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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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Title: 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.
Authors: Turck, Dominique (AUTHOR), Bohn, Torsten (AUTHOR), Cámara, Montaña (AUTHOR), Castenmiller, Jacqueline (AUTHOR), De Henauw, Stefaan (AUTHOR), Jos, Ángeles (AUTHOR), Maciuk, Alexandre (AUTHOR), Mangelsdorf, Inge (AUTHOR), McNulty, Breige (AUTHOR), Naska, Androniki (AUTHOR), Pentieva, Kristina (AUTHOR), Siani, Alfonso (AUTHOR), Thies, Frank (AUTHOR), Frenzel, Thomas (AUTHOR), Aguilera‐Gómez, Margarita (AUTHOR), Marcon, Francesca (AUTHOR), Neuhäuser‐Berthold, Monika (AUTHOR), Nuin Garciarena, Irene (AUTHOR), Turla, Emanuela (AUTHOR), Favata, Areti (AUTHOR)
Source: EFSA Journal. May2026, Vol. 24 Issue 5, p1-13. 13p.
Subject Terms: *Microalgae, *Toxicity testing, Docosahexaenoic acid, Dietary supplements, Infant formulas, European Union law
Company/Entity: European Union
Abstract: Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an oil derived from the microalga‐like organism Schizochytrium sp. A2 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The oil is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents around 40% of total fatty acids. The applicant proposes the use of the NF as an ingredient in infant formula and follow‐on formula and in food supplements for adults (excluding pregnant and lactating women), at a maximum intake of 3 g DHA per day. The evidence provided by the applicant does not allow the determination of the species to which Schizochytrium sp. A2 belongs. Although batch analyses showed that tested marine biotoxins were below their respective limits of quantification, since it is unknown to which species the production strain belongs, the concern that the strain Schizochytrium sp. A2 has the potential to produce other toxins than those tested remains. Due to the unresolved taxonomic identity of the production strain, the qualified presumption of safety qualification of the production strain cannot be used in the safety assessment of this NF. Furthermore, no toxicological studies conducted with the NF itself were submitted. While toxicological data exist for DHA‐rich algal oils derived from other Schizochytrium strains, these cannot be used to establish the safety of the oil produced from strain A2. The Panel concludes that, based on the available data, the safety of the NF (oil produced from Schizochytrium sp. A2) cannot be established. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: 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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  Data: *<searchLink fieldCode="DE" term="%22Microalgae%22">Microalgae</searchLink><br />*<searchLink fieldCode="DE" term="%22Toxicity+testing%22">Toxicity testing</searchLink><br /><searchLink fieldCode="DE" term="%22Docosahexaenoic+acid%22">Docosahexaenoic acid</searchLink><br /><searchLink fieldCode="DE" term="%22Dietary+supplements%22">Dietary supplements</searchLink><br /><searchLink fieldCode="DE" term="%22Infant+formulas%22">Infant formulas</searchLink><br /><searchLink fieldCode="DE" term="%22European+Union+law%22">European Union law</searchLink>
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  Data: Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an oil derived from the microalga‐like organism Schizochytrium sp. A2 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The oil is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents around 40% of total fatty acids. The applicant proposes the use of the NF as an ingredient in infant formula and follow‐on formula and in food supplements for adults (excluding pregnant and lactating women), at a maximum intake of 3 g DHA per day. The evidence provided by the applicant does not allow the determination of the species to which Schizochytrium sp. A2 belongs. Although batch analyses showed that tested marine biotoxins were below their respective limits of quantification, since it is unknown to which species the production strain belongs, the concern that the strain Schizochytrium sp. A2 has the potential to produce other toxins than those tested remains. Due to the unresolved taxonomic identity of the production strain, the qualified presumption of safety qualification of the production strain cannot be used in the safety assessment of this NF. Furthermore, no toxicological studies conducted with the NF itself were submitted. While toxicological data exist for DHA‐rich algal oils derived from other Schizochytrium strains, these cannot be used to establish the safety of the oil produced from strain A2. The Panel concludes that, based on the available data, the safety of the NF (oil produced from Schizochytrium sp. A2) cannot be established. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.2903/j.efsa.2026.10097
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        Text: English
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      – SubjectFull: Microalgae
        Type: general
      – SubjectFull: Toxicity testing
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      – SubjectFull: European Union law
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      – SubjectFull: European Union
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