Division SUMMARY OF PERTINENT SCIENTIFIC DATA

In addition to the requirement of Article 15(3)(g) of Regulation (EC) No 1924/2006 for a summary of the application, applicants shall provide a summary of the pertinent scientific data, which shall contain the following information:

1. 1..

   the summary of data from pertinent human studies, indicating to what extent the relationship between the food and the claimed effect is supported by the totality of human data;

2. 2..

   the summary of data from pertinent non-human studies, indicating how, and to what extent, the pertinent non-human studies may help to support the relationship between the food and the claimed effect in humans;

3. 3..

   the overall conclusions, by taking into account the totality of the data, including evidence in favour and not in favour and by weighing the evidence. The overall conclusions should clearly define to what extent:

   1. (a)

      the claimed effect of the food is beneficial for human health;

   2. (b)

      a cause and effect relationship is established between the consumption of the food and the claimed effect in humans (such as the strength, consistency, specificity, dose-response, and biological plausibility of the relationship);

   3. (c)

      the quantity of the food and pattern of consumption required to obtain the claimed effect could reasonably be consumed as part of a balanced diet;

   4. (d)

      the specific study group(s) in which the evidence was obtained is representative of the target population for which the claim is intended.