Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific 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

Following a request from the European Commission, EFSA was asked to address the scientific comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific 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. Comments submitted to EFSA via the European Commission Services originated from the applicants (BASF SE and Stepan Lipid Nutrition). Part of the comments received were related to legal aspects (i.e. allocation of competencies in Regulation (EC) 178/2002, principle of proportionality, the Charter of Fundamental Rights of the European Union), to the (general) approach of the NDA Panel in assessing health claim applications and to the assessment of the claimed effect (i.e. whether beneficial or not). EFSA has reviewed only the scientific comments and shared them with the chair of the NDA Panel and the chair of the NDA Working Group on Claims. In its opinion, adopted on 11 December 2014, the NDA Panel concluded 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. The comments received do not require any change to the conclusions of the NDA Panel.