International comparison of cosmetic outcomes of breast conserving surgery and radiation therapy for women with ductal carcinoma in situ of the breast

Purpose: To assess the cosmetic impact of breast conserving surgery (BCS), whole breast irradiation (WBI) fractionation and tumour bed boost (TBB) use in a phase III trial for women with ductal carcinoma in situ (DCIS) of the breast. Materials and methods: Baseline and 3-year cosmesis were assessed using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System and digital images in a randomised trial of non-low risk DCIS treated with postoperative WBI +/- TBB. Baseline cosmesis was assessed for four geographic clusters of treating centres. Cosmetic failure was a global score of fair or poor. Cosmetic deterioration was a score change from excellent or good at baseline to fair or poor at three years. Odds ratios for cosmetic deterioration by WBI dose-fractionation and TBB use were calculated for both scoring systems. Results: 1608 women were enrolled from 11 countries between 2007 and 2014. 85-90% had excellent or good baseline cosmesis independent of geography or assessment method. TBB (16 Gy in 8 fractions) was associated with a >2-fold risk of cosmetic deterioration (p

A fixed carbohydrate: protein ratio <= 1.8 on an energy basis consumed in the context of an energy-restricted diet and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

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 &lt;= 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 No conclusions could be drawn from two unpublished studies investigating the effect of ready-to-eat meals with a CHO: P ratio &lt;= 1.8 on body weight. The remaining 14 human intervention studies investigated the effect of diets targeting a CHO: P ratio &lt;= 1.8 as compared to diets targeting a CHO: P ratio &gt;= 3.0 on overweight and obese adults in the context of energy restriction. Four out of seven studies lasting &lt; 12 weeks reported an effect of a CHO: P ratio &lt;= 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 &lt;= 1.8 on an energy basis consumed in the context of an energy-restricted diet and reduction of body weight. (C) 2017 European Food Safety Authority

Vibigaba (germinated brown rice) and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood pressure. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Vibigaba. The Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal blood pressure'. The Panelconsiders that maintenance of normal blood pressure is a beneficial physiological effect. The Panelnotes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to theclaim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention study as being pertinent to the claim. The Panelnotes theimportant methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood pressure.Non peer reviewe

Curcumin and normal functioning of joints: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Suomen Terveysravinto Oy, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to curcumin and normal functioning of joints. The food that is proposed as the subject of the health claim is curcumin. The Panel considers that curcumin is sufficiently characterised. The claimed effect proposed by the applicant is 'normal functioning of joints by reducing the biomarkers of inflammation'. The target population proposed by the applicant is the general population. Upon a request from EFSA to clarify whether the claimed effect is related to the normal function of joints or rather to the reduction of inflammation, the applicant did not address this issue in the reply. The Panel assumes that the claimed effect refers to the maintenance of joint function. The Panel considers that maintenance of joint function is a beneficial physiological effect. The Panel considers that no conclusions can be drawn from 15 human intervention studies conducted in patients with osteoarthritis or rheumatoid arthritis and from one study in obese subjects on serum cytokines for the scientific substantiation of the claim. In the absence of evidence for an effect of curcumin on the normal function of joints in humans, the results of the human studies on curcumin pharmacokinetics, safety and mechanistic studies, the animal studies and the in vitro studies submitted by the applicant cannot be used as a source of data for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of curcumin and maintenance of joint function. (C) 2017 European Food Safety Authority

Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

EFSA asked the Panelon Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. The update takes into accounts experiences gained with evaluation of additional health claim applications related to antioxidants, oxidative damage and cardiovascular health, and the information collected from a Grant launched in 2014. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the antioxidants, oxidative damage and cardiovascular health. The document was subject to public consultation (from 12 July to 3 September 2017). This document supersedes the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims

Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol concentration: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood cholesterol concentrations. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Vibigaba. The Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal blood cholesterol levels'. The Panelconsiders that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect. The Panelnotes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention s being pertinent to the claim. The Panelnotes the important methodological limitations of the study study a(e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol concentration.Non peer reviewe

Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Vibigaba. The Panelconsiders that the germinated brown rice Vibigaba is sufficiently characterised. The claimed effect proposed by the applicant is contribution to the maintenance of normal glycated haemoglobin level'. The Panelconsiders that maintenance of long-term normal blood glucose concentration is a beneficial physiological effect. The Panelnotes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim. The applicant did not reply to a specific request from EFSA to provide this information. The applicant identified one human intervention study as being pertinent to the claim. The Panelnotes the important methodological limitations of the study (e.g. statistical methods used for data analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration.Non peer reviewe

Lactobacillus\ua0fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No\ua01924/2006

Following an application from Biosearch Life, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No1924/2006 via the Competent Authority of France, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Lactobacillusfermentum CECT 5716 and decreases the Staphylococcus load in breast milk. High Staphylococcus load in breast milk is a risk factor for infectious mastitis. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The Panelconsiders that Lactobacillusfermentum CECT 5716 is sufficiently characterised. In the context of this application, the Staphylococcus load in breast milk can be considered a risk factor for the development of infectious mastitis, as long as evidence is provided that the consumption of Lactobacillusfermentum CECT 5716 reduces the Staphylococcus load in breast milk as well as the incidence of infectious mastitis. Three human intervention studies investigated the effect of Lactobacillus fermentum CECT 5716 on the Staphylococcus load of breast milk in lactating women. One of these studies was conducted in lactating women free of infectious mastitis at baseline. The Panelconsiders that no conclusions can be drawn from this study for the scientific substantiation of the claim owing to important methodological limitations. The other two studies were conducted in lactating women with infectious mastitis and, therefore, the effect of the intervention on the incidence of infectious mastitis cannot be assessed. The Panelconcludes that a cause and effect relationship has not been established between the consumption of Lactobacillusfermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis

Sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque which reduces the risk of dental caries : evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Cargill R&D Centre Europe, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No1924/2006 via the Competent Authority of Belgium, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque which reduces the risk of caries. The food proposed by the applicant as the subject of the health claim, sugar-free hard confectionery with at least 90% erythritol, is sufficiently characterised. In the context of this application, the weight of dental plaque, and/or the counts of Streptococcusmutans in dental plaque, and/or the concentration of organic acids in plaque (primarily acetic acid and lactic acid) can be considered as risk factor(s) in the development of dental caries, as long as evidence is provided that the consumption of the food that is the subject of the health claim reduces one or more of the proposed risk factors and the incidence of dental caries. One human intervention study did not show an effect of sugar-free hard confectionery with at least 90% erythritol on the incidence of dental caries in children on either mixed or permanent dentition. The Panelconcludes that a cause and effect relationship has not been established between the consumption of sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque which reduces the risk of dental caries.Non peer reviewe