Green kiwifruit (lat. Actinidia deliciosa var. Hayward) and maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Zespri International Limited, 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 green kiwifruit (lat. Actinidia deliciosa var. Hayward) and maintenance of normal defecation. 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 green kiwifruit. The Panel considers that green kiwifruit (Actinidia deliciosa var. Hayward) is sufficiently characterised. The claimed effect proposed by the applicant is 'maintenance of normal defecation'. Maintenance of normal defecation is a beneficial physiological effect provided that it does not result in diarrhoea. All human intervention studies submitted had different limitations and could not be used on their own for the scientific substantiation of the claim. However, the results of six pertinent human intervention studies are consistent with respect to an effect of consuming daily between two and four green kiwifruits var. Hayward on an increase in stool frequency. Two out of four studies in which a validated instrument was used to assess stool consistency showed an effect also on stool consistency. There is evidence for a plausible mechanism by which kiwifruit could exert an effect on normal defecation. The consumption of kiwifruit in the studies did not result in diarrhoea. A cause and effect relationship has been established between the consumption of green kiwifruit (Actinidia deliciosa var. Hayward) and maintenance of normal defecation. The following wordings reflect the scientific evidence: 'consumption of kiwifruit contributes to the maintenance of normal defecation'. In order to obtain the claimed effect, two large green kiwifruits (i.e. around 200 g of kiwi flesh) should be consumed

Scientific advice related to nutrient profiling for the development of harmonised mandatory front-of-pack nutrition labelling and the setting of nutrient profiles for restricting nutrition and health claims on foods

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

L-carnitine and contribution to normal lipid metabolism:evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of Germany, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L-carnitine. The Panelconsiders that L-carnitine is sufficiently characterised. The claimed effect proposed by the applicant is normal lipid metabolism'. The target population proposed by the applicant is the general population. The Panelconsiders that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panelconsiders that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panelconcludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target population

Symbiosal((R)) and lowering of blood pressure and reduced risk of hypertension : evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Flan-Biotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, 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 Symbiosal((R)), lowering of blood pressure and reduced risk of hypertension. The Panel considers that the food, Symbiosal((R)), which is the subject of the health claim, and the food, table salt, which Symbiosal((R)) should replace, are sufficiently characterised. Lowering of blood pressure is a beneficial physiological effect. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with some methodological limitations showed an effect of Symbiosal((R)) on blood pressure in the context of a self-selected diet with a maximum of 3 g/day added salt. The Panel also took into account that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study, that no evidence was provided in support of a mechanism by which Symbiosal((R)) could induce a decrease in blood pressure upon oral consumption as compared to table salt in vivo in humans, and the low biological plausibility of the effect observed in the human intervention study. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal((R)) and lowering of blood pressure. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (>= 1.10 mg), zeaxanthin (>= 0.20 mg) and docosahexaenoic acid (DHA) (>= 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is 'reduces loss of vision'. The target population proposed by the applicant is 'healthy adults over 50 years of age'. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

L-carnitine and contribution to normal lipid metabolism : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of Germany, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L-carnitine. The Panelconsiders that L-carnitine is sufficiently characterised. The claimed effect proposed by the applicant is normal lipid metabolism'. The target population proposed by the applicant is the general population. The Panelconsiders that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panelconsiders that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panelconcludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target population. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Xanthohumol in XERME (R), a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from TA-XAN AG, 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 Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME (R), a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. 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 xanthohumol in XERME (R), a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME (R), a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body'. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME (R) on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME (R) on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME (R), a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Black tea and maintenance of normal endothelium-dependent vasodilation : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Unilever NV, 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 Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to black tea and maintenance of normal endothelium-dependent vasodilation. 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 black tea beverages, either freshly prepared or reconstituted from water extract powders of black tea, characterised by the content of flavanols (expressed as catechins plus theaflavins) of at least 30mg per 200mL serving. The Panelconsiders that black tea characterised by the content of flavanols (expressed as catechins plus theaflavins) is sufficiently characterised. The claimed effect proposed by the applicant is improvement of endothelium-dependent vasodilation'. The Panelconsiders that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect. Of the five human intervention studies provided on the chronic effect of black tea consumption on endothelium-dependent vasodilation, two investigated the effect after regular consumption of black tea for a sufficiently long time period (i.e. at least 4weeks). These two studies did not allow an effect of black tea on endothelium-dependent vasodilation to be established. The Panelconcludes that a cause and effect relationship has not been established between the consumption of black tea and maintenance of normal endothelium-dependent vasodilation. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Carbohydrate solutions and contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Specialised Nutrition Europe (SNE), 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 Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to carbohydrate solutions and contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise. 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 carbohydrate solutions containing glucose, mixtures of glucose and fructose, sucrose and/or maltodextrins. The Panel considers that carbohydrate solutions are sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is 'contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise', which is considered by the Panel as a beneficial physiological effect. The Panel concludes that a cause and effect relationship has been established between the consumption of carbohydrate solutions and the improvement of physical performance during high-intensity and long-lasting physical exercise. The target population is healthy trained adults performing high-intensity (at least at 65% of the VO2max) and long-lasting (at least 60 min) physical exercise. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe