Extension of use of isomalto‐oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283 (2025)

Keywords: extension of use, food supplement, IMO, isomalto‐oligosaccharide, novel foods

1.1. Background and Terms of Reference as provided by the requestor

Isomalto‐oligosaccharide (IMO) was authorised under certain conditions of use pursuant to Article 4 of the former Regulation (EC) No 258/971 by the United Kingdom (UK) Food Safety in February 2016 (https://ec.europa.eu/food/system/files/2016‐11/novel‐food_authorisation_2016_auth‐letter_isomalto‐oligosaccharide_en.pdf).

On 26 March 2021, the company BioNeutra North America Inc. submitted a request to the European Commission (EC) in accordance with Article 10 of Regulation (EU) 2015/22832 for an extension of use of IMO as a novel food.

The application requests to extend the use of IMO to include 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. It is also proposed for use in food supplements as defined in Directive 2002/46/EC3 for the general population older than 10 years.

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the European Commission asks the European Food Safety Authority (EFSA) to provide a scientific opinion on IMO.

In addition, the EFSA is requested to include in its scientific opinion a statement as to if, and if so to what extent, the proprietary data for which the applicant is requesting data protection was used in elaborating the opinion in line with the requirements of Article 26(2)(c) of Regulation (EU) 2015/2283.

1.2. Additional information

In February 2009, an application from Bioneutra was accepted by the United Kingdom Food Standards Agency (UK FSA) to place IMO on the European Union (EU) market as a novel food ingredient.

On 7 December 2012, the UK FSA concluded that IMO meets the criteria for acceptance as a novel food, as defined in Article 3(1) of Regulation (EC) No 258/97.

The Commission forwarded the initial assessment report to all Member States on 31 January 2013. No reasoned safety objections were presented by the Commission or the Member States, and the applicant's IMO powder and syrup were considered to have complied with the criteria laid down in Article 3(1) of Regulation No 258/97.

In June 2014, the applicant requested labelling requirement amendment, so that foods containing the novel food (NF) can be labelled as ‘a source of glucose’. The Advisory Committee on Novel Foods and Processes (ACNFP) concluded that the new proposed labelling did not pose any safety concerns for diabetics and was consistent with the way that other glycaemic carbohydrates are labelled in the EU.

On 23 October 2015, Member States and the European Commission were consulted on the proposed change and no reasoned safety objections were presented. The authorisation was amended to replace the requirement to label products containing IMO as unsuitable for diabetics with a requirement to label the products as ‘a source of glucose’. The NF was authorised under certain conditions of use pursuant to Article 4 of the former Regulation (EC) No 258/97 by the UK FSA in February 2016 (https://ec.europa.eu/food/system/files/2016‐11/novel‐food_authorisation_2016_auth‐letter_isomalto‐oligosaccharide_en.pdf).

2.1. Data

The safety assessment of this NF is based on data supplied in this application and the previous assessment of the NF (UK FSA,2012) and information submitted by the applicant following EFSA's requests for supplementary information.

Administrative and scientific requirements for NF applications referred to in Article 10 of Regulation (EU) 2015/2283 are listed in Commission Implementing Regulation (EU) 2017/2469.4

A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of a NF application (EFSA NDA Panel,2016). As indicated in this guidance, it is the duty of the applicant to provide all the available (proprietary, confidential and published) scientific data (including both data in favour and not in favour) that are pertinent to the safety of the NF.

This NF application includes a request for protection of proprietary data in accordance with Article 26 of Regulation (EU) 2015/2283. The data requested by the applicant to be protected comprise: two safety and tolerability studies of IMO in healthy adults (2012, 2020), their summaries and supplemental data, the compositional data and related expert opinion, the original NF application to the UK FSA, product batch data, certificates of analysis, description of analytical methods, laboratory accreditation certificates, intake reports and stability data.

2.2. Methodologies

The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA NDA Panel,2016) and the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. The legal provisions for the assessment are laid down in Article 11 of Regulation (EU) 2015/2283 and in Article 7 of Commission Implementing Regulation (EU) 2017/2469.

This assessment concerns only the risks that might be associated with consumption of the NF under the proposed conditions of use and is not an assessment of the efficacy of the NF with regard to any claimed benefit.

3.1. Introduction

The NF which is the subject of this application for extension of use is isomalto‐oligosaccharide (IMO). The NF is produced via enzyme‐catalysed hydrolysis of food grade starch from different plant‐based crops and consists of glucose oligomers with degrees of polymerisation (DP) of 3–9, along with various amounts of mono‐ and disaccharides. According to Article 3.2(a) of NF regulation (EU) 2015/2283, the NF falls under category (i), i.e. ‘food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997’.

