Overview
The EFSA NDA Panel assessed a DHA-rich oil from Schizochytrium sp. strain ATCC 20889 proposed for infant and follow-on formula. The batch-to-batch table reports heavy metals for five batches, all below the limits of quantification; the Panel concluded that safety had not been established because the strain was not characterised at species level. 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 of the oil after addition of high oleic sunflower oil (Table 1, Heavy metals, p. 7).
Methods (brief)
Mercury by an AOAC method and cadmium, arsenic, lead and copper by ICP (AOAC chapter 9), as listed in Table 1. The batches analysed are the finished oil after blending with high oleic sunflower oil and deodorisation. No certified reference material or recovery data are given in the opinion.
Evidence Fitness
LOQ-censored results for five batches of one applicant’s oil. The Panel did not establish safety, because the source strain was not identified to species level, not because of metals. The same five-batch data are reprinted in the 2025 resubmission opinion Safety of oil from Schizochytrium limacinum (strain ATCC-20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283, so the two records are one data set. This is an EFSA scientific opinion summarising applicant data (source_type report), not an independent survey.