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Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008

2026-01-20Artigo científico Acesso restrito
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dc.contributor.authorEFSA Panel on Food Additives and Flavourings (FAF)
dc.contributor.authorCastle, Laurence
dc.contributor.authorAndreassen, Monica
dc.contributor.authorAquilina, Gabriele
dc.contributor.authorBastos, Maria Lourdes
dc.contributor.authorBoon, Polly
dc.contributor.authorFallico, Biagio
dc.contributor.authorFitzGerald, Rex
dc.contributor.authorFrutos Fernandez, Maria Jose
dc.contributor.authorGundert-Remy, Ursula
dc.contributor.authorUrsula Gundert‐Remy
dc.contributor.authorGürtler, Rainer
dc.contributor.authorHoudeau, Eric
dc.contributor.authorKurek, Marcin
dc.contributor.authorLouro, Henriqueta
dc.contributor.authorMorales, Patricia
dc.contributor.authorPassamonti, Sabina
dc.contributor.authorBarmaz, Stefania
dc.contributor.authorCarfì, Maria
dc.contributor.authorCivitella, Consuelo
dc.contributor.authorGagliardi, Gabriele
dc.contributor.authorLodi, Federica
dc.contributor.authorMartino, Carla
dc.contributor.authorMazzoli, Elena
dc.contributor.authorMech, Agnieszka
dc.contributor.authorRasinger, Josef Daniel
dc.contributor.authorRincon, Ana Maria
dc.contributor.authorRuggeri, Laura
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorZakidou, Panagiota
dc.date.accessioned2026-10-02T11:37:46Z
dc.date.available2026-10-02T11:37:46Z
dc.date.issued2026-01-20
dc.description.abstractThis guidance document applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food additive, submitted under Regulation (EC) No 1333/2008. It defines the scientific data required to evaluate if the food additive is safe under the proposed conditions of use, in accordance with Articles 1 and 6 of Regulation (EC) No 1333/2008. The data requirements pertain to the characterisation of the proposed food additive, including the description of its identity, manufacturing process, specifications, stability, reaction and fate in foods and methods of analysis in food; the proposed uses and use levels and the dietary exposure; the safety data, including information on the genotoxic potential of the food additive, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should provide data in accordance with this guidance document to support the safety assessment of the proposed food additive. Based on the submitted data, EFSA will assess the safety of the food additive in line with the risk assessment principles described in this document and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.eng
dc.identifier.citationEFSA J. 2026 Jan 20;24(1):e9778. doi: 10.2903/j.efsa.2026.9778. eCollection 2026 Jan
dc.identifier.doi10.2903/j.efsa.2026.9778
dc.identifier.issn1831-4732
dc.identifier.pmid41567612
dc.identifier.urihttp://hdl.handle.net/10400.18/11375
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2026.9778
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectEnvironmental Genotoxicity
dc.subjectFood Additives
dc.subjectSafety Assessment
dc.subjectEFSA Guidance
dc.subjectAuthorisation
dc.subjectFood Additives
dc.subjectRisk Assessment
dc.subjectTiered Approach
dc.subjectGenotoxicidade Ambiental
dc.titleGuidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008eng
dc.typejournal article
dcterms.referenceshttps://pmc.ncbi.nlm.nih.gov/articles/instance/12817064/bin/EFS2-24-e9778-s001.pdf
dspace.entity.typePublication
oaire.citation.issue1
oaire.citation.startPagee9778
oaire.citation.titleEFSA Journal
oaire.citation.volume24
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameLouro
person.givenNameHenriqueta
person.identifier157627
person.identifier.ciencia-id721D-2BB1-7DB1
person.identifier.orcid0000-0001-9744-7332
person.identifier.scopus-author-id6507971479
relation.isAuthorOfPublication2361a951-8b9a-4b90-92d6-f6384003a242
relation.isAuthorOfPublication.latestForDiscovery2361a951-8b9a-4b90-92d6-f6384003a242

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