(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

On 17 December 2022, the company NutriLeads B.V. (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place rhamnogalacturonan-I enriched carrot fibre (cRG-I) on the Union market as a novel food. The applicant requested for the novel food to be used in a number of foods intended for the general population, food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4) and total diet replacement for weight control as defined in Regulation (EU) No 609/2013. Subsequently, on 15 December 2025, the applicant modified the initial request in the application on the use of rhamnogalacturonan-I enriched carrot fibre (cRG-I) in food supplements, foods for special medical purposes and meal replacement for weight control to exclude infants and young children.

(4)

On 17 December 2022, the applicant also made a request to the Commission for the protection of the following proprietary data: identity (5), compositional data (6) and toxicological information (7).

(5)

On 8 November 2023, the Commission requested the European Food Safety Authority (‘the Authority’) to provide a scientific opinion on rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food.

(6)

On 25 June 2025, the Authority adopted its scientific opinion on the ‘Safety of rhamnogalacturonan-I enriched carrot fibre (cRG-I) as a novel food pursuant to Regulation (EU) 2015/2283’ (8) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that that the novel food, cRG-I, a rhamnogalacturonan-rich polysaccharide fraction derived from carrot pomace, is safe under the proposed conditions of use.

(8)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data on the identity, compositional data and toxicological information without which it could not have assessed the novel food and reached its conclusion.

(9)

The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2), point (b), of Regulation (EU) 2015/2283.

(10)

The applicant declared that they held proprietary and exclusive rights of reference to the relevant studies, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(11)

The Commission assessed all the information provided by the applicant and considers that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on the identity, compositional data and toxicological information, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place rhamnogalacturonan-I enriched carrot extract (cRG-I) on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)

However, such restriction of the authorisation and the reference to the data contained in the applicant’s file for their sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(13)

It is appropriate that the inclusion of rhamnogalacturonan-I enriched carrot extract (cRG-I) as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In line with the conditions of use of food supplements containing rhamnogalacturonan-I enriched carrot extract (cRG-I) as proposed by the applicant, it is necessary to inform the consumers in that regard by appropriate labelling of the designation of the novel food and about the uses of food supplements containing rhamnogalacturonan-I enriched carrot extract (cRG-I).

(14)

The applicant originally proposed that the novel food be placed on the Union market under the name rhamnogalacturonan-I enriched carrot fibre (cRG-I). In its scientific opinion, the Authority characterised the novel food as a purified, rhamnogalacturonan-rich polysaccharide fraction isolated from carrot pomace through enzymatic and physical processing steps. The Authority further noted that, although the novel food consists predominantly of non-digestible carbohydrates, they did not assess whether the material meets the legal definition of ‘dietary fibre’ laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council (9). Therefore, it has not been demonstrated that the fibre component meets the definition set out in Annex I to Regulation (EU) No 1169/2011. The use of the term ‘rhamnogalacturonan-I enriched carrot fibre (cRG-I)’ in the designation of the novel food could therefore mislead consumers as to its nutritional properties and composition. Therefore, it is appropriate to replace the term ‘rhamnogalacturonan-I enriched carrot fibre (cRG-I)’ with ‘rhamnogalacturonan-I enriched carrot extract (cRG-I)’.

(15)

Rhamnogalacturonan-I enriched carrot extract (cRG-I) should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(16)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,