Scientific Opinion on the substantiation of a health claim related to the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol® and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006

Tabs

Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2013;11(7):3327 [16 pp.].
doi
10.2903/j.efsa.2013.3327
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 (J.J.) 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 France following an application by Laboratoire Lescuyer
Question Number
EFSA-Q-2012-00968
Adopted
12 July 2013
Published
26 July 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (408.47 KB)
Abstract

Following an application from Laboratoire Lescuyer, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, 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 the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol® and reduction of blood LDL-cholesterol concentrations. The Panel considers that the food 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. High LDL-cholesterol is a risk factor in the development of coronary heart disease. In weighing the evidence, the Panel took into account that, although no evidence was provided for an LDL-cholesterol lowering effect of any of the single food constituents in Limicol® at the proposed conditions of use or as to how the ingredients individually or in any combination could contribute to the claimed effect and despite the lack of a dose-response relationship observed in one human intervention study, three human intervention studies conducted by two independent research groups showed an effect of the combination of food ingredients in Limicol® on blood LDL-cholesterol concentrations. The Panel concludes that a cause and effect relationship has been established between the consumption of the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol® and a reduction in blood LDL-cholesterol concentrations.

Summary

Following an application from Laboratoire Lescuyer, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, 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 the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol® and reduction of blood LDL-cholesterol concentrations.

The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The application includes a request for the protection of proprietary data.

The food that is the subject of the health claim is Limicol®. The Panel considers that the food, the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol®, which is the subject of the health claim, is sufficiently characterised.

The claimed effect proposed by the applicant is “oral consumption of the food supplement Limicol® significantly reduces circulating low-density lipoprotein-cholesterol (LDL-cholesterol) level, thus reducing the risk of coronary heart disease”. The target population proposed by the applicant is “males and females from 18 to 65 years with mild to moderate hypercholesterolaemia”. The Panel considers that reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. High LDL-cholesterol is a risk factor in the development of coronary heart disease.

The applicant provided as pertinent to the claim three published human intervention studies together with the full study reports.

The Panel notes that the three human intervention studies, which were conducted by two independent research groups showed an effect of the combination of 600 mg artichoke leaf dry extract with 30‑36 mg caffeoylquinic acids, 500 mg red yeast rice with 2 mg monacolin K, 10 mg sugar-cane derived policosanols, 20 mg French maritime pine bark extract with 18 mg OPC, 30 mg garlic dry extract with 0.25 mg allicin, 30 mg α-tocopherol equivalents, 5 mg riboflavin and 9 mg inositol hexanicotinate in Limicol® on LDL-cholesterol concentrations when consumed daily in three doses with the major meals. The Panel also notes that doubling the dose of the food that is the subject of the health claim did not have an additional effect on LDL-cholesterol concentrations.

The applicant claims that monacolins in red yeast rice, sugar cane-derived policosanols and the artichoke leaf extract are the food constituents in Limicol® which are responsible for the claimed effect. The Panel notes the well established role of monacolin K at doses of 10 mg per day in lowering LDL-cholesterol. However, the Panel also notes that the available evidence does not establish that any of the other food constituents in Limicol®, including policosanols and artichoke leaf extract, exert an LDL-cholesterol lowering effect in humans on their own and that at the proposed conditions of use no evidence has been provided for an LDL-cholesterol lowering effect of any of the food constituents in Limicol®, or as to how the ingredients individually or in any combination could contribute to the claimed effect.

In weighing the evidence, the Panel took into account that although no evidence was provided for an LDL-cholesterol lowering effect of any of the single food constituents in Limicol® at the proposed conditions of use or as to how the ingredients individually or in any combination could contribute to the claimed effect, and despite the lack of a dose-response relationship observed in one human intervention study, three human intervention studies conducted by two independent research groups showed an effect of the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol® on blood LDL-cholesterol concentrations.

The Panel concludes that a cause and effect relationship has been established between the consumption of the combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate in Limicol® and a reduction in blood LDL-cholesterol concentrations.

The Panel considers that the following wording reflects the scientific evidence: “A combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate reduces blood LDL-cholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease.”

The Panel considers that in order to bear the claim a product should provide 600 mg artichoke leaf dry extract with 30-36 mg caffeoylquinic acids, 500 mg red yeast rice with 2 mg monacolin K, 10 mg sugar-cane derived policosanols, 20 mg French maritime pine bark extract with 18 mg OPC, 30 mg garlic dry extract with 0.25 mg allicin, 30 mg α-tocopherol equivalents, 5 mg riboflavin and 9 mg inositol hexanicotinate in three daily doses to be consumed with the major meals. The target population is adults in the general population wishing to reduce their blood cholesterol concentrations.

In relation to restrictions of use, the Panel refers to the Summary of Product Characteristics of lovastatin-containing medicinal products available on the EU market.

The Panel also refers to the opinion by the EFSA CONTAM Panel on citrinin, a nephrotoxic mycotoxin which can be produced by some strains of Monascus purpureus.

Keywords
Artichoke, monacolin K, OPC, garlic, vitamins, cholesterol, health claims
Print on demand
Number of Pages
16