Scientific Opinion on the safety of "conjugated linoleic acid (CLA)-rich oil" (Tonalin. TG 80) as a Novel Food ingredient1

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to carry out the additional assessment for Tonalin (R) TG 80, a conjugated linoleic acid (CLA)-rich oil, as a food ingredient in the context of Regulation (EC) No. 258/97. Tonalin. TG 80 consists of approximately 80 % of the two CLA isomers a c9,t11:t10, c12 (1:1). Tonalin. TG 80 is intended by the applicant as an ingredient for milk-, yoghurt-or fruit-type products and other unspecified products for adult consumers. The applicant suggests a daily intake of 4.5 g Tonalin. TG 80. The available data from non-human studies do not indicate a risk for genotoxicity, reproductive toxicity, carcinogenicity or allergenicity. The extent of the effects of CLA on insulin resistance and on markers of cardiovascular risk appears to be species-dependent. Therefore the focus of this safety assessment relies mainly on the large number of available human studies. Based on the assessment of these studies, the Panel considers that CLA consumption does not appear to have adverse effects on insulin sensitivity, blood glucose control or liver function for up to six months, and that observed effects on blood lipids are unlikely to have an impact on cardiovascular risk. Long-term effects of CLA intake on insulin sensitivity and the arterial wall have not been adequately addressed in humans. The Panel concludes that the safety of Tonalin. TG 80 has been established for the proposed uses at intakes of 4.5 g per day (corresponding to 3.5 g CLA), for up to six months. The safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use. The safety of CLA consumption by type-2 diabetic subjects has not been established.