Biotec firm Lycotec has submitted a dossier to the European Food Safety Authority (EFSA) to gain a health claim for its L-tug ingredient, which it claims can be added to chocolate to reduce cholesterol.
L-tug is derived from lycopene, a pigment found in tomatoes and other red fruit and veg that is recognized as safe for food-use in Europe and the US.
Lycotec submitted an Article 14 disease risk factor reduction claim to EFSA last week. It proposed that: “L-tug has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.”
Article 14 health claims have a 30% success rate. Of the 70 claims submitted, only 20 have been granted.
No panacea concept
We asked Lycotec CEO Ivan Petyaev how he expected to succeed where so many others had failed.
“We are not claiming ‘a new panacea’ for all products and for everybody, like some applicants may try to do, but provide a tailored design, unique for each food matrix, and more defined targeted population which could maximize the benefit of application of our product(s),” he said.
The Lycotec chief said his company had nine studies and other supporting data to back up its claim and had proprietary technology data that could be adapted specifically for chocolate or other food fat matrices.
According to Lyotec, the L-tug ingredient works by guiding smaller lipid particles to hepatocytes, intelligent cells in the liver that can break down lipids more easily.
Cholesterol health claims
The only EU-approved health claim for chocolate or cocoa is Barry Callebaut’s heart health claim . It says that 200 mg of cocoa flavanols in cocoa beverages or dark chocolate contribute to normal blood flow.
Most EU cholesterol health claims are to ‘maintain normal cholesterol’ with ingredients such as linoleic acid or guar gum. However, there are approved claims to reduce/lower blood cholesterol, for barley beta-glucans, oat beta glucan, plant sterols and plant stanol esters. These authorized claims carry the same wording as Lycotec’s proposed claim.
Cholesterol lowering products tend to come in drinks or spreads such as Benecol and also cereals such as Kellogg’s Optivita brand and Quaker Oat Granola.
Lycotec previously said it would also apply for a ‘new function’ Art. 13.5 claim. These claims are based on emerging and proprietary science rather than disease risk reduction, like Art. 14 claims, and do not oblige companies to publish their data.
“We would like to cover both markets, but we cannot apply for both Articles at the same time. Hence we started with the more ‘powerful’ one, but 13.5 is our next target - in a short time,” said Petyaev.
Lycotec has partnered with an unnamed chocolate manufacturer that will produce L-tug chocolate for a medium-sized European country - however the ingredient will also be available to other firms.
“We start in Europe and certainly would like to have partners with right vision to drive our chocolate and our brand around the globe,” said Petyaev.
EFSA aims to respond to Art. 14 health claims within half a year, but the process often takes much longer.