Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283
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 Schizochytrium sp. (strain ATCC‐20889) as a novel food (NF) pursuant to Regulation (EU) 2015...
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Wiley
2025-01-01
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| Online Access: | https://doi.org/10.2903/j.efsa.2025.9156 |
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| author | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Montaña Cámara Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Ángeles Jos Alexandre Maciuk Inge Mangelsdorf Breige McNulty Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Helle Katrine Knutsen Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Irene Nuin Garciarena Emanuela Turla Harry J. McArdle |
| author_facet | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Montaña Cámara Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Ángeles Jos Alexandre Maciuk Inge Mangelsdorf Breige McNulty Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Helle Katrine Knutsen Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Irene Nuin Garciarena Emanuela Turla Harry J. McArdle |
| author_sort | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) |
| collection | DOAJ |
| description | 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 Schizochytrium sp. (strain ATCC‐20889) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 40%–43% of fatty acids. The available evidence indicates that the source organism (strain ATCC‐20889) belongs to the species Schizochytrium limacinum. The applicant intends to market the NF as an ingredient in infant formulae (IF) and follow‐on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory presence of DHA to IF and FOF at the levels of 20–50 mg/100 kcal. Schizochytrium limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF, the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use. |
| format | Article |
| id | doaj-art-373ef057ee5a4fda9a3989741c780f37 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
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| series | EFSA Journal |
| spelling | doaj-art-373ef057ee5a4fda9a3989741c780f372025-01-31T12:06:04ZengWileyEFSA Journal1831-47322025-01-01231n/an/a10.2903/j.efsa.2025.9156Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckTorsten BohnMontaña CámaraJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstÁngeles JosAlexandre MaciukInge MangelsdorfBreige McNultyAndroniki NaskaKristina PentievaAlfonso SianiFrank ThiesMargarita Aguilera‐GómezFrancesco CubaddaThomas FrenzelMarina HeinonenHelle Katrine KnutsenMonika Neuhäuser‐BertholdMorten PoulsenMiguel Prieto MaradonaJosef Rudolf SchlatterAlexandros SiskosHenk vanLoverenIrene Nuin GarciarenaEmanuela TurlaHarry J. McArdleAbstract 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 Schizochytrium sp. (strain ATCC‐20889) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 40%–43% of fatty acids. The available evidence indicates that the source organism (strain ATCC‐20889) belongs to the species Schizochytrium limacinum. The applicant intends to market the NF as an ingredient in infant formulae (IF) and follow‐on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory presence of DHA to IF and FOF at the levels of 20–50 mg/100 kcal. Schizochytrium limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF, the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.https://doi.org/10.2903/j.efsa.2025.9156algaedocosahexaenoic acid (DHA)fatty acidinfants and young childrennovel foodssafety |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Montaña Cámara Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Ángeles Jos Alexandre Maciuk Inge Mangelsdorf Breige McNulty Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Helle Katrine Knutsen Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Irene Nuin Garciarena Emanuela Turla Harry J. McArdle Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Journal algae docosahexaenoic acid (DHA) fatty acid infants and young children novel foods safety |
| title | Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full | Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr | Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed | Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_short | Safety of oil from Schizochytrium limacinum (strain ATCC‐20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort | safety of oil from schizochytrium limacinum strain atcc 20889 for use in infant and follow on formula as a novel food pursuant to regulation eu 2015 2283 |
| topic | algae docosahexaenoic acid (DHA) fatty acid infants and young children novel foods safety |
| url | https://doi.org/10.2903/j.efsa.2025.9156 |
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