Oat Beta-Glucan Achieves Disease Reduction Claim as Soy Protein and Actimel Claims Fail European Hurdle

Following an application from CreaNutrition AG, the Authority was required to deliver an opinion on a health claim related to the effects of oat beta-glucan on lowering blood cholesterol.

Nov 17 2011 --- The European Commission Regulation has authorized a disease reduction health claim (Article 14) on oat beta glucans, but soy protein and a Danone claim for Actimel have not made the European Union list of permitted claims.

Following an application from CreaNutrition AG, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of oat beta-glucan on lowering blood cholesterol. The claim proposed by the applicant was worded as follows: ‘The inclusion of oat beta-glucan as part of a balanced diet can actively lower/reduce blood LDL (low-density lipoprotein) and total cholesterol’. On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 December 2010 that a cause and effect relationship had been established between the consumption of oat beta-glucan and lowering of blood LDL-cholesterol concentrations. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of the Regulation, and should be included in the Union list of permitted claims.

Ruedi Duss at CreaNutrition described the positive EFSA [European Food Safety Authority] opinion that predated the european authorization as a powerful benefit that can be added to a wide range of final products including cereals, bakery products and beverages and more products to become an integral part of the daily diet. “By consuming just three grams a day of oat beta-glucan, a reduction in LDL of up to ten percent can be achieved. This can be via either one daily dose of three grams or three doses of one gram per quantified serving. We expect the industry will be able to use this positive EFSA opinion of products by the start of 2012,” he says.

But there was less positive news for soy protein and Danone claims that were officially rejected. Following an application from HarlandHall Ltd (on behalf of the Soya Protein Association, the European Vegetable Protein Federation and the European Natural Soyfood Manufacturers Association), the Authority was required to deliver an opinion on a health claim related to the effects of soy protein on the reduction of blood cholesterol concentrations. The claim proposed by the applicants was worded as follows: ‘Soy protein has been shown to lower/reduce blood cholesterol; blood cholesterol lowering may reduce the risk of (coronary) heart disease’. On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 30 July 2010 that a cause and effect relationship had not been established between the consumption of soy protein and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised, the Authority stated.

Meanwhile following an application from Danone France, submitted pursuant to Article 14, the Authority was required to deliver an opinion on a health claim related to the effects of Actimel, a fermented milk product containing Lactobacillus casei DN-114 001 and yoghurt symbiosis on the reduction of the presence of Clostridium difficile toxins in the gut . The claim proposed by the applicant was worded as follows: ‘Fermented milk containing the probiotic Lactobacillus casei DN-114001 and yogurt symbiosis decreases presence of Clostridium difficile toxins in the gut (of susceptible ageing people). Presence of Clostridium difficile toxins is associated with the incidence of acute diarrhoea’. On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 December 2010 that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Actimel and reduction of the risk of C. difficile diarrhoea by reducing the presence of C. difficile toxins. Accordingly, as the claim does not comply with the requirements of the Regulation, it should not be authorised.