Safety assessment of titanium dioxide (E171) as a food additive
Abstract 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 reproduc...
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| Format: | Article |
| Language: | English |
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Wiley
2021-05-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2021.6585 |
| _version_ | 1818255711001378816 |
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| author | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Ursula Gundert‐Remy Rainer Gürtler Trine Husøy Melania Manco Wim Mennes Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Emanuela Corsini Francesco Cubadda Didima De Groot Rex FitzGerald Sara Gunnare Arno Christian Gutleb Jan Mast Alicja Mortensen Agnes Oomen Aldert Piersma Veronika Plichta Beate Ulbrich Henk Van Loveren Diane Benford Margherita Bignami Claudia Bolognesi Riccardo Crebelli Maria Dusinska Francesca Marcon Elsa Nielsen Josef Schlatter Christiane Vleminckx Stefania Barmaz Maria Carfí Consuelo Civitella Alessandra Giarola Ana Maria Rincon Rositsa Serafimova Camilla Smeraldi Jose Tarazona Alexandra Tard Matthew Wright |
| author_facet | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Ursula Gundert‐Remy Rainer Gürtler Trine Husøy Melania Manco Wim Mennes Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Emanuela Corsini Francesco Cubadda Didima De Groot Rex FitzGerald Sara Gunnare Arno Christian Gutleb Jan Mast Alicja Mortensen Agnes Oomen Aldert Piersma Veronika Plichta Beate Ulbrich Henk Van Loveren Diane Benford Margherita Bignami Claudia Bolognesi Riccardo Crebelli Maria Dusinska Francesca Marcon Elsa Nielsen Josef Schlatter Christiane Vleminckx Stefania Barmaz Maria Carfí Consuelo Civitella Alessandra Giarola Ana Maria Rincon Rositsa Serafimova Camilla Smeraldi Jose Tarazona Alexandra Tard Matthew Wright |
| author_sort | EFSA Panel on Food Additives and Flavourings (FAF) |
| collection | DOAJ |
| description | Abstract 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 < 100 nm. In addition, the Panel noted that constituent particles < 30 nm amounted to less than 1% of particles by number. The Panel therefore considered that studies with TiO2 NPs < 30 nm were of limited relevance to the safety assessment of E 171. The Panel concluded that although gastrointestinal absorption of TiO2 particles is low, they may accumulate in the body. Studies on general and organ toxicity did not indicate adverse effects with either E 171 up to a dose of 1,000 mg/kg body weight (bw) per day or with TiO2 NPs (> 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. |
| first_indexed | 2024-12-12T17:16:12Z |
| format | Article |
| id | doaj.art-acbb5485147a4b3ea7a79920b5ff5904 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-12T17:16:12Z |
| publishDate | 2021-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-acbb5485147a4b3ea7a79920b5ff59042022-12-22T00:17:46ZengWileyEFSA Journal1831-47322021-05-01195n/an/a10.2903/j.efsa.2021.6585Safety assessment of titanium dioxide (E171) as a food additiveEFSA Panel on Food Additives and Flavourings (FAF)Maged YounesGabriele AquilinaLaurence CastleKarl‐Heinz EngelPaul FowlerMaria Jose Frutos FernandezPeter FürstUrsula Gundert‐RemyRainer GürtlerTrine HusøyMelania MancoWim MennesPeter MoldeusSabina PassamontiRomina ShahIne Waalkens‐BerendsenDetlef WölfleEmanuela CorsiniFrancesco CubaddaDidima De GrootRex FitzGeraldSara GunnareArno Christian GutlebJan MastAlicja MortensenAgnes OomenAldert PiersmaVeronika PlichtaBeate UlbrichHenk Van LoverenDiane BenfordMargherita BignamiClaudia BolognesiRiccardo CrebelliMaria DusinskaFrancesca MarconElsa NielsenJosef SchlatterChristiane VleminckxStefania BarmazMaria CarfíConsuelo CivitellaAlessandra GiarolaAna Maria RinconRositsa SerafimovaCamilla SmeraldiJose TarazonaAlexandra TardMatthew WrightAbstract 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 < 100 nm. In addition, the Panel noted that constituent particles < 30 nm amounted to less than 1% of particles by number. The Panel therefore considered that studies with TiO2 NPs < 30 nm were of limited relevance to the safety assessment of E 171. The Panel concluded that although gastrointestinal absorption of TiO2 particles is low, they may accumulate in the body. Studies on general and organ toxicity did not indicate adverse effects with either E 171 up to a dose of 1,000 mg/kg body weight (bw) per day or with TiO2 NPs (> 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.https://doi.org/10.2903/j.efsa.2021.6585Titanium dioxideE 171CAS No 13463‐67-7 |
| spellingShingle | EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Ursula Gundert‐Remy Rainer Gürtler Trine Husøy Melania Manco Wim Mennes Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Emanuela Corsini Francesco Cubadda Didima De Groot Rex FitzGerald Sara Gunnare Arno Christian Gutleb Jan Mast Alicja Mortensen Agnes Oomen Aldert Piersma Veronika Plichta Beate Ulbrich Henk Van Loveren Diane Benford Margherita Bignami Claudia Bolognesi Riccardo Crebelli Maria Dusinska Francesca Marcon Elsa Nielsen Josef Schlatter Christiane Vleminckx Stefania Barmaz Maria Carfí Consuelo Civitella Alessandra Giarola Ana Maria Rincon Rositsa Serafimova Camilla Smeraldi Jose Tarazona Alexandra Tard Matthew Wright Safety assessment of titanium dioxide (E171) as a food additive EFSA Journal Titanium dioxide E 171 CAS No 13463‐67-7 |
| title | Safety assessment of titanium dioxide (E171) as a food additive |
| title_full | Safety assessment of titanium dioxide (E171) as a food additive |
| title_fullStr | Safety assessment of titanium dioxide (E171) as a food additive |
| title_full_unstemmed | Safety assessment of titanium dioxide (E171) as a food additive |
| title_short | Safety assessment of titanium dioxide (E171) as a food additive |
| title_sort | safety assessment of titanium dioxide e171 as a food additive |
| topic | Titanium dioxide E 171 CAS No 13463‐67-7 |
| url | https://doi.org/10.2903/j.efsa.2021.6585 |
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