The European Commission (EC) intends to authorise for the first time a health claim arising from the combined effects of a number of substances, in a decision that affects firms backing the synergistic effect of nutrients in their products.
By publishing a Draft Commission Regulation , the EC intends to press ahead with greenlighting a health claim made on foods and to the reduction of disease risk, in this case a reduction in blood LDLcholesterol concentrations that contributes to coronary heart disease.
“The Authority was required to deliver an opinion on a health claim related to the combination of artichoke leaf dry extract, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers (OPC) from French maritime pine bark, garlic dry extract, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate and the reduction of blood LDL-cholesterol concentrations,” the draft outlined.
The claim proposed by the applicant was worded, “Limicol has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease”
Five years to mull over
In what could be seen as a victory for Limicol’s makers, French company Laboratoire Lescuyer, the progress made so far had not been without its delays and setbacks.
The draft, which revealed that the EFSA expressed its positive opinion back in 2013, suggests that the Commission, along with the Member States, took five years to make a decision to authorise a health claim.
Five years to mull over ‘The highest scientific recognition in the EU’
At the time Laboratoire Lescuyer said of EFSA’s positive opinion in 2014 that it was “the result of five years of research”, and acknowledged EFSA’s recognition as “equivalent to the highest scientific recognition as possible at the European level”.
Placed on the market in 2008, Limicol is a dietary supplement that is available in tablet form. Its combination of red rice yeast, plant extracts and vitamins have been tested on 184 subjects.
Results have been encouraging with Limicol claiming to reduce total cholesterol by -15.3%, 21.4% of LDL cholesterol and 12.2% triglycerides in the first month.