Eine 64-jährige Patientin stellte sich mit multiplen Lungenfiliae in beiden Lungenlappen bei progredientem HER2 positivem Mammakarzinom unter laufender Zweitlinientherapie mit Xeloda/Hercpetin vor. CT-morphologische zeigte sich eine polytope Lungenmetastasierung mit zehn Metastasen. Auf ausdrücklichen Wunsch der Patientin erfolgte in zwei Sitzungen die antero-laterale Thorakotomie mit Wedgeresektionen und Lymphknotenexstirpation nach Narunke zunächst rechts, dann links im Abstand von sechs Wochen. Insgesamt wurden vierzehn Metastasen entnommen. Histologisch lag bei elf der vierzehn Metastasen eine R0-Resektion vor, drei Metastasen waren histologisch randbildend. Eine postoperative HER2-Blockade wurde von der Patientin abgelehnt. Eine antihormonelle Therapie mit Anastrozol wurde durchgeführt und wird bis heute eingenommen.

Following an application from the European Natural Soyfood Manufacturers Association (ENSA), the European Vegetable Protein Federation (EUVEPRO) and the Soya Protein Association (SPA), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to isolated soy protein (ISP) and reduction of blood LDL-cholesterol concentrations, referring to disease risk reduction. The food constituent that is the subject of the health claim, ISP (as defined by the applicant), is sufficiently characterised in relation to the claimed effect. A reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of CHD. In weighing the evidence, the Panel took into account that under similar conditions four randomised controlled trials (RCTs) reported an effect of ISP on blood LDL/non-HDL cholesterol concentrations, whereas 14 RCTs did not report such an effect, and another RCT showed no consistent effects. The Panel also took into account that most of these RCTs were at high risk of bias, that differences in the results obtained between trials appear unrelated to the dose of ISP used, to sample size or to study duration, and that the evidence provided in support of a possible mechanism was not convincing. A cause and effect relationship has not been established between the consumption of ISP (as defined by the applicant) and a reduction in blood LDL-cholesterol concentrations. (C) European Food Safety Authority, 2012

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on a health claim pursuant to Article 13 of Regulation (EC) No 1924/ 2006 in the framework of further assessment in relation to Bifidobacterium animalis subsp. lactis LMG P-21384 and changes in bowel function. The food constituent that is the subject of the health claim, B. animalis subsp. lactis LMG P-21384, is sufficiently characterised. The claimed effect, 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 that it does not result in diarrhoea. No human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of B. animalis subsp. lactis LMG P-21384 and changes in bowel function. (C) European Food Safety Authority, 2012

The Panel on Dietetic Products, Nutrition and Allergies (NDA) has been asked by the European Food Safety Authority (EFSA) to draft guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. This guidance has been drawn from scientific opinions of the NDA Panel on such health claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document, endorsed by the NDA Panel on 25 March 2011, was released for public consultation from 26 April 2011 to 31 August 2011.

Following a request from the European Commission, pursuant to Article 13 of Regulation (EC) No 1924/2006, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim related to vitamin K2 and contribution to the normal function of the heart and blood vessels. The food constituent that is the subject of the claim, vitamin K2, is sufficiently characterised. The claimed effect, contribution to the normal function of the heart and blood vessels, is a beneficial physiological effect. The proposed target population is the general population. In weighing the evidence, the Panel took into account the absence of human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim, the inconsistency of the results reported in two cross-sectional studies regarding arterial calcification in women, that the results of two prospective cohort studies are in conflict regarding the risk of coronary heart disease associated with vitamin K2 intakes, that high intakes of vitamin K2 were associated with a significantly lower degree of aortic calcification in one prospective cohort study after adjustment for confounders, and that the evidence provided for a proposed mechanism is weak. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin K2 and contribution to the normal function of the heart and blood vessels.

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 deliver an opinion on the scientific substantiation of a health claim related to hyaluronic acid and protection of the skin against dehydration. The food constituent that is the subject of the health claim, hyaluronic acid, is sufficiently characterised. The claimed effect, protection of the skin against dehydration, is a beneficial physiological effect. The target population proposed by the applicant is the general population. No human studies have been 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 hyaluronic acid and protection of the skin against dehydration.

