The European Food Safety Authority has begun assessing the first of over 220 applications that have been submitted under Articles 13 and 14 of EC Regulation 1924/2006 (as amended) on nutrition and health claims made on foods. Although there appears to be some overlap, Article 14 relates to “Reduction of disease risk claims and claims referring to children’s development and health”, while Article 13 relates to “function” health claims other than those covered by Article 14. The EC is to draw up a “positive list” of permitted “function” health claims by 31 January 2010. [Check out and for further details.]

Of the eight applications that have so far been assessed (five of which relate to children’s health and three to reduction of disease risk), only one (on phytosterols) was successful. The EFSA Panel noted that plant sterols have been sufficiently characterized and that the data supported the cholesterol-lowering effect of these substances, particularly when added to fat-based foods, although it suggested that “products to which phytosterols are added should be consumed only by people who need and want to lower their blood cholesterol”. The following health claim wording was approved: “plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease". The next step in the approval process is for the favourable EFSA verdict to be forwarded to the European Commission (EC) and Member States, who will then proceed with possible authorisation of the health claims. [Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on a request from Unilever PLC/NV on plant sterols and lower/reduced blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No. 1924/2006 (Question No. EFSA-Q-2008-085). Adopted on 11 July 2008. The EFSA Journal 2008, 781, 1. Available at on the internet.] {178773}

Among the failed applications were two that made claims for dairy foods and healthy body weight in children and adolescents and good dental health in children – these failed because a cause and effect relationship was not considered to have been established (these opinions can be accessed via . {178859-60}

Clearly EFSA has its work cut out because it anticipates thousands of claims under Article 13. A letter dated 3 September 2008 from EFSA to the EC notes the need for cooperation between the EC, Member States and EFSA (as well as the European Medicines Agency, EMEA, in the area of botanicals) in processing these applications (this letter can be viewed at .

The above item was taken from the October 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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