Following an application from Lycotec Ltd, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to “L-tug lycopene” and reduction of blood low-density lipoprotein (LDL)-cholesterol.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The application included a request for the protection of proprietary data.
The food that is the subject of the health claim is L-tug lycopene (i.e. Lyc-O-Mato® embedded in fat-rich matrices by a manufacturing process claimed as proprietary and confidential by the applicant). The Panel considers that the food, L-tug lycopene, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed by the applicant is “decreases blood cholesterol and triglycerides levels”. Therefore, “L-tug lycopene” is the substance, “LDL-cholesterol” is the risk factor and “coronary heart disease” (CHD) is the human disease. The target population proposed by the applicant comprises “healthy adults who wish to lower their blood cholesterol levels”. In reply to a request from the European Food Safety Authority (EFSA), the applicant confirmed that the health relationship proposed is related to lowering LDL-cholesterol concentrations, which decreases the risk of CHD. The Panel considers that reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of CHD.
The applicant identified eight unpublished human intervention studies as pertinent to the claim.
The eight human intervention studies provided were conducted with L-tug lycopene in different food matrices, followed similar protocols, and, as indicated by the applicant, were exploratory in nature. 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.
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. The Panel also notes that, for one of the studies, a number of discrepancies exist between the version provided to EFSA and the published version, regarding the number of subjects included, the participant flow and the presence or absence of randomisation. The Panel considers that no conclusions can 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.