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As part of a series of scientific opinions on dietary references values (DRVs) for micronutrients for the European population, the EFSAPanel on Dietetics Products, Nutrition and Allergies (NDA)is reviewing the scientific evidence to set DRVs for sodium. The protocol presented in this document describes the methodology that will beapplied for: i) the assessment of possible relationships between sodium intake and health outcomes, including dose-response relationship(s), where applicable, and ii) the integration of different lines of evidence for setting DRVs. In particular,systematic reviews on the relationship between sodium intake and blood pressure, cardiovascular disease, bone mineral density, bone mineral content, and osteoporotic fractures will be conducted. The protocol will be implemented in 2018. The outcome will be usedby the NDA Panel to completeits scientific opinion on DRVs for sodium.A public consultation will be organised once the scientific opinion is complete (Spring 2019; https://www.efsa.europa.eu/en/calls/consultations). This protocol will be published as an Annex to the scientific opinion (Annex A). Further information EFSA's work on DRVs: https://www.efsa.europa.eu/en/topics/topic/dietary-reference-values-and-dietary-guidelines

EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1495/full

EFSA asked the Panel on 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., This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1364/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1272/full

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on proline-specific oligopeptidase (Tolerase (R) G) as a novel food ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is an enzyme preparation of prolyl-oligopeptidase produced with a genetically modified Aspergillus niger self clone strain. The target population is the general adult population. The results from a bacterial reverse mutation test and of an in vitro chromosome aberration test did not indicate genotoxicity. The Panel considers that the reported effects observed in a 90-day rat study are treatment-related effects and can be attributed to the higher energy consumption by these animals. Taking into account the intended maximum use level for Tolerase (R) G, its daily consumption would correspond to 2,746 mg TOS/person or to 39.2 mg TOS/kg body weight (bw) per day, when considering a default body weight of 70 kg for an adult person. The margin between this value and the dose in the rats, which caused effects attributable to the excess energy intake, is approximately 45. Noting this margin, the Panel considers that it is unlikely that such effects would occur in human at the intended use levels. The Panel concludes that the NF, Tolerase (R) G, is safe for the intended use at the intended use level. (C) 2017 European Food Safety Authority.

Following an application from Laboratoires Nutrition et Cardiometabolisme, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Stablor (R) and decrease in visceral fat while preserving lean mass. The food Stablor (R), a drink preparation with defined macro- and micronutrient composition and a specific proportion of amino acids ( tryptophan to neutral amino acids ratio) which is the subject of the health claim, is sufficiently characterised. The Panel considers that reduction of visceral fat while maintaining lean body mass in the context of an energy restricted diet is a beneficial physiological effect in overweight or obese subjects with abdominal fat and cardiometabolic risk factors. Four human studies were submitted by the applicant as pertinent to the claimed effect. In weighing the evidence, the Panel took into account that one human study from which conclusions could be drawn for scientific substantiation of the claimed effect did not show an effect of Stablor (R) on visceral fat mass in the context of an energy restricted diet. The Panel concludes that a cause and effect relationship has not been established between the consumption of Stablor (R) and reduction of visceral fat while maintaining lean body mass in the context of an energy restricted diet. (C) 2017 European Food Safety Authority.

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 taxifolin‐rich extract from Dahurian Larch as a food ingredient in the context of Regulation (EC) No 258/97. The novel food (NF) is a taxifolin‐rich water–ethanol extract from the wood of the Dahurian Larch and contains a minimum of 90% taxifolin. The Panel considers that the taxifolin‐rich extract is sufficiently characterised and that its compositional data and specifications do not raise safety concerns. The NF is intended to be added to non‐alcoholic beverages, to yogurt and to chocolate confectionery. The Panel considers that the data on genotoxicity do not raise concern. In a subchronic rat study performed in accordance with OECD standards, the highest dose tested (i.e. 1,500 mg/kg bw) was considered to be the NOAEL. The margin of exposure (MOE) of the combined intake (158 mg) from the intended food uses (including 100 mg from food supplements) would result to about 660 for an adult weighing 70 kg. For adolescents, taking into account a default body weight of 45 kg, the MOE of the combined intake (146 mg) would be about 460. In the absence of a high percentile intake estimate for children between 9 and 14 years of age, the Panel considers the P97.5 intake estimate from the intended food uses (except from food supplements) for children between 10 and 17 years, i.e. 46 mg/day. Taking into account a default body weight of 29.4 kg (P5 body weight for children aged 10–14 years as suggested by EFSA Scientific Committee ()), the resulting MOE would be about 960.