The two approvals are for Raisio/McNeil Nutritional’s Benecol and Unilever’s pro.activ and mean the companies’ products can continue making cholesterol-lowering claims that state:
“Plant stanol/sterol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.”
Danone’s Danacol has also been handed a positive opinion by the European Food Safety Authority (EFSA), but has yet to pass through the European Commission and member state process and into the official Community register of laws, as it was assessed by EFSA at a later date.
First off the rank
Benecol and pro.activ are the first to obtain regulatory approval for the use of a disease risk reduction health claim under the 2006 nutrition and health claim regulations. There were five other article 14 claims approved but these were for children’s health claims relating to calcium, vitamin D, protein and omega-3.
Fourteen rejected claims including those from BioSerae (cholesterol reduction), Valio (arterial stiffening) and Martek (neural development of brain and eyes) were also published and are now law.
One authorisation application was withdrawn by the applicant and another will be the subject of further review.
Products across the European Union’s 27 member states have six months to bring their claims in line with the approved and rejected lists.
To see the register of published claims click here.
Raisio welcomed the fact its claim had won official approval. “This is the first authorisation for a disease risk reduction claim granted to food products within the European Community, and thereby represents an important landmark in European decision-making.”
The company said that the favourable scientific opinion from EFSA would “revolutionise” the use of health claims in Europe. And it would make it easier for consumers to choose food products with scientifically proven and validated effect.
Ingmar Wester, research and development director at the company’s ingredients division added: “The approval from the EU Commission strengthens the pioneering role of plant stanol ester used in Benecol products as an effective cholesterol-lowering food ingredient. We are very pleased with the approval.”
Unilever was not available for comment at the time of publication.
Coronary heart disease
The value of the European cholesterol-lowering market, including food supplements and functional foods, has been estimated at more than €500m.
The approvals come amidst a batch of more than 175 claims relating to cholesterol and cardiovascular health that are due for review by EFSA, some of which appeared in the first batch of article 13.1 health claim opinions and most of which received negative opinions.
High cholesterol is one the main causes of Coronary Heart Disease (CHD); the most common cause of death in the UK, according to the British Heart Foundation. Of the 94,000 UK deaths attributed to CHD each year, about 40 per cent are linked to high cholesterol levels.
In the summary of its scientific opinion, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found: “…1.5 - 1.9 g and 2.0 - 2.4 g plant sterols/plant stanols per day was observed to lower blood LDL-cholesterol by an average of 8.5 % and 8.9 %, respectively. The Panel concludes that for an intake of 1.5 - 2.4 g/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.”