(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 April 2020, the company Mibelle Group Biochemistry (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place apple fruit cell culture biomass on the Union market as a novel food. The applicant requested for apple fruit cell culture biomass to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3).

(4)

On 2 December 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of apple fruit cell culture biomass as a novel food.

(5)

On 24 May 2023, the Authority adopted its scientific opinion on the ‘Safety of apple fruit cell culture biomass as a novel food pursuant to Regulation (EU) 2015/2283’ (4) in accordance with Article 11 of Regulation (EU) 2015/2283.

(6)

In its scientific opinion, the Authority concluded that the novel food apple fruit cell culture biomass, is safe under the proposed conditions of use, in food supplements for the adult population at maximum levels of 0,15 mg/day. Therefore, that scientific opinion gives sufficient grounds to establish that apple fruit cell culture biomass, when used under the proposed conditions of use fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(7)

It is appropriate that the inclusion of apple fruit cell culture biomass 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 apple fruit cell culture biomass as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers by appropriate labelling that food supplements containing apple fruit cell culture biomass is intended for the adult population.

(8)

Apple fruit cell culture biomass 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.

(9)

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