Following an application from Synbiotec S.r.l., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, 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 SYNBIO (R), a combination of Lactobacillus rhamnosus IMC 501((R)) and Lactobacillus paracasei IMC 502((R)), and maintenance of normal defecation. The Panel considers that the food, SYNBIO (R), which is the subject of the health claim, is sufficiently characterised. Maintenance of normal defecation is a beneficial physiological effect. The applicant identified three human intervention studies which investigated the effect of SYNBIO (R) on outcome measures (i.e. frequency of defecations, faecal bulk and stool consistency) related to the claimed effect. The Panel notes that no evidence was provided that the tools used to assess changes in bowel habits in response to an intervention were valid. Therefore, no conclusions could be drawn from these studies for the scientific substantiation of a claim on SYNBIO (R) and maintenance of normal defecation. In the absence of evidence for an effect of SYNBIO (R) on the maintenance of normal defecation in humans, studies which investigated the presence of L. rhamnosus IMC 501((R)) and L. paracasei IMC 502((R)) in the faeces of participants who consumed foods enriched with these strains were not considered by the Panel. The Panel concludes that a cause and effect relationship has not been established between the consumption of SYNBIO (R) and maintenance of normal defecation. (C) European Food Safety Authority, 2015

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of 'Cetyl Myristoleate Complex' (CMC) as a novel food ingredient in the light of additional information submitted by the applicant. In its previous opinion of 2010, the Panel concluded that the safety of CMC as an ingredient in food supplements at an intake of 3.3 g per day has not been established. This conclusion was based on the considerations that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. In 2012, the Commission requested EFSA to review and update its opinion by taking into account a new subchronic 90day oral toxicity study conducted with "Cetylated Fatty Acid Esters Powder 50 %" in mice. In its opinion of 2013, the Panel considered that a new 90-day study cannot serve as a reliable source of information supporting the absence of adverse effects of CMC. The dossier of this new mandate contains three new references which were not submitted and hence not considered in the previous assessments. The Panel notes that two references do not address the concerns expressed by the Panel in its previous assessments. The third reference provided is a report on an in vitro hydrolysis study demonstrating a low rate of hydrolysis of cetyl myristoleate and cetyl myristate. The Panel notes the low rate of hydrolysis of the two esters found in this in vitro hydrolysis study and therefore reiterates the need for adequate safety information on the unhydrolysed esters contained in CMC as expressed in its opinions of 2010 and 2013. The Panel concludes that, even after considering the newly submitted information, the safety of 'Cetyl Myristoleate Complex' has not been established. (C) European Food Safety Authority, 2014

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. The food constituent, beta-palmitate, that is the subject of the health claim, is sufficiently characterised. Contribution to softening of stools is a beneficial physiological effect for infants. In weighing the evidence the Panel took into account that, out of two human intervention studies with important methodological limitations, one suggested a stool-softening effect of beta-palmitate whereas the second did not, that one animal study did not support a stool-softening effect of beta-palmitate, and that the evidence provided for a mechanism by which beta-palmitate could contribute to the softening of stools is weak. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-palmitate and softening of stools.

Following an application from DSM Nutritional Products and Kemin Foods, 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 a combination of lutein and zeaxanthin and improved vision under bright light conditions. The Panel considers that the food is sufficiently characterised. Improved vision under bright light conditions is a beneficial physiological effect. The applicant provided a total of 10 published and one unpublished human intervention studies as being pertinent to the health claim. Five studies investigated the effects of lutein and/or zeaxanthin on macular pigment optical density, but did not assess vision, whereas two studies investigated the effects of lutein only. Two further studies had already been evaluated by the Panel in a previous assessment. No conclusions could be drawn from one further small (no effect) study. In a further trial with a large number of missing data owing to drop-out/non-compliance of study subjects, a combination of lutein and zeaxanthin had no effect on any outcomes of visual function in the population of subjects completing the protocol as planned. In weighing the evidence, the Panel took into account that the one study from which conclusions could be drawn did not show an effect of lutein plus zeaxanthin on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of lutein and zeaxanthin and improved vision under bright light conditions.

