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Risk assessment

Safety Assessment: Change of conditions of use for the novel food, isomalto-oligosaccharides


An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in April 2021 from Bioneutra Incorporated, North America (“the applicant”) for the authorisation of the proposed extension of use of isomalto-oligosaccharides (IMOs) as a novel food.

The novel food are IMOs which are intended to be used as a food ingredient and as an ingredient in food supplements. IMOs are manufactured by the enzyme hydrolysis of starch which is sourced from different plant crops (e.g., cereals, legumes, and roots).

IMOs are currently authorised as a novel food in the UK (assimilated Commission Implementing Regulation (EU) 2017/2470). This new application is an extension of the intended uses of IMOs, seeking to use the novel food within the food categories: ice cream and dairy desserts, instant coffee and tea, table-top sweeteners, cakes, muffins, pies, pastries, breakfast cereals, condiments/relishes, gravies and sauces, gelatines, puddings, fillings, jams and jellies, yoghurts, milk-based drinks, snack foods, and sweet sauces, toppings and syrups, and as an ingredient in food supplements.

To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. Please note the Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the extension of use of the food is safe, and not putting consumers at a nutritional disadvantage.

The FSA and FSS concluded that the applicant had provided sufficient information to assure the proposed extension of use for IMOs, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in foods was not considered to be nutritionally disadvantageous.

Safety assessment