In addition to its current authorised uses, the NF is herein proposed to be used as a food ingredient in ice cream and dairy desserts, instant coffee and tea, tabletop 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. The target population is the general population. The NF is also proposed for use in food supplements at a maximum use level of 30 g/day for the general population older than 10 years of age.

3.2. Identity of the NF

The NF is isomalto‐oligosaccharide. Other names include IMO (soluble fibre from pea/tapioca/corn), IMO (fibre sources from vegetable) and oligo‐isomaltose. Its current trade name is VitaFiber® (IMO syrup and IMO‐powder) [previously VitaSugar™ (IMO syrup and IMO‐powder)].

IMOs are defined as any oligosaccharide possessing an isomaltose moiety [i.e. two d‐glucopyranoside units joined by an α‐(1–6) glucosidic linkage]. The NF is a mixture of glucose oligomers linked through α‐(1–4) or α‐(1–6) glucosidic bonds, including mono‐ and disaccharides (about 30%), as well as oligomers with DP of 3–9 (about 70%). The NF comes in both syrup and powder form.

Size exclusion chromatography was used to separate and quantify oligosaccharides up to DP 6 using authentic standards, whereas the characterisation of higher DP oligosaccharides was prevented by technical constraints and the lack of representative standards. Further analysis was conducted using hydrophilic interaction high‐performance liquid chromatography with fluorescence and mass selective detection (HILIC‐HPLC‐FLD‐MS), which allowed separation and identification of DP groups based on their oligomeric mass, confirming the presence of DP 7, DP 8 and DP 9 oligosaccharides. The presence of the isomaltose moiety was verified by 1H NMR, which allowed to determine the α‐1,6 linkage proportion in the individual fractions of separated DP 3 to DP 9 oligosaccharides. 1H NMR analysis of six different production lots without DP fractionation showed that the product as a whole is composed of 55%–59% oligosaccharides with α‐1,6 linkages.

The applicant notes that the exact distribution of the individual di‐, tri‐ and larger oligosaccharides in the NF will vary depending on the manufacturing conditions used to produce the mixture.

3.3. Production process

The Panel notes that an assessment of the production process for the NF when produced via enzyme‐catalysed hydrolysis of starch from different sources of plant‐based crops was conducted by the UK FSA(2012) and did not raise any concern. The applicant does not seek to amend the production process from what was assessed at that time, but indicated a change in enzyme in the saccharification phase of the process because of the discontinuation of the original product. Considering the important increase in anticipated intake of the NF based on the new proposed uses and use levels, EFSA carried out a thorough re‐assessment of the production process.

Briefly, IMO is produced in accordance with current Good Manufacturing Practice (GMP) via enzyme‐catalysed hydrolysis of starch from different sources of plant‐based crops (e.g. cereals, legumes, and roots). The safety of all enzymes used in the production process was assessed by the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids with a positive outcome. The manufacturing process is briefly summarised in Figure1.

Certificates of analysis were provided for all raw materials.

The Panel considers that the production process is sufficiently described and does not raise safety concerns.

3.4. Compositional data

The NF consists of a mixture of glucose oligomers linked through α‐(1–4) or α‐(1–6) glucosidic bonds, with DP of 3–9, along with various amounts of mono‐ and disaccharides, in syrup or powder form. In order to confirm that the manufacturing process is reproducible and adequate to produce the NF with the required characteristics on a commercial scale, the applicant provided updated analytical information for five independent batches of the NF in each form (Table1), demonstrating that the NF is compliant with specifications laid out in the Union List of novel foods for syrup and powder preparations of IMO.

The Panel notes that there are no standardised nationally or internationally recognised methods available for the identification and quantification of individual types of saccharides. The applicant developed and validated two in‐house methods using size exclusion and normal phase high‐performance liquid chromatography with a refractive index detector (SE‐HPLC‐RI and NP‐HPLC‐RI).

The applicant investigated the solubility of the NF in powder form at different temperatures. Solubility at 25°C was characterised by 79.2% Brix and 78.41% dissolved solids.

Satisfactory information was provided on the accreditation of the laboratories that conducted the analyses presented in the application.

The Panel considers that the information provided on the composition is sufficient to characterise the NF.

3.5. Specifications

The specifications of the NF are indicated in Tables2 and 3 for syrup and powder forms, respectively. The specifications will be kept as indicated in the Union List, with the addition of microbiological parameters, which the Panel considers will reinforce the safety of the NF.

The Panel considers that the information provided on the specifications of the NF is sufficient and does not raise safety concerns.

3.6. History of use of the NF and/or of its source

3.7. Proposed uses and use levels and anticipated intake

3.8. Absorption, distribution, metabolism and excretion (ADME)

The NF consists of about 60% of glycaemic (i.e. digestible, available) carbohydrates – including monosaccharides, disaccharides and oligosaccharides – and 20% of ‘dietary fibre’ by weight (c.f. Sections3.4 and 3.9).

