Putting aside European Union-wide approval of the nutrient to safely deliver cholesterol-reducing benefits, Germany’s Federal Institute for Risk Assessment (BfR) said some research showed consumption of sterol-stanol fortified foods like breads, milks and margarines among the non-cholesterol challenged could be problematic.
It called on the European Food Safety Authority (EFSA) to perform a safety review of the nutrient after a literature scan highlighted potential health issues, especially a Dutch study published in 2011 in Atherosclerosis that signaled potential cardiovascular problems via retinal analysis.
“The results of this study provide evidence that the record intake of plant sterols in healthy individuals, the plant sterol-containing foods in larger amounts or over a long period, may be associated with cardiovascular risks," the BfR stated.
It noted another Belgian study published in the British Journal of Nutrition that showed 21% of pre-school children in a particular Flemish region regularly ate foods with phytosterols, along with 58% of adults.
Harald Dittmar, managing director of the German Association of Food Supplements, Cosmetics and Pharmaceuticals (BDIH), said members of his group had been informed of the BfR call, but noted there was no legal requirement to take any action.
“Of course it is important manufacturers take care for the health of the consumer but this ingredient has been through the European approval process already and so it can still be used as a food ingredient,” he said.
EFSA has not indicated whether it would heed the BfR call.
EFSA on plant stanols and sterols
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) affirmed in 2010 the efficacy of plant sterols and stanols. In that opinion it noted, “Over 80 randomised, controlled trials have investigated the effect of plant sterols/plant stanols added to a wide range of food formats on blood concentrations of LDL-cholesterol.”
“A number of meta-analyses on these trials has shown that plant sterols/plant stanols lower LDL cholesterol in a dose-dependent manner with the effect appearing to taper off at daily intakes greater that about 2g. The efficacy for lowering LDL-cholesterol is similar for plant sterols and plant stanols.”
“The Panel concludes that for an intake of 1.5-2.4g/d an average reduction of between 7 and 10.5% can be expected. The Panel considers that such a reduction is of biological significance in terms of reduced risk of coronary heart disease.”
“The Panel concludes that the blood LDL cholesterol lowering effect is usually established within the first 2-3 weeks and can be sustained by a continued consumption of plant sterols/stanols. This effect has been shown up to 85 weeks.”