Following the draft guidance on the scientific requirements for health claims related to muscle function and physical performance being subject to public consultation during the summer (from 16 July to 2nd September 2018), EFSA has now published the final version of the document – “Guidance on the scientific requirements for health claims related to muscle function and physical performance”
This guidance is intended to support applicants in preparing their applications for the substantiation of health claims in this area. The document focuses on several key issues:
- examples of claimed effects which are considered to be beneficial physiological effects,
- definition of the target population for which the claim is intended;
- characteristics of the human intervention studies which can provide evidence for the scientific substantiation of specific claims addressed in this guidance (e.g. appropriate outcome variables and methods of measurement, suitable study group(s), suitable controls).
The guidance, however, does not intend to a) provide an exhaustive list of beneficial physiological effects and studies/outcome variables which could be acceptable for claim substantiation, or b) address potential health relationships and related outcome variables/methods of measurement which have not yet been considered by the Panel in the context of a particular application.
New in this update is the definition of terms to describe parameters related to physical exercise (e.g. physical fitness, physical activity, physical exercise, and physical performance), and exercise characteristics (e.g. intensity/load, frequency, duration, and mode/type). Also, a new addition to the guidance is a paragraph on claims based on the essentiality of nutrients, meaning nutrients that are required for normal human body function such as protein for growth or maintenance of muscle mass and magnesium for muscle function. In addition, more detailed information on accepted outcome parameters related to muscle function is provided.
Please refer to the full guidance document for a more comprehensive overview. Are you looking for regulatory and/or clinical support? Our team of experts is more than happy to support you on your claim substantiation journey.