Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of isomalto-oligosaccharide (IMO) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of glucose oligomers with degrees of polymerisation of 3-9, along with various amounts of mono- and disaccharides. The NF comes in both syrup and powder form. The applicant intends to extend the current uses of the NF as an ingredient in several foods, and use the NF in food supplements aimed at the general population older than 10 years of age. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. Along with literature data, the applicant carried out a tolerability study in adult volunteers with the NF at doses up to 120 g/day. The Panel concludes that this study provides reassurance that the NF is tolerable at doses of 120 g/day. Conservative intake estimates resulting from the use of the NF as an ingredient according to the currently authorised uses and new proposed uses result in a highest intake estimate in adolescents of 112 g/day at the 95th percentile, and reach 142 g/day in adolescents when the use as a food supplement is included. The Panel notes this amount is higher than the dose of 120 g/day for which tolerability has been demonstrated. However, considering the source, compositional characterisation, production process and nature of the NF, as well as the available nutritional and toxicological data on the NF, the Panel considers that the NF does not present safety concerns under the proposed conditions of use.

Extension of use of isomalto‐oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283 / Null, Null; Turck, Dominique; Bohn, Torsten; Castenmiller, Jacqueline; De , ; Henauw, Stefaan; Hirsch‐ernst, Karen Ildico; Maciuk, Alexandre; Mangelsdorf, Inge; Mcardle, Harry J.; Naska, Androniki; Pentieva, Kristina; Siani, Alfonso; Thies, Frank; Tsabouri, Sophia; Vinceti, Marco; Aguilera‐gómez, Margarita; Cubadda, Francesco; Frenzel, Thomas; Heinonen, Marina; Marchelli, Rosangela; Neuhäuser‐berthold, Monika; Poulsen, Morten; Prieto Maradona, Miguel; Schlatter, Josef Rudolf; Siskos, Alexandros; van Loveren, Henk; Albert, Océane; Knutsen, Helle Katrine. - In: EFSA JOURNAL. - ISSN 1831-4732. - 22:2(2024), pp. 1-16. [10.2903/j.efsa.2024.8543]

Extension of use of isomalto‐oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283

Vinceti, Marco;Marchelli, Rosangela;
2024

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of isomalto-oligosaccharide (IMO) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of glucose oligomers with degrees of polymerisation of 3-9, along with various amounts of mono- and disaccharides. The NF comes in both syrup and powder form. The applicant intends to extend the current uses of the NF as an ingredient in several foods, and use the NF in food supplements aimed at the general population older than 10 years of age. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. Along with literature data, the applicant carried out a tolerability study in adult volunteers with the NF at doses up to 120 g/day. The Panel concludes that this study provides reassurance that the NF is tolerable at doses of 120 g/day. Conservative intake estimates resulting from the use of the NF as an ingredient according to the currently authorised uses and new proposed uses result in a highest intake estimate in adolescents of 112 g/day at the 95th percentile, and reach 142 g/day in adolescents when the use as a food supplement is included. The Panel notes this amount is higher than the dose of 120 g/day for which tolerability has been demonstrated. However, considering the source, compositional characterisation, production process and nature of the NF, as well as the available nutritional and toxicological data on the NF, the Panel considers that the NF does not present safety concerns under the proposed conditions of use.
2024
22
2
1
16
Extension of use of isomalto‐oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283 / Null, Null; Turck, Dominique; Bohn, Torsten; Castenmiller, Jacqueline; De , ; Henauw, Stefaan; Hirsch‐ernst, Karen Ildico; Maciuk, Alexandre; Mangelsdorf, Inge; Mcardle, Harry J.; Naska, Androniki; Pentieva, Kristina; Siani, Alfonso; Thies, Frank; Tsabouri, Sophia; Vinceti, Marco; Aguilera‐gómez, Margarita; Cubadda, Francesco; Frenzel, Thomas; Heinonen, Marina; Marchelli, Rosangela; Neuhäuser‐berthold, Monika; Poulsen, Morten; Prieto Maradona, Miguel; Schlatter, Josef Rudolf; Siskos, Alexandros; van Loveren, Henk; Albert, Océane; Knutsen, Helle Katrine. - In: EFSA JOURNAL. - ISSN 1831-4732. - 22:2(2024), pp. 1-16. [10.2903/j.efsa.2024.8543]
Null, Null; Turck, Dominique; Bohn, Torsten; Castenmiller, Jacqueline; De , ; Henauw, Stefaan; Hirsch‐ernst, Karen Ildico; Maciuk, Alexandre; Mangelsdorf, Inge; Mcardle, Harry J.; Naska, Androniki; Pentieva, Kristina; Siani, Alfonso; Thies, Frank; Tsabouri, Sophia; Vinceti, Marco; Aguilera‐gómez, Margarita; Cubadda, Francesco; Frenzel, Thomas; Heinonen, Marina; Marchelli, Rosangela; Neuhäuser‐berthold, Monika; Poulsen, Morten; Prieto Maradona, Miguel; Schlatter, Josef Rudolf; Siskos, Alexandros; van Loveren, Henk; Albert, Océane; Knutsen, Helle Katrine
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