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
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 ↗
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 ( 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.
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.
ANNEX (1) In Table 1 (Authorised novel foods) the following entry is inserted in alphabetical order: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection ‘ Schizochytrium limacinum (ATCC-20889) 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 limacinum ”. Authorised on 18 August 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. 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’ Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 (2) In Table 2 (Specifications), the following entry is inserted in alphabetical order: Authorised Novel Food Specifications ‘ Schizochytrium limacinum (ATCC-20889) oil Description/Definition: 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’
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