Cycloastragenol. EC No.159

March 2014: Application from K&L Gates, on behalf of Telomerase Activation Science Inc., for cycloastragenol under the Novel Food Regulation (EC) 258/97. Application Withdrawn

Background

This page detials on an application for cycloastragenol. An application was submitted and the applicant intends to market cycloastragenol as a novel food ingredient to be incorporated into food supplements.

Cycloastragenol is obtained from Astragalus trojanus a perennial flowering shrub of the Fabaceae (or legume) family. Other species of Astragalus, most notably A. membranaceus, which also contain cycloastragenol are available in food supplements in the EU. Cycloastragenol is the most common triterpede aglycone (often referred to as astragalosides) found in Astragalus sp. Triterpede aglycones belong to a class of secondary plant metabolites known as saponins. The applicant states that the product is to be used for the maintenance or enhancement of physiological functions in the body that are associated with wellbeing and health.

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Application Status: Withdrawn

The application forcycloastragenol was assessed by the UK under Regulation 258/97 (EC). The application was  fist reviewed by the Committee  in February 2014 to assess it whether the proposed use met the requirements under the regulation. Namely that it is safe, not misleading and would not put consumers as a nutritional disadvantage. The committee reviewed this application a number of times, after requesting more information from the applicant. 

The Committee did not complete an assessment of this product. The application was withdrawn by the applicant, and no authorisation took place.

Application Files