Valens, the Slovenian ingredients and supplements manufacturer, is celebrating its barley beta-glucan, LDL cholesterol-lowering health claims victory, it says would not have been possible without a “huge investment”.
The European Food Safety Authority’s Panel on Dietetic Products, Nutrition and Allergies (NDA) issued the positive article 14, disease risk factor reduction opinion this week. Agro giant Cargill was also issued a positive opinion for a similar claim for barley beta-glucan.
The Valens opinion related to its ingredient, Reduchol, which the NDA agreed could reduce the risk of heart disease if at least 3g are consumed per day.
“After a huge investment Valens International sees this as an important success which will enable even stronger health claims for producers using Reduchol in a wide range of food products,” said general manager, Jure Pavlic.
“prompt and supportive communication”
Pavlic praised the communication it had with the NDA during the process.
“Further, this opinion gives Valens International a competitive advantage when it comes to marketing its product. The health claim application was submitted in May 2011 and the prompt and supportive communication with the EFSA must be noted.”
“During the evaluation process, EFSA made it clear which additional information was required to perform the evaluation and VALENS Int. delivered all the requisite data on time. No stop-the-clock procedures were called for and Valens believes this is due to the high quality of the health claim application which was prepared with scientific support from the Nutrition Institute in Ljubljana, Slovenia.”
The dossier included eight studies deemed pertinent by the NDA – two meta analyses including one that contained 11 randomised clinical trials; there were a further six human studies.
Of 591 patients in those 11 trials barley beta-glucans lowered total and LDL cholesterol concentrations by 0.3mmol/L and by 0.27 mmol/L respectively. HDL-cholesterol concentrations were not affected.
Eight studies in the other meta-analysis showed 0.35mmol/L total cholesterol reduction and 0.26mmol/L lower in LDL cholesterol.
The NDA opinion can be found here.