botanical extract derived from both Panax notoginseng and Astragalus membranaceus (AstraGin™) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a combination of an ethanol extract of the roots of A. membranaceus and a hot water extract of the roots of P. notoginseng. The NF contains 1.5–5% total saponins, 0.1–0.5% ginsenoside Rb1 and 0.01–0.1% astragaloside I. Both plants that are used to produce the NF have a long history of use, especially in traditional Chinese medicine. Information on the production process and the composition of the NF is sufficient and does not raise safety concerns. The applicant proposed to use the NF as a food supplement for the general adult population, excluding pregnant women, at a maximum daily amount of 350 mg. Taking into account these conditions of use, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The provided genotoxicity studies do not raise concerns for genotoxicity of the NF. Based on the findings of a subchronic toxicity study, supported by a subacute toxicity study, the Panel identified the overall no observed adverse effect level (NOAEL) of the NF at 100 mg/kg body weight (bw) per day. By applying an uncertainty factor of 200, the Panel concludes that the NF is safe at an intake level of 0.5 mg/kg bw per day, corresponding to a maximum daily intake of 35 mg of the NF for the target population, i.e. adults excluding pregnant women.

Abstract 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 dried whole cell Euglena gracilis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. E. gracilis is a single‐cell microalga which occurs widely in nature and is commonly found in freshwater habitats. The NF, the dried biomass of E. gracilis, is produced by fermentation and its major constituent (> 50%) is a β‐glucan polysaccharide. The applicant proposed to use the NF in food supplements, in foods for total diet replacement for weight control and as a food ingredient added to a number of food products. The target population proposed by the applicant is the general population, except for food supplements and for foods for total diet replacement for which the target population is the general population from 12 months of age onwards. 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 study, up to the highest dose tested, i.e. 3,300 mg NF/kg body weight, considered as the no observed adverse effect level (NOAEL). The margins of exposure between this dose and the high (95th percentile) intake estimates, range from 33 for infants to 192 for adults. The Panel considers that in view of the QPS status of the source of the NF, supported by the compositional data and lack of toxicity observed in the 90‐day study, the margins of exposure are sufficient. The Panel considers that the NF, i.e. dried whole cell Euglena gracilis, is safe at the proposed uses and use levels.

Abstract 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 also contains D‐lactose, sialic acid and a small fraction of other related oligosaccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coli K‐12 DH1. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow‐on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 6′‐SL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of naturally occurring 6′‐SL in breastfed infants on a body weight basis. The intake of 6′‐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 6′‐SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with the added NF or breast milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.

Abstract 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 barley starch to be used in the manufacturing of several foods as ingredient, of the food additive modified starch and of glucose syrups pursuant to Article 21(2) of Regulation (EU) No 1169/2011, as notified by Lyckeby Starch AB. The applicant provided information on the manufacturing process and data on the content of total protein, gluten and allergenic proteins in barley starch. The applicant also performed IgE‐binding in vitro tests, which were considered inconclusive by the Panel. No human intervention studies with barley starch or food products thereof were provided by the applicant, except for a DBPCFC with barley starch hydrolysate in cereal allergic individuals. The Panel notes that glucose syrups based on barley have been already exempted from allergen labelling as per Annex II of Regulation (EU) No 1169/2011 and that the current application is for the exemption from labelling of all foods manufactured from barley starch. In all the scenarios considered for the anticipated intake, the calculated total protein intake from barley starch was above the MED/MOED for wheat (expressed in mg of wheat protein) in adults (10 mg) and children (2 mg). The Panel concludes that the data available are insufficient to conclude on the likelihood of adverse allergic reactions in cereal‐allergic individuals upon consumption of barley starch under the conditions of use proposed by the applicant, and that the consumption of foodstuffs produced from barley starch as starting (raw) material or foodstuffs containing barley starch as an ingredient is unlikely to cause an adverse reaction in individuals with coeliac disease who are not allergic to cereals, provided that the value of gluten for ‘gluten‐free’ foods (20 mg/kg) is not exceeded.

