(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 Schizochytrium sp. (FCC-3204) oil as an authorised novel food.
(4)    Commission Implementing Regulation (EU) 2021/1326  authorised the placing on the market of Schizochytrium sp. (FCC-3204) oil as a novel food.
(5)    On 23 December 2023, the company Fermentalg (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to change the conditions of use of the novel food Schizochytrium sp. (FCC-3204) oil. The applicant requested to extend the use of the novel food Schizochytrium sp. (FCC-3204) oil to protein products, excluding dairy analogues, intended for the general population.

(6)    On 23 December 2023, the applicant also made a request to the Commission for the protection of the following proprietary data: a taxonomic analysis , a viable cell analysis  and a certificate of the analyses of the protein products to which the novel food was added .
(7)    On 15 February 2024, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to provide a scientific opinion on the change of the conditions of use of Schizochytrium sp. (FCC-3204) oil as a novel food.
(8)    On 24 September 2024, the Authority adopted its scientific opinion on the ‘Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC-3204) 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 novel food, Schizochytrium sp. (FCC-3204) oil, is safe under the proposed conditions of use and therefore it is appropriate to amend its conditions of use. 
(10)    The information provided in the application and the Authority’s scientific opinion give sufficient grounds to establish that the changes to the conditions of use of Schizochytrium sp. (FCC-3204) oil are in accordance with Article 12(1) of Regulation (EU) 2015/2283 and should be approved.
(11)    In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the taxonomic analysis, the viable cell analysis and the certificate of the analyses of the protein products to which the novel food was added, without which it could not have assessed the novel food and reached its conclusion.
(12)    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), point (b), of Regulation (EU) 2015/2283.
(13)    The applicant declared that they held proprietary and exclusive rights of reference to the taxonomic analysis, the viable cell analysis and the certificate of the analyses of the protein products to which the novel food was added, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data. 
(14)    The Commission assessed all the information provided by the applicant and considers that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the taxonomic analysis, the viable cell analysis and the certificate of the analyses of the protein products to which the novel food was added, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place Schizochytrium sp. (FCC-3204) oil for use in protein products, excluding dairy analogues, on the market within the Union during a period of five years from the entry into force of this Regulation.
(15)    However, such restriction of the authorisation 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.
(16)    The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(17)    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,