Cristin-resultat-ID: 1976589
Sist endret: 3. februar 2022, 10:39
NVI-rapporteringsår: 2021
Resultat
Vitenskapelig artikkel
2021

Safety assessment of titanium dioxide (E171) as a food additive

Bidragsytere:
  • Maged Younes
  • Gabriele Aquilina
  • Laurence Castle
  • Karl-Heinz Engel
  • Paul Fowler
  • Maria Jose Frutos Fernandez
  • mfl.

Tidsskrift

EFSA Journal
ISSN 1831-4732
NVI-nivå 1

Om resultatet

Vitenskapelig artikkel
Publiseringsår: 2021
Volum: 19
Artikkelnummer: e06585
Open Access

Beskrivelse Beskrivelse

Tittel

Safety assessment of titanium dioxide (E171) as a food additive

Sammendrag

The present opinion deals with an updated safety assessment of the food additive titanium dioxide (E 171) based on new relevant scientific evidence considered by the Panel to be reliable, including data obtained with TiO2 nanoparticles (NPs) and data from an extended one-generation reproductive toxicity (EOGRT) study. Less than 50% of constituent particles by number in E 171 have a minimum external dimension 30 nm) up to the highest dose tested of 100 mg/kg bw per day. No effects on reproductive and developmental toxicity were observed up to a dose of 1,000 mg E 171/kg bw per day, the highest dose tested in the EOGRT study. However, observations of potential immunotoxicity and inflammation with E 171 and potential neurotoxicity with TiO2 NPs, together with the potential induction of aberrant crypt foci with E 171, may indicate adverse effects. With respect to genotoxicity, the Panel concluded that TiO2 particles have the potential to induce DNA strand breaks and chromosomal damage, but not gene mutations. No clear correlation was observed between the physico-chemical properties of TiO2 particles and the outcome of either in vitro or in vivo genotoxicity assays. A concern for genotoxicity of TiO2 particles that may be present in E 171 could therefore not be ruled out. Several modes of action for the genotoxicity may operate in parallel and the relative contributions of different molecular mechanisms elicited by TiO2 particles are not known. There was uncertainty as to whether a threshold mode of action could be assumed. In addition, a cut-off value for TiO2 particle size with respect to genotoxicity could not be identified. No appropriately designed study was available to investigate the potential carcinogenic effects of TiO2 NPs. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, the Panel concluded that E 171 can no longer be considered as safe when used as a food additive.

Bidragsytere

Maged Younes

  • Tilknyttet:
    Forfatter
    ved Tyskland
  • Tilknyttet:
    Forfatter
    ved Sveits
  • Tilknyttet:
    Forfatter
    ved Storbritannia og Nord-Irland

Gabriele Aquilina

  • Tilknyttet:
    Forfatter
    ved Istituto Superiore di Sanità

Laurence Castle

  • Tilknyttet:
    Forfatter
    ved Storbritannia og Nord-Irland

Karl-Heinz Engel

  • Tilknyttet:
    Forfatter
    ved Technische Universität München

Paul Fowler

  • Tilknyttet:
    Forfatter
    ved University of Aberdeen
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