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Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on hydroxytyrosol, which is chemically synthesised, as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The applicant intends to add hydroxytyrosol to fish and vegetable oils up to 215 mg/kg and to margarines up to 175 mg/kg. The target group is the general population which excludes children under 36 months of age, pregnant women and breastfeeding women. Considering the no observed adverse effect level (NOAEL) of 50 mg/kg body weight per day from a subchronic oral toxicity study with the NF and the maximum anticipated daily intake for the NF, the margin of exposure (MoE) would result in 100 for children (3-9 years of age) and at least 200 for adolescents, adults (excluding pregnant and breastfeeding women) and elderly. Taking into account that the anticipated daily intake of the NF would be in the range of or even less than the exposure of hydroxytyrosol from the consumption of olive oils and olives, which has not been associated with adverse effects, and considering the similar kinetics of hydroxytyrosol in rats and humans, the Panel considers that the MoE for the NF at the intended uses and use levels is sufficient for the target population. The Panel concludes that the novel food, hydroxytyrosol, is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

Following an application from Laboratoires Nutrition et Cardiométabolisme, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Stablor® and decrease in visceral fat while preserving lean mass. The food Stablor®, a drink preparation with defined macro‐ and micronutrient composition and a specific proportion of amino acids (tryptophan to neutral amino acids ratio) which is the subject of the health claim, is sufficiently characterised. The Panel considers that reduction of visceral fat while maintaining lean body mass in the context of an energy restricted diet is a beneficial physiological effect in overweight or obese subjects with abdominal fat and cardiometabolic risk factors. Four human studies were submitted by the applicant as pertinent to the claimed effect. In weighing the evidence, the Panel took into account that one human study from which conclusions could be drawn for scientific substantiation of the claimed effect did not show an effect of Stablor® on visceral fat mass in the context of an energy restricted diet. The Panel concludes that a cause and effect relationship has not been established between the consumption of Stablor® and reduction of visceral fat while maintaining lean body mass in the context of an energy restricted diet. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for taxifolin-rich extract from Dahurian Larch as a food ingredient in the context of Regulation (EC) No 258/97. The novel food (NF) is a taxifolin-rich water-ethanol extract from the wood of the Dahurian Larch and contains a minimum of 90% taxifolin. The Panel considers that the taxifolin-rich extract is sufficiently characterised and that its compositional data and specifications do not raise safety concerns. The NF is intended to be added to non-alcoholic beverages, to yogurt and to chocolate confectionery. The Panel considers that the data on genotoxicity do not raise concern. In a subchronic rat study performed in accordance with OECD standards, the highest dose tested (i.e. 1,500 mg/kg bw) was considered to be the NOAEL. The margin of exposure (MOE) of the combined intake (158 mg) from the intended food uses (including 100 mg from food supplements) would result to about 660 for an adult weighing 70 kg. For adolescents, taking into account a default body weight of 45 kg, the MOE of the combined intake (146 mg) would be about 460. In the absence of a high percentile intake estimate for children between 9 and 14 years of age, the Panel considers the P97.5 intake estimate from the intended food uses (except from food supplements) for children between 10 and 17 years, i.e. 46 mg/day. Taking into account a default body weight of 29.4 kg (P5 body weight for children aged 10-14 years as suggested by EFSA Scientific Committee (2012)), the resulting MOE would be about 960. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on proline-specific oligopeptidase (Tolerase® G) as a novel food ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is an enzyme preparation of prolyl-oligopeptidase produced with a genetically modified Aspergillus niger self clone strain. The target population is the general adult population. The results from a bacterial reverse mutation test and of an in vitro chromosome aberration test did not indicate genotoxicity. The Panel considers that the reported effects observed in a 90-day rat study are treatment-related effects and can be attributed to the higher energy consumption by these animals. Taking into account the intended maximum use level for Tolerase®-G, its daily consumption would correspond to 2,746 mg TOS/person or to 39.2 mg TOS/kg body weight (bw) per day, when considering a default body weight of 70 kg for an adult person. The margin between this value and the dose in the rats, which caused effects attributable to the excess energy intake, is approximately 45. Noting this margin, the Panel considers that it is unlikely that such effects would occur in human at the intended use levels. The Panel concludes that the NF, Tolerase®-G, is safe for the intended use at the intended use level. [ABSTRACT FROM AUTHOR]

