Considering the potential health risks therefore, the SCF felt that consumers needed greater clarification on products containing these substances.
As a result, the use of the word 'phyto' is to be replaced by the word 'plant' because it is felt that consumers have a better understanding of this word. In addition, the words 'with added plant stanols/plant sterols' must be in the same field of vision as the name of the product, and the amount of plant sterols/stanols per 100g or per 100 ml must be given in the list of ingredients.
The SCF also ruled that a statement must indicate whether a product is intended exclusively for people who want to lower their blood cholesterol level, and that patients on cholesterol lowering drugs must consume the product under medical supervision. In the same field of vision as the former statement, it must be indicated that the consumption of more than 3g/day of added plant sterols/stanols should be avoided.
There must be a visible and legible statement that the product may not be nutritionally appropriate for pregnant and breastfeeding women and children under the age of five years. A definition must be given of a portion of the food or food ingredient concerned (preferably in g or ml) with a statement of the amount of plant sterol/plant stanol that each portion contains.
The regulation enters into force on 21 April 2004. Foods and food ingredients with added phytostanol esters already on the market in the EU, or 'yellow fat spreads with added phytosterol esters' that were authorised by Commission Decision 2000/500/EC and were produced six months after entry into force of this regulation, must comply with the labeling provisions laid down in this regulation.
But despite the new legislation, plant sterols are likely to be rolled out in more health-driven products such as spreads and 'milk and yoghurt type' products. There have also been favourable opinions from European food safety authorities for plant sterol-enriched frankfurters and cold meats (requested by Valio).
Finnish firm Oy Karl Fazer Fazerintie is hoping to get approval for plant sterol-enriched bakery products, grain-based snacks and gum arabic pastilles. These are currently under discussion by the Standing Committee on the Food Chain and Animal Health.
Cholesterol is a key component in the development of artherosclerosis, the accumulation of fatty deposits on the inner lining of arteries. Mainly as a result of this, cholesterol increases the risks of heart disease, stroke and other vascular diseases.
According to the World Health Organisation, almost one fifth (18 per cent) of global stroke events (mostly nonfatal events) and about 56 per cent of global heart disease are attributable to total cholesterol levels above 3.2 mmol/l. This amounts to about 4.4 million deaths (7.9 per cent of the total) and 2.8 per cent of the global disease burden.
In 2003, the European phytosterol market was worth $75 million, according to new data from Frost & Sullivan, and it will continue to grow by 15 per cent each year to 2010.