Clinoptilolite. EC No. 51

January 2004: Application from Euremica Environmental to approve clinoptilolite as a food supplement. Status: Rejected September 2008.

Background

Clinoptilolite is a naturally occurring zeolite, formed by the devitrification (ie the conversion of glassy material to crystalline material) of volcanic ash in lake and marine waters millions of years ago. Clinoptilolite is currently used in applications such as drinking water purification and as an animal feed additive. Euremica Environmental Ltd propose to market clinoptilolite as a food supplement in the EU. 

Legal Background

Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).

One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.

Application Status: Rejected

Following an initial public consultation period and the discussion of this application at the 4 February 2004 and 29 September 2005 meetings of the Advisory Committee on Novel Food and Processes (ACNFP), the UK Competent Authority has formulated a negative initial opinion for this novel food application. The application closed in September 2008.

Application Files