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

Official Journal EN of the European Union L series 2025/1515 29.7.2025 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 (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(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(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 Schizochytriumsp. 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(3). The strain of Schizochytriumsp. 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(4), the production process(5)and the compositional data(6). (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 Schizochytriumsp. oil as a novel food. (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) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35, ELI: http:// data.europa.eu/eli/reg/2013/609/oj). (4) Annexes 3, 4, 46, 47, 64 and 67. (5) Annexes 5, 6, 7, 11, 12, 12bis, 17, 18, 48, 49, 50, 52, 53, 70 and 71. (6) Annexes 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 36, 37, 38, 39, 40, 41, 42, 43, 54, 55, 56, 59, 60, 61, 62 and 63. ELI: http://data.europa.eu/eli/reg_impl/2025/1515/oj 1/5EN OJ L, 29.7.2025 (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’(7)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 Schizochytriumsp., 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, (7) EFSA Journal 2025;23:e9156. 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/1515/ojEN OJ L, 29.7.2025 HAS ADOPTED THIS REGULATION: Article 1 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. Article 2 Only the company BioPlus Life Sciences(8)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. 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 5 years from the date of entry into force of this Regulation without the agreement of the company BioPlus Life Sciences. 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, 28 July 2025. For the Commission The President Ursula VON DER LEYEN (8) Address: Pharmed Gardens, Whitefield Road, Bangalore 560048 INDIA. ELI: http://data.europa.eu/eli/reg_impl/2025/1515/oj 3/5ANNEX (1) In Table 1 (Authorised novel foods) the following entry is inserted in alphabetical order: Additional specific labelling Other Authorised novel food Conditions under which the novel food may be used Data protection requirements requirements ‘Schizochytrium Specified food category Maximum levels of DHA The designation of the novel food Authorised on 18 August 2025. This limacinum(ATCC- on the labelling of the foodstuffs inclusion is based on proprietary Infant formula and In accordance with 20889) oil containing it shall be “Oil from the scientific evidence and scientific data follow-on formula as Regulation (EU) microalgae Schizochytrium protected in accordance with Article 26 defined in Regulation No 609/2013 limacinum”. of Regulation (EU) 2015/2283. (EU) No 609/2013 Applicant: BioPlus Life Sciences, Pharmed Gardens, Whitefield Road, Bangalore 560048 INDIA. During the period of data protection, the novel food Schizochytrium limacinum (ATCC-20889) oil is authorised for placing on the market within the Union only by BioPlus Life Sciences, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of BioPlus Life Sciences. End date of the data protection: 18 August 2030’ 4/5 ELI: http://data.europa.eu/eli/reg_impl/2025/1515/oj EN OJ L, 29.7.2025(2) In Table 2 (Specifications), the following entry is inserted in alphabetical order: Authorised Novel Food Specifications ‘Schizochytrium limacinum Description/Definition: (ATCC-20889) oil The novel food is an oil produced from the strain ATCC-20889 of the microalgae species Schizochytrium limacinum. Composition: Acid value: ≤ 0,5 mg KOH/g Peroxide value (PV): ≤ 5,0 meq/kg oil Moisture and volatiles: ≤ 0,05 % Unsaponifiables: ≤ 4,5 % Trans-fatty acids: ≤ 1,0 % Docosahexaenoic acid (DHA): ≥ 32 % p-anisidine value: ≤ 10’ ELI: http://data.europa.eu/eli/reg_impl/2025/1515/oj 5/5 OJ L, 29.7.2025 EN