Commission Implementing Regulation (EU) 2025/1515 of 28 July 2025 authorising the placing on the market of Schizochytrium limacinum (ATCC-20889) oil as a novel food and amending Implementing Regulation (EU) 2017/2470

1 Schizochytrium limacinum (ATCC-20889) oil is authorised to be placed on the market within the Union. Schizochytrium limacinum (ATCC-20889) oil shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2 The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Only the company BioPlus Life Sciences is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 18 August 2025, unless a subsequent applicant obtains an authorisation for the novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the company BioPlus Life Sciences.

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the company BioPlus Life Sciences.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.