Following an application from InQpharm Europe 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 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 standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight.The Panel considers that the food is sufficiently characterised.A reduction in body weight is a beneficial physiological effect for overweight individuals.The applicant identified a total of four human intervention studies which investigated the effects of the aqueous extract from white kidney bean on body weight as being pertinent to the claim.No conclusions could be drawn from two of these four studies.In weighing the evidence, the Panel took into account that one human intervention study showed an effect of the standardised aqueous extract from white kidney bean in reducing body weight when consumed for 12 weeks, that the reduction in body weight was mostly through a reduction in body fat and that the effect of the standardised aqueous extract from white kidney bean on body weight was supported by a second study of shorter duration.However, the Panel also took into account that the first study was at risk of bias, that the supportive study suffered from methodological limitations and that no evidence was provided for a mechanism by which the standardised aqueous extract from white kidney bean could exert the claimed effect.The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of the standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight.

Following an application from Natural Alternative International, Inc. (NAI), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-alanine and increase in physical performance during short-duration, high-intensity exercise. The food constituent that is the subject of the claim is beta-alanine, which is sufficiently characterised. The Panel considers that an increase in physical performance during short-duration, high-intensity exercise is a beneficial physiological effect. In weighing the evidence the Panel took into account that only one out of 11 pertinent human intervention studies (including 14 pertinent outcomes) from which conclusions could be drawn showed an effect of beta-alanine on physical performance during short-duration, high intensity exercise. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-alanine and an increase in physical performance during short-duration, high intensity exercise.

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted 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 zinc and normal growth. The food constituent, zinc, which is the subject of the health claim, is sufficiently characterised. Normal growth is a beneficial physiological effect for infants and young children. The Panel considers that the role of zinc in normal growth is well established. Growth retardation is one of the clinical manifestations of severe zinc deficiency. Zinc supplementation has been reported to stimulate growth and development in zinc-deficient infants and young children. The Panel concludes that a cause and effect relationship has been established between the dietary intake of zinc and normal growth. The following wording reflects the scientific evidence: "zinc contributes to normal growth". The target population is infants and children up to three years of age. (C) European Food Safety Authority, 2014

Following an application from Leiber 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 Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Yestimun® and defence against pathogens in the upper respiratory tract. The food that is the subject of the health claim, Yestimun®, which consists of (1,3)-(1,6)-β-D-glucans from brewer’s yeast cell wall, is sufficiently characterised. The claimed effect, defence against pathogens in the upper respiratory tract, is a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of Yestimun® ((1,3)-(1,6)-β-D-glucans from brewer’s yeast cell wall) and defence against pathogens in the upper respiratory tract.

Following an application from Minami Nutrition Health BVBA, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, 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 eicosapentaenoic acid (EPA) and "reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with attention deficit hyperactivity disorder (ADHD)-like symptoms". The food constituent, EPA, which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is "reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms. These children are also characterised by less hyperactivity and/or coexisting oppositional behaviour". Upon a request by EFSA for clarification, the applicant indicated that the disease was ADHD, which is classified as such in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), that the risk factor for the disease was an elevated AA/EPA ratio in blood, and that the target population for the claim was children with diagnosis of ADHD. The Panel considers that the evidence provided does not establish that reducing the AA/EPA ratio reduces the risk of ADHD in children, and considers that the target population is a diseased population (i.e. children with ADHD). The Panel concludes that the claimed effect relates to the treatment of a disease, and that therefore the health claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006. (C) European Food Safety Authority, 2013

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, the 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 combination of lycopene, vitamin E, lutein and selenium and "helps to prepare and activate tanning". The Panel considers that the combination of lycopene, vitamin E, lutein and selenium is sufficiently characterised. The claimed effect proposed by the applicant is "helps to prepare and activate tanning". Tanning (i.e. increasing the pigmentation of the skin) may contribute to the protection of the skin against UV-induced damage. The Panel considers that protection of the skin from UV-induced (including photo-oxidative) damage is a beneficial physiological effect. A claim on a combination of lycopene, vitamin E, lutein and selenium and protection of the skin from UV-induced (including photo-oxidative) damage has already been assessed by the Panel with an unfavourable outcome. The reference provided by the applicant for the scientific substantiation of this claim was the same as in the previous submission. (C) European Food Safety Authority, 2012

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vitis vinifera L. seeds extract and "helps to decrease swollen legs". The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. Upon EFSA's request for clarification, the applicant stated that the claimed effect was "helps to decrease swollen legs", and that the beneficial physiological effect could be related to "helps to refine legs". In the context of the references provided for the scientific substantiation of the claim, and in particular of the human intervention study which was conducted with the food constituent that is the subject of the health claim, the Panel notes that the claim refers to the reduction of peripheral oedema in the context of chronic clinical conditions (e.g. chronic venous insufficiency) where the reduction of peripheral oedema is a therapeutic target for the treatment of the condition. The Panel considers that the reduction of peripheral oedema in the context of chronic clinical conditions is a therapeutic target for the treatment of the condition and does not comply with the criteria laid down in Regulation (EC) No 1924/2006. (C) European Food Safety Authority, 2012