Following an application from H.J. Heinz Supply Chain Europe B.V., submitted for authorisation of a health claim pursuant to Article 14 of Regulation ( EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies ( NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to 'Nutrimune®' and immune defence against pathogens in the gastrointestinal ( GI) tract and upper respiratory tract ( URT). The food 'Nutrimune®' (a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74) which is the subject of the health claim is sufficiently characterised. The Panel considers that immune defence against pathogens in GI tract and URT is a beneficial physiological effect. One human intervention study from which conclusions can be drawn showed an effect of 'Nutrimune®' on immune defence against pathogens in the GI tract and the URT, and the results from one animal study could support an effect of 'Nutrimune®' on defence against pathogens in the GI tract. However, there were inconsistencies in the reporting of the process and criteria used for the diagnosis of URTI in the human intervention study, the results of this study have not been replicated, and no evidence was provided for a plausible mechanism by which 'Nutrimune®' could exert the claimed effect in vivo in humans. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of 'Nutrimune®' and immune defence against pathogens in the gastrointestinal and upper respiratory tracts. [ABSTRACT FROM AUTHOR]

EFSA asked the Panel on Dietetic Products, Nutrition and Allergies ( NDA) to update the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim published in 2011. Since then, the NDA Panel has gained considerable experience in the evaluation of health claims. Lessons learnt from these experiences have been translated into a new General scientific guidance for stakeholders on health claim applications (published in January 2016). In this context, it is noted the need to adapt the existing guidance to the new scientific and technical developments in this area. This guidance document presents a common format for the organisation of information for the preparation of a well-structured application for authorisation of health claims which fall under Articles 13(5), 14 and 19 of Regulation ( EC) No 1924/2006. This guidance outlines the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim. [ABSTRACT FROM AUTHOR]

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation ( EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies ( NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin C and protection of DNA, proteins and lipids from oxidative damage. The Panel considers that vitamin C is sufficiently characterised and that protection of DNA, proteins and lipids from oxidative damage is a beneficial physiological effect. The target population proposed by the applicant is infants (from birth) and young children up to 3 years of age. The Panel has previously assessed a claim on vitamin C and protection of DNA, proteins and lipids from oxidative damage with a favourable outcome. The target population was the general population. The Panel considers that the role of vitamin C in protection of DNA, proteins and lipids from oxidative damage applies to all ages, including infants and young children up to 3 years of age. The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin C and protection of DNA, proteins and lipids from oxidative damage. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derived dietary reference values (DRVs) for thiamin (vitamin B1). The Panel considers that data from depletion-repletion studies in adults on the amount of dietary thiamin intake associated with the erythrocyte transketolase activity coefficient (αETK) < 1.15, generally considered to reflect an adequate thiamin status, or with the restoration of normal (baseline) erythrocyte transketolase activity, without a sharp increase in urinary thiamin excretion, can be used to estimate thiamin requirement. In the absence of new scientific evidence, the Panel endorses the average requirement (AR) of 0.072 mg/MJ (0.3 mg/1,000 kcal) for all adults proposed by the Scientific Committee for Food (SCF) in 1993 on the basis of one depletion-repletion study, in which both αETK and urinary thiamin excretion were measured. Results from other depletion-repletion studies are in agreement with this value. The Panel agrees on the coefficient of variation of 20% used by the SCF to cover uncertainties related to distribution of thiamin requirements in the general population, and endorses the population reference intake (PRI) of 0.1 mg/MJ (0.4 mg/1,000 kcal) set by the SCF for all adults. The same AR and PRI as for adults, expressed in mg/MJ, are proposed for infants aged 7-11 months, children aged 1 to < 18 years, and during pregnancy and lactation, under the assumption that the relationship between thiamin requirement and energy requirement is the same in all population groups. [ABSTRACT FROM AUTHOR]

