Commission Implementing Regulation (EU) 2026/1306 of 11 June 2026 authorising the placing on the market of rhamnogalacturonan-I enriched carrot extract (cRG-I) as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2026/1306
• Articles: 5

Article 1

1.   Rhamnogalacturonan-I enriched carrot extract (cRG-I) is authorised to be placed on the market within the Union.

Rhamnogalacturonan-I enriched carrot extract (cRG-I) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

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

Article 2

Only the company NutriLeads B.V.  ( 10 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 2 July 2026, unless a subsequent applicant obtains an authorisation for the novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the company NutriLeads B.V.

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 the company NutriLeads B.V.

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

‘ Rhamnogalacturonan-I enriched carrot extract

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘‘Rhamnogalacturonan-I carrot extract’’.

2.

The labelling of food supplements containing the novel food shall bear a statement that the food supplements should not be consumed by children under 3 years of age.

Authorised on 2 July 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: NutriLeads B.V., Bronland 12-N. 6708 WH Wageningen, NETHERLANDS.

During the period of data protection, the novel food Rhamnogalacturonan-I enriched carrot extract (cRG-I) is authorised for placing on the market within the Union only by NutriLeads B.V., 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 NutriLeads B.V.

End date of the data protection: 2 July 2031.’

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

1 500  mg/day for the general population above 3 years of age

Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for infants and young children

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

1 500  mg/day

Meal replacement for weight control, excluding meal replacement for infants and young children

500 mg/meal

Processed cereal based food and baby food for infants and young children as defined by Regulation (EU) No 609/2013

In accordance with the particular nutritional requirements of infants and young children and with a maximum of 625 mg/100 ml (for beverages) and 450 mg/100 g (meals)

Muesli and similar mixed breakfast cereals

5 000  mg/100 g

Cereal bars

3 750  mg/100 g

Fruit based drinks, except product defined in part I of Annex I to Directive 2001/112/EC

500 mg/100 ml

Biscuits, rusks and cookies

3 750  mg/100 g

Soups and soup concentrates

750 mg/100 ml (marketed as such or reconstituted according to the instructions)

Flavoured milk-based drinks

750 mg/100 g

Yogurt based drinks

750 mg/100 g

Milk analogues

750 mg/100 g

Cream analogues

10 000  mg/100 g

Cheese analogues

3 750  mg/100 g

Yogurt analogues

1 200  mg/100 g

(2)

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

Authorised Novel Food

Specifications

‘ Rhamnogalacturonan-I enriched carrot extract

Description/Definition :

The novel food is an extract of carrot pomace selectively enriched for rhamnogalacturonan-I domains by an enzymatic process (degrading selectively the pectin portion), followed by inactivation of the enzymes and further purification, heat treatment, drying and pasteurisation.

Source: Daucus carota L. , subspecies Sativus.

Physical and chemical properties :

Colour: Off-white to beige

Odour/taste: Neutral

Solubility: soluble in water

Water activity: < 0,6

Composition :

Rhamnogalacturonan-I: ≥ 70 %

Rhamnose: ≥ 9 %

Moisture: ≤ 7 %

Free sugars: ≤ 3 %

Soluble dietary fibre: ≥ 60 %

Total dietary fibre: ≥ 70 %

Crude protein: ≤ 4 %

Ash: ≤ 5 %

Fat: ≤ 2 %

Contaminants :

Lead: ≤ 1,0 mg/kg

Cadmium: ≤ 1,0 mg/kg

Arsenic: ≤ 0,1 mg/kg

Mercury: ≤ 0,1 mg/kg

Perchlorate: ≤ 0,05 mg/kg

Microbiological criteria:

TAMC: ≤ 1 × 10 3 CFU/g

TYMC: ≤ 1 × 10 2 CFU/g

Bacillus cereus : < 1 × 10 2 CFU/g

Enterobacteriaceae: < 1 × 10 2 CFU/g

Escherichia coli : < 10 CFU/g

Salmonella spp.: not detected in 25 g

Listeria monocytogenes : not detected in 25 g

Sulphite reducing anaerobes: < 30 CFU/g

Abbreviations: CFU, colony forming units; TAMC, total aerobic microbial count; TYMC, total yeast and mould count.’