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

Lycopene extracted from tomatoes is authorised within the EU as food colouring agent (E160d). The lycopene oleoresin from tomatoes to be used as a novel food ingredient contains 5-15 % lycopene and is prepared by a production process identical to that for the production of the additive E160d, although E160d is prepared using an additional concentration step to obtain an oleoresin that contains 60-70 % lycopene.

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 was asked to deliver an opinion on the scientific substantiation of a health claim related to krill oil and maintenance of joint comfort. The Panel considers that krill oil is sufficiently characterised. The claimed effect proposed by the applicant is “helps to improve the comfort of sensitive joints”. The Panel considers that maintenance of joint comfort is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of krill oil and maintenance of joint comfort.

Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm®mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm®mix, which is the subject of the claim, is sufficiently characterised in relation to the claimed effect. Reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of coronary heart disease. The Panel notes that no evidence was provided that plant sterols or constituents other than plant sterols in Cholesternorm®mix, which have a role in the claimed effect, could reasonably be expected to have an effect on blood LDL-cholesterol concentrations at the proposed conditions of use. The Panel notes that no human interventions 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 a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations at the proposed conditions of use.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific opinion on the Tolerable Upper Intake Level (UL) of the n-3 LCPUFAs eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA). Available data are insufficient to establish a UL for n-3 LCPUFA (individually or combined) for any population group. At observed intake levels, consumption of n-3 LCPUFA has not been associated with adverse effects in healthy children or adults. Long-term supplemental intakes of EPA and DHA combined up to about 5 g/day do not appear to increase the risk of spontaneous bleeding episodes or bleeding complications, or affect glucose homeostasis immune function or lipid peroxidation, provided the oxidative stability of the n-3 LCPUFAs is guaranteed. Supplemental intakes of EPA and DHA combined at doses of 2 6 g/day, and of DHA at doses of 2 4 g/day, induce an increase in LDL-cholesterol concentrations of about 3 % which may not have an adverse effect on cardiovascular disease risk, whereas EPA at doses up to 4 g/day has no significant effect on LDL cholesterol. Supplemental intakes of EPA and DHA combined at doses up to 5 g/day, and supplemental intakes of EPA alone up to 1.8 g/day, do not raise safety concerns for adults. Dietary recommendations for EPA and DHA based on cardiovascular risk considerations for European adults are between 250 and 500 mg/day. Supplemental intakes of DHA alone up to about 1 g/day do not raise safety concerns for the general population. No data are available for DPA when consumed alone. In the majority of the human studies considered, fish oils, also containing DPA in generally unknown (but relatively low) amounts, were the source of EPA and DHA.

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 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for ‘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 that is isolated from cheese whey and skimmed milk, and purified. The applicant intends to add bLF to foods for particular nutritional uses, i.e. infant and follow-on formulae, dietary food for special medical purposes, dairy products, yoghurts and yoghurt drinks, and chewing gums. According to the applicant, the high intake estimate for infants would be 1.1 g bLF per day. For adults, the applicant’s calculation estimates a mean and 97.5th percentile intake of 0.6 and 2.1 mg/kg bodyweight per day, respectively, and a mean and 97.5th percentile daily intake of about 45 mg and 150 mg, respectively. The Panel notes that the safety of bLF as a novel food ingredient has already been assessed with a favourable outcome. That evaluation was to a significant extent based on safety data on bLF produced by Morinaga. The Panel also notes that the applicant intends maximum use levels of bLF in foods which are equivalent or lower than those intended by the applicant of the previous Opinion, and that the range of foods to which it is intended to add bLF is smaller. Consequently, the estimated intake levels described for the present application are comparable for infants and lower for all other population groups. The Panel concludes that the novel food ingredient, bLF, is safe under the proposed uses and use levels.

