Novel food ruling is near, says Forbes
submitted, as part of a group of manufacturers, a set of guidelines
to the EU covering the sale of phytosterol products.
Canadian phytosterols company Forbes MediTech last week said it has submitted, as part of a group of manufacturers, a set of guidelines to the EU covering the sale of phytosterol products.
The company submitted an application to the EU for the use of Reducola in milk and fruit drinks in August 2000 and is awaiting results from the EU committee responsible for novel foods applications.
However EU authorities are concerned about the risk of over-consumption of phytosterols when consumers use food products containing phytosterols made by different manufacturers. Forbes and othermanufacturers have been working together to develop a uniform method oflabelling food products containing phytosterols that would allow consumersto choose a variety of products and not consume more phytosterols than isnecessary to lower their cholesterol.
The draft guidelines are expected to be taken into consideration when regulations covering the sale of phytosterol products in the EU are developed and finalized. Forbes anticipates that the regulation will be developed in early 2003 and finalized in the second quarter of 2003. It is expected that the Reducola Novel Food application and applications from other manufacturers will receive approvals for marketing at that time.
It is expected that European food products will then be able to make the medicalclaim that phytosterols contribute to the lowering of cholesterol. Forbesanticipates an increase in interest of Reducola and non-brandedphytosterols from the various food manufacturers once the EU approvals arein place.
"Although there is no guarantee of resolution, we have seen a substantialincrease in interest for Forbes' supply of sterols in anticipation that EUapprovals may be forthcoming," said Jeff Motley, vice-president ofCommercial Operations for Forbes.
Forbes received GRAS clearance to sell Reducola in food products and dietary supplements under the US' Dietary Supplement Health Education Act (DSHEA) in May 2000. Forbes said the sale of Reducola in US dietary supplements has been a significant source of income for the company in the last year.
Food manufacturers, however, can only advertise health claimspreviously issued by the FDA, which is in the final stages of issuing a ruling on health claims for phytosterols. This should also lead to an increase in demand for Reducola and non-branded phytosterols if the final rule onhealth claims for phytosterols is favourable.