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment of, lactoferrin. as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections of a scientific nature raised by Member States. Bovine lactoferrin (bLF) is a protein that occurs naturally in cow's milk. The applicant intends to market bLF as an ingredient for food supplements, infant and follow-on formulae, dietetic food for special medical purposes and sports nutrition, and for a variety of foods. For infants with an age of 0 - 6 months, the applicant has estimated an intake of approximately 200 mg per kg bodyweight and 1.2 g bLF per day at the proposed use level. For adults, the mean and 95th percentile daily intakes were calculated to be about 1.4 g and 3.4 g for an adult person. The toxicological information provided by the applicant included information from an in vitro genotoxicity study, a single dose study, a four week and a thirteen week oral repeated dose study in rats. The Panel notes that the estimated intake of "lactoferrin" for infants up to the age of one year of approximately 210 mg/kg bw per day would be around ten times lower than the highest dose (2,000 mg/kg bw per day) tested in the subchronic thirteen week rat study, which did not show adverse effects related to bLF. For adults above 19 years of age the proposed intake is approximately 100 times lower. This level of anticipated intake is considered a high intake scenario as opposed to a worst-case situation. The data provided suggest the absence of adverse effects of lactoferrin at the proposed levels of consumption. The Panel concludes that the novel food ingredient bLF is safe under the proposed uses and use levels. (C) European Food Safety Authority, 2012

Following an application from Vivatech 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 Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to “Transitech®” and “improves transit and durably regulates it”. The food that is the subject of the health claim is “Transitech®”, a food supplement which contains dried parts of Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids standardised for hydroxyanthracene derivatives, of Althaea officinalis L., of Rosa centifolia L., of Ocimum basilicum L., of Coriandrum sativum L., dried juice of Cynara scolymus L. standardised for cynarine, Saccharomyces cerevisiae subsp. cerevisiae UVAFERM SC, Bifidobacterium longum R0175 and Lactobacillus helveticus R0052. The information provided was insufficient to establish that Saccharomyces cerevisiae subsp. cerevisiae UVAFERM SC was sufficiently characterised. The Panel considers that if in a combination of several microorganisms and/or ingredients one microorganism or ingredient used in the combination is not sufficiently characterised, then the combination is considered to be not sufficiently characterised. The food, “Transitech®”, which is the subject of the claim, is not sufficiently characterised. The Panel concludes that a cause and effect relationship cannot be established between the consumption of “Transitech®” and “improves transit and durably regulates it”.

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vitis viniferaL. seeds extract and “helps to drain the body in case of water accumulation”. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. The claimed effect proposed by the applicant is “helps to drain the body in case of water accumulation”. Upon EFSA's request for clarification on the specific physiological function that is the subject of the health claim, together with the outcome measures which could be used for the scientific evaluation of that function, the applicant indicated that “increase of body drainage” was a beneficial physiological effect in the context of “a normal venous circulation in the legs”. The applicant acknowledged that this claim referred to the same physiological function of the body as another health claim application on Vitis vinifera L. seeds extract and maintenance of normal venous blood flow. The Panel considers that maintenance of normal venous blood flow is a beneficial physiological effect. A claim on Vitis viniferaL. seeds extract and maintenance of normal venous blood flow has already been assessed by the Panel with an unfavourable outcome. The reference provided by the applicant for the scientific substantiation of this claim was already considered in the previous submission.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment. This opinion addresses the scientific substantiation of health claims related to microorganisms for which the Panel considered in previous opinions that the data provided were not sufficient to characterise the microorganisms in question. The criteria used by the Panel for the characterisation of food constituents that are bacteria and combinations thereof, which are the subject of health claims, are: species identification by DNA- DNA hybridisation or 16S rRNA gene sequence analysis and/or sequence analysis of other relevant genetic markers; strain identification by DNA macrorestriction followed by pulsed-field gel electrophoresis, randomly amplified polymorphic DNA analysis, or other internationally accepted genetic typing molecular methods. Only when these two criteria are fulfilled is the bacterium considered to be sufficiently characterised. In the case of combinations of several bacteria, the Panel considers that if one microorganism used in the combination is not sufficiently characterised, the combination proposed is not sufficiently characterised. The Panel considers that the food constituents which are the subject of this opinion are not sufficiently characterised. On the basis of the data presented, the Panel concludes that a cause and effect relationship cannot be established between the consumption of the food constituents which are the subject of this opinion and the claimed effects. (C) European Food Safety Authority, 2012.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on health claims pursuant to Article 13.1 of Regulation (EC) No 1924/2006 in the framework of further assessment related to Saccharomyces boulardii ATY-SB-101 and the following claimed effects: "maintains and restores the natural flora" and "modulating both innate and adaptive host immunity to respond against pathogen infection". The food constituent that is the subject of the claims, Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837), is not sufficiently characterised. On the basis of the data presented, the Panel concludes that a cause and effect relationship cannot be established between the consumption of Saccharomyces boulardii ATY-SB-101 (BCCM/MUCL 53837) and the proposed claimed effects. (C) European Food Safety Authority, 2012.

