New validated test method for phytosterols will bolster uptake of cholesterol-fighting ingredients, Cargill says

Cargill and FDA have jointly announced a new validated method for measuring the levels of plant sterols and stanols in foods and dietary supplements.  The method, developed over a number of years, is simpler, more accurate and less prone to error, experts say.

The method can reliably determine the content of the five major phytosterols (campesterol, campestanol, stigmasterol, beta-sitosterol, and sitostanol) that are the subject of the US Food and Drug Administration’s health claim on the relationship between phytosterols and the reduced risk of coronary heart disease.

“Historically there have been methods to verify the cholesterol content, but you don’t add cholesterol to foods,” Steve Hansen, principal scientist at Cargill Inc, told NutraIngredients-USA. 

“There were really no validated methods for measuring these phytosterols,” he said. “Some companies like Cargill and others had their own methods.”

One method, one standard

Hansen said a major goal of the method development was to make it as easy inexpensive and foolproof as possible.  And having one method means the quoted content of these materials can be more consistent across the industry.

“One of the benefits is that we made it very simple.  We’ve been doing it within Cargill for about 15 years (Hanson published a paper on the method in 2010). We do the extraction in one vessel and we use minimal solvents.  I actually see this a simpler method that is actually more elegant.  You really minimize the chances for error. It’s simple and it’s very precise and accurate,” he said.

Cargill markets its sterol ingredient under the Corowise brand name.  The ingredient shows up in a variety of products including baked goods, fortified milks and juices and chewable dietary supplements. 

The new method will figure into work done to promote the ingredients by the International Plant Sterols and Stanols Association (IPSSA), which was formed in 2015.

“IPSSA was formed mainly because we are looking at a global health problem,” said Alex Eapen, principal scientist in Cargill’s regulatory affairs group. “Cardiovascular disease is the No. 1 cause of death globally, and IPSSA was established to try to educate the public about the compelling evidence that plant sterols and stanols lowers that risk and reduces LDL cholesterol. The group also works to educate regulatory bodies about the safety of these ingredients.”

While those are brave words, IPSSA has since its inception had a relatively low profile on the international ingredient stage. Eapen said that is about to change.

“IPSSA does plan to sponsor one international scientific meeting a year.  The last one was held at the end of October at the University of Manitoba in Winnipeg. A communications committee has been formed and a plan is in place to develop some more B2C marketing,” he said.

Market for ingredients slowly ramping up

More marketing could only be a good thing.  The group, formed by six players – Danone, Raisio, Unilever, Cargill, BASF and Arboris – has a goal of  propelling these  cholesterol-lowering plant ingredients into the media and policy spotlights to raise awareness of the multi-billion dollar global category.

Plant stanols and sterols have regulator-backed, cholesterol-lowering health claims in the European Union, the US and parts of the world including Asia and south America, but the category has stalled in some mature markets as it has struggled to move beyond a core niche of typically older, heart disease-concerned people. Cargill said the global market for the ingredients stands at about 10,000 to 12,000 MT per year, with relatively modest growth. Nevertheless, one source puts the global market for all applications, including pharmaceuticals and feed, will grow to $7.2 billion by 2020.

In the EU products must deliver 1.5-2.4 g equivalents of plant sterols and/or plant stanols per day to bear coronary heart disease risk reduction health claims via cholesterol reduction.

In the US products must deliver at least 0.5 g per Reference Amount Customarily Consumed (RACC) for a total daily intake of 2 g plant sterols and/or plant stanols to bear the disease risk reduction health claim.