COMMISSION IMPLEMENTING REGULATION (EU) 2025/688

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2025/688 | 10.4.2025 ---|---|--- 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 (Text with EEA relevance) 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 (1), and in particular Article 12 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 (2) 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 (3) 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 (4), a viable cell analysis (5) and a certificate of the analyses of the protein products to which the novel food was added (6). ---|--- (7) | On 15 February 2024, 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. (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’ (7) 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, ---|--- HAS ADOPTED THIS REGULATION: Article 1 The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. Article 2 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 9 April 2025. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 327, 11.12.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/2283/oj. (2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72, ELI: http://data.europa.eu/eli/reg_impl/2017/2470/oj). (3) Commission Implementing Regulation (EU) 2021/1326 of 10 August 2021 authorising the placing on the market of Schizochytrium sp. (FCC-3204) oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 288, 11.8.2021, p. 24, ELI: http://data.europa.eu/eli/reg_impl/2021/1326/oj). (4) Annex 3 – under Section 3.2 ‘Identity of the NF’. (5) Annex 35 – under Section 3.3 ‘Production process’. (6) Annex 51 – under Section 3.4 ‘Compositional data’. (7) EFSA Journal 2024;22:e9043. (8) Address: 4 rue Rivière 33500 Libourne, France. * * * 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.’ * * * ELI: http://data.europa.eu/eli/reg_impl/2025/688/oj ISSN 1977-0677 (electronic edition) * * *