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 LDL-cholesterol 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”
New EC direction?
According to Luca Bucchini, managing director of Hylobates Consulting, Italy, the product represents a change of direction for future health claims in which the EC has opened the door to a different kind of health claim.
The EC’s health claim register is indicative of their previous stance with all claim statuses authorised only for single substances, such as carbohydrate-electrolyte solutions.
Referring to the positive opinion the European Food and Safety Authority (EFSA) expressed back in 2013, Bucchini suggested, “The delay was probably due to the stated preference of the EC to authorise claims only for single substances.”
“The health claims regulation has been very frustrating for brands because products are made with several substances, but you can't really have a specific claim for the combination so it's hard to make anything new or original.
“I have some scepticism on the scientific side in that synergistic effect of nutrients are probably not as common, and EFSA may always say that your "combo claim" is not new,” he added.
“But as a consultant I can't just say "forget product, or combo, claim applications; they have never succeeded". This may be to prove the lone exception but still...”
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.
According to Bucchini, the delay mainly centred on three of the submitted studies necessary to have the claim approved.
He said that while EFSA had agreed that these studies were necessary to have the claim approved, the French company also had proprietary as well as an exclusive right of reference, adding, “there were grounds for the French company to have exclusive usage rights to the claim for 5 years!”
“In the past you would tell companies “forget about a product (i.e. combination) health claim”, he commented.
“Now there is a little hope that studies on combination of ingredients make sense. It's easy to understand that is easier to come up and patent a combination of substances than a new substance, which also may have a novel food problem.”
‘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.
