Browsing by Subject "health claim"

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  • EFSA Panel Dietetic Prod Nutr; Heinonen, Marina (2017)
    Following an application from Marks and Spencer PLC, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, 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 a CHO:P ratio = 3.0 on overweight and obese adults in the context of energy restriction. Four out of seven studies lasting <12 weeks reported an effect of a CHO: P ratio
  • EFSA Panel Dietetic Prod Nutr All (2018)
    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 Panel on 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 improvement of attention. 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. The Panel considers that black tea characterised by its content of tea solids, caffeine and L-theanine, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is 'improves attention'. The Panel considers that improvement of attention is a beneficial physiological effect. Three human intervention studies provided by the applicant show an effect of black tea on attention under the conditions of used proposed by the applicant. The applicant proposed that the claimed effect depends on the concerted action of two substances, caffeine and L-theanine, both of which are present in black tea. The Panel considers that the effect of black tea on attention observed in the three human intervention studies provided by the applicant can be explained by its caffeine content. The Panel concludes that a cause and effect relationship has been established between the consumption of black tea and improvement of attention. The Panel considers that the effect of black tea on attention can be explained by its caffeine content. The following wording reflects the scientific evidence: 'Owing to its caffeine content, black tea improves attention'. In order to obtain the claimed effect, 2-3 servings of black tea providing at least 75 mg of caffeine in total should be consumed within 90 min. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr (2018)
    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.
  • EFSA Panel Dietetic Prod Nutr & A (2018)
    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.
  • EFSA Panel Dietetic Prod Nutr (2017)
    Following an application from Laboratoire Nurilia 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 Condensyl (R) and decreases sperm DNA damage. High sperm DNA damage is a risk factor for male subfertility/infertility'. Condensyl (R) is a fixed combination of opuntia fruit dry extract, N-acetyl cysteine, zinc, nicotinamide, vitamins B2, B6, B12 and E, and folic acid. The Panel considers that Condensyl (R) is sufficiently characterised. The Panel assumes that the disease that is the subject of the application is male infertility and that the target population for the claim includes males wishing to increase their fertility but excludes males with clinical infertility. The Panel considers that the reduction of DNA sperm damage is a beneficial physiological effect in the context of reducing the risk of male infertility. The applicant provided four human intervention studies conducted in males with clinical infertility, from which no conclusions could be drawn for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Condensyl (R) and reduction of DNA sperm damage in the context of reducing the risk of male infertility. (C) 2017 European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nutr; Heinonen, Marina (2017)
    Following an application from Suomen Terveysravinto Oy, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, 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 curcumin and normal functioning of joints. The food that is proposed as the subject of the health claim is curcumin. The Panel considers that curcumin is sufficiently characterised. The claimed effect proposed by the applicant is 'normal functioning of joints by reducing the biomarkers of inflammation'. The target population proposed by the applicant is the general population. Upon a request from EFSA to clarify whether the claimed effect is related to the normal function of joints or rather to the reduction of inflammation, the applicant did not address this issue in the reply. The Panel assumes that the claimed effect refers to the maintenance of joint function. The Panel considers that maintenance of joint function is a beneficial physiological effect. The Panel considers that no conclusions can be drawn from 15 human intervention studies conducted in patients with osteoarthritis or rheumatoid arthritis and from one study in obese subjects on serum cytokines for the scientific substantiation of the claim. In the absence of evidence for an effect of curcumin on the normal function of joints in humans, the results of the human studies on curcumin pharmacokinetics, safety and mechanistic studies, the animal studies and the in vitro studies submitted by the applicant cannot be used as a source of data for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of curcumin and maintenance of joint function. (C) 2017 European Food Safety Authority.
  • EFSA Panel Dietetic Prod Nut (2018)
    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.
  • EFSA Panel Dietetic Prod Nutr (2018)
    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.
  • EFSA Panel Dietetic Prod Nutr (2017)
    Following an application from Laboratoires Nutrition et Cardiometabolisme, 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 (R) and decrease in visceral fat while preserving lean mass. The food Stablor (R), 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 (R) 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 (R) and reduction of visceral fat while maintaining lean body mass in the context of an energy restricted diet. (C) 2017 European Food Safety Authority.
  • Turck, Dominique; EFSA NDA Panel (2017)
    Following an application from Cargill R&D Centre Europe, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No1924/2006 via the Competent Authority of Belgium, 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 sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque which reduces the risk of caries. The food proposed by the applicant as the subject of the health claim, sugar-free hard confectionery with at least 90% erythritol, is sufficiently characterised. In the context of this application, the weight of dental plaque, and/or the counts of Streptococcusmutans in dental plaque, and/or the concentration of organic acids in plaque (primarily acetic acid and lactic acid) can be considered as risk factor(s) in the development of dental caries, as long as evidence is provided that the consumption of the food that is the subject of the health claim reduces one or more of the proposed risk factors and the incidence of dental caries. One human intervention study did not show an effect of sugar-free hard confectionery with at least 90% erythritol on the incidence of dental caries in children on either mixed or permanent dentition. The Panelconcludes that a cause and effect relationship has not been established between the consumption of sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque which reduces the risk of dental caries.
  • EFSA Panel Dietetic Products Nutr (2018)
    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.
  • Turck, Dominique; EFSA NDA Panel (2017)
    Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 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 Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration. 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 Vibigaba. The Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal glycated haemoglobin level'. The Panelconsiders that maintenance of long-term normal blood glucose concentration is a beneficial physiological effect. The Panelnotes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention study as being pertinent to the claim. The Panelnotes the important methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration.
  • Turck, Dominique; EFSA NDA Panel (2017)
    Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 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 Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood cholesterol concentrations. 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 Vibigaba. The Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal blood cholesterol levels'. The Panelconsiders that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect. The Panelnotes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention s being pertinent to the claim. The Panelnotes the important methodological limitations of the study study a(e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol concentration.
  • Turck, Dominique; EFSA NDA Panel (2017)
    Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 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 Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood pressure. 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 Vibigaba. The Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal blood pressure'. The Panelconsiders that maintenance of normal blood pressure is a beneficial physiological effect. The Panelnotes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to theclaim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention study as being pertinent to the claim. The Panelnotes theimportant methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood pressure.
  • Turck, Dominique; EFSA NDA Panel (2017)
    Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 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 Vibigaba (germinated brown rice) and reduction of body weight in the context of an energy-restricted diet. 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 Vibigaba. The Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is in the context of an energy-restricted diet contributes to weight loss'. The Panelconsiders that reduction of body weight in the context of an energy-restricted diet is a beneficial physiological effect. The Panelnotes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant identified one human intervention study as being pertinent to the claim. The Panelnotes the important methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and reduction of body weight in the context of an energy-restricted diet.
  • EFSA Panel Dietetic Prod Nutr Al (2018)
    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.