Isomalto-oligosaccharide. EC No. 103

January 2009: Application from Bioneutra Inc, for the authorisation of Isomalto-oligosaccharide (IMO) under the Novel Food Regulation (EC) 258/97. Authorised July 2013.


This page presents information pertaining to the application for Isomalto-oligosccharide under novel food regulation 258/97.

Oligosaccharides are carbohydrates that are largers than one, two or three monosaccharides but less than polysaccarides (i.e. sugars longer than six monosaccharides). Isomalto-oligosaccharide (IMO) is a mixture of glucose oligomers linked to isomlatose, pannose and other branched oligosaccharides. 

The applicant’s intention is to market this novel carbohydrate for use in a range of foods such as beverages, cereal products and confectionery. The applicant’s IMO is prepared so that the content of isomaltose and larger oligosaccharides (with 3-9 degrees of polymerisation) is not less than 90% while glucose content is no more than 5%.

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

Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. 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).

The application for Isomalto-oligosaccharide was assessed by the UK under Regulation 258/97 (EC). The application was accepted in January 2009 and was reviewed by the Committee 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 completed its assessment and published its positive opinion. This opinion was shared with the other Member States resulting in the product being authorised by the EU subject to the conditions specified in the authorisation.