Scientific Opinion on the substantiation of a health claim related to fermented milk containing Lactobacillus casei DN-114 001 plus yoghurt symbiosis (Actimel\uae), and reduction of Clostridium difficile toxins in the gut of patients receiving antibiotics and reduced risk of acute diarrhoea in patients receiving antibiotics pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Danone Produits Frais France submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to a fermented milk drink Actimel\uae containing Lactobacillus casei (Lc) DN-114 001 and reduction of the presence of Clostridium difficile toxins in the gut which reduces the incidence of acute diarrhoea. The Panel considers that the food constituent, Actimel\uae, which is the subject of the health claim, is sufficiently characterised. The Panel considers that reducing the risk of Clostridium difficile diarrhoea by reducing the presence of C. difficile toxins is a beneficial physiological effect. In total the applicant indicated seven publications on human studies, three unpublished human studies, eight published and one unpublished non-human studies to be pertinent for the claimed effect. In weighing the evidence, the Panel took into account that human and animal studies showed partial survival of Lc DN-114 001 during its gastrointestinal passage, that one human intervention study with Actimel\uae which showed a statistically significant risk reduction for CDAD had considerable limitations, that there were only limited data on the effect of Actimel\uae on the reduction C. difficile toxins (the risk factor) in humans, that one study which showed an inhibitory effect of Lc DN-114 001 on the growth of C. difficile in vitro does not predict the occurrence of an effect against C. difficile in humans, that five further human studies do not support the proposed mechanisms by which Actimel\uae could exert the claimed effect, and that the evidence provided from a further two animal and three in vitro studies does not establish that effects of Actimel\uae or Lc DN-114 001 in these model systems related to immune function and infection can predict the occurrence of such effects in humans. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Actimel\uae and a reduction of the risk of C. difficile diarrhoea by reducing the presence of C. difficile toxins

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on establishing Food-Based Dietary Guidelines

This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) provides guidance on the translation of nutrient based dietary advice into guidance, intended for the European population as a whole, on the contribution of different foods or food groups to an overall diet that would help to maintain good health through optimal nutrition (food-based dietary guidelines). The main focus of this Opinion is put on the scientific process of developing food-based dietary guidelines (FBDG) for the diverse European populations, following a stepwise approach which should ideally consist of: 1) Identification of diet-health relationships, 2) Identification of country specific diet-related health problems, 3) Identification of nutrients of public health importance, 4) Identification of foods relevant for FBDG, 5) Identification of food consumption patterns, 6) Testing and optimising FBDG and 7) Graphical representations of FBDG. FBDG should focus on the diet-disease relationships of particular relevance to the specific population and should be developed using a multi-disciplinary approach. The early involvement of stakeholders is recommended to promote the acceptance of the outcome. FBDG should be consistent with other public policies that have an impact on food availability and be integrated with other policies related to health promotion. Once established, FBDG should be implemented and their impact monitored and evaluate

Scientific opinion on the substantiation of health claims related to olive oil and maintenance of normal blood LDL-cholesterol concentrations (ID 1316, 1332), maintenance of normal (fasting) blood concentrations of triglycerides (ID 1316, 1332), maintenance of normal blood HDL-cholesterol concentrations (ID 1316, 1332) and maintenance of normal blood glucose concentrations (ID 4244) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to olive oil and maintenance of normal blood LDL-cholesterol concentrations, maintenance of normal (fasting) blood concentrations of triglycerides, maintenance of normal blood HDL-cholesterol concentrations and maintenance of normal blood glucose concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claims is olive oil. The Panel considers that olive oil is sufficiently characterised in relation to the claimed effect

Scientific opinion on the substantiation of health claims related to maize oil and maintenance of normal blood LDL-cholesterol concentrations (ID 3086) pursuant to article 13(1) of regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to maize oil and maintenance of normal blood LDL-cholesterol concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claim is maize oil. The Panel considers that maize oil is sufficiently characterised in relation to the claimed effect. The claimed effect is \u201ccorn oil with a guaranteed polyunsaturated fatty acids content (56 % of total fatty acids), supplemented with vitamin E\u201d. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to maintenance of normal LDL-blood cholesterol concentrations. The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect. No studies that investigated whether maize oil had a cholesterol-lowering effect beyond what could be expected from the fatty acid composition of maize oil have been provided. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of maize oil and maintenance of normal blood LDL-cholesterol concentrations beyond what could be expected from the fatty acid composition of maize oil. A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome. A claim on linoleic acid and maintenance of normal blood cholesterol concentrations has also already been assessed with a favourable outcome

