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

• CELEX: Implementing Regulation (EU) 2025/97
• Articles: 5

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company BioNeutra North America Inc.  ( 18 ) is authorised to place on the market within the Union isomalto-oligosaccharide as specified in the Annex, for a period of 5 years from the date of entry into force of this Regulation, 11 February 2025, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of BioNeutra North America Inc.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation, without the agreement of BioNeutra North America Inc.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Isomalto-oligosaccharide

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “isomalto-oligosaccharide”.

2.

The designation of the novel food on the labelling shall be accompanied by indication that the isomalto-oligosaccharide is a source of glucose.

3.

The labelling of food supplements containing isomalto-oligosaccharide shall bear a statement that they should not be consumed by children under 10 years of age.

Authorised on 11 February 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: BioNeutra North America Inc., 9608 25 Avenue NW, Edmonton, Alberta T6N 1J4, Canada. During the period of data protection, the novel food isomalto-oligosaccharide is authorised for placing on the market within the Union only by BioNeutra North America Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of BioNeutra North America Inc.

End date of the data protection: 11 February 2030.’

Ice cream, dairy desserts

8 %

Instant coffee and tea

10 %

Table-top sweeteners

100 %

Cakes, muffins and pies

20 %

Pastries

15 %

Breakfast cereals

10 %

Savoury sauces, gravies and condiments

10 %

Gelatines and puddings

15 %

Fruit pie fillings

15 %

Fruit spreads (except products defined in Part I of Annex I to Directive 2001/113/EC)

50 %

Yoghurts

2,5 %

Milk-based drinks

5 %

Cereal-, fruit- or vegetable-based snacks

5 %

Sweet sauces, toppings and syrups

50 %

Food supplements as defined in Directive 2002/46/EC, for the general population, excluding children, under the age of 10 years

10 g/day

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised novel food

Specification

‘ Isomalto-oligosaccharide

Powder

Solubility (water) (%): > 99,0

Glucose (% dry basis): ≤ 5,0

Isomaltose + DP3 to DP9 (% dry basis): ≥ 90,0

Moisture (%): ≤ 4,0

Sulphated ash (g/100 g): ≤ 0,3

Heavy metals:

Lead (mg/kg): ≤ 0,5

Arsenic (mg/kg): ≤ 0,5

Microbiological criteria:

Total Aerobic Microbial Count: ≤ 1 000 CFU/g

Yeasts and moulds: ≤ 100 CFU/g

Escherichia coli : Absence in 10 g

Salmonella spp.: Absence in 25 g

Syrup

Dried solids (g/100 g): > 75

Glucose (% dry basis): ≤ 5,0

Isomaltose + DP3 to DP9 (% dry basis): ≥ 90

pH: 4–6

Sulphated ash (g/100 g): ≤ 0,3

Heavy metals:

Lead (mg/kg): ≤ 0,5

Arsenic (mg/kg): ≤ 0,5

Microbiological criteria:

Total Aerobic Microbial Count: ≤ 1 000 CFU/g

Yeasts and moulds: ≤ 100 CFU/g

Escherichia coli : Absence in 10 g

Salmonella spp.: Absence in 25 g

CFU: colony forming units’