Commission amends conditions of use and specifications of the novel food isomalto-oligosaccharide

With the implementation of Regulation (EU) 2025/97 of 21 January 2025, the Commission amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specifications of the novel food isomalto-oligosaccharide.

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific studies and data submitted in support of the application, namely, the compositional analyses data and expert opinion on those data; the product batch data; the request of the applicant to the competent authorities of the United Kingdom in accordance with Article 4 of Regulation (EC) No 258/97 to place isomalto-oligosaccharide on the market as a novel food ingredient; the certificates of analyses; the descriptions of the analytical methods; the laboratory accreditation certificates; the isomalto-oligosaccharide intake assessment reports; the stability study; the double-blind, randomised, placebo controlled study to investigate the effects of isomalto-oligosaccharide in healthy adults; and the randomised, triple-blind, placebo-controlled, parallel study to evaluate the safety and tolerability of isomalto-oligosaccharide on a healthy adult population, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place its isomalto-oligosaccharide on the market within the Union during a period of 5 years from the entry into force of this Regulation.

However, restricting the authorisation of isomalto-oligosaccharide and the reference to the scientific studies and data contained in the applicant’s file to the sole use by them does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

It is appropriate that the inclusion of isomalto-oligosaccharide produced by the applicant as a novel food in the Union list of novel foods contains also the information referred to in Article 9(3) of Regulation (EU) 2015/2283.

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