Overview
The EFSA Panel on Nutrition, Novel Foods and Food Allergens assessed a DHA-rich oil from the microalga Schizochytrium limacinum strain FCC-3204 for use in infant and follow-on formula. The applicant’s batch-to-batch table reports mercury, cadmium, total arsenic, lead, copper and iron for five batches, nearly 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 < 0.005 mg/kg, cadmium < 0.005 mg/kg and lead < 0.01 mg/kg (LOQ) in all five batches (Table 1, Metals, pp. 7-9).
- Total arsenic < 0.01 mg/kg in four batches and 0.01 (± 0.003) mg/kg in batch 0419028 (Table 1).
- Iron < 0.2 mg/kg in three batches, 0.23 and 0.80 mg/kg in two (Table 1).
Methods (brief)
Five independent batches of the refined oil were analysed by laboratories whose accreditation was documented; the opinion does not name the metal method in Table 1. Results below LOQ are printed as ’< LOQ’. No certified reference material or recovery data are given in the opinion.
Evidence Fitness
Five applicant batches of a single manufacturer’s oil, reported as LOQ-censored values; this shows that the oil supplies negligible toxic metals at its low use level in formula (about 63 mg oil per 100 mL), but it says nothing about other suppliers. 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
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