Repository logo
 
Publication

Scientific opinion on the safety of a proposed amendment of the conditions of use of the food additive sorbitan monostearate (E 491) in enzyme preparations

2025-06-25Journal article Open access
Simple item page
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, 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.authorBarat Baviera, José Manuel
dc.contributor.authorLeblanc, Jean-Charles
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorRuggeri, Laura
dc.date.accessioned2025-11-13T12:17:53Z
dc.date.available2025-11-13T12:17:53Z
dc.date.issued2025-06-25
dc.description.abstractThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety evaluation of a proposed amendment of the conditions of use of the food additive sorbitan monostearate (E 491) in accordance with Annex III, Part 3 to Regulation (EC) No 1333/2008, with respect to the intended use as a food additive in preparations of the food enzyme asparaginase (also known as acrylamide reducing yeast, or ARY). The group of sorbitan esters (E 491–495) was re‐evaluated by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2017. The ANS Panel established a group ADI of 10 mg sorbitan/kg body weight (bw) per day applicable to the food additives E 491–495. In the present opinion the Panel calculated an updated dietary exposure estimate of sorbitan resulting from the current authorised uses of the group of sorbitan esters (E 491–495), and from the proposed amendment of the conditions of use of sorbitan monostearate (E 491) in enzyme preparations. In updating the dietary exposure with the latest dietary surveys available, the group ADI of 10 mg sorbitan/kg bw per day was exceeded in toddlers and children at the 95th percentile in the refined non‐brand loyal scenario for a limited number of dietary surveys. This observation holds true either considering the proposed amendment of the conditions of use of the food additive E 491 or only the currently permitted uses in the exposure calculations. The same conclusions apply to the dietary exposure estimates for consumers of food supplements, for which the ADI is exceeded in children at the 95th percentile. The Panel however concluded that the conservative assumptions made in the refined scenarios have resulted in a clear overestimation of the dietary exposure and therefore that the calculated exceedance of the acceptable daily intake (ADI) is not of safety concern. The Panel concluded that the proposed amendment of the conditions of use of sorbitan monostearate (E 491) in preparations of the food enzyme ARY has little impact on the current dietary exposure to sorbitan resulting from the already permitted uses and reported use levels of sorbitan esters (E 491–495) and would not be of safety concern.eng
dc.identifier.citationEFSA J. 2025 Jun 25;23(6):e9487. doi: 10.2903/j.efsa.2025.9487. eCollection 2025 Jun
dc.identifier.doi10.2903/j.efsa.2025.9487
dc.identifier.eissn1831-4732
dc.identifier.pmid40567513
dc.identifier.urihttp://hdl.handle.net/10400.18/10604
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9487
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectSorbitan Monostearate
dc.subjectSafety Assessment
dc.subjectEnvironmental Genotoxicity
dc.subjectARY
dc.subjectE 491
dc.subjectAcrylamide Reducing Yeast
dc.subjectFood Additive
dc.subjectSorbitan Esters
dc.subjectGenotoxicidade Ambiental
dc.titleScientific opinion on the safety of a proposed amendment of the conditions of use of the food additive sorbitan monostearate (E 491) in enzyme preparationseng
dc.typejournal article
dcterms.referenceshttps://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903%2Fj.efsa.2025.9487&file=efs29487-sup-0001-AnnexA.xlsx
dspace.entity.typePublication
oaire.citation.issue6
oaire.citation.startPagee9487
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

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
2025 EFSA Journal - 2025 - - Scientific opinion on the safety of a proposed amendment of the conditions of use E491.pdf
Size:
235.42 KB
Format:
Adobe Portable Document Format
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
4.03 KB
Format:
Item-specific license agreed upon to submission
Description:
Download

Collections

DGH - Artigos em revistas internacionais
INSA - Artigos em revistas internacionais