Managing director Ruedi Duss said his company had been contacted “about four times” by EFSA’s Panel on Dietetic Products, Nutrition and Allergies with questions about its €2m dossier.
“They had many questions and our exchanges with them were very constructive, especially as we submitted the claim before any of the subsequent clarifications about the process became apparent,” Duss said.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that CreaNutrition’s dossier demonstrated the cholesterol-lowering effect if 3g per day were consumed.
The submission contained 22 references including three meta-analyses and 19 randomised controlled trials.
The NDA opinion can be found here.
Duss said the opinion, if ratified by the European Commission and member states, would greatly assist a small company like CreaNutrition in its marketing efforts.
He said it was potentially more useful than the generic article 13 submission that has won a positive opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) but which relates to maintenance, rather than reduction of normal blood cholesterol concentrations.
For CreaNutrition’s article 14 submission, the NDA said the following claim represented the science: “Oat beta-glucan has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of (coronary) heart disease.”