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Following an application from Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, 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 organic foods and contribution to the protection of body cells and molecules (lipids and DNA) from oxidative damage. The scope of the application was proposed to fall under a health claim referring to children's development and health. The food proposed by the applicant as the subject of the health claim is ‘organic foods’. The applicant claimed that organic foods are characterised by their lower level of pesticides residues compared with foods not labelled as organic. The Panel notes, however, that in the application and the human studies submitted the nutritional composition and the pesticide concentration in ‘organic food’ are not reported. The Panel considers that organic foods which are the subject of the health claim, and the foods that they are intended to replace are not sufficiently characterised. Therefore, the Panel concludes that a cause and effect relationship cannot be established between the consumption of organic foods and contribution to the protection of body cells and molecules (lipids and DNA) from oxidative damage. [ABSTRACT FROM AUTHOR]

Following an application from BENEO 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 isomaltulose and normal energy-yielding metabolism. 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 isomaltulose. The Panel considers that isomaltulose is sufficiently characterised. The claimed effect proposed by the applicant is ‘normal energy-yielding metabolism’. The Panel considers that contribution to normal energy-yielding metabolism is a beneficial physiological effect. A number of human studies applying indirect calorimetry measurements or stable isotope methodologies have shown the postprandial metabolic utilisation of isomaltulose as energy source. However, all energy-containing macronutrients (i.e. carbohydrates, proteins, and lipids) supply the body with energy and this property is not specific to isomaltulose. The Panel concludes that a cause and effect relationship has been established between the intake of isomaltulose and contribution to energy-yielding metabolism. The following wording reflects the scientific evidence: ‘isomaltulose contributes to normal energy-yielding metabolism’. Since the contribution to energy-yielding metabolism is not specific to isomaltulose but applies to all energy containing macronutrients (i.e. carbohydrates, proteins, and lipids) that supply the body with metabolisable energy and any amount would contribute to the claimed effect, the Panel cannot set conditions of use for this claim. The applicant proposes that isomaltulose should replace other sugars in foods and/or beverages. The target population is the general population. [ABSTRACT FROM AUTHOR]

Following an application from Pharmactive Biotech Products, S.L. submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, 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 affron® and contributes to maintain a healthy mood. 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 affron®, an aqueous saffron extract with a content of the sum of crocins and safranal typically between 3.5% and 3.9%. The Panel notes that affron® is sufficiently characterised. The claimed effect proposed by the applicant is 'contributes to maintain a healthy mood'. The Panel notes that increase in positive mood is a beneficial physiological effect for individuals with low mood or anxiety. One human intervention study showed that consumption of affron® at a dose of 28 mg/day for 4 weeks improves mood in a population of adults with low mood. However, the results have not been replicated in other studies. The information supplied by the applicant did not provide evidence for a plausible mechanism by which affron® could exert the claimed effect. The Panel concludes that the evidence is insufficient to establish a cause and effect relationship between the consumption of affron® and increase in positive mood. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 (1012CFU) 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 (1012CFU) 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 FROM AUTHOR]

Following an application from Han-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 ®, lowering of blood pressure and reduced risk of hypertension. The Panel considers that the food, Symbiosal ®, which is the subject of the health claim, and the food, table salt, which Symbiosal ® 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 ® 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 ® 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 ® and lowering of blood pressure. [ABSTRACT FROM AUTHOR]

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®, 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®, a xanthohumol‐enriched roasted malt extract. The Panel considers that xanthohumol in XERME®, 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® on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME® 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®, a xanthohumol‐enriched roasted malt extract, and protection of DNA from oxidative damage. [ABSTRACT FROM AUTHOR]

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 Panel on 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. [ABSTRACT FROM AUTHOR]

