(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 28 May 2020, the company SAVANNA Ingredients GmbH (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place cellobiose on the Union market as a novel food. The applicant requested for cellobiose to be used in a number of foods intended for the general population, including food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) intended for the general population, excluding infants and young children.

(4)

On 28 May 2020, the applicant also made a request to the Commission for the protection of proprietary data for data on the identity (4), production process (5), composition (6), genotoxicity (7), subchronic toxicity (8) and human studies (9).

(5)

On 23 September 2020, the Commission, requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of cellobiose as a novel food.

(6)

On 28 September 2022, the Authority adopted its scientific opinion on the ‘Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283’ (10) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that cellobiose is safe under the proposed conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that cellobiose, when used in a number of foods intended for the general population, including food supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants and young children, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on data on the identity, production process, composition, genotoxicity, subchronic toxicity and human studies 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 its claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(10)

The applicant declared that it held proprietary and exclusive rights of reference to the data on the identity, production process and composition, and genotoxicity, subchronic toxicity and human 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 considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on the identity, production process, composition, genotoxicity, subchronic toxicity and human studies should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place cellobiose on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)

However, restricting the authorisation of cellobiose and the reference to the data contained in the applicant’s file for its 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 cellobiose 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 this regard, in line with the conditions of use of food supplements containing cellobiose as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers through the use of an appropriate label that food supplements containing cellobiose should not be consumed by infants and young children.

(14)

Cellobiose 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.

(15)

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