Scientific Opinion on the substantiation of a health claim related to “L-tug lycopene” and reduction of blood LDL-cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2015;13(2):4025 [8 pp.].
doi
10.2903/j.efsa.2015.4025
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (JJ) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the United Kingdom following an application by Lycotec Ltd
Question Number
EFSA-Q-2014-00590
Adopted
6 February 2015
Published
26 February 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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 food constituent that is the subject of the 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 constituent, L-tug lycopene, which is the subject of the claim, is sufficiently characterised. 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 The Panel notes that the unpublished studies submitted to support the claim were exploratory in nature and insufficient information was provided to allow the scientific evaluation of these studies. 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.

Summary

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.

Keywords
L-tug lycopene, cholesterol, LDL-cholesterol, coronary heart disease, health claims
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Number of Pages
8