“Unilever is surprised by this move as in 2008 EFSA already reviewed studies looking at the intake of plant sterols and plant stanols in most European populations and did not raise concerns about the consumption of plant sterols outside of the target group,” a Unilever spokesperson told NutraIngredients.
The German Federal Institute for Risk Assessment (BfR) said a review was necessary after research indicated cardiovascular problems may be linked to overconsumption of sterol margarines, milks and breads by children and others that did not have raised cholesterol levels.
Unilever, maker of the plant sterol food brand, pro.activ, added: “The BfR’s call for a safety assessment on plant sterols is based on only one new study that reports no association between sterol consumption and a potential marker of CVD risk. The study only reports an association in one of the sub-analyses.”
The spokesperson said the German agency had disregarded other positive studies while focusing on the Dutch study (Kelly et al) that was published last year in Atherosclerosis. A Belgian intake study that showed high levels of plant sterol-stanol food consumption among children and wider population was also referenced by the BfR.
Plant sterols and stanols are backed by a European Union cholesterol-lowering health claim and are also approved in other jurisdictions such as Norway, Switzerland, the United States, Australia, New Zealand, South Africa, Brazil, Israel, Iceland, Japan and Canada.
“This study has not changed the consensus of scientific opinion that there is no link between plant sterol consumption and CVD [cardiovascular disease] risk, independent of the proven cholesterol lowering effect,” the Unilever spokesperson added.
Raisio, the Finnish stanol supplier and owner of the Benecol range of stanol-driven cholesterol-lowering foods, said the BfR call was an overreaction to very little data.
“Only associations between changes in serum plant sterols and vascular markers were described in the Kelly study,” said Raisio R&D director, Ingmar Wester.
“No significant effects on the vascular markers themselves were measured.”
Both companies affirmed that their products were labelled to indicate they were targeted at those with cholesterol issues.
“Unilever’s Flora/Becel pro.activ products all have clear labeling on pack, identifying the target groups for the product, as it is a compulsory requirement as the result of the novel foods approval,” Unilever aid.
Raisio added that there was evidence that non-cholesterol challenged people could also benefit from stanols-sterol consumption.
“Studies in children have shown that early childhood introduction of nutritional habits aimed at atherosclerosis prevention reduces children's serum total cholesterol concentration,” it said.
This included, “the consumption of foods with added plant stanol ester or plant sterol ester would be beneficial also for children.”
Stanols versus sterols
Raisio added that the 85-week Kelly study performed with 30 people differentiated between stanols and sterol effects.
“Both plant stanol ester and plant sterol ester lowered significantly LDL cholesterol. But, serum campesterol and sitosterol concentrations were increased in plant sterol users, reduced in plant stanol users, whereas no change was recorded in controls,” the company said.
“Retinal images were taken to measure microcirculation that is assumed to be an indirect marker of cardiovascular health. No statistically significant difference was detected amongst the three groups in retinal microvasculature. However, changes in serum campesterol concentration was associated with an increase in retinal venulardiameter.”
An EFSA spokesperson said the Parma, Italy-based agency had not, “received any requests to look into issues related to plant sterols and stanols.”