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

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2010; 8(5):1600 [43 pp.].
doi
10.2903/j.efsa.2010.1600
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen.
Acknowledgements

The Panel wishes to thank for the preparatory work related to this opinion: The members of the Working Group on Novel Foods: Karl-Heinz Engel, Ines Golly, Marina Heinonen, Pagona Lagiou, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser-Berthold, Annette Pöting, Seppo Salminen, Hendrik Van Loveren and Hans Verhagen, the hearing expert Ambroise Martin, and EFSA’s staff member Silvia Valtueña Martínez for the preparatory work provided to this EFSA scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-2009-00750
Adopted
30 April 2010
Published in the EFSA Journal
21 May 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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® 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.

Keywords
Conjugated Linoleic Acid, insulin sensitivity, blood lipids, novel food ingredient, Cognis
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Number of Pages
43