(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list 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) establishing a Union list of authorised novel foods was adopted.

(3)

On 29 July 2019, the company MBio, Monaghan Mushrooms (‘the applicant’) submitted an application to the Commission pursuant to 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 vitamin D2 mushroom powder to be used in 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 in 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. During the application process, the applicant agreed to exclude children under 3 years of age from the request for authorisation of the novel food in food supplements.

(4)

The applicant also submitted a request to the Commission for the protection of proprietary data for a number of original data submitted in support of the application, namely, data concerning the production process (5); compositional data: particle size (6), physico-chemical properties (7), vitamin D analysis (8), nutritional analysis (9), vitamin D2 analysis (10), vitamin D analysis validation (11), stability studies (12), toxicological analysis (13), data concerning tachysterol and lumisterol (14), ergosterol ratio analysis (15), vitamin D ratio analysis (16), data concerning ergosterol (17); specifications of fresh mushrooms (18); data concerning allergenicity (19).

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 24 January 2020, requesting it to provide a scientific opinion by carrying out an assessment of the safety of vitamin D2 mushroom powder as a novel food.

(6)

On 24 February 2021, the Authority adopted its scientific opinion on the ‘Safety of Vitamin D2 mushroom powder (Agaricus bisporus) as a novel food pursuant to Regulation (EU) 2015/2283’ (20). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(7)

In that opinion, the Authority concluded that vitamin D2 mushroom powder is safe at the proposed uses and use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that vitamin D2 mushroom powder under the specific conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(8)

A labelling requirement should be provided in order to properly inform the consumers that infants and children under 3 years of age should not consume food supplements containing vitamin D2 mushroom powder.

(9)

In its opinion, the Authority considered that the data concerning the production process and compositional data served as a basis to establish the safety of the novel food. On this basis, the Commission considers that the conclusions on the safety of vitamin D2 mushroom powder could not have been reached without that data.

(10)

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

(11)

The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to those data under national law, and that therefore third parties cannot lawfully access or use those data or refer to those data.

(12)

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data concerning the production process; compositional data: particle size, physico-chemical properties, vitamin D analysis, nutritional analysis, vitamin D2 analysis, vitamin D analysis validation, stability studies, toxicological analysis, data concerning tachysterol and lumisterol, ergosterol ratio analysis, vitamin D ratio analysis, data concerning ergosterol contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place vitamin D2 mushroom powder on the market within the Union during that period.

(13)

However, restricting the authorisation of vitamin D2 mushroom powder and the reference to the data contained in the applicant’s file for the sole use of the applicant, does not prevent other 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 under Regulation (EU) 2015/2283.

(14)

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,