The European Food Safety Authority (EFSA) has concluded that oil derived from the microalgae Schizochytrium limacinum (strain ATCC-20889) is safe for use in infant and follow-on formulas at DHA concentrations of 20–50 milligrams per 100 kilocalories.
Infant formulas in the EU are required to contain DHA, an omega-3 fatty acid important for brain and retinal development. The microalgae oil could provide an alternative to fish-based DHA for vegetarian and vegan consumers or those with allergies. It could also help to address sustainability issues such as overfishing.
Demand for plant-based baby and infant foods is rising significantly — a report from 2022 found that vegan and organic products were a key driver of the infant nutrition market, while an analysis published last year predicted that sales of infant plant-based protein products would increase by $611.18 million by 2028.

No concerns
The EFSA’s evaluation concludes that the microalgae oil does not contain contaminants such as heavy metals, marine biotoxins, or microorganisms. The oil was also found to have consistent quality over time, and the production process reportedly complies with good manufacturing practices (GMP).
The approval could pave the way for the microalgae oil to be used in other food products for both adults and children.
“The Panel considers that there are no concerns with regard to the toxicity of the NF [novel food],” says the EFSA. “The Panel concludes that the NF is safe under the proposed conditions of use.”