French supplier Sylvan Bio is seeking dialogue with the European Food Safety Authority (EFSA) and EU authorities after the agency said in a just-issued positive article 13.5 health claim opinion there was no difference between Sylvan’s red yeast rice and others on the market.
Sylvan has been working with UK supplier Gee Lawson and French consultancy Nutraveris and Gee Lawson managing director Jonathan Shorts told us this morning, “there are clear differences between the red yeast rice forms EFSA is not picking up on.”
“We are attempting to speak with them about it,” Shorts said, noting his company had first teamed with Sylvan at the 2010 Vitafoods trade show in Geneva because it was fed up with the low quality red yeast rice it had been sourcing from China.
Since May 2012, red yeast rice has been able to use a general function NHCR article 13.1 claim linking it to cholesterol management, but Sylvan sought to gain a claim specific to its form of red yeast rice via the article 13.5 proprietary and emerging science route.
The EU nutrition and health claims regulation (NHCR) dossier contained two key trials (one published, one unpublished) that utilised Sylvan’s red yeast rice (monacolin K) but EFSA’s health claims panel said there were no grounds to issue a specific additional claim to Sylvan.
“The Panel considers that the evidence provided by the applicant does not establish that monacolin K in SYLVAN BIO red yeast rice is different from monacolin K in other red yeast rice preparations with respect to its effect on blood LDL-cholesterol concentrations,” wrote EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) in its opinion.
“The Panel could have reached this conclusion without the human intervention study claimed as proprietary by the applicant."
It added: “The Panel considers that the following wording reflects the scientific evidence: ‘Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol concentrations’.”
“The Panel considers that in order to obtain the claimed effect, 10mg of monacolin K from fermented red yeast rice preparations should be consumed daily. The target population is adults in the general population.”
Red yeast rice is most commonly used as a colouring but is finding its way into more and more supplement products - helped by the EU-backed claim.
Shorts said major European supplement players were interested in it and noted two distinct pricing bands - European material at about $25/kilogram and non-European at $10-12/kilo.
There are limits in some markets however where monacolin K is classified as a medicinal ingredient or where 10mg/day is classified as medicinal dose and therefore not able to be used in foods or make food-based health claims.