Claims – Art. 14 EC Reg. 1924/2006 approved – Artichoke leaf dry extract (blood LDL-cholesterol reduction)

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 LDLcholesterol 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.

The proposed wording reflects the scientific evidence:

“A combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugarcane 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 LDLcholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease.“

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 sugarcane 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.

(fount EFSA scientific opinion)

Surely that product will help the blood LDL-cholesterol reduction, but the claim and the proposed wording seem to be really too technical for the average consumer understanding.

What do you think about the increasing complexity in this area? Which impact could have a similar claim to the consumers?

I’m eager to hear your opinions!

One thought on “Claims – Art. 14 EC Reg. 1924/2006 approved – Artichoke leaf dry extract (blood LDL-cholesterol reduction)

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