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Flavouring group evaluation 418 (FGE. 418): 3‐[3‐(2‐isopropyl‐5‐methyl‐cyclohexyl)‐ureido]‐butyric acid ethyl ester

2025-01-31Journal article Open access
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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
dc.contributor.authorBoon, Polly
dc.contributor.authorFallico, Biagio
dc.contributor.authorFitzGerald, Reginald
dc.contributor.authorFrutos-Fernandez, Maria Jose
dc.contributor.authorGrasl-Kraupp, Bettina
dc.contributor.authorGundert-Remy, Ursula
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.authorBenigni, Romualdo
dc.contributor.authorChipman, Kevin
dc.contributor.authorCordelli, Eugenia
dc.contributor.authorDegen, Gisela
dc.contributor.authorEngel, Karl-Heinz
dc.contributor.authorFowler, Paul
dc.contributor.authorCarfí, Maria
dc.contributor.authorGagliardi, Gabriele
dc.contributor.authorMech, Agnieszka
dc.contributor.authorMultari, Salvatore
dc.contributor.authorMartino, Carla
dc.date.accessioned2025-11-10T15:42:01Z
dc.date.available2025-11-10T15:42:01Z
dc.date.issued2025-01-31
dc.description.abstractThe EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of 3‐[3‐(2‐isopropyl‐5‐methyl‐cyclohexyl)‐ureido]‐butyric acid ethyl ester [FL‐no: 16.136] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and it is chemically synthesised. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 16.136] was considered sufficient. The chronic dietary exposure to [FL‐no: 16.136] estimated using the added portions exposure technique (APET) is calculated to be 860 μg/person per day for a 60‐kg adult and 540 μg/person per day for a 15‐kg 3‐year‐old child. [FL‐no: 16.136] did not show genotoxic effects in bacterial mutagenicity and mammalian cell micronucleus assays in vitro. No ADME studies on [FL‐no: 16.136] were provided. In a prenatal developmental toxicity study, no maternal or fetal toxicity was observed in rats dosed up to 1000 mg/kg body weight (bw) per day. In a 90‐day toxicity study in rats, no adverse effects were observed. In this study, the Panel considered that the NOAEL is 777 and 923 mg/kg bw per day (the highest dose tested) for male and female rats, respectively. Considering the lowest NOAEL of 777 mg/kg bw per day, as a reference point, adequate margins of exposure of 55 × 103 and 21 × 103 were calculated for adults and children, respectively, when considering the chronic APET dietary exposure estimates. The Panel concluded that the use of 3‐[3‐(2‐isopropyl‐5‐methylcyclohexyl)‐ureido]‐butyric acid ethyl ester [FL‐no: 16.136] as a flavouring substance under the proposed conditions of use does not raise a safety concern at the dietary exposure estimates calculated using the APET approach.eng
dc.identifier.citationEFSA J. 2025 Jan 31;23(1):e9201. doi: 10.2903/j.efsa.2025.9201. eCollection 2025 Jan
dc.identifier.doi10.2903/j.efsa.2025.9201
dc.identifier.eissn1831-4732
dc.identifier.pmid39896350
dc.identifier.urihttp://hdl.handle.net/10400.18/10580
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9201
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subject3‐[3‐(2‐Isopropyl‐5‐Methyl‐Cyclohexyl)‐Ureido]‐Butyric Acid Ethyl Ester
dc.subjectSafety Assessment
dc.subjectFGE.418
dc.subjectFL‐no: 16.136
dc.subjectGenotoxicidade Ambiental
dc.titleFlavouring group evaluation 418 (FGE. 418): 3‐[3‐(2‐isopropyl‐5‐methyl‐cyclohexyl)‐ureido]‐butyric acid ethyl estereng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue1
oaire.citation.startPagee9201
oaire.citation.titleEFSA Journal
oaire.citation.volume23
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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