(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 14 December 2020, the company Luxidum GmbH (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place vitamin D2 mushroom powder 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. The applicant also requested the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) excluding food supplements for infants, and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), excluding foods for special medical purposes intended for infants. Subsequently, on 5 July 2024, the applicant modified the initial request in the application on the use of vitamin D2 mushroom powder in food supplements to exclude young children.

(4)

On 14 December 2020, the applicant also made a request to the Commission for the protection of the following proprietary data: the production process (5) and the stability tests, including the respective certificate of analysis (6).

(5)

On 28 May 2021, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of vitamin D2 mushroom powder as a novel food.

(6)

On 30 April 2024, the Authority adopted its scientific opinion on the ‘Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2020/2226)’ (7) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that the novel food, vitamin D2 mushroom powder, 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 data concerning the production process and the stability tests, including the respective certificate analysis, 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)(b) of Regulation (EU) 2015/2283.

(10)

The applicant declared that it held proprietary and exclusive rights of reference to the data on the production process and the stability tests, including the respective certificate analysis, at the time it 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 production process and the stability tests, including the respective certificate analysis, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place vitamin D2 mushroom powder 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 vitamin D2 mushroom powder 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)

A labelling requirement should be provided in order to properly inform the consumers that infants and young children should not consume food supplements containing vitamin D2 mushroom powder.

(14)

It is appropriate that the inclusion of vitamin D2 mushroom powder 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.

(15)

Vitamin D2 mushroom powder 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,