Scientific Opinion on the substantiation of a health claim related to an equimolar mixture of the CLA isomers c9,t11 and t10,c12 (marketed as Clarinol® and Tonalin®) and “contributes to a reduction in body fat mass” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik Van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

EFSA Journal
EFSA Journal 2015;13(1):3953 [11 pp.].
doi
10.2903/j.efsa.2015.3953
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands
Question Number
EFSA-Q-2014-00580
Adopted
11 December 2014
Published
8 January 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Following an application from BASF SE and Stepan Lipid Nutrition, submitted for the authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to an equimolar mixture (marketed under the trade names Clarinol® and Tonalin®) of the two conjugated linoleic acid (CLA) isomers c9,t11 and t10,c12. The Panel considers that the food is sufficiently characterised. The claimed effect is “contributes to a reduction in body fat mass”. In previous assessments on the safety of these equimolar isomeric mixtures of CLA, the NDA Panel considered that the observed increase in plasma and urinary concentrations of isoprostanes, which may indicate an increase in lipid peroxidation, and the increase in some markers of subclinical inflammation associated with CLA consumption, together with the limited data available on the effects of CLA on vascular function, may indicate a potential for vascular damage in the longer term. The Panel considers that the information provided does not establish that a reduction in body fat mass, when accompanied by an increase in markers of lipid peroxidation and inflammation, is a beneficial physiological effect for the target population. The Panel concludes that a cause and effect relationship has not been established between the consumption of an equimolar mixture of the CLA isomers c9,t11 and t10,c12, marketed under the trade names of Clarinol® and Tonalin®, and a beneficial physiological effect.

Keywords
CLA, conjugated linoleic acid, Clarinol®, Tonalin®, body fat mass, health claims
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Number of Pages
11