Following an application from DoubleGood AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, 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 a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate and reduction of post-prandial glycaemic responses.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application included a request for the protection of proprietary data.
The food that is the subject of the health claim is a combination of five amino acids, i.e. L-threonine, L-valine, L-leucine, L-isoleucine and L-lysine, plus chromium picolinate, which are dissolved in table water. The amounts of the single constituents, an overview of the manufacturing process and information on stability and batch-to-batch analyses were provided. The Panel considers that the food, a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate, is sufficiently characterised.
The claimed effect is “reduces the post-prandial blood glucose response”. The target population proposed by the applicant is “adults in the general population wishing to reduce their post-prandial blood glucose responses”.
Decreasing post-prandial glycaemic responses may be beneficial, for example, to individuals with impaired glucose tolerance, as long as post-prandial insulinaemic responses are not disproportionally increased. In view of the proposed mechanism, i.e. “stimulating insulin release via the insulinogenic properties of the amino acids in the food”, the applicant was invited to provide evidence that a reduction of post-prandial blood glucose responses achieved by an increase in insulin secretion is a beneficial physiological effect for the proposed target population. No such evidence was provided by the applicant.
The Panel notes that the evidence provided by the applicant does not establish that a reduction in post-prandial glycaemic responses achieved by an increase in insulin secretion is a beneficial physiological effect for the target population in the context of this application.
The Panel considers that a cause and effect relationship has not been established between the consumption of the food, a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate, which is the subject of the health claim, and a beneficial physiological effect for the target population.