(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)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising placing on the Union market of a novel food and on the updating of the Union list.

(4)

On 10 April 2017, the company Skotan S.A. (‘the Applicant’) made a request in accordance with Article 4 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) to the competent authority of Poland to place Yarrowia lipolytica yeast biomass on the Union market as a novel food within the meaning of point (d) of Article 1(2) of that Regulation. The application requested for Yarrowia lipolytica yeast biomass to be used in food supplements. The maximum use levels proposed by the applicant are 3 g per day for children from 3 to 9 years of age, and 6 g per day thereafter.

(5)

On 15 November 2017, the competent authority of Poland issued its initial assessment report. In that report, it came to the conclusion that Yarrowia lipolytica yeast biomass meets the criteria for novel foods set out in Article 3(1) of Regulation (EC) No 258/97.

(6)

Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

(7)

While the request for placing Yarrowia lipolytica yeast biomass on the Union market as a novel food was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

(8)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘Authority’) on 22 June 2018, asking it to provide a scientific opinion by carrying out an assessment for Yarrowia lipolytica yeast biomass as a novel food.

(9)

On 17 January 2019, the Authority adopted the ‘Scientific Opinion on the safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283’ (4). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(10)

The opinion of the Authority gives sufficient grounds to establish that Yarrowia lipolytica yeast biomass in the proposed use and use levels, when used in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

(11)

Directive 2002/46/EC of the European Parliament and of the Council (5) lays down requirements on food supplements. The use of Yarrowia lipolytica yeast biomass should be authorised without prejudice to the requirements of that Directive.

(12)

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