Guidance on the scientific requirements for health claims related to muscle function and physical performance (Revision 1)

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 The draft guidance was subject to public consultation from 16 July to 2 September 2018.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

Scientific Opinion on the substantiation of a health claim related to Rosbacher drive^® and increased attention pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Hassia Mineralquellen GmbH & Co KG, 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 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 Rosbacher drive® and increased attention. The Panel considers that Rosbacher drive®, which contains natural mineral water plus grape juice, lemon juice, pomegranate juice, elderberry juice, isomaltulose, sucrose, fructose syrup, caffeine, ascorbic acid and natural flavourings, is sufficiently characterised. The claimed effect, increased attention, is a beneficial physiological effect. The single study which was carried out with Rosbacher drive® was an open-label, non-randomised sequential study and the study did not report on any outcomes of attention. 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 Rosbacher drive® and increased attention

Safety of synthetic N-acetyl-d-neuraminic acid as a novel food pursuant to Regulation (EC) No 258/97

Non peer reviewe

Assessment of genetically modified maize Bt11\ua0x\ua0MIR162\ua0x\ua01507\ua0x\ua0GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No\ua01829/2003 (application EFSA-GMO-DE-2010-86)

In this opinion, the GMO Panel\ua0assessed the four-event stack maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 and three of its subcombinations, independently of their origin. The GMO Panel\ua0previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four-event stack maize did not give rise to food/feed safety issues.\ua0Based on the nutritional assessment of the compositional characteristics of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non-GM maize varieties. In the case of\ua0accidental release of viable grains of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 into the environment, this\ua0would not raise environmental safety concerns. The GMO Panel\ua0concludes that maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 is nutritionally equivalent to and as safe as its non-GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel\ua0assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11\ua0 7\ua0MIR162\ua0 7\ua01507\ua0 7\ua0GA21 and its subcombinations. A minority opinion expressed by a GMO Panel\ua0member is appended to this opinion

Dietary Reference Values for riboflavin

Non peer reviewe

Safety of phenylcapsaicin as a novel food pursuant to Regulation (EU) 2015/2283

Peer reviewedPublisher PD

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts : evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Peer reviewedPublisher PD

GlycoLite™ and helps to reduce body weight : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewedPublisher PD