Abstract Following an application from BioGaia AB submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to orodispersible lozenges containing a combination of Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 and normal gum function. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The Panel considers that orodispersible lozenges containing L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 are sufficiently characterised. Maintenance of normal gum function is a beneficial physiological effect. Out of the two studies from which conclusions could be drawn and that investigated the effect of lozenges containing L. reuteri at the proposed conditions of use (i.e. consumption twice daily) on appropriate gingival outcomes (bleeding on probing (PoB) and gingival index (GI)) in subjects with gingivitis, but without periodontitis, one showed a large effect on BoP and other gingival outcomes and one showed no effect. No effect was found in one study with the use of one lozenge daily. The three studies that investigated, at the proposed conditions of use, modified GI (and not BoP or GI) in subjects with gingivitis, but without periodontitis, or were conducted in patients with periodontitis support an effect of lozenges with L. reuteri on gum function. Some evidence has been provided for mechanisms by which consumption of lozenges containing L. reuteri could improve outcomes of gingivitis in patients with chronic periodontitis but the relevance of such mechanisms for the target population of the claim (i.e. subjects without periodontitis) is unclear. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of orodispersible lozenges containing a combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 and maintenance of normal gum function.

Abstract 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 chromium‐enriched biomass of Yarrowia lipolytica as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed chromium‐enriched biomass of Y. lipolytica. This yeast species is widespread in nature, can be found in the environment and in foods, and was attributed the qualified presumption of safety (QPS) status for production purposes in 2018, including food and feed products based on biomass of the yeast. The production process, fermentation in the presence of chromium chloride, includes a heat‐killing step of the yeast, resulting in the absence of viable Y. lipolytica in the NF. The maximum total chromium content of the NF is 23 μg Cr/g, with the chromium present as Cr(III). The applicant proposed to use the NF as a food supplement. The target population proposed by the applicant is the general population from 3 years of age onwards, with maximum proposed use levels of 2 g/day for children from 3 to 9 years of age and 4 g/day thereafter. At the proposed use levels of the NF, the combined intake of chromium provided by the NF, in addition to a background diet high in chromium, would result in total chromium intakes well below the tolerable daily intake (TDI) for chromium(III) for all target population groups. The Panel concludes that the NF, chromium‐enriched biomass of Y. lipolytica, is safe under the proposed conditions of use.

Abstract Following an application from Tchibo GmbH submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Coffee C21 and protection of DNA from strand breaks. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Coffee C21. The Panel considers that Coffee C21, a coffee standardised by its concentration of caffeoylquinic acids (CQA), trigonelline and N‐methylpyridinium (NMP), is sufficiently characterised in relation to the claimed effect. The Panel considers that the claimed effect, protection of DNA from strand breaks, is a beneficial physiological effect. Out of the two human intervention studies from which conclusion could be drawn, one study provides some evidence that daily consumption of Coffee C21 (750 mL/day) for 4 weeks decreases DNA strand breaks in habitual coffee drinkers after coffee withdrawal over the previous four weeks. However, the results of this study were not replicated in another study conducted under similar conditions in the same study centre. No studies performed in a different setting, from which conclusions could be drawn, were available. No evidence has been provided for a mechanism by which coffee (including Coffee C21) would reduce DNA damage in human cells by reducing DNA strand breaks. The Panel concludes that a cause and effect relationship has not been established between the consumption of Coffee C21 and protection of DNA from strand breaks.

Abstract Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of astaxanthin when used as a novel food in food supplements at maximum levels of 8 mg/day, taking into account the overall cumulative intake of astaxanthin from all food sources. In 2014, the NDA Panel assessed the safety of the novel astaxanthin‐rich ingredient derived from microalgae Haematococcus pluvialis in the context of an application submitted under Regulation (EC) No 258/1997. In that opinion, the NDA Panel considered that the acceptable daily intake (ADI) for astaxanthin was 0.034 mg/kg body weight (bw) set by the EFSA FEEDAP Panel in 2014. In 2019, the FEEDAP Panel adopted an opinion which concerned the renewal of the authorisation of dimethyldisuccinate‐astaxanthin and a new use of the additive for crustaceans and other fish than salmonids. In that assessment, the FEEDAP Panel derived a new ADI of 0.2 mg astaxanthin/kg bw which replaced the ADI of 0.034 mg/kg bw established in 2014. By taking into account an updated exposure assessment for astaxanthin from the background diet (fish and crustaceans) in combination with 8 mg from food supplements, the NDA Panel concludes that (i) such combined exposure to astaxanthin is safe for adults, (ii) 14 to

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on vitamin D2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ingredient produced from Agaricus bisporus mushrooms that have been exposed to ultraviolet (UV) light to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains concentrations of vitamin D provided by vitamin D2 in the ranges of 1,000–1,300 μg/g. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods and beverages, including food for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above seven months of age. The Panel concludes that the NF, used as an ingredient, is safe for the general population at the proposed condition of use in foods and beverages and that the NF used as a food supplement, is safe for individuals above 1 year. The Panel, however, notes that the UL for infants aged 0–6 months may be exceeded in high consumers of infant formula (IF) and/or follow‐on formula (FoF) that may also be high consumers of foods fortified with the NF and for infants aged 7–12 months consuming a daily vitamin D oral supplementation of 10 μg. However, the Panel considers this scenario unlikely as complementary feeding in high consumers of IF and/or FoF may be limited. Furthermore, the combined consumption of vitamin D via fortified foods and supplements does not specifically concern this NF application. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations.

