BAKGRUNN (fra kommisjonsforordningen)

(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  has established a Union list of novel foods.
 

(3)    The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Yarrowia lipolytica yeast biomass as an authorised novel food.
 

(4)    Commission Implementing Regulation (EU) 2019/760  authorised the placing on the market of Yarrowia lipolytica yeast biomass as a novel food for use in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council , excluding food supplements for infants and young children.
 

(5)    Commission Implementing Regulation (EU) 2023/938  authorised change of the conditions of use of the novel food Yarrowia lipolytica yeast biomass, in particular extension of use of the novel food to meal replacements for weight control intended for the adult population.
 

(6)    On 5 July 2020, the company Skotan S.A. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the conditions of use of the novel food Yarrowia lipolytica yeast biomass. In particular, the applicant requested to extend the use of Yarrowia lipolytica yeast biomass to a number of foods. 
 

(7)    On 9 November 2020, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of the extension of use of Yarrowia lipolytica yeast biomass as a novel food.
 

(8)    On 26 October 2023, the Authority adopted its scientific opinion on the ‘Safety of an extension of use of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283’  in accordance with Article 11 of Regulation (EU) 2015/2283.
 

(9)    In its scientific opinion, the Authority concluded that the proposed extension of use of the novel food Yarrowia lipolytica yeast biomass is safe under the proposed conditions of use, and therefore it is appropriate to amend the conditions of use of Yarrowia lipolytica yeast biomass.
 

(10)    In its scientific opinion, the Authority noted that given the newly proposed uses of the novel food, that limits for lead, mercury, cadmium and arsenic should be added to the specifications.
 

(11)    The information provided in the application and the opinion of the Authority give sufficient grounds to establish that the changes to the specifications and the conditions of use and of the novel food are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.
 

(12)    It is appropriate that the changes to the conditions of use of the novel food contain the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In this regard, considering additional uses of the novel food it is appropriate to change specific labelling requirement concerning the use of the novel food in food supplements.
 

(13)    The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. 
 

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