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May 15, 2026EFSA JournalOpen Access

Safety of oil from Schizochytrium sp. A2 for use in infant and follow‐on formula as a novel food pursuant to regulation (EU) 2015/2283

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Authors

NNNovel Foods and Food Allergens (NDA) EFSA Panel on NutritionDTDominique TurckTBTorsten Bohn

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Overview

Randomized trial evaluates the safety of Schizochytrium sp. A2 oil in infant formula, indicating safety concerns remain unresolved.

Key Points

  • To assess the safety of Schizochytrium sp. A2 oil as a novel food for infant and follow-on formulas.
  • Review of safety evidence as per Regulation (EU) 2015/2283
  • Assessment of proposed intake levels of 3 g DHA per day
  • Evaluation of existing toxicological data from other Schizochytrium strains.
  • Safety of Schizochytrium sp. A2 oil cannot be established due to unresolved species identity.
  • Batch analyses show marine biotoxins below limits, but potential for unknown toxins remains.
  • No specific toxicological studies for oil from strain A2 were provided.

Cite This Study

Nutrition et al. (2026) studied this question.

synapsesocial.com/papers/6a06b74ce7dec685947aa47chttps://doi.org/10.2903/j.efsa.2026.10097
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Assessment on the Safety of DHA-rich Algal Oil From <i>Schizochytrium Limacinum</i> Strain ATCC 20889 for Use in Infant Formula and Follow-On Formula (RP2358)2026
  2. 2Safety Assessment on the Change of Specification of the Novel Food <i>Schizochytrium</i> sp. Oil Rich in DHA and EPA (RP2180)2026
  3. 3Safety of infant milks: Contamination with cereulide. A commentary by ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology, and Nutrition)2026
  4. 4Assessment on the Safety of an Extension of Use of DHA-rich Oil From <i>Schizochytrium</i> sp. Strain FCC-3204 for Use in All Protein Products (RP2316)2026
  5. 5Safety of the fungal biomass from Fusarium species strain flavolapis as a novel food pursuant to Article 10 of Regulation (EU) 2015/22832025 · 1 citations