Overview
The EFSA NDA Panel assessed a DHA-rich oil from Schizochytrium limacinum strain TKD-1 for infant and follow-on formula. The applicant’s five-batch analysis reports mercury, cadmium, arsenic, lead, copper and iron, 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
- Mercury, cadmium and arsenic < 0.005 mg/kg and lead < 0.05 mg/kg (LOQ) in all five batches (Table 1, Metals, p. 7).
- Copper < 0.05 mg/kg and iron < 0.1 mg/100 g in all batches (Table 1).
Methods (brief)
Metals by Chinese national standard GB 5009.268-2016 (ICP-MS), copper by GB 5009.13-2017 and iron by AOAC 984.27 with ICP-OES, per 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 LOQ (0.05 mg/kg) is higher than in the other Schizochytrium opinions, so ‘below LOQ’ here is a weaker statement. 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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