Commission authorizes Schizochytrium limacinum (TKD-1) oil as a novel food
European Union
Jul 31, 2024
On July 30, 2024, the European Commission (EC) authorized the placing on the market of Schizochytrium limacinum (TKD-1) oil as a novel food and amended Implementing Regulation (EU) 2017/2470.
In its scientific opinion, the Authority concluded that the novel food, oil produced from the strain TKD-1 belonging to species Schizochytrium limacinum, is safe under the proposed conditions of use. The Authority noted that the proposed use levels are in accordance with Regulation (EU) No 609/2013 and its supplementing Regulation (EU) 2016/127. The Authority also noted that the available evidence indicates that the source organism (Schizochytrium sp., strain TKD-1) belongs to the species Schizochytrium limacinum. In its opinion, the Authority further noted that the source organism that is assessed in the application is Schizochytrium limacinum (strain TKD-1) and not the generic Schizochytrium sp. Therefore, that scientific opinion gives sufficient grounds to establish that Schizochytrium limacinum (TKD-1) 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 limacinum (TKD-1) 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.
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