Nordic Sugar and Valens Report EFSA Health Claims Success

An EFSA Panel concluded that a cause and effect relationship has been established between the consumption of sugar beet fibre and increasing faecal bulk.VALENS Int. has gained an EFSA positive opinion regarding the cholesterol-lowering effect of its barley beta-glucan ingredient Reduchol.

Dec 13 2011 --- The EFSA Panel has published its positive Scientific Opinion for Sugar Beet Fibre for digestive health. New scientific evidence supported the application for the claim “increasing faecal bulk”. The EFSA (European Food and Safety Authority) Panel considers sugar beet fibre sufficiently characterized and the claim to be a beneficial physiological effect. The Panel concludes that a cause and effect relationship has been established between the consumption of sugar beet fibre and increasing faecal bulk.

Many large bowel disorders may be attributed to lack of faecal bulk (Kritchevsky, 2001). In the clinical studies that support the application and the new claim, various benefits are reported such as improved bowel function, regularity and prevention of constipation to mention some.

“To our customers, the claim means a new marketing opportunity. Producers of bakery products, cereals, bars etc may consider using wordings on their packaging such as ‘improving digestive health’ or ‘good for your stomach/bowels’,” says Lars-Erik Hansson, Business Manager at applicant company Nordic Sugar AS in Copenhagen. However, wordings must be expressed in a suitable way in each language and according to national guidelines. In order to bear the claim in the EU, a food product should be at least "high in fibre" which means at least 6 grams of fibre per 100. Fibrex (67% fibre content) could be used on its own or in combination with the other few fibres approved for the same claim.

The final decision from the European Commission is expected during 2012.

Meanwhile Slovenian functional ingredients producer VALENS Int. has gained an EFSA positive opinion regarding the cholesterol-lowering effect of its barley beta-glucan ingredient Reduchol and reducing the risk of heart disease

Following an application by Slovenian functional ingredients producer VALENS Int. submitted pursuant to Article 14 of Regulation (EC) No 1924/2006, EFSA delivered an opinion on the scientific substantiation of a health claim related to barley beta-glucans and the lowering of blood cholesterol and reduced risk of heart disease, referring to disease risk reduction and including a request for the protection of proprietary data.

A cause-and-effect relationship has been established between the consumption of barley beta-glucans and the lowering of blood LDL-cholesterol concentrations. Several pertinent studies were provided in the health claim application showing that at doses of at least 3 g/day the ingredient produce a decrease in total and LDL-cholesterol concentrations in both normo- and hypercholesterolaemic subjects, and that there is evidence supporting the biological plausibility of the mechanism of the effect. Based on this scientific data, at least 3 g of barley beta-glucans should be consumed per day in order to obtain the claimed effect. In practice, this could be divided into smaller portions per day.

After a huge investment VALES Int. sees this as an important success which will enable even stronger health claims for producers using Reduchol in a wide range of food products. Further, this opinion gives VALENS Int. a competitive advantage when it comes to marketing its product. The health claim application was submitted in May 2011 and the prompt and supportive communication with the EFSA must be noted. During the evaluation process, EFSA made it clear which additional information was required to perform the evaluation and VALENS Int. delivered all the requisite data on time. No stop-the-clock procedures were called for and Valens believes this is due to the high quality of the health claim application which was prepared with scientific support from the Nutrition Institute (Ljubljana, Slovenia).

Reduchol is a concentrated source of natural water-soluble dietary fibre produced from barley grains. A superior source of barley beta-glucan is produced using innovative and patented technology to improve human nutrition and deliver health benefits. The excellent biological activity of Reduchol is achieved with a state-of-the art production process that does not involve the use of any chemicals or enzymes. The cholesterol-lowering effect of Reduchol relates to its ability to achieve improved viscosity of a food bolus in the small intestine and to thus delay the absorption of cholesterol.

The news comes as the European trade association EHPM argues that the six-month transition period given for Article 13.1 claims that will be rejected for use in the European Union is too short and impractical for food supplement manufacturers.

Commenting following the confirmation of the six-month transition period at a conference in Berlin last week, EHPM said that with a shelf life of up to three years for most supplement products the short length of time for transition would result in significant costs for SMEs.

“Given the short deadline, companies would have to change their labels and they will not be able to produce packaging on such short notice and sell through their stock,” said EHPM Director of European Policy Cynthia Rousselot. “The result may be a shortage of stock for consumers.”

“A more proportionate approach would be to extend the proposed transition period from six months to at least 18 months,” she continued. “Given that the enforcement of the regulation will be in the hands of the Member States, we trust that they will take into consideration the shelf life of our products when determining the timeframe for the withdrawal of these from the market.”