Commission authorizes Schizochytrium sp. (CABIO-A-2) oil as a novel food

On July 30, 2024, the European Commission (EC) authorized the placing on the market of Schizochytrium sp. (CABIO-A-2) oil as a novel food and amending Implementing Regulation (EU) 2017/2470.

On 26 October 2023, the Authority adopted its scientific opinion on the ‘Safety of oil from Schizochytrium sp. (strain CABIO-A-2) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283’  in accordance with Article 11 of Regulation (EU) 2015/2283.

In its scientific opinion, the Authority concluded that the novel food, oil produced from the strain CABIO-A-2 of the microalgae Schizochytrium sp., is safe under the proposed conditions of use. The Authority noted, that as the proposed use levels are in accordance with Regulation (EU) No 609/2013 and its supplementing Commission Delegated Regulation (EU) 2016/127 (5), the intake of docosahexaenoic acid (DHA) from infant formula and follow on formula containing the novel food at the proposed use levels is within the range foreseen by that Regulation. Therefore, that scientific opinion gives sufficient grounds to establish that Schizochytrium sp. (CABIO-A-2) oil, when used under the proposed conditions of use, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283. It is appropriate that the inclusion of Schizochytrium sp. (CABIO-A-2) oil as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.

Schizochytrium sp. (CABIO-A-2) 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.

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