The article 14 disease reduction opinion was delivered after requests for claim authorisation advice from the European Commission and France, and collates data backing three positive stanol/sterol cholesterol-lowering opinions issued to date.
The third of these was publicised on Friday – for Danone’s Danacol – along with the general opinion and means the biggest three players in the area have all earned positive opinions – with Unilever’s pro.activ and Raisio/McNeill Nutritional’s Benecol also winning positive opinions from the assessor last year.
The opinion – which references more than 80 clinical trials and issues guidance on dosage between 1.5 and 2.4g of plant sterols and stanols – notes the benefits have been demonstrated in margarines, mayonnaise, salad dressings, milk, yoghurts and cheese but less so in other formats.
A Unilever spokesperson told NutraIngredients.com this morning the company was “delighted” with the opinion.
"Once the approval process is completed, we look forward to being able to link the benefits of a daily intake of plant sterols from Becel/Flora pro.activ cholesterol products for reducing the risk of heart disease,” she said.
A Danone spokesperson said the opinions were, "recognition of Danacol's efficiency and of the value of the scientific research conducted by Danone."
The opinion, like all EFSA health claim opinions, now requires authorisation by the Commission and member states.
Raisio was not able to be contacted before publication.
An EFSA spokesperson said the opinion, the first EFSA has issued of its kind, was “an important piece of work”, as it would directly and concisely assist the risk managers – the Commission and the member states – to implement EFSA’s opinions in the form of on-market health claims.
“It advises them in how to behave in the claims authorisation process,” she said, noting the EC may request further similar advice in relation to other nutrient areas.
Two-ish gram optimum
The new general opinion highlighted meta-analyses conducted on some of the 80 clinical trials and found sterols and stanols could be effective in reducing LDL-cholesterol levels in a dose dependent manner up to “about 2g” per day. After that there was a tapering-off effect.
Sterols and stanols were equally efficient, said EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).
More precisely, the NDA said dosage between 1.5g-1.9g of stanols/sterols could lower LDL cholesterol levels by 8.5 per cent, while daily dosage between 2g and 2.4g could reduce cholesterol by 8.9 per cent.
Across the dose range – 1.5g-2.4g – an average reduction of between seven and 10.5 per cent was noted.
“The Panel considers that such a reduction is of biological significance in terms of reduced risk of coronary heart disease,” the NDA summarised.
It said while a cholesterol-lowering effect could usually be observed after 2-3 weeks, ongoing consumption in studies had shown effects up to 85 weeks.
The same claim has been issued for all three dossiers. It reads: “Plant stanol esters have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease.”
The NDA's plant sterol/stanol opinion can be found here.
Its Danacol opinion can be found here.