EFSA stands by snub on stanol-sterol cholesterol lowering extension

By Nathan Gray contact

- Last updated on GMT

Europe’s health claims regulator says it stands by a previous rebuttal of industry suggestions that the approved time for plant stanols and sterols to achieve cholesterol lowering effects be shortened from 2-3 weeks to 1-2 weeks.

Earlier this year the European Food Safety Authority (EFSA) concluded that plant stanols, sterols, and stanol esters, could more powerfully reduce cholesterol after assessing fresh data submitted by category leaders Raisio and Unilever. EFSA said sterol-stanol consumption of 1.5-3g per day for 2-3 weeks could lower LDL cholesterol by 11.3 or 11.4% respectively – and therefore reduce the risk of coronary heart disease.

At the time however​, the regulator also rebuffed a suggestion of both companies that the approved time to achieve the effects be shortened from 2-3 weeks to 1-2 weeks, in addition to refusing an extension for stanol-sterol claims to be applied to other new food forms including “fat spreads, dairy products, cheese, rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat based milk drinks.”

Comments submitted by Raisio Nutritional Ltd after the EFSA opinion questioned stance taken, by the regulator, with particular reference to the ‘transparency and consistency’ of EFSA’s Dietetic Products, Nutrition and Allergies (NDA) panel conclusion.

In response to the feedback from Raisio, EFSA said that the comments do not change its initial conclusions: “The minimum duration required to achieve the maximum effect of plant sterols and stanols on LDL-cholesterol lowering is two to three weeks. The comments received do not change the conclusions of the NDA Panel.”

EFSA added that while plant stanol esters added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol levels, “the size of the cholesterol-lowering effect of plant stanols added to other food formats is less well established,”

The full responses to the comments can be found here for stanol esters​ and here for stanols-sterols​.

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1 comment

yes but...

Posted by Ed Terry,

Plant sterols do lower serum cholesterol but they are not harmless. In high enough doses, plant sterols can take the place of cholesterol in cell membranes, resulting in membranes that are more fragile and more susceptible to damage.

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