Guidance on the scientific requirements for health claims related to muscle function and physical performance

Nutrition, Novel Foods Efsa Panel on; Turck, Dominique; Castenmiller, Jacqueline; Henauw, Stefaan De; Hirsch‐Ernst, Karen Ildico; Kearney, John; Knutsen, Helle Katrine; Maciuk, Alexandre; Mangelsdorf, Inge; McArdle, Harry J; Naska, Androniki; Peláez, Carmen; Pentieva, Kristina; Thiès, Frank; Tsabouri, Sophia; Bresson, Jean‐Louis; Burlingame, Barbara; Dean, Tara; Fairweather‐Tait, Susan J.; Heinonen, Marina; Neuhäuser‐Berthold, Monika; Nowicka, Grażyna; Sanz, Yolanda; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Loveren, Henk Van; Willatts, Peter; Martin, Ambroise; Strain, J. J.; Heng, Leng; Martínez, Silvia Valtueña; Siani, Alfonso

doi:10.2903/j.efsa.2018.5434

Cited by 9 publications

(3 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The proportion of essential amino acids (34–37%) makes CSE a good source of indispensable amino acids (Table 1). The claimed effects related to amino acids are growth or maintenance of muscle mass, maintenance of normal muscle function, faster recovery of muscle function/strength/glycogen stores after exercise, faster recovery from muscle fatigue after exercise and skeletal muscle tissue repair [33]. However, these claimed effects are not established in terms of a cause–effect relationship and have been evaluated by the EFSA Panel with an unfavorable opinion [33].…”

Section: Discussionmentioning

confidence: 99%

Coffee Silverskin Extract: Nutritional Value, Safety and Effect on Key Biological Functions

et al. 2019

View full text Add to dashboard Cite

This study aimed to complete the scientific basis for the validation of a coffee silverskin extract (CSE) as a novel food ingredient according to European legislation. Nutritional value, safety, effects on biochemical biomarkers and excretion of short chain fatty acids (SCFAs) in vivo of CSE were assessed. Proteins, amino acids, fat, fatty acids, fiber, simple sugars and micronutrients were analyzed. For the first time, toxicological and physiological effects were evaluated in vivo by a repeated-dose study in healthy Wistar rats. Hormone secretion, antioxidant (enzymatic and no-enzymatic) and anti-inflammatory biomarkers, and dietary fiber fermentability of CSE (analysis of SCFAs in feces) were studied in biological samples. This unique research confirms the feasibility of CSE as a human dietary supplement with several nutrition claims: “source of proteins (16%), potassium, magnesium, calcium and vitamin C, low in fat (0.44%) and high in fiber (22%)”. This is the first report demonstrating that its oral administration (1 g/kg) for 28 days is innocuous. Hormone secretion, antioxidant or anti-inflammatory biomarkers were not affected in heathy animals. Total SCFAs derived from CSE fiber fermentation were significantly higher (p < 0.05) in male treated rats compared to male control rats. All the new information pinpoints CSE as a natural, sustainable and safe food ingredient containing fermentable fiber able to produce SCFAs with beneficial effects on gut microbiota.

show abstract

Section: Discussionmentioning

confidence: 99%

Coffee Silverskin Extract: Nutritional Value, Safety and Effect on Key Biological Functions

et al. 2019

View full text Add to dashboard Cite

show abstract

“…The table is categorized according to health domain, although it should be noted that this is somewhat arbitrary, as an overlap often exists between these domains in terms of regulation and effects of intervention (see Section 5.2 ). The table includes data from the guidance documents on the scientific requirements for health claims issued by EFSA [ 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 , 116 ], however without consequently following the same categorization. These EFSA documents provide useful background information, definitions, pitfalls and points of attention and are revised from time to time using the experience gained during the evaluations.…”

Section: Assessing Health Optimisation In Non-diseased Individualsmentioning

confidence: 99%

Nutrition to Optimise Human Health—How to Obtain Physiological Substantiation?

Witkamp

2021

Nutrients

View full text Add to dashboard Cite

Demonstrating in an unambiguous manner that a diet, let alone a single product, ‘optimizes’ health, presents an enormous challenge. The least complicated is when the starting situation is clearly suboptimal, like with nutritional deficiencies, malnutrition, unfavourable lifestyle, or due to disease or ageing. Here, desired improvements and intervention strategies may to some extent be clear. However, even then situations require approaches that take into account interactions between nutrients and other factors, complex dose-effect relationships etc. More challenging is to substantiate that a diet or a specific product optimizes health in the general population, which comes down to achieve perceived, ‘non-medical’ or future health benefits in predominantly healthy persons. Presumed underlying mechanisms involve effects of non-nutritional components with subtle and slowly occurring physiological effects that may be difficult to translate into measurable outcomes. Most promising strategies combine classical physiological concepts with those of ‘multi-omics’ and systems biology. Resilience-the ability to maintain or regain homeostasis in response to stressors-is often used as proxy for a particular health domain. Next to this, quantifying health requires personalized strategies, measurements preferably carried out remotely, real-time and in a normal living environment, and experimental designs other than randomized controlled trials (RCTs), for example N-of-1 trials.

show abstract

“…The revised guidance was discussed and adopted at the NDA Plenary meeting on 27 September 2018, and is published in the EFSA Journal (EFSA NDA Panel, 2018). EFSA is committed to publishing the comments received during the public consultation, as well as a short report on the outcome of the consultation.…”

Section: Considerationmentioning

confidence: 99%

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

2018

EFSA Supporting Publications

View full text Add to dashboard Cite

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation at its plenary meeting on 28 June 2018. The written public consultation was open from 16 July to 2 September 2018. EFSA received comments from three interested parties. EFSA and its NDA Panel wish to thank all stakeholders for their contributions. The present report summarises the outcome of the public consultation, and includes a summary of the comments received and how they were addressed. In particular, the report describes the revisions of the draft guidance that have been applied in light of the comments received. The guidance was discussed and adopted at the NDA Plenary meeting on 27 September 2018, and is published in the EFSA Journal.

show abstract

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Cited by 9 publications

References 27 publications

Coffee Silverskin Extract: Nutritional Value, Safety and Effect on Key Biological Functions

Coffee Silverskin Extract: Nutritional Value, Safety and Effect on Key Biological Functions

Nutrition to Optimise Human Health—How to Obtain Physiological Substantiation?

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Contact Info

Product

Resources

About