Safety of synthetic cannabidiol 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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is trans-cannabidiol (CB...

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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, Maciuk, A., Mangelsdorf, I., 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:idus.us.es:11441/182494
Acceso en línea:https://hdl.handle.net/11441/182494
https://doi.org/10.2903/j.efsa.2025.9527
Access Level:acceso abierto
Palabra clave:CBD
Food supplement
Novel foods
Safety
Synthetic cannabidiol
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spelling Safety of synthetic cannabidiol 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 MencíaMaciuk, A.Mangelsdorf, I.Hirsch-Ernst, K. I.CBDFood supplementNovel foodsSafetySynthetic cannabidiolFollowing a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is trans-cannabidiol (CBD), produced by chemical synthesis and proposed to be used in food supplements at a level of 30 mg/day. The target population is the general population, excluding pregnant and lactating women. 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 concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. synthetic cannabidiol, cannot be established.European Food Safety AuthorityNutrición y Bromatología, Toxicología y Medicina Legal2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/182494https://doi.org/10.2903/j.efsa.2025.9527reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésEFSA Journal, 23 (7), e9527.https://doi.org/10.2903/j.efsa.2025.9527info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1824942026-06-17T12:51:07Z
dc.title.none.fl_str_mv Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283
title Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283
spellingShingle Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
CBD
Food supplement
Novel foods
Safety
Synthetic cannabidiol
title_short Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283
title_full Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283
title_fullStr Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283
title_full_unstemmed Safety of synthetic cannabidiol as a novel food pursuant to Regulation (EU) 2015/2283
title_sort Safety of synthetic cannabidiol 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
Maciuk, A.
Mangelsdorf, I.
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
Maciuk, A.
Mangelsdorf, I.
Hirsch-Ernst, K. I.
author_role author
author2 Turck, D.
Bohn, T.
Cámara, M.
Castenmiller, J.
De Henauw, S.
Jos Gallego, Ángeles Mencía
Maciuk, A.
Mangelsdorf, I.
Hirsch-Ernst, K. I.
author2_role author
author
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 CBD
Food supplement
Novel foods
Safety
Synthetic cannabidiol
topic CBD
Food supplement
Novel foods
Safety
Synthetic cannabidiol
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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is trans-cannabidiol (CBD), produced by chemical synthesis and proposed to be used in food supplements at a level of 30 mg/day. The target population is the general population, excluding pregnant and lactating women. 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 concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. synthetic cannabidiol, cannot be established.
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/11441/182494
https://doi.org/10.2903/j.efsa.2025.9527
url https://hdl.handle.net/11441/182494
https://doi.org/10.2903/j.efsa.2025.9527
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv EFSA Journal, 23 (7), e9527.
https://doi.org/10.2903/j.efsa.2025.9527
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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