Views wanted on novel food opinions

Wednesday 30 November 2005

Following consultations and discussions, the Agency's expert advisory committee on novel foods has published its draft opinions on two applications, one for a novel food supplement and the other as 'substantially equivalent' to an existing ingredient.

Any comments on these opinions will be passed to the Advisory Committee on Novel Foods and Processes (ACNFP) during its assessment of these substances.

A novel food is defined as a food or food ingredient that does not have a significant history of consumption within the EU before May 1997. All novel foods are subject to a pre-market safety assessment under the novel foods regulation (EC) 258/97. In the UK the ACNFP carries out all novel food assessments.

The first application is from Euremica Environmental to approve clinoptilolite as a food supplement. Clinoptilolite is a naturally occurring zeolite, which is currently used in purifying drinking water and as an animal feed additive. The ACNFP does not support the approval of this novel food ingredient because it felt the safety data provided by Euremica Environmental for the approval of clinoptilolite as a novel food ingredient are inadequate.

The second application is from Prima Pharm, which wants its ingredient approved on the grounds that it is comparable with the Diminicol phytosterol ingredient that was authorised in 2004. The ACNFP opinion is that the phytosterols marketed by Prima Pharm can be considered to be substantially equivalent to the existing phytosterol ingredient marketed by Teriaka.

All comments on these draft opinions should be received by the ACNFP secretariat by 10 December 2005.