Isomalto-oligosaccharide (extension of use)

May 2014: Application from Bioneutra Inc., Canada to extend the use of Isomalto-oligosaccharide for use in a limited number of additional foods under the Novel Food Regulation (EC) 258/97. Application Withdrawn.


Bioneutra’s isomalto-oligosaccharide was authorised in July 2013 to be added to a range of foods. Bioneutra has now submitted an application to extend the uses of its isomalto-oligosaccharide into additional foods (desserts, crackers, nutritional food bars, edible ices, flavoured drinks, sweet sauces, toppings and syrups, ready-to-eat savouries and snacks and foods intended for particular nutritional uses). The applicant also makes a suggestion for amending the labelling of foods containing this ingredient. Isomalto-oligosaccharide is a novel carbohydrate. Isomalto-oligosaccharide preparations generally consist of glucose oligomers with degrees of polymerisation of 3 to 10, depending on the method of production, along with variable amounts of monomeric and dimeric material. 

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Application Status: Withdrawn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 for isomalto-oligosaccharide was assessed by the UK under Regulation 258/97 (EC). The application was accepted in May 2014 and was reviewed by the Committee to assess 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.

There was an original authorisation for this, however the extension of use was reviewd by the committee at several times with no conclusive consenus of saftey being reacahed. It was decided  that the extension of use would not be authorised and the applicant subsquentially withdrew the application. However, under this application the committee accepted an amendment to the labelling of isomalto-oligosaccharide.