Overview
The EFSA NDA Panel assessed a DHA-rich oil from Schizochytrium sp. strain CABIO-A-2 for infant and follow-on formula. The batch table reports lead, arsenic, mercury, cadmium, copper and iron for five batches, all below the limits of quantification. 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
- Lead and arsenic < 0.05 mg/kg, mercury < 0.005 mg/kg and cadmium < 0.01 mg/kg (LOQ) in all five batches (Table 1, Metals, pp. 7-8).
- Copper < 0.01 to < 0.05 mg/kg and iron < 0.02 to < 0.1 mg/kg (Table 1).
Methods (brief)
Lead, arsenic and cadmium by BS EN ISO 17294-2:2016 (ICP-MS, modified), mercury by BS EN 13806:2002, copper and iron by ISO 17294-2 or AOCS Ca 17-01, as listed in Table 1. No certified reference material or recovery data are given in the opinion.
Evidence Fitness
LOQ-censored data for five batches of one applicant’s oil; the lead and arsenic LOQs are 0.05 mg/kg. 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.
Related evidence
Update history
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