BioNeutra isomalto-oligosaccharides in new food categories and in food supplements up to 10 g/day (over 10 years of age): isomaltose + DP3–DP9 ≥ 90 % DM, glucose ≤ 5 %, new microbiological criteria (total aerobic count ≤ 1000 CFU/g, E. coli absent in 10 g, Salmonella absent in 25 g); EFSA — two in-house HPLC-RI methods, because there are no standards
Commission Implementing Regulation (EU) 2025/97, published on 22 January 2025, adds to the Union list of novel foods a separate entry for the isomalto-oligosaccharides of BioNeutra North America Inc. (Edmonton, Canada), with new uses in more than a dozen food categories and in food supplements. Isomalto-oligosaccharides had already been authorised by a decision of the UK authority in 2016; those conditions of use apply to everyone, while the new ones apply for 5 years, until 11 February 2030, only to the applicant (data protection). The basis is the EFSA opinion of 14 December 2023.
- Maximum levels in the new uses: ice cream and dairy desserts 8 %, instant coffee and tea 10 %, table-top sweeteners 100 %, cakes, cookies, muffins and pies 20 %, sweet bakery products 15 %, breakfast cereals 10 %, savoury sauces and condiments 10 %, gelatins and puddings 15 %, fruit pie fillings 15 %, fruit spreads 50 % (except the jams, jellies and marmalades of Directive 2001/113/EC), yoghurts 2.5 %, milk-based drinks 5 %, snacks 5 %, sweet sauces, toppings and syrups 50 %, food supplements 10 g/day. The applicant proposed 30 g/day in supplements, but reduced the dose because the product is a source of glucose.
- Specification: powder — solubility in water > 99.0 %, glucose ≤ 5.0 % DM, isomaltose + DP3 to DP9 ≥ 90.0 % DM, moisture ≤ 4.0 %, sulphated ash ≤ 0.3 g/100 g, lead and arsenic ≤ 0.5 mg/kg; syrup — total solids > 75 g/100 g, pH 4–6, glucose and oligosaccharides as for the powder. New microbiological criteria, at EFSA’s request, for both forms: total aerobic microbial count ≤ 1000 CFU/g, yeasts and moulds ≤ 100 CFU/g, Escherichia coli absent in 10 g, Salmonella spp. absent in 25 g.
- Methods (EFSA): EFSA notes that there are no standardised national or international methods for the identification and quantification of individual saccharides — the applicant developed and validated two in-house methods: size-exclusion (SE-HPLC-RI) and normal-phase (NP-HPLC-RI) with a refractive index detector. In five batches of each form isomaltose + DP3–DP9 amounted to 89.88–92.34 %, glucose 0.25–1.41 %, maltose 6.97–9.04 %; dietary fibre (AOAC 2009.01) 15.7–21.4 g/100 g in the syrup and 22.3–32.8 g/100 g in the powder; metals by ICP-MS (USP <233>) — lead below 0.02 mg/kg.
- Safety (EFSA): the product consists of glucose oligomers with α-(1–4) and α-(1–6) bonds and a degree of polymerisation of 3–9, obtained by enzymatic hydrolysis of starch (cereals, pulses, roots). According to EFSA, a tolerability study in adults provides reassurance that the product is tolerable at 120 g/day; conservative intake estimates for adolescents reach 112 g/day (95th percentile), and 142 g/day with supplements — EFSA nevertheless sees no concern. Labelling: the name “isomalto-oligosaccharides”, a statement that they are a source of glucose, and on supplements — that they are not for children under 10.