D-beta-hydroxybutyrate ester. EC No.155

September 2013 : Application from TDeltaS for the authorisation of D-beta-hydroxybutyrate ester, under the Novel Food Regulation (EC) 258/97. Application Withdrawn.


D-β-hydroxybutyrate ester is a ‘ketone body’ which are produced by the body during periods of limited glucose availability such as during intense and prolonged physical exertion. The applicant suggests that consumption of D-β-hydroxybutyrate ester during periods of intense exercise will maintain physical and cognitive performance and is proposing its use in food supplements that will be used exclusively by high performance athletes. D-β-hydroxybutyrate ester is a novel food and before any new food product can be introduced on the European market, it must be rigorously assessed for safety. 

Legal Backgroud

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Application Status: Withdrawn

The applicaiton was withdrawn from the applicant and not futher action was taken by the ANCFP and the FSA.

Application Files