<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Younes Maged</style></author><author><style face="normal" font="default" size="100%">Gabriele Aquilina</style></author><author><style face="normal" font="default" size="100%">Laurence Castle</style></author><author><style face="normal" font="default" size="100%">Karl‐Heinz Engel</style></author><author><style face="normal" font="default" size="100%">Paul Fowler</style></author><author><style face="normal" font="default" size="100%">Maria Jose Frutos Fernandez</style></author><author><style face="normal" font="default" size="100%">Peter Fürst</style></author><author><style face="normal" font="default" size="100%">Ursula Gundert‐Remy</style></author><author><style face="normal" font="default" size="100%">Rainer Gürtler</style></author><author><style face="normal" font="default" size="100%">Trine Husøy</style></author><author><style face="normal" font="default" size="100%">Melania Manco</style></author><author><style face="normal" font="default" size="100%">Wim Mennes</style></author><author><style face="normal" font="default" size="100%">Peter Moldeus</style></author><author><style face="normal" font="default" size="100%">Sabina Passamonti</style></author><author><style face="normal" font="default" size="100%">Romina Shah</style></author><author><style face="normal" font="default" size="100%">Ine Waalkens‐Berendsen</style></author><author><style face="normal" font="default" size="100%">Detlef Wölfle</style></author><author><style face="normal" font="default" size="100%">Emanuela Corsini</style></author><author><style face="normal" font="default" size="100%">Francesco Cubadda</style></author><author><style face="normal" font="default" size="100%">Didima De Groot</style></author><author><style face="normal" font="default" size="100%">Rex FitzGerald</style></author><author><style face="normal" font="default" size="100%">Sara Gunnare</style></author><author><style face="normal" font="default" size="100%">Arno Christian Gutleb</style></author><author><style face="normal" font="default" size="100%">Jan Mast</style></author><author><style face="normal" font="default" size="100%">Mortensen, Alicja</style></author><author><style face="normal" font="default" size="100%">Agnes Oomen</style></author><author><style face="normal" font="default" size="100%">Aldert Piersma</style></author><author><style face="normal" font="default" size="100%">Veronika Plichta</style></author><author><style face="normal" font="default" size="100%">Beate Ulbrich</style></author><author><style face="normal" font="default" size="100%">Henk van Loveren</style></author><author><style face="normal" font="default" size="100%">Diane Benford</style></author><author><style face="normal" font="default" size="100%">Margherita Bignami</style></author><author><style face="normal" font="default" size="100%">Claudia Bolognesi</style></author><author><style face="normal" font="default" size="100%">Riccardo Crebelli</style></author><author><style face="normal" font="default" size="100%">Maria Dusinska</style></author><author><style face="normal" font="default" size="100%">Francesca Marcon</style></author><author><style face="normal" font="default" size="100%">Elsa Nielsen</style></author><author><style face="normal" font="default" size="100%">Josef Schlatter</style></author><author><style face="normal" font="default" size="100%">Christiane Vleminckx</style></author><author><style face="normal" font="default" size="100%">Stefania Barmaz</style></author><author><style face="normal" font="default" size="100%">Maria Carfí</style></author><author><style face="normal" font="default" size="100%">Consuelo Civitella</style></author><author><style face="normal" font="default" size="100%">Alessandra Giarola</style></author><author><style face="normal" font="default" size="100%">Ana Maria Rincon</style></author><author><style face="normal" font="default" size="100%">Rositsa Serafimova</style></author><author><style face="normal" font="default" size="100%">Camilla Smeraldi</style></author><author><style face="normal" font="default" size="100%">Jose Tarazona</style></author><author><style face="normal" font="default" size="100%">Alexandra Tard</style></author><author><style face="normal" font="default" size="100%">Wright, Matthew</style></author></authors><translated-authors><author><style face="normal" font="default" size="100%">EFSA Panel on Food Additives and Flavourings (FAF)</style></author></translated-authors></contributors><titles><title><style face="normal" font="default" size="100%">Safety assessment of titanium dioxide (E171) as a food additive</style></title><secondary-title><style face="normal" font="default" size="100%">EFSA Journal</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">CAS No 13463-67-7</style></keyword><keyword><style  face="normal" font="default" size="100%">E 171</style></keyword><keyword><style  face="normal" font="default" size="100%">titanium dioxide</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">Jan-05-2021</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">19</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;The present opinion deals with an updated safety assessment of the food additive titanium dioxide (E&amp;nbsp;171) based on new relevant scientific evidence considered by the Panel&amp;nbsp;to be reliable, including data obtained with TiO2&amp;nbsp;nanoparticles (NPs) and data from an extended one-generation reproductive toxicity (EOGRT) study. Less than 50% of constituent particles by number in E&amp;nbsp;171 have a minimum external dimension &amp;lt; 100 nm. In addition, the Panel&amp;nbsp;noted that constituent particles &amp;lt; 30 nm amounted to less than 1% of particles by number. The Panel&amp;nbsp;therefore considered that studies with TiO2&amp;nbsp;NPs &amp;lt; 30 nm were of limited relevance to the safety assessment of E&amp;nbsp;171. The Panel&amp;nbsp;concluded that although gastrointestinal absorption of TiO2&amp;nbsp;particles is low, they may accumulate in the body. Studies on general and organ toxicity did not indicate adverse effects with either E&amp;nbsp;171 up to a dose of 1,000 mg/kg body weight (bw) per day or with TiO2&amp;nbsp;NPs (&amp;gt; 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&amp;nbsp;171 and potential neurotoxicity with TiO2&amp;nbsp;NPs, together with the potential induction of aberrant crypt foci with E&amp;nbsp;171, may indicate adverse effects. With respect to genotoxicity, the Panel&amp;nbsp;concluded that TiO2&amp;nbsp;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&amp;nbsp;particles and the outcome of either&amp;nbsp;in&amp;nbsp;vitro&amp;nbsp;or&amp;nbsp;in&amp;nbsp;vivo&amp;nbsp;genotoxicity assays. A concern for genotoxicity of TiO2&amp;nbsp;particles that may be present in E&amp;nbsp;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&amp;nbsp;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&amp;nbsp;particle size with respect to genotoxicity could not be identified. No appropriately designed study was available to investigate the potential carcinogenic effects of TiO2&amp;nbsp;NPs. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, the Panel&amp;nbsp;concluded that E&amp;nbsp;171 can no longer be considered as safe when used as a food additive.&lt;/p&gt;
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