Safety of oil from Schizochytrium sp. A2 for use in infant and follow-on formula as a novel food pursuant to regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an oil derived from the microalga-like organism Schizochytrium sp. A2 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The oil is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents around 40% of total fatty acids. The applicant proposes the use of the NF as an ingredient in infant formula and follow-on formula and in food supplements for adults (excluding pregnant and lactating women), at a maximum intake of 3 g DHA per day. The evidence provided by the applicant does not allow the determination of the species to which Schizochytrium sp. A2 belongs. Although batch analyses showed that tested marine biotoxins were below their respective limits of quantification, since it is unknown to which species the production strain belongs, the concern that the strain Schizochytrium sp. A2 has the potential to produce other toxins than those tested remains. Due to the unresolved taxonomic identity of the production strain, the qualified presumption of safety qualification of the production strain cannot be used in the safety assessment of this NF. Furthermore, no toxicological studies conducted with the NF itself were submitted. While toxicological data exist for DHA-rich algal oils derived from other Schizochytrium strains, these cannot be used to establish the safety of the oil produced from strain A2. The Panel concludes that, based on the available data, the safety of the NF (oil produced from Schizochytrium sp. A2) cannot be established.