New food supplement prepares for market entry?
could be the next new food supplement, as UK food watchdog sets out
to assess a new application it has received for market approval.
The Food Standards Agency (FSA) reports this week that the UK-based firm Euremica Environmental is proposing to market clinoptilolite - a naturally occuring zeolite - as a food supplement in capsule form.
"We hope to be marketing the product throughout the EU as soon as approval is given, which could be as early as the first week in June 2004," Rob Sampson at Euremica Environmental told NutraIngredients.com.
"We'll start by rapidly rolling out the food supplement in the UK, moving on to countries in Europe where we have agents - Benelux, France and Spain - and eventually all over the EU," added Sampson.
Pitching the product under the trade name Zeolife, the UK company has applied to market the food supplement as 'helping to maintain a healthy body by accelerating the elimination of heavy metals and mycotoxins, as well as by providing a source of silicon.'
The UK firm is proposing to manufacture the supplement in capsules - the shell from gelatine and water - with each containing 250mg of micronised clinoptilolite, to be sold in tubs containing 120 capsules. Each tub will bear directions to take two capsules in the morning and two in the evening, totalling four capsules (equivalent to 1 gram of clinoptilolite) per day.
In addition to zeolite, according to Euremica Environmental, other ingredients in the food supplement are rice flour, magnesium stearate and silicon dioxide.
Currently used in such diverse applications as drinking water purification and as an animal feed additive, clinoptilolite, which in Greek means 'oblique feather stone', is a member of the zeolite group of minerals and was formed by the devitrification - the conversion of glassy material to crystalline material - of volcanic ash in lake and marine waters millions of years ago.
The EU has approved it for usein the category of "Binders, anti-caking agents and coagulants" in feedingstuffs for pigs, rabbits and poultry at levels of up to 20,000 mg/kg (Commission Regulation, 2001).
Before any new food product can be introduced on to the European market it must be rigorously assessed for safety. In the UK the assessment of novel foods is carried out by an independent committee of scientists appointed by the Food Standards Agency named the Advisory Committee on Novel Foods and Processes (ACNFP).
According to an FSA statement this week, the product is being sought for approval under Regulation (EC) No 258/97 concerning novel foods and novel food ingredients.
The UK firm said that deposits of clinoptilolite exist in several locations around the world but the company imports the product from a single mine at Duaringa, Queensland, Australia.
"This deposit is a very high purity clinoptilolite and, unlike many deposits, contains very low levels of lead. Its iron content confers a pale pinkish colour," it added.
The rock is crushed, milled and packed in Australia prior to shipping.
Initial discussions about Euremica Environmental's application are due at the ACNFP's meeting on 4 February 2004. Under the process, the FSA has 90 days - from the date of application, in this case the 5 January - to study the dossier, after which time it moves to the rest of the EU member states, who have 60 days to consider the application.
Any comments on the application should be sent to the ACNFP Secretariat by 2 February 2004 and will be passed to the Committee before it finalises its opinion on this novel food ingredient.
