Overview
The EFSA NDA Panel re-assessed DHA-rich oil from strain ATCC-20889, now identified as Schizochytrium limacinum, for infant and follow-on formula. Heavy metals in five batches are all below the limits of quantification; the batch data match those in the 2022 opinion. The oil is an ingredient that infant formula makers add to meet the EU DHA requirement of 20 to 50 mg per 100 kcal.
Key numbers
- Mercury, cadmium, arsenic, lead and copper all < 0.01 mg/kg (LOQ) in batches 1 to 5 (Table 1, Heavy metals, p. 7).
Methods (brief)
Mercury by an AOAC method and the other metals by ICP (AOAC chapter 9), per Table 1; batches are the oil after addition of high oleic sunflower oil and deodorisation. No certified reference material or recovery data are given in the opinion.
Evidence Fitness
This resubmission reprints the same five-batch table as the 2022 opinion Safety of oil from Schizochytrium sp. (strain ATCC 20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283 (identical sterol and metal rows), so it is not independent evidence. With the strain now identified as S. limacinum, the Panel concluded the oil is safe under the proposed conditions of use. This is an EFSA scientific opinion summarising applicant data (source_type report), not an independent survey.