The guidance affirms positions on biomarkers in cardiovascular health such as LDL and HDL cholesterol, triglycerides, and blood pressure and re-emphasised the need for clinical, human trials in antioxidant claims which have performed very poorly under the nutrition and health claims regulation (NHCR).
“Some comments were considered to be too detailed and technical to be covered in a guidance document, for example comments on experimental design and methods, statistical analysis or exhaustive lists of appropriate outcome measures for claimed effects,” the preamble to the received comments summary states.
“Given that health claims are often technically complex and unique, outcome measures for claimed effects need to be considered in the context of a specific application, and are difficult to cover in a guidance document.”
Kathy Musa-Veloso, Cantox International associate director in food and nutrition, said the guidance was “useful.”
“The guidance document has been revised to include blood pressure reductions within the normal range as beneficial in the context of function claims related to blood pressure, and also in relation to other health outcomes related to cardiovascular health,” she said.
“It clarified that reductions in homocysteine levels or increases in HDL concentrations cannot be used to support heart disease risk-reduction claims and that flow-mediated dilation is an example of a well-established in vivo method for assessing endothelium-dependent vasodilation.”
“Many other useful points of clarification have been included in the revised guidance document.”
Antioxidants players may be disappointed to see the guidance itself state: “It is not established that changes in the overall antioxidant capacity of plasma exert a beneficial physiological effect in humans…”
It goes on: “In the context of an adequate supply of these vitamins and essential minerals, a specific induction of antioxidant enzymes such as superoxide dismutase (SOD), catalase, glutathione peroxidase (GSH-Px) and haemoxigenase, or limiting the decrease in glutathione, is considered a beneficial physiological effect only if such changes provide (additional) protection of cells and molecules from oxidative damage, which should be demonstrated in vivo in humans.”
“Therefore, induction of antioxidant enzymes cannot be used alone as evidence for claims related to the ‘antioxidant defence system’ for non-essential food constituents.”
“Premature” and “healthy” ageing are considered too general and outside the scope of the regulation, while DNA protection is possible but, “changes in the overall antioxidant capacity of plasma” are not considered suitable outcome measures.
Protein and lipid protection claims are deemed possible, along with HDL and LDL cholesterol claims, triglyceride claims and blood pressure claims.
Disease versus disease risk factors
Key concerns raised by the 57 commenting parties included whether or not only reduction in disease risk factors but reduction in disease risk should be considered. EFSA responded: “…data on the reduction of the incidence of a disease can be used for the scientific substantiation of function claims if the disease denotes a clear dysfunction of a particular organ or tissue (e.g. data on coronary events can be used for the scientific substantiation of a health claim on normal cardiac function).”
Sustained versus long-lasting effects
Commenters wondered how long-term nutritional intervention benefits could be clinically demonstrated under the terms of the NHCR. EFSA responded that the, “the effect does not refer to the persistence of the effect after discontinuation of the food/constituent, but rather to the maintenance of the effect over time during continuous consumption of the food/constituent in order to exclude adaptation through compensatory mechanisms”.
The submitted comments can be found here.
The guidance can be found here.