EU clears raft of sterol approvals

It will also boost sterol sales for the four companies concerned - the US-based Archer Daniels Midland (ADM), food giant Unilever and the smaller Finnish firms Teriaka and Pharmaconsult, which will license its Multibene technology for combining sterols with other nutrients to food manufacturers.

Last year the European phytosterol market was worth $75 million but Frost & Sullivan forecasts annual growth of 15 per cent, boosted by anticipated new product launches.

The approvals come more than two years after most companies made the initial applications under European novel foods regulations, which require that an ingredient not included in foods prior to 1997 must be assessed for safety by a scientific panel.

Plant sterols and sterol esters have already been widely available in other markets and often in some of the food applications only recently approved by the EU. ADM's sterol and sterol ester products have been sold for several years in food products in North America, Europe and East Asia.

But the Commission decision allows the use in European Union markets of the firm's plant sterols and sterol esters in products such as salad dressings including mayonnaise; milk type products such as semi and skimmed milks which may incorporate fruits and/or cereals; yellow fat spreads; fermented milk products such as yoghurt, soya drinks and cheese type products (in which the milk fat or protein has been partially replaced by vegetable fat or protein).

ADM noted that it is "the only significant supplier ofsterols and sterol esters granted Novel Foods authorisation"​.

Another North American sterol supplier, Forbes Medi-Tech is still waiting for novel foods approval for its Reducol, made with byproducts from wood processing. The ingredient could prove popular in Europe given its non-genetically modified source.

Teriaka's Diminicol, now approved for use in yellow fat spreads, milk-based fruit drinks and yoghurt and cheese-type products, is said to be 'completely natural', made by partly dissolving free plant sterols or stanols in water and food fat. Not requiring the costly esterification process, it is significantly cheaper than other sterol ingredients.

Meanwhile Unilever, category leader in the UK and several other European markets with its Flora ProActiv range, has gained approval for use of phytosterol esters in milk and milk-type products. Multibene can be used in yellow fat spreads, milk and yoghurt-type products and spicy sauces, such as dressings.

While the Commission has previously included labelling requirements specific to each novel foods approval, it has now released a generic regulation on phytosterol labeling, following the approvals of a number of different sterol products. This will also apply to sterol-based foods already on the market, such as those containing Raisio's Benecol.

The regulation has more detailed requirements for servings, recommended at up to 3 grams per day, and also includes a cholesterol reduction statement that can appear on food labels: 'This product is intended exclusively for people who want to lower their blood cholesterol level'.

This is likely to significantly raise consumer awareness of cholesterol-lowering foods.

The new approvals also come at a time when consumers are increasingly aware of the benefits of lowering cholesterol. Recent research shows that lowering cholesterol could have a more dramatic effect on heart disease risk than previously thought.