Scientific Opinion on the substantiation of health claims related to iron and formation of red blood cells and haemoglobin (ID 374, 2889), oxygen transport (ID 255), contribution to normal energy-yielding metabolism (ID 255), reduction of tiredness and fatigue (ID 255, 374, 2889), biotransformation of xenobiotic substances (ID 258), and activity of heart, liver and muscles (ID 397) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to iron and formation of red blood cells and haemoglobin, oxygen transport, contribution to normal energy-yielding metabolism, reduction of tiredness and fatigue, biotransformation of xenobiotic substances and \u201cactivity of heart, liver and muscles\u201d. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is iron. The Panel considers that iron is sufficiently characterised

Scientific Opinion on the substantiation of health claims related to beta-glucans and maintenance or achievement of normal blood glucose concentrations (ID 756, 802, 2935) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to beta-glucans and maintenance or achievement of normal blood glucose concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim are beta-glucans, which are soluble cereal fibres. Beta-glucans are non-starch polysaccharides composed of glucose molecules in long linear glucose polymers with mixed \u3b2-(1\u21924) and \u3b2-(1\u21923) links with an approximate distribution of 70% to 30%. This opinion applies to beta-glucans naturally present in foods and those forms added to foods. The Panel considers that beta-glucans are sufficiently characterised. The claimed effect is \u201ccontribution to the maintenance of healthy blood glucose levels\u201d. The target population is assumed to be the general population. In the context of the proposed wording, the Panel assumes that the claimed effect refers to the long-term maintenance or achievement of normal blood glucose concentrations. The Panel considers that long-term maintenance or achievement of normal blood glucose concentrations is a beneficial physiological effect. In weighing the evidence the Panel took into account that the only two studies presented from which conclusions could be drawn for the substantiation of the claim showed no effect of beta-glucans consumption on the long-term maintenance or achievement of normal blood glucose concentrations. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of beta-glucans and the long-term maintenance or achievement of normal blood glucose concentrations

Scientific Opinion on the substantiation of health claims related to Lactobacillus plantarum 299 (DSM 6595, 67B) (ID 1078) and decreasing potentially pathogenic intestinal microorganisms pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Lactobacillus plantarum 299 (DSM 6595, 67B) and decreasing potentially pathogenic intestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is Lactobacillus plantarum 299 (DSM 6595, 67B). The Panel considers that Lactobacillus plantarum 299 (DSM 6595, 67B) is sufficiently characterised. The claimed effect is \u201cincrease the amount of lactobacilli in the intestine/decrease the amount of enterobacteriaceae/inhibit pathogenic bacteria\u201d. The target population is assumed to be the general population. The Panel considers that decreasing potentially pathogenic intestinal microorganisms might be a beneficial physiological effect. No references were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum 299 (DSM 6595, 67B) and decreasing potentially pathogenic intestinal microorganisms

Scientific Opinion on the substantiation of health claims related to cocoa flavanols and protection of lipids from oxidative damage (ID 652, 1372, 1506, 3143), and maintenance of normal blood pressure (ID 1507) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to cocoa flavanols and protection of lipids from oxidative damage, and maintenance of normal blood pressure. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is cocoa flavanols. The Panel considers that cocoa flavanols is sufficiently characterised

Scientific Opinion on the substantiation of health claims related to Lactobacillus johnsonii BFE 6128 and \u201cnatural defences/immune system\u201d (ID 990) and \u201cskin health\u201d (ID 991) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Lactobacillus johnsonii BFE 6128 and \u201cnatural defences/immune system\u201d and \u201cskin health\u201d. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is Lactobacillus johnsonii BFE 6128. The Panel considers that Lactobacillus johnsonii BFE 6128 is sufficiently characterise

Scientific Opinion on the substantiation of health claims related to lutein and protection of DNA, proteins and lipids from oxidative damage (ID 3427), protection of the skin from UV-induced (including photo-oxidative) damage (ID 1605, 1779) and maintenance of normal vision (ID 1779, 2080) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to lutein and protection of DNA, proteins and lipids from oxidative damage, protection of the skin from UV-induced (including photo-oxidative) damage and maintenance of normal vision. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references which EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is lutein. The Panel considers that lutein is sufficiently characterised