The European Food Safety Authority (EFSA) published two positive scientific opinions for glycaemic carbohydrates after German firm Dextro Energy submitted dossiers for the ingredient claiming it helped the ‘maintenance of normal brain functions’ and ‘contributes to normal cognitive functions’. A third claim, assessed by EFSA after UK-based Lycotec submitted a dossier for its L-tug lycopene ingredient and the reduction of blood LDL-cholesterol, was dismissed.
Concerning the two article 13.5 claims submitted by Dextro Energy, the EFSA NDA Panel concluded that “a cause and effect relationship has been established between the consumption of glycaemic carbohydrates and contribution to normal cognitive function,” while a claim on glycaemic carbohydrates and ‘maintenance of normal brain function’ has already been assessed by the Panel - with a favourable outcome.
In it’s opinion on cognitive functioning, the NDA Panel added that a daily intake of 130 grams of glycaemic carbohydrates has been estimated to cover the glucose requirement of the brain, and that such amounts can be consumed as part of a balanced diet.
“Ingestion of a significant amount of carbohydrates might be defined as 15 % (about 20 g) of the daily dose of 130 g carbohydrates needed for normal brain function,” stated EFSA. “Analogous to the condition of use for vitamins and minerals 15 % should also be seen as significant and defined as the condition of use of the claim for glucose and normal cognitive function.”
The second EFSA opinion in response to the claim on brain functioning stated that an article 13.1 opinion published in 2011 previously assessed and offered a favourable outcome on the link between glycaemic carbohydrates help to maintain brain functioning.
A third NDA Panel opinion stated that an article 14 dossier submitted by Lycotec, which suggested a link between the consumption of the company’s L-tug lycopene ingredient and a decrease in blood LDL-cholesterol levels could not be accepted because there is not currently enough evidence to support the claim.
The Panel said unpublished studies submitted to support the claim were exploratory in nature and that the studies contained ‘insufficient information’ to allow their evaluation.
“The Panel notes that the information provided was insufficient to allow a scientific evaluation of the studies, and therefore EFSA requested that the applicant provide the full study reports. In reply, the applicant claimed that no additional information on the studies existed,” EFSA said in its opinion.
“From the limited information available in the application, the Panel notes that the studies were not randomised and that some methodological aspects, such as the definition of primary outcome(s), power calculations, treatment of missing data, compliance or correction for multiplicity of outcomes, were not considered in the study reports, possibly because of the exploratory nature of these studies, as claimed by the applicant.”
As a result, the NDA Panel said conclusions could be drawn from these studies for the scientific evaluation of the claim.
“On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of L-tug lycopene and reduction of blood LDL-cholesterol,” said EFSA.