EFSA denies sterol/stanol claim expansion appeal

By Shane Starling

- Last updated on GMT

Related tags European union

The European Food safety Authority (EFSA) rejected a submission from a Dutch plant sterol supplements firm calling for the EU approved, cholesterol-lowering health claim to be expanded to food supplements and other food categories.

The EFSA claim that was written into EU law in October, 2009, permits products to state benefits can be gained with 2g consumption per day on spreads, mayonnaise, salad dressings and dairy products, but not food supplements or any other food group.

A more general claim that sterol/stanol consumption can be beneficial can however be utilised by food supplements and other foodstuffs.

It can be found here​.

In its submission to the European Commission dated August 25, 2009, Innoceutics managing director, Dirk Verhaeghe, said meta analyses, including those submitted to EFSA by applicants, indicated benefits beyond the categories that appear in the claim and called for its revision before it entered the legislature.

What? When? With what?

He said one meta analysis of 601 studies provided ample evidence that, “all food formats should be eligible for the disease reduction claim for plant sterols/stanols”.

Verhaeghe said the claim should be refined to reflect the benefits of consuming sterols and stanols in more than one sitting and at certain times (i.e. with a meal).

But EFSA, in referencing the same studies, said the evidence was not strong enough.

“The Panel acknowledge that some evidence suggest an impact of the time and frequency on the LDL-cholesterol-lowering effect, but did not find the database sufficient to draw firm conclusions on this aspect.”

It said while foods such as gel capsules, tablets, chocolate, orange juice, croissants and pasta had shown cholesterol-lowering effects, the number of studies was too limited and results inconsistent to draw firm cholesterol-lowering conclusions.

Sterols v stanols

EFSA also addressed a request from Finnish-based stanols specialist and Benecol brand owner, Raisio, for a distinction between the effectiveness of stanols and sterols, after a study showed increased cholesterol-lowering benefits for stanols in dosages above 3g per day.

The agency did not engage the request because it had focused on doses up to 2.4g per day, it said, a level at which no difference in efficacy had been detected.

The official claim states that a cholesterol-lowering benefit can be achieved with consumption of 2g of sterols or stanols per day.

Conflict of interest

Innoceutics also drew attention to stated conflicts of interest between EFSA Panel members with links to Danone and Unilever, which EFSA dismissed noting all Panel members were, “scrutinized carefully in accordance with the EFSA procedure for identifying and handling potential declarations of interest.”

“EFSA concluded that the experts did not have a conflict of interest in relation to an advice given to the European Commission to ensure that conditions of use are given in a coherent way for health claims related to plant sterols and stanols and lowering of LDL-cholesterol. This advice was considered to be of a general nature and not directly related to any food business operator.”

Innoceutics' submission and EFSA’s response can be found at the bottom of this page​.

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