For cardiovascular health claims, EFSA’s NDA Panel seemed to embrace most of the generally accepted biomarkers. For antioxidant claims, EFSA stressed that physiological effects should be demonstrated in vivo.
The European Food Safety Authority (EFSA; Parma, Italy) has published draft guidance on scientific substantiation for health claims related to antioxidant, oxidative damage, and cardiovascular health. For cardiovascular health claims, EFSA’s NDA Panel seemed to embrace most of the generally accepted biomarkers. For antioxidant claims, EFSA stressed that physiological effects should be demonstrated in vivo.
EFSA addressed the biomarkers it considers generally acceptable in scientific substantiation for cardiovascular health claims, including LDL and HDL cholesterol, triglycerides, and blood pressure.
For foods stating that the absence or reduced content of a constituent is beneficial on LDL cholesterol, EFSA stated: “Substantiation may be based on evidence for an independent role of the food constituent in increasing LDL-cholesterol concentration. For example, for claims on a reduced content of saturated fatty acids (SFAs) in relation to blood LDL-cholesterol concentration, SFAs in mixed diets have been shown to increase blood LDL-cholesterol concentration when compared to carbohydrates which have a neutral effect on LDL-cholesterol concentration, and therefore SFAs in mixed diets have an independent role in increasing LDL-cholesterol concentration.”
For food stating that a replacement of a constituent is beneficial, EFSA stated: “Substantiation may be based on evidence for an independent role of the replaced food constituent in increasing LDL-cholesterol concentration, together with evidence for the lack of an effect or a reduced effect of the food constituent which is used for replacement (e.g. claims for unsaturated fats and reduced LDL-cholesterol concentration when replacing saturated fats).”
EFSA stated: “Maintenance of normal HDL-cholesterol concentration is a beneficial physiological effect as long as LDL-cholesterol concentration is not increased.”
EFSA stated that maintaining normal blood concentrations of triglycerides or a reduction in fasting triglyceride concentration within the normal range may be considered beneficial.
EFSA also addressed the study population: “With respect to the study population, results from studies conducted in hypertriglyceridaemic treated with lifestyle measures only (e.g. diet) could be used for the scientific substantiation claims. However, the rationale for extrapolation of results obtained in hypertriglyceridaemic under treatment with ‘triglyceride-lowering’ medications (e.g. fibrates) to the target the claim should be provided, and will be considered on a case-by-case basis (e.g. evidence of interaction between the food and the medications used on the claimed effect).”
EFSA stated that maintenance of normal blood pressure or reductions in blood pressure within the normal range is considered beneficial.
Regarding study population, it added: “With respect to the study population, results from studies conducted in hypertensive subjects treated with lifestyle measures only (e.g. diet) could be used for the scientific substantiation of these claims. However, the rationale for extrapolation of results obtained with blood pressure-lowering medications (e.g. ACE-inhibitors, calcium channel blockers and diuretics) to the target population will be considered on a case-by-case basis (e.g. evidence and the medications used on the claimed effect).”
Endothelial Function, Platelet Aggregation, Homocysteine
EFSA stated that an improvement in certain endothelial functions (e.g., endothelium-dependent vasodilation), decreasing platelet aggregation, and maintenance of normal homocysteine metabolism may be beneficial.
As per its usual disclaimer, EFSA noted: “It is not intended that the [guidance] document should include an exhaustive list of beneficial effects and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out in order to illustrate the approach of the NDA Panel, as well as some examples which are currently under consideration within ongoing evaluations.”
The agency is also currently working on or has released guidance on the following topics:
Guidance is meant to provide companies submitting applications for health claims with more information on the type of scientific substantiation that EFSA in general is seeking.