Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283

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 the Rhizomucor pusillus biomass powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a filamentous fungus bioma...

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Autores: EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck, D., Bohn, T., Cámara, M., Castenmiller, J., De Henauw, S., Jos Gallego, Ángeles Mencía, Hirsch-Ernst, K. I.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:dnet:idus________::7b506bb39da38f16b3ca0016866195e6
Acceso en línea:https://hdl.handle.net/11441/184477
https://doi.org/10.2903/j.efsa.2025.9707
Access Level:acceso abierto
Palabra clave:Filamentous fungi
Mycoprotein
Novel foods
Rhizomucor pusillus
Safety
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spelling Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)Turck, D.Bohn, T.Cámara, M.Castenmiller, J.De Henauw, S.Jos Gallego, Ángeles MencíaHirsch-Ernst, K. I.Filamentous fungiMycoproteinNovel foodsRhizomucor pusillusSafetyFollowing 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 the Rhizomucor pusillus biomass powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a filamentous fungus biomass powder. The novel food is intended for use as an ingredient in various food products, targeting the general population when used as a food ingredient or whole food, individuals above 18 years excluding pregnant and lactating women in the case of food supplements, and adults for meal replacement for weight control. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Based on the data provided the Panel considers that there are no concerns regarding genotoxicity. Results from the 90-day study did not show effects of toxicological relevance for humans up to the highest dose tested (19,668 mg/kg body weight (bw) per day). Under the proposed conditions of use, the highest intake estimates of the NF range from 539 to 1013 mg/kg bw per day. Taking into account the production process, the identity and compositional characterisation data and the lack of toxicity in the provided studies, the Panel considers that the resulting margin of exposure (MoE) for each population group is sufficient (37 for infants, 19 for young children, 26 for other children, 34 for adolescents and 31 for adults). The Panel considers that the likelihood of the NF triggering allergic reactions is low. The Panel concludes that the NF is safe under the proposed conditions of use.European Food Safety AuthorityNutrición y Bromatología, Toxicología y Medicina Legal2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/184477https://doi.org/10.2903/j.efsa.2025.9707reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésEFSA Journal, 23 (12), e9707. https://doi.org/10.2903/j.efsa.2025.9707info:eu-repo/semantics/openAccessoai:dnet:idus________::7b506bb39da38f16b3ca0016866195e62026-06-17T12:51:07Z
dc.title.none.fl_str_mv Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
title Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
spellingShingle Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
Filamentous fungi
Mycoprotein
Novel foods
Rhizomucor pusillus
Safety
title_short Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
title_full Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
title_fullStr Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
title_full_unstemmed Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
title_sort Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283
dc.creator.none.fl_str_mv EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
Turck, D.
Bohn, T.
Cámara, M.
Castenmiller, J.
De Henauw, S.
Jos Gallego, Ángeles Mencía
Hirsch-Ernst, K. I.
author EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
author_facet EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
Turck, D.
Bohn, T.
Cámara, M.
Castenmiller, J.
De Henauw, S.
Jos Gallego, Ángeles Mencía
Hirsch-Ernst, K. I.
author_role author
author2 Turck, D.
Bohn, T.
Cámara, M.
Castenmiller, J.
De Henauw, S.
Jos Gallego, Ángeles Mencía
Hirsch-Ernst, K. I.
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Nutrición y Bromatología, Toxicología y Medicina Legal
dc.subject.none.fl_str_mv Filamentous fungi
Mycoprotein
Novel foods
Rhizomucor pusillus
Safety
topic Filamentous fungi
Mycoprotein
Novel foods
Rhizomucor pusillus
Safety
description 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 the Rhizomucor pusillus biomass powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a filamentous fungus biomass powder. The novel food is intended for use as an ingredient in various food products, targeting the general population when used as a food ingredient or whole food, individuals above 18 years excluding pregnant and lactating women in the case of food supplements, and adults for meal replacement for weight control. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Based on the data provided the Panel considers that there are no concerns regarding genotoxicity. Results from the 90-day study did not show effects of toxicological relevance for humans up to the highest dose tested (19,668 mg/kg body weight (bw) per day). Under the proposed conditions of use, the highest intake estimates of the NF range from 539 to 1013 mg/kg bw per day. Taking into account the production process, the identity and compositional characterisation data and the lack of toxicity in the provided studies, the Panel considers that the resulting margin of exposure (MoE) for each population group is sufficient (37 for infants, 19 for young children, 26 for other children, 34 for adolescents and 31 for adults). The Panel considers that the likelihood of the NF triggering allergic reactions is low. The Panel concludes that the NF is safe under the proposed conditions of use.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/184477
https://doi.org/10.2903/j.efsa.2025.9707
url https://hdl.handle.net/11441/184477
https://doi.org/10.2903/j.efsa.2025.9707
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv EFSA Journal, 23 (12), e9707.
https://doi.org/10.2903/j.efsa.2025.9707
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv European Food Safety Authority
publisher.none.fl_str_mv European Food Safety Authority
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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