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 deliver an opinion on the scientific substantiation of a health claim related to Opti EFAX™ and maintenance of normal blood HDL-cholesterol concentrations. The food that is the subject of the health claim, Opti EFAX™, which is standardised pure krill oil, is sufficiently characterised in relation to the claimed effect. The claimed effect, maintenance of normal blood HDL-cholesterol concentrations, is a beneficial physiological effect. The target population proposed by the applicant is the general population. No human studies have been 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 Opti EFAX™ and maintenance of normal blood HDL-cholesterol concentrations.

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 a request from the European Commission, pursuant to Article 13.1 of Regulation (EC) No 1924/2006, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim related to isoleucine-proline-proline (IPP) and valine-proline-proline (VPP) and maintenance of normal blood pressure. The food constituent that is the subject of the claim, the tripeptides isoleucine-proline-proline (IPP) and valine-proline-proline (VPP), is sufficiently characterised. The claimed effect, maintenance of normal blood pressure, is a beneficial physiological effect. The proposed target population is the general population. In weighing the evidence, the Panel took into account that 15 of the human intervention studies provided, of which seven were adequately powered to detect small between-group differences in systolic blood pressure, did not observe an effect of IPP and VPP on systolic blood pressure or diastolic blood pressure; that interpretation of the results from nine out of the ten studies which reported an effect of IPP and VPP on office systolic blood pressure was limited by methodological weaknesses; that the animal and in vitro/ex vivo studies did not provide additional information on the effect of IPP and VPP on blood pressure in humans; and that there is no convincing evidence for a mechanism by which IPP and VPP could exert the claimed effect in humans at the proposed dose. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of IPP and VPP and maintenance of normal blood pressure. (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 health claim pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment related to Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms. The food constituent that is the subject of the health claim, Saccharomyces cerevisiae var. boulardii CNCM I-1079, is sufficiently characterised. The claimed effect, defence against pathogenic gastro-intestinal microorganisms, is a beneficial physiological effect. The proposed target population is the general population. The Panel notes that the evidence provided is not sufficient to establish that the strains Saccharomyces cerevisiae var. boulardii CNCM I-1079 and Saccharomyces cerevisiae var. boulardii Hansen CBS 5926, which were used in the studies provided, are identical, and considers that owing to the possibility that the effects are strain-specific, results obtained with one strain cannot be extrapolated to another strain. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Saccharomyces cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastro-intestinal microorganisms. (C) European Food Safety Authority, 2012

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to draft guidance on scientific requirements for health claims related to functions of the nervous system, including psychological functions. This guidance has been drawn from scientific opinions of the NDA Panel on such health claims. Thus, this guidance represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document will include an exhaustive list of beneficial effects and studies/outcome measures that are acceptable. Rather, it presents examples drawn from evaluations already carried out to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document was endorsed by the NDA Panel on 16 September 2011, and was released for public consultation from 17 October 2011 to 16 December 2011.

The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) to draft guidance on scientific requirements for health claims related to physical performance. This guidance has been drawn from scientific opinions of the NDA Panel on such health claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in this area. It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out in order to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document, endorsed by the NDA Panel on 24 November 2011, was released for public consultation from 19 December 2011 to 09 March 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 medium-chain triglycerides and reduction in body weight. 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 medium-chain triglycerides. In the context of the references provided, the Panel assumes that the food constituent which is the subject of the health claims is medium-chain fatty acids, which should replace long-chain fatty acids in triglycerides in order to obtain the claimed effect. The Panel considers that the food constituent, medium-chain fatty acids, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effect.The claimed effect is "weight management". The target population is assumed to be overweight individuals in the general population who wish to reduce their body weight. The Panel considers that reduction in body weight is a beneficial physiological effect.In weighing the evidence, the Panel took into account that the results from the human intervention studies provided are inconsistent with respect to the effects of medium-chain triglycerides on body weight loss, and that the evidence in support of a mechanism by which medium-chain triglycerides could exert the claimed effect is weak and not convincing.The Panel concludes that a cause and effect relationship has not been established between the consumption of medium-chain triglycerides and reduction in body weight.