Safety of dried biomass powder of         Chlamydomonas reinhardtii THN 6 as a novel food pursuant to Regulation (EU) 2015/2283.

Dominique Turck; Montaña Cámara; Torsten Bohn; Jacqueline Castenmiller; Stefaan De Henauw; 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; Harry J McArdle; Morten Poulsen; Miguel Prieto Maradona; Josef Rudolf Schlatter; Alexandros Siskos; Henk van Loveren; Reinhard Ackerl; Maria Glymenaki; Karen Ildico Hirsch-Ernst; EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

doi:10.2903/j.efsa.2025.9413

Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food pursuant to Regulation (EU) 2015/2283.

Dominique Turck, Montaña Cámara, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, 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, Harry J McArdleMorten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Reinhard Ackerl, Maria Glymenaki, Karen Ildico Hirsch-Ernst, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

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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 dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of C. reinhardtii THN 6, cannot be established.

Original language	English
Article number	e9413
Number of pages	9
Journal	EFSA Journal
Volume	23
Issue number	4
DOIs	https://doi.org/10.2903/j.efsa.2025.9413 https://doi.org/10.2903/j.efsa.2025.9413
Publication status	Published - 30 Apr 2025

Keywords

algae
biomass
food ingredient
novel foods
safety

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10.2903/j.efsa.2025.9413

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Turck, D., Cámara, M., Bohn, T., Castenmiller, J., De Henauw, S., Jos, Á., Maciuk, A., Mangelsdorf, I., McNulty, B., Naska, A., Pentieva, K., Siani, A., Thies, F., Aguilera-Gómez, M., Cubadda, F., Frenzel, T., Heinonen, M., Knutsen, H. K., Neuhäuser-Berthold, M., ... EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) (2025). Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 23(4), Article e9413. https://doi.org/10.2903/j.efsa.2025.9413, https://doi.org/10.2903/j.efsa.2025.9413

@article{17b00db4e5d1473b912bb7a687e90f88,

title = "Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 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 dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of C. reinhardtii THN 6, cannot be established. ",

keywords = "algae, biomass, food ingredient, novel foods, safety",

author = "Dominique Turck and Monta{\~n}a C{\'a}mara and Torsten Bohn and Jacqueline Castenmiller and {De Henauw}, Stefaan and {\'A}ngeles Jos and Alexandre Maciuk and Inge Mangelsdorf and Breige McNulty and Androniki Naska and Kristina Pentieva and Alfonso Siani and Frank Thies and Margarita Aguilera-G{\'o}mez and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and Knutsen, {Helle Katrine} and Monika Neuh{\"a}user-Berthold and McArdle, {Harry J} and Morten Poulsen and {Prieto Maradona}, Miguel and Schlatter, {Josef Rudolf} and Alexandros Siskos and {van Loveren}, Henk and Reinhard Ackerl and Maria Glymenaki and Hirsch-Ernst, {Karen Ildico} and {EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)}",

note = "{\textcopyright} 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.",

year = "2025",

month = apr,

day = "30",

doi = "10.2903/j.efsa.2025.9413",

language = "English",

volume = "23",

journal = "EFSA Journal",

issn = "1831-4732",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "4",

}

Turck, D, Cámara, M, Bohn, T, Castenmiller, J, De Henauw, S, Jos, Á, Maciuk, A, Mangelsdorf, I, McNulty, B, Naska, A, Pentieva, K, Siani, A, Thies, F, Aguilera-Gómez, M, Cubadda, F, Frenzel, T, Heinonen, M, Knutsen, HK, Neuhäuser-Berthold, M, McArdle, HJ, Poulsen, M, Prieto Maradona, M, Schlatter, JR, Siskos, A, van Loveren, H, Ackerl, R, Glymenaki, M, Hirsch-Ernst, KI & EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) 2025, 'Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food pursuant to Regulation (EU) 2015/2283.', EFSA Journal, vol. 23, no. 4, e9413. https://doi.org/10.2903/j.efsa.2025.9413, https://doi.org/10.2903/j.efsa.2025.9413

TY - JOUR

T1 - Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food pursuant to Regulation (EU) 2015/2283.

AU - Turck, Dominique

AU - Cámara, Montaña

AU - Bohn, Torsten

AU - Castenmiller, Jacqueline

AU - De Henauw, Stefaan

AU - Jos, Ángeles

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McNulty, Breige

AU - Naska, Androniki

AU - Pentieva, Kristina

AU - Siani, Alfonso

AU - Thies, Frank

AU - Aguilera-Gómez, Margarita

AU - Cubadda, Francesco

AU - Frenzel, Thomas

AU - Heinonen, Marina

AU - Knutsen, Helle Katrine

AU - Neuhäuser-Berthold, Monika

AU - McArdle, Harry J

AU - Poulsen, Morten

AU - Prieto Maradona, Miguel

AU - Schlatter, Josef Rudolf

AU - Siskos, Alexandros

AU - van Loveren, Henk

AU - Ackerl, Reinhard

AU - Glymenaki, Maria

AU - Hirsch-Ernst, Karen Ildico

AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

PY - 2025/4/30

Y1 - 2025/4/30

N2 - 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 dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of C. reinhardtii THN 6, cannot be established.

AB - 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 dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of C. reinhardtii THN 6, cannot be established.

KW - algae

KW - biomass

KW - food ingredient

KW - novel foods

KW - safety

UR - https://pubmed.ncbi.nlm.nih.gov/40309405/

U2 - 10.2903/j.efsa.2025.9413

DO - 10.2903/j.efsa.2025.9413

M3 - Article

C2 - 40309405

SN - 1831-4732

VL - 23

JO - EFSA Journal

JF - EFSA Journal

IS - 4

M1 - e9413

ER -

Safety of dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food pursuant to Regulation (EU) 2015/2283.

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Keywords

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