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 ≤ 1.8 on an energy basis in the context of an energy-restricted diet and body weight. The Panel considers that the food/constituent that is the subject of the health claim is sufficiently characterised. The Panel also considers that reduction of body weight in the context of an energy-restricted diet is a beneficial physiological effect. The target population proposed by the applicant is 'adults between the ages of 18 and 70 years with excess body weight'. No conclusions could be drawn from two unpublished studies investigating the effect of ready-to-eat meals with a CHO:P ratio ≤ 1.8 on body weight. The remaining 14 human intervention studies investigated the effect of diets targeting a CHO:P ratio ≤ 1.8 as compared to diets targeting 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 ≤ 1.8 on body weight in overweight/obese subjects, whereas no significant effect was observed in six out of the seven studies lasting 12 weeks or more. The Panel considers that these studies do not provide evidence for a sustained effect of the food/constituent on body weight. The Panel concludes that a cause and effect relationship has not been established between the consumption of a fixed CHO:P ratio ≤ 1.8 on an energy basis consumed in the context of an energy-restricted diet and reduction of body weight. [ABSTRACT FROM AUTHOR]

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® and decreases sperm DNA damage. High sperm DNA damage is a risk factor for male subfertility/infertility'. Condensyl® 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® 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® and reduction of DNA sperm damage in the context of reducing the risk of male infertility. [ABSTRACT FROM AUTHOR]

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. [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 an application from Essential Sterolin Products (Pty) Ltd., 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 European Food Safety Authority (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 a combination of beta‐sitosterol and beta‐sitosterol glucoside and normal function of the immune system. 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 a combination of beta‐sitosterol and beta‐sitosterol glucoside in a ratio 100:1. The Panel considers that a combination of beta‐sitosterol and beta‐sitosterol glucoside in a ratio 100:1 is sufficiently characterised. The claimed effect proposed by the applicant is 'normal function of the immune system by restoring balance between TH1‐TH2 mediated immunity'. The Panel notes that the claimed effect 'normal function of the immune system by restoring balance between TH1‐ and TH2‐mediated immunity' does not refer to a specific function of the body which can be assessed in vivo in humans by generally accepted methods, but rather to a mechanism of action by which the food/constituent could exert the claimed effect. The Panel considers that the claimed effect does not refer to any specific health claim as required by Regulation (EC) No 1924/2006. The Panel concludes that a cause and effect relationship cannot be established between the consumption of a combination of beta‐sitosterol and beta‐sitosterol glucoside in a ratio 100:1 and a beneficial physiological effect. [ABSTRACT FROM AUTHOR]

Following an application from analyze & realize GmbH 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 GlycoLite™. The Panel considers that the food, an aqueous extract from white kidney bean (Phaseolus vulgaris L.) standardised by its in vitro α‐amylase inhibitory activity (GlycoLite™) which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is 'helps to reduce body weight'. The proposed target population is 'overweight people from the age of 18 years who want to lose or manage their weight'. The Panel considers that a reduction in body weight is a beneficial physiological effect for overweight individuals. Two human intervention studies, carried out in the same centres and by the same research group, showed an effect of 3 g of GlycoLite™ on body weight when consumed daily for 12 weeks in the context of an energy restricted diet. The results have not been replicated in a different setting. One study of short duration and methodological limitations showed an effect of GlycoLite™ on body weight when eating ad libitum. No evidence for a plausible mechanism by which GlycoLite™ could exert a reduction in body weight in vivo in humans has been provided. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of an aqueous extract from white kidney bean (P. vulgaris L.) standardised by its in vitro α‐amylase inhibitory activity (GlycoLite™) and a reduction of body weight either under energy restriction or when eating ad libitum. [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 Nutrition, Novel Foods and Food Allergens (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. Two human intervention studies were submitted as being pertinent to the claim, which were evaluated by the Panel in the previous application. One human intervention study from which conclusions could be drawn showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT. The post hoc re‐analysis of the two human studies combined does not address the methodological limitations of the second study raised in the previous opinion, i.e. that the study was not planned, designed, randomised and analysed as a multicentre study, and that the large disparity of subjects in the three centres was not duly justified. The results from one animal study could support an effect of Nutrimune on defence against pathogens in the GI tract. 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 GI tract and URT. [ABSTRACT FROM AUTHOR]