While monosaccharides are directly absorbed in the small intestine, glycaemic carbohydrates with higher DP are enzymatically degraded, first through the action of salivary amylase and then in the small intestine by pancreatic amylase. Their degradation products are further hydrolysed to glucose by enterocyte brush border membrane enzymes. Isomaltase (i.e. oligo‐1,6‐glucosidase) hydrolyses the α‐1,6 linkage in isomaltose and oligosaccharides. Absorbed monosaccharides are transported to the liver and then to the systemic circulation (EFSA NDA Panel,2010).

Dietary fibres are passing to the large intestine undigested and form a substrate for the colonic microflora (EFSA NDA Panel,2010).

Within the framework of this request for extension of use, further corroborating information on the fate of the NF has been provided by the applicant and is summarised below.

3.9. Nutritional information

From a nutritional point of view, the NF consists of about 60% of glycaemic (i.e. digestible, available) carbohydrates, including monosaccharides, disaccharides and oligosaccharides, and 20% of dietary fibre (i.e. non‐digestible carbohydrates, assessed by the AOAC 2009.01 method) by weight (c.f. Section3.4).

Dietary Reference Values (DRVs) have been established by EFSA for glycaemic carbohydrates (Reference Intake range between 45 and 60 E%) and dietary fibre (Adequate Intake of 25 g/day for adults) from mixed diets (EFSA NDA Panel,2010). EFSA's definition of dietary fibre in that context (i.e. non‐digestible carbohydrates plus lignin) does not reflect the additional requirement of having a beneficial physiological effect demonstrated by generally accepted scientific evidence laid down in Annex I of Regulation (EC) 1169/2011 for:

1. edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic, or chemical means and,

2. edible synthetic carbohydrate polymers.

It is out of the scope of this opinion to establish whether the fraction of non‐digestible carbohydrates present in the NF meets the legal definition of dietary fibre in the EU or not.

The Panel assumes that the NF, under the proposed conditions of use and use levels, will replace other sources of digestible and non‐digestible carbohydrates in the diet.

The Panel considers that the NF per se is not nutritionally disadvantageous.

3.10. Toxicological information

In its application to the UK FSA, the applicant summarised a series of data relating to genotoxicity, toxicity and human tolerance of IMO from other manufacturers, and presented a human tolerability study of its own (Unpublished Study,2012). At the time, the UK FSA Committee did not identify any concerns relating to the toxicity or tolerability of IMO at the proposed intake levels.

Within the framework of this extension of use, the applicant carried out a new tolerability study in humans with the NF (Unpublished Study,2020), and updated the information available in the literature regarding human exposure to IMO. No new original studies investigating the genotoxicity, (sub)acute or (sub)chronic exposure to the NF were provided.

In the light of the available data, the Panel considered that no new toxicological studies on the NF were required.

3.11. Allergenicity

In its 2012 assessment, the UK FSA Committee did not raise any concerns relating to allergenicity, other than stating that the NF will need to be labelled in accordance with requirements for food allergens if it is derived from one of the allergenic crops identified in EU labelling legislation (Directive 2000/13/EC and Regulation (EU) 1169/2011), unless a specific exemption is obtained following an evaluation by EFSA.

The Panel considers that, owing to the low amount of protein present, the NF is unlikely to trigger allergic reactions in the target population under the proposed conditions of use.

5.1. Protection of proprietary data in accordance with Article 26 of Regulation (EU) 2015/2283

The Panel could not have reached the conclusion on the safety of the NF under the proposed conditions of use without the data claimed as proprietary by the applicant [two safety and tolerability studies of IMO in healthy adults (2012, 2020), their summaries and supplemental data, the compositional data and related expert opinion, the original NF application to UK FSA, product batch data, certificates of analysis, description of analytical methods, laboratory accreditation certificates, intake reports and stability data].

Dietary exposure estimates to the Novel Food for each population group from each EU dietary survey: already authorised uses

Dietary exposure estimates to the Novel Food for each population group from each EU dietary survey: already authorised uses and extended proposed uses as a food ingredient

1.

Annex A Dietary exposure estimates to the Novel Food for each population group from each EU dietary survey: already authorised uses

Information provided in this Annex is shown in an Excel file (downloadable at https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.8543#support‐information‐section).

Annex B Dietary exposure estimates to the Novel Food for each population group from each EU dietary survey: already authorised uses and extended proposed uses as a food ingredient

Information provided in this Annex is shown in an Excel file (downloadable at https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.8543#support‐information‐section).

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Supplementary Materials