Following the adoption of Regulation ( EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and presentation of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in 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. Besides, its normal consumption should not be nutritionally disadvantageous. To that end, information is requested on the description, production process, composition, stability data, specifications, data from experience of continued use in a third country and on the proposed conditions of use of the traditional food for the EU market. The structure of the notification dossier should follow the sections presented in this guidance. 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 application should be comprehensive and complete. 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. [ABSTRACT FROM AUTHOR]

Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the novel food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of novel foods. Requirements which should be covered in all applications 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. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies ( NDA) was asked to deliver a scientific opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation ( EU) No 1169/2011 - for permanent exemption from labelling. Behenic acid is produced from rapeseed-mustard seed variants prevalent in India, namely Brassica juncea (L.) Czern. (oriental mustard), Brassica rapa (L.) (brown/yellow Sarson or Toria) , Brassica napus (L.) (rapeseed) and Brassica nigra (L.) W.D.J.Koch (black mustard). No human or animal allergenicity data were provided by the applicant for either behenic acid or the emulsifiers manufactured from behenic acid. Based on enzyme-linked immunosorbent assay ( ELISA) data, the Panel considers that proteins and peptides may not be carried over into behenic acid after the two distillation steps reported in the manufacturing process in amounts beyond 1 mg/kg. The Panel notes that the maximum amount of mustard protein that could be consumed from emulsifiers manufactured from behenic acid (E 470a, E 471 and E 477) on a single occasion by an adult under the proposed conditions of use would be around 0.00119 mg, which is about 1,000 times lower than the protein doses reported to trigger allergic reactions in mustard-allergic individuals (around 1 mg). On the basis of the data presented, the Panel concludes that oral consumption of emulsifiers manufactured using behenic acid from mustard seeds (E 470a, E 471 and E 477) are unlikely to trigger an allergic reaction in susceptible individuals (i.e. mustard-allergic individuals) under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies ( NDA) was asked to deliver a scientific opinion on synthetic l-ergothioneine, marketed as Ergoneine®, as a novel food submitted pursuant to Regulation ( EC) No 258/97 of the European Parliament and of the Council. The novel food, synthetic l-ergothioneine, is produced by a one-pot patented manufacturing process. Chemically, l-ergothioneine is a derivative of thiolhistidine, and it is naturally present in a number of foodstuffs such as mushrooms, some varieties of black and red beans, offal and cereals. The production process for the novel food is sufficiently described and does not raise concerns about the safety of the novel food. The information on the composition, specifications, batch-to-batch variability and stability of the novel food is sufficient and does not raise safety concerns. The applicant intends to use the novel food in quantities of up to 5 mg per serving in alcohol-free beverages, cereal bars, milk, fresh dairy products and chocolate. The applicant also proposes to provide the novel food as a food supplement, with a daily dose of up to 30 mg/day for adults and 20 mg/day for children. The target population is children above 3 years of age and the general adult population, except pregnant and breastfeeding women. Considering the NOAEL of 800 mg/kg bw per day, which was based on two subchronic toxicity studies in rats, and the maximum estimated intake levels for l-ergothioneine from all sources, the Panel concludes that the margins of safety of 470 for adults (except pregnant and breastfeeding women) and of 216 for children above 3 years of age are sufficient. The Panel concludes that the novel food, synthetic l-ergothioneine (marketed as Ergoneine®), is safe under the intended conditions of use as specified by the applicant. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the energy conversion factor of d-tagatose to be used for calculating the energy value of foods to be declared in nutrition labelling. Energy conversion factors for nutrients for the purpose of nutrition labelling have been set based on the concept of metabolisable energy ( ME). The same methodology has been applied to calculate the energy conversion factor for d-tagatose in this opinion. The assessment is based on a dossier prepared for Nutrilab NV and submitted by Bioresco Ltd. At present, data are insufficient to derive an accurate ME value for d-tagatose. Relying on the human data indicating a mean absorption rate of 80% (range 69-88%) and a urinary excretion of either 1% or 5%, the corresponding energy values for d-tagatose would be 2.8 kcal/g (11.8 kJ/g) and 2.96 kcal/g (12.4 kJ/g), respectively. Taking into account that the remaining 20% of d-tagatose which is not absorbed in the small intestine is fermented in the colon and may deliver at least some energy, e.g. in form of short-chain fatty acids, the Panel concludes that a rounded estimate of the energy conversion factor for d-tagatose based on the available data and calculated as ME would be 3 kcal/g (12.5 kJ/g). The Panel considers that additional data on the absorption, distribution, metabolism and excretion of d-tagatose in humans would help in the calculation of a more accurate energy conversion factor for d-tagatose based on the concept of ME. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies ( NDA) derives dietary reference values ( DRVs) for potassium. The Panel decides to set DRVs on the basis of the relationships between potassium intake and blood pressure and stroke. The Panel considers that randomised controlled trials and an observational cohort study carried out in a European adult population provide evidence that a potassium intake of 3,500 mg (90 mmol)/day has beneficial effects on blood pressure in adults. Furthermore, there is consistent evidence from observational cohort studies that potassium intakes below 3,500 mg/day are associated with a higher risk of stroke. Available data cannot be used to determine the average requirement of potassium but can be used as a basis for deriving an adequate intake ( AI). A potassium intake of 3,500 mg/day is considered adequate for the adult population and an AI of 3,500 mg/day for adult men and women is proposed. For infants and children, the AIs are extrapolated from the AI for adults by isometric scaling and including a growth factor. An AI of 750 mg (19 mmol)/day is set for infants aged 7-11 months. For children, AIs from 800 mg (20 mmol)/day (1-3 years old) to 3,500 mg/day (15-17 years old) are set. Considering that the daily accretion rate of potassium in fetal and maternal tissues can be met by the adaptive changes which maintain potassium homeostasis during pregnancy, the AI set for adults applies to pregnant women. For lactating women, the amount of potassium needed to compensate for the losses of potassium through breast milk is estimated and an AI of 4,000 mg (102 mmol)/day is proposed. [ABSTRACT FROM AUTHOR]

