The Novel Foods approval means UK-based supplier Naturis is authorised to use its ingredient in " yellow fat spreads, salad dressings, milk type products, fermented milk type products, soy drinks, and cheese type products" across the EU's 27 member states.
"This approval is significant because it strengthens our heart health range," Naturis product portfolio manager, Gary Smith, told NutraIngredients.com.
"Our initial focus will be spreads and dairy products as well as supplements.
We have held preliminary talks with companies in these areas and now that we have this approval can continue these discussions."
Products containing the company's ingredient derived from US-grown, non-GMO soy beans would be on shelves by year's end, he said.
The ingredient, for which branding was being established, would be marketed on its non-GMO (genetically modified organisms) status.
"We expect key players will be interested in a non-GMO product.
Co-branding may be an option if our clients are interested in that," Smith said, adding the company would focus on western European markets to begin with.
"But we have the distribution network in place to deal with eastern Europe and are looking at that too," he said.
The ingredient would be priced at about €13 per kilogram, similar to existing "tall oil" sterol offerings on the market.
Substantial equivalence Naturis applied for "substantial equivalence" to the UK Food Standards Agency (FSA) in February 2007 under EU Novel Foods regulations.
The application cost almost €2000.
The equivalent product referenced in the application is an Archer Daniels Midlands (ADM) offering called CardioAid.
In its positive opinion the FSA noted an absence of objections to the application and that the ingredient was indeed substantially equivalent to CardioAid.
FSA is "content that phytosterols sold by Naturis meets the criteria for equivalence" it said in its letter to Naturis.
Other major plant sterol suppliers include Cognis' Vegapure and Forbes MediTech's Reducol.
Cognis' Vegapure range - comprising free sterols, sterol esters and spray dried sterols - is used in rye breads, rolls, and rye-based crisp breads as well as dairy applications.
Finland's Raisio produces a plant stanol called Benecol that appears in a range of end-products bearing the same name, and which are the market leaders along with Unilever's pro.activ range.
Cargill is awaiting Novel Foods approval for its Corowise ingredient in a range of categories including juices.
Naturis is a €14m natural ingredient supplier that is part of the ACI Group.
It specialises in ingredients in the areas of heart, brain, digestive and bone health.
These include pre- and probiotics, beta-glucans, omega-3s and calcium.
About 4000 tons of plant sterols (excluding plant stanols) are sold in Europe each year.
Approved cholesterol-lowering claims for plant sterol/stanol products exist in most European countries as well as the US.