EFSA approved the Benecol claim submitted by McNeil Nutritionals, which has a licensing agreement with Benecol owner Raisio to distribute and market Benecol products in some countries including the UK.
Benecol is Finnish company, Raisio’s, flagship brand based on its plant stanol ester ingredients. Raisio and McNeil Nutritionals worked together on the claim dossier that included numerous human trials – indeed the dossier contained only human studies.
The article 14 disease reduction claim is exactly the same as the one approved by EFSA recently in response to Unilever’s plant sterol application.
It states: “Plant stanol esters have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease.”
Ingmar Vester, the research and development director of Raisio’s ingredients division, said Raisio was “very pleased” about the EFSA decision, which meant it was business as usual for Benecol products throughout the 27-Member State European Union.
“We knew that our human data was very strong and Unilever’s plant sterol cholesterol-lowering claim was approved some time ago so we were confident,” he told NutraIngredients.com. “We now look forward to the claim being officially approved by the European Commission.”
Raisio said it expected that process to take about 3-4 months.
Along with the Benecol verdict, EFSA also issued negative opinions for a further four article 14 claims relating children’s development and omega-3 consumption and submitted by Pharma Consulting & Industries.
Parma, Italy-based EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found insufficient evidence backed claims for children’s brain health in the areas of “mental development”, “concentration”, “thinking capacity” and “learning ability”.
The negative opinions come on the back of three otheromega-3 claims submitted by Pharma Consulting & Industries relating to eye health, “calming” and “serenity” that were not accepted by the NDA.
In all cases a “cause and effect relationship … [was not] … established between the consumption of EPA and DHA” and the particular type of mental development.
In some cases such as “thinking capacity”, these benefits were deemed by EFSA to not be sufficiently defined.
The NDA said in its Benecol opinion: “On the basis of the data presented, a clinically significant LDL-cholesterol lowering effect of about 10 per cent can be achieved by a daily intake of plant stanol esters equivalent to 2g of plant stanols in an appropriate food (e.g. fat-based foods and low-fat foods such as yoghurt), preferably with meals.”
It noted the scale of the cholesterol-lowering effect may differ in other food matrices, but concluded, “a cause-effect relationship has been established betweenthe intake of plant stanol esters and lowering of LDL-cholesterol, in a dose-dependent manner.”
It added the products should only be consumed by “people who need and want to lower their blood cholesterol and that patients on cholesterol-lowering medication should only consume the product under medical supervision.”
It is expected the European Commission will deliver decisions on some of EFSA’s opinions by year’s end. EFSA has about 200 further article 14 claims and 2500 article 13 claims to be assessed by January 31, 2010.
So far it has ruled on 22 claims, with positive opinions issued on five.
To access EFSA’s article 14 opinions click here.