At doses between 2.6 g and 3 g per day, the scientific literature showed stanols gave an average cholesterol reduction of 12%, compared to 8% for sterols, Mikko Laavainen, VP of licensed brands at Raisio, told us this morning.
“At these dosages they are not the same – that is what our analysis tells us so we would like the European Food Safety Authority (EFSA) to look at it. Is there an efficacy difference? We are confident there is.”
“We want EFSA to perform a separate evaluation of plant sterols at 2.6 g to 3 g.”
Raisio, along with Unilever and Danone, were among the first winners under the nutrition and health claims regulation back in 2008 when the EU gave the thumbs up to sterols and stanols ability to control cholesterol.
Laavainen said the high-dose results show the nutrients have significant molecular and efficacy differences that need to be recognised in claims and the law.
It is not the first time the company has raised the point as it did so two years ago in protest of similar US Food and Drug Administration grouping.
Finnish Member of the European Parliament (MEP) Sirpa Pietikäinen raised the matter in the summer when she asked, “Given the lack of precise scientific assessment of the properties of plant sterols and plant sterol esters, does the Commission deem the grouping together of plant stanols and sterols (both free and esterified) justified?”
She continued: “Does the Commission plan to mandate EFSA to separately assess the efficacy of plant sterols at an daily intake of 2.6 to 3.0 g without the inclusion of plant stanol ester data?”
Pietikäinen reintroduced the question to the Strasbourg, France, parliament this month.
Raisio was annoyed when EFSA’s NDA panel in May last year agreed to broaden and homogenise claims around stanols and sterols, following a Unilever application.