Following an application from Nutrilinks Sarl 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 Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on a health claim related to "Femilub (R)" and maintenance of vaginal moisture. The food that is the subject of the health claim, "Femilub (R)", which is a combination of macadamia oil, borage oil, perilla oil, d-alpha-tocopherol and biotin, is sufficiently characterised. The claimed effect, maintenance of vaginal moisture, is a beneficial physiological effect. No human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect relationship has not been established between the consumption of "Femilub (R)" and maintenance of vaginal moisture. (C) European Food Safety Authority, 2012

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vitis vinifera L. seeds extract and maintenance of normal venous blood flow. The Panel considers that the food constituent, which is the subject of the health claim, is sufficiently characterised. The claimed effect, maintenance of normal venous blood flow, is a beneficial physiological effect. The applicant identified two human intervention studies as pertinent to the health claim. Owing to the very limited information provided in relation to one study, and that the second study was conducted with a food not complying with the characterisation of the food which is the subject of the health claim and did not measure venous blood flow, the Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of Vitis vinifera L. seeds extract and maintenance of normal venous blood flow. (C) European Food Safety Authority, 2012

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, the 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 combination of Paullinia cupana Kunth (guarana) and Camellia sinensis (L.) Kuntze (green tea) extracts and reduction of body weight. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. The claimed effect, reduction of body weight, is a beneficial physiological effect for overweight subjects. One human intervention study from which no conclusions could be drawn for the scientific substantiation of the claim was provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of Paullinia cupana Kunth (guarana) and Camellia sinensis (L.) Kuntze (green tea) extracts and a reduction in body weight. (C) European Food Safety Authority, 2012

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 rye fibre and changes in bowel function, reduction of post-prandial glycaemic responses 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 constituent that is the subject of the health claims is rye fibre. The Panel considers that rye fibre is sufficiently characterised in relation to the claimed effects.Changes in bowel functionThe claimed effect is "gut health". The target population is assumed to be the general population. In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to changes in bowel function. The Panel considers that changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools may be a beneficial physiological effect, provided these changes do not result in diarrhoea.In weighing the evidence, the Panel took into account that the results of all four human intervention studies considered showed an effect of rye fibre on various outcome measures related to bowel function. The Panel also notes the known mechanism by which rye fibre exerts the claimed effect.On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of rye fibre and changes in bowel function.The Panel considers that in order to bear the claim a food should be at least "high in fibre" as per Annex to Regulation (EC) No 1924/2006. The target population is the general population.Reduction of post-prandial glycaemic responsesThe claimed effect is "carbohydrate metabolism and insulin sensitivity". The target population is assumed to be individuals who wish to reduce their post-prandial glycaemic responses. In the context of the proposed wordings, the Panel assumes that the claimed effect relates to the reduction of postprandial glycaemic responses. The Panel considers that reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect.In weighing the evidence, the Panel took into account that the three human intervention studies provided from which conclusions could be drawn for the scientific substantiation of the claim, did not show an effect of rye fibre on post-prandial glycaemic responses.On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of rye fibre and reduction of post-prandial glycaemic responses.Maintenance of normal blood LDL-cholesterol concentrationsThe claimed effect is "cardiovascular system". The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal blood LDL-cholesterol concentrations. The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.In weighing the evidence, the Panel took into account that the only human intervention study provided from which conclusions could be drawn for the scientific substantiation of the claim did not show an effect of rye fibre on blood LDL-cholesterol 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 rye fibre and maintenance of normal blood LDL-cholesterol concentrations.