Abstract 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 selenium‐enriched biomass of Yarrowia lipolytica as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed selenium‐enriched biomass of Y. lipolytica. This yeast species is widespread in nature, can be found in the environment and in foods, and was attributed the qualified presumption of safety (QPS) status for production purposes in 2018, including food and feed products based on biomass of the yeast. The production process, fermentation in the presence of sodium selenite, includes a heat‐killing step of the yeast, resulting in the absence of viable Y. lipolytica in the NF. The maximum total selenium content in the NF is 200 μg Se/g, mainly present as organic selenium compounds. The applicant proposed to use the NF as a food supplement. The target population proposed by the applicant is the general population from 3 years of age onwards, with maximum proposed use levels of 0.2 g/day for children from 3 to 9 years of age and 1 g/day thereafter. The Panel considers that the yeast biomass is not of safety concern at the proposed use levels. The Panel also considers that the selenium provided by the NF is as safe as selenium from other dietary sources. However, the Panel notes that, at the use levels proposed by the applicant, the intake of the NF could, in combination with a background diet high in selenium, lead to total selenium intakes exceeding the UL for selenium in all target population groups, except for children from 7 to 9 years. Furthermore, the Panel considers that newly emerging data warrant a reassessment of the UL for selenium.

Abstract 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 extension of use of calcium l‐methylfolate to be used as a source of folate added for nutritional purposes to infant and follow‐on formula, baby food and processed cereal‐based food pursuant to Regulation (EU) 609/2013. In 2004, EFSA assessed the use of calcium l‐methylfolate as a source of folate in foods for particular nutritional uses, food supplements and foods intended for the general population. The new alternative synthetic step proposed to produce the nutrient source, using platinum as a catalyst, did not raise any safety concern and the production process was found to consistently yield a product in line with the proposed specifications. Based on the studies assessed in the previous evaluation, it was concluded that calcium l‐methylfolate is non‐genotoxic and that subchronic and embryotoxicity/teratogenicity studies in rats did not reveal any adverse effects up to the highest doses tested. The Panel considered that no additional toxicological studies are required on the nutrient source. The intervention study in healthy infants provided by the applicant did not indicate differences in growth and tolerance parameters in infants who consumed either an infant formula supplemented with calcium l‐methylfolate or with folic acid, and did not raise concerns regarding safety or tolerability of the infant formula with the proposed nutrient source. The study also provided further supporting evidence for the bioavailability of calcium l‐methylfolate. The Panel considers that calcium l‐methylfolate is a source from which folate is bioavailable and concludes that calcium l‐methylfolate is safe under the proposed uses and use levels for infants and young children.

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on heat‐killed Mycobacterium setense manresensis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an encapsulated ingredient composed of 200 mg mannitol and ≤ 105 heat‐killed, freeze‐dried M. setense manresensis. The information provided on the efficacy of the heat inactivation process demonstrates that the applied thermal process effectively kills all M. setense manresensis. The Panel considers that the NF is sufficiently described and characterised. The NF is intended by the applicant to be marketed exclusively in food supplements (gelatine capsules) for the general adult population excluding, children, pregnant and lactating women. The NF is not intended to be an alternative to standard treatment against tuberculosis. The applicant proposed an intake of one capsule (with ≤ 105 heat‐killed, freeze‐dried M. setense manresensis) for 14 consecutive days and a minimum of 6 months with no consumption of the NF, before another intake for fourteen days may follow. M. setense is not considered to be a suitable microorganism species for the qualified presumption of safety (QPS). Genetic analyses of the genome indicate the absence of the ability to produce exotoxins. The Panel considers that consumption of heat‐killed M. setense manresensis would not contribute to the pool of transmissible antimicrobial resistance genes already present in the intestinal microbiota. The Panel concludes that the NF is safe under the proposed conditions of use.

