Commission Implementing Regulation (EU) 2025/688 of 9 April 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. (FCC-3204) oil

Implementing Regulation (EU) 2025/688 · Regulation · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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

Only the company Fermentalg ( 8 ) is authorised to place on the market within the Union the novel food Schizochytrium sp. (FCC-3204) oil for use in protein products and intended for the general population, for a period of five years from 30 April 2025, unless a subsequent applicant obtains an authorisation for the novel food to be used in protein products without reference to the scientific data protected pursuant to Article 3 or with the agreement of the company Fermentalg.

Article 3

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 five years from the date of entry into force of this Regulation without the agreement of the company Fermentalg.

Article 4

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

Supplementary provisions

ANNEXSupplementary provisions

ANNEX In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for Schizochytrium sp. (FCC-3204) oil is replaced by the following: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection ‘ Schizochytrium sp. (FCC-3204) oil Specified food category Maximum levels of DHA The designation of the novel food on the labelling of the foodstuffs containing it shall be “Oil from the microalgae Schizochytrium sp.”. The labelling of food supplements containing Schizochytrium sp. (FCC-3204) oil shall bear a statement that they should not be consumed by infants and children under 3 years of age. Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 Food supplements as defined in Directive 2002/46/EC for the general population above 3 years of age 1 g/day Protein products, excluding dairy analogues 1 g/100 g Authorised for use in protein products, excluding dairy analogues, on 30 April 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Fermentalg, 4 rue Rivière 33500 Libourne, France. During the period of data protection, the novel food for use in protein products, excluding dairy analogues, is authorised for placing on the market within the Union only by Fermentalg, unless a subsequent applicant obtains authorisation for the same novel food without reference to the proprietary scientific evidence or scientific data protected under Article 26 of Regulation (EU) 2015/2283 or with the agreement of Fermentalg. End date of the date protection: 30 April 2030.’

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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