EU Safety Assessment on “DHA Rich Oil” as Novel Food in Infant Formulae and Follow-On-Formulae

Posted By: Trace One

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On October 19, 2020, the European Food Safety Authority’s scientific panel delivered an opinion on the “Safety of Schizochytrium sp. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283” following request from the European Commission.

The Novel Food, an oil rich in docosahexaenoic acid (DHA), is isolated from the microalgae by mechanical extraction.

The scope of the document is to highlight the safety of the strain Schizochytrium sp. In target group of infants and young children and the scientific opinions were recorded as below:

  • The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF (Infant formulae) and FOF (follow-on-formula) at the level of 20–50 mg/100 kcal.
  • The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns.
  • The composition of the NF indicates the absence of marine biotoxins in the NF. Based on the information provided, the microalga is not expected to survive the manufacturing process.
  • Toxicological tests conducted with the NF were not performed. However, based on the available toxicological data on various forms of oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process and the composition of the NF, the Panel considers there are no concerns with regard to toxicity of the NF.


The EFSA Panel concludes that the Novel Food is safe under the proposed conditions of use and is not an assessment of the efficacy of the NF with regard to any claimed benefit.


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