Commission Implementing Regulation (EU) 2025/1515

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001^note, and in particular Article 12(1) thereof,Whereas:

(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^note 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. oil as an authorised novel food.

(4)On 24 May 2023, the company BioPlus Life Sciences (‘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. oil. The applicant requested to extend the use of the novel food Schizochytrium sp. oil to infant formula and follow-on formula as defined by Regulation (EU) No 609/2013 of the European Parliament and of the Council^note. The strain of Schizochytrium sp. oil concerned by the application is specified as strain ATCC 20889.

(5)On 30 August 2024, the applicant also made a request to the Commission for the protection of the following proprietary data: the identity^note, the production process^note and the compositional data^note.

(6)On 10 October 2023, the Commission requested the European Food Safety Authority (‘the Authority’) to provide a scientific opinion on the change of the conditions of use of Schizochytrium sp. oil as a novel food.

(7)On 28 November 2024, the Authority adopted its scientific opinion on the ‘Safety of oil from Schizochytrium limacinum (strain ATCC-20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283’^note in accordance with Article 11 of Regulation (EU) 2015/2283.

(8)In its scientific opinion, the Authority concluded that the oil produced from the strain ATCC-20889 belonging to species Schizochytrium limacinum, is safe under the proposed conditions of use. Noting that the safety assessment data identifies the strain ATCC-20889 as belonging to species Schizochytrium limacinum, and therefore this specific source organism, not the generic Schizochytrium sp., was assessed by the Authority, it follows that the application should be regarded as a request for the authorisation of a new novel food for use in infant and follow-on formula, rather than a modification of the conditions of use of an already authorised novel food

(9)The information provided in the application and the Authority’s scientific opinion give sufficient grounds to establish that Schizochytrium limacinum (ATCC-20889) oil when used in infant formula and follow-on formula in accordance with the Regulation (EU) No 609/2013 fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(10)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the data on the identity, the production process and compositional data, without which it could not have assessed the novel food and reached its conclusion.

(11)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.

(12)The applicant declared that they held proprietary and exclusive rights of reference to the data on the identity, the production process and compositional data, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(13)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, data on the identity, the production process and the compositional data, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place on the market within the Union Schizochytrium limacinum (ATCC-20889) oil in infant formula and follow-on formula as defined by Regulation (EU) No 609/2013 during a period of five years from the entry into force of this Regulation.

(14)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.

(15)Schizochytrium limacinum (ATCC-20889) oil 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.

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

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