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation ( EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies ( NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to calcium and contribution to the normal development of bones. The Panel considers that calcium is sufficiently characterised and that contribution to the normal development of bones is a beneficial physiological effect. The target population proposed by the applicant is infants (from birth) and young children up to 3 years of age. The Panel has previously assessed a claim on calcium and normal growth and development of bone with a favourable outcome. The target population was children and adolescents. The Panel considers that the role of calcium in the development of bones applies to all ages including infants and young children up to 3 years of age. The Panel concludes that a cause and effect relationship has been established between the dietary intake of calcium and contribution to the normal development of bones. [ABSTRACT FROM AUTHOR]

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation ( EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies ( NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin E and protection of DNA, proteins and lipids from oxidative damage. The Panel considers that vitamin E is sufficiently characterised and that protection of DNA, proteins and lipids from oxidative damage is a beneficial physiological effect. The target population proposed by the applicant is infants (from birth) and young children up to 3 years of age. The Panel has previously assessed a claim on vitamin E and protection of DNA, proteins and lipids from oxidative damage with a favourable outcome. The target population was the general population. The Panel considers that the role of vitamin E in protection of DNA, proteins and lipids from oxidative damage applies to all ages, including infants and young children up to 3 years of age. The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin E and protection of DNA, proteins and lipids from oxidative damage. [ABSTRACT FROM AUTHOR]