Isomaltulose. EC No. 47

October 2003: Application from Cerestar to approve isomaltulose as a novel food ingredient. Authorised April 2005.


Isomaltulose, an isomer of sucrose, is a reducing disaccharide, composed of a glucose and fructose molecule, joined by a 1,6-glycosidic bond. It is reported to occur naturally at low levels in honey as well as in sugar cane extract. Cerestar proposed to market isomaltulose for use as a novel food ingredient in the EU. Approval was sought under Regulation (EC) No 258/97 concerning novel foods and novel food ingredients. 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: Authorised

In the UK the assessment of novel foods is carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP). Following an initial public consultation period and the discussion of this application at the 20 November 2003 and 4 February 2004 meetings of the ACNFP, the UK Competent Authority formulated an initial opinion on this novel food ingredient. In April 2005 Cerestar was granted authorisation to market isomaltulose in the EU by Commission Decision 2005/457/EC.