Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) 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 extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food (NF) pursuant to Regulation (EU) 20...
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2024-10-01
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.9043 |
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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 Harry J. McArdle Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Irene Nuin Garciarena Emanuela Turla Silvia Valtueña Martínez Helle Katrine Knutsen |
| 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 Harry J. McArdle Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Irene Nuin Garciarena Emanuela Turla Silvia Valtueña Martínez Helle Katrine Knutsen |
| 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 extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in protein products at a maximum use level of 1 g of docosahexaenoic acid (DHA) in 100 g of product. The Panel considers that the information provided on the composition and the production process is sufficiently described and does not raise safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided demonstrated the absence of viable cells in the NF. Under the proposed extension of use, the highest intake estimate (at the 95th percentile) of DHA from the NF in protein products is 6.3 mg DHA/kg bw per day for adolescents. The Panel notes that the exposure to DHA from the new intended use of the NF in protein products is very low compared to the exposure to DHA from the already authorised food categories (excluding food supplements). The Panel concludes that the NF (oil from S. limacinum (FCC‐3204)) is safe under the new intended use. |
| format | Article |
| id | doaj-art-099103eb77d841c28e91654350b954ae |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-099103eb77d841c28e91654350b954ae2025-08-20T02:34:24ZengWileyEFSA Journal1831-47322024-10-012210n/an/a10.2903/j.efsa.2024.9043Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) 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 McNultyHarry J. McArdleAndroniki NaskaKristina PentievaAlfonso SianiFrank ThiesMargarita Aguilera‐GómezFrancesco CubaddaThomas FrenzelMarina HeinonenMonika Neuhäuser‐BertholdMorten PoulsenMiguel Prieto MaradonaJosef Rudolf SchlatterAlexandros SiskosHenk vanLoverenIrene Nuin GarciarenaEmanuela TurlaSilvia Valtueña MartínezHelle Katrine KnutsenAbstract 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 extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in protein products at a maximum use level of 1 g of docosahexaenoic acid (DHA) in 100 g of product. The Panel considers that the information provided on the composition and the production process is sufficiently described and does not raise safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided demonstrated the absence of viable cells in the NF. Under the proposed extension of use, the highest intake estimate (at the 95th percentile) of DHA from the NF in protein products is 6.3 mg DHA/kg bw per day for adolescents. The Panel notes that the exposure to DHA from the new intended use of the NF in protein products is very low compared to the exposure to DHA from the already authorised food categories (excluding food supplements). The Panel concludes that the NF (oil from S. limacinum (FCC‐3204)) is safe under the new intended use.https://doi.org/10.2903/j.efsa.2024.9043algaDHAdocosahexaenoic acidextension of usenovel foodsafety |
| 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 Harry J. McArdle Androniki Naska Kristina Pentieva Alfonso Siani Frank Thies Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Monika Neuhäuser‐Berthold Morten Poulsen Miguel Prieto Maradona Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Irene Nuin Garciarena Emanuela Turla Silvia Valtueña Martínez Helle Katrine Knutsen Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Journal alga DHA docosahexaenoic acid extension of use novel food safety |
| title | Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full | Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr | Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed | Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_short | Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort | safety of an extension of use of oil from schizochytrium limacinum strain fcc 3204 as a novel food pursuant to regulation eu 2015 2283 |
| topic | alga DHA docosahexaenoic acid extension of use novel food safety |
| url | https://doi.org/10.2903/j.efsa.2024.9043 |
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