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 (Text with EEA relevance)
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 sp. (FCC-3204) oil as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470. 2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the following entry is inserted: ‘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 (2) in Table 2 (Specifications), the following entry is inserted: ‘Authorised Novel Food Specifications Schizochytrium sp. (FCC-3204) oil Description/Definition: The novel food is an oil produced from the strain FCC-3204 of the microalgae Schizochytrium sp. 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): ≥ 32,0 % p-anisidine value: ≤ 10’
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