High sodium and low potassium intakes are associated with increased levels of blood pressure and risk of cardiovascular diseases. Assessment of habitual dietary habits are helpful to evaluate their intake and adherence to healthy dietary recommendations. In this study, we determined sodium and potassium food-specific content and intake in a Northern Italy community, focusing on the role and contribution of adherence to Mediterranean diet patterns. We collected a total of 908 food samples and measured sodium and potassium content using inductively coupled plasma mass spectrometry. Using a validated semi-quantitative food frequency questionnaire, we assessed habitual dietary intake of 719 adult individuals of the Emilia-Romagna region. We then estimated sodium and potassium daily intake for each food based on their relative contribution to the overall diet, and their link to Mediterranean diet patterns. The estimated mean sodium intake was 2.15 g/day, while potassium mean intake was 3.37 g/day. The foods contributing most to sodium intake were cereals (33.2%), meat products (24.5%, especially processed meat), and dairy products (13.6%), and for potassium they were meat (17.1%, especially red and white meat), fresh fruits (15.7%), and vegetables (15.1%). Adherence to a Mediterranean diet had little influence on sodium intake, whereas potassium intake was greatly increased in subjects with higher scores, resulting in a lower sodium/potassium ratio. Although we may have underestimated dietary sodium intake by not including discretionary salt use and there may be some degree of exposure misclassification as a result of changes in food sodium content and dietary habits over time, our study provides an overview of the contribution of a wide range of foods to the sodium and potassium intake in a Northern Italy community and of the impact of a Mediterranean diet on intake. The mean sodium intake was above the dietary recommendations for adults of 1.5–2 g/day, whilst potassium intake was only slightly lower than the recommended 3.5 g/day. Our findings suggest that higher adherence to Mediterranean diet patterns has limited effect on restricting sodium intake, but may facilitate a higher potassium intake, thereby aiding the achievement of healthy dietary recommendations.

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) derived dietary reference values (DRVs) for sodium. Evidence from balance studies on sodium and on the relationship between sodium intake and health outcomes, in particular cardiovascular disease (CVD)‐related endpoints and bone health, was reviewed. The data were not sufficient to enable an average requirement (AR) or population reference intake (PRI) to be derived. However, by integrating the available evidence and associated uncertainties, the Panel considers that a sodium intake of 2.0 g/day represents a level of sodium for which there is sufficient confidence in a reduced risk of CVD in the general adult population. In addition, a sodium intake of 2.0 g/day is likely to allow most of the general adult population to maintain sodium balance. Therefore, the Panel considers that 2.0 g sodium/day is a safe and adequate intake for the general EU population of adults. The same value applies to pregnant and lactating women. Sodium intakes that are considered safe and adequate for children are extrapolated from the value for adults, adjusting for their respective energy requirement and including a growth factor, and are as follows: 1.1 g/day for children aged 1–3 years, 1.3 g/day for children aged 4–6 years, 1.7 g/day for children aged 7–10 years and 2.0 g/day for children aged 11–17 years, respectively. For infants aged 7–11 months, an Adequate Intake (AI) of 0.2 g/day is proposed based on upwards extrapolation of the estimated sodium intake in exclusively breast‐fed infants aged 0–6 months.

Abstract Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) revised its 2009 Opinion on the appropriate age for introduction of complementary feeding of infants. This age has been evaluated considering the effects on health outcomes, nutritional aspects and infant development, and depends on the individual's characteristics and development. As long as foods have an age‐appropriate texture, are nutritionally appropriate and prepared following good hygiene practices, there is no convincing evidence that at any age investigated in the included studies (

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) has derived dietary reference values (DRVs) for chloride. There are no appropriate biomarkers of chloride status, no balance studies and no adequate evidence on the relationship between chloride intake and health outcomes that can be used to set DRVs for chloride. There is a close relationship between sodium and chloride balances in the body. Sodium chloride is the main source of both electrolytes in European diets and similar urinary excretion levels of sodium and chloride (on a molar basis) are typically observed in Western populations. Hence, the Panel considered that reference values for chloride can be set at values equimolar to the reference values for sodium for all population groups, and are as follows: 1.7 g/day for children aged 1–3 years, 2.0 g/day for children aged 4–6 years, 2.6 g/day for children aged 7–10 years, 3.1 g/day for children aged 11–17 years and 3.1 g/day for adults including pregnant and lactating women. Consistent with the reference values for sodium, these levels of chloride intake are considered to be safe and adequate for the general EU population, under the consideration that the main dietary source of chloride intake is sodium chloride. For infants aged 7–11 months, an adequate intake of 0.3 g/day is set.

Abstract 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 viable embryonated eggs of the whipworm Trichuris suis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a food supplement in the format of a 15‐mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.