Fifth draft statement on the safety of Titanium Dioxide (E171) as a Food Additive- Introduction

This is a draft statement for discussion. This does not represent the views of the Committee and should not be cited.

Introduction

1.  Titanium dioxide (TiO2) was an authorised Food Additive (E171) in the EU until 7^th August 2022. It currently remains authorised in the UK, under Retained EU Regulation No. 1333/2008 and Retained EU Regulation No. 231/2012. It is used in food as a colour to make food more visually appealing, to give colour to food that would otherwise be colourless, or to restore the original appearance of food. It is commonly used in products such as bakery products, soups, broths, sauces, salad dressings, savoury based sandwich spreads, processed nuts, confectionary, chewing gum, food supplements and cake icing.
2. Titanium dioxide has been the subject of multiple safety evaluations. In 2016, the EFSA ANS (Food Additives and Nutrient Sources) Panel evaluated the safety of E171 TiO2 and identified several uncertainties in their evaluation included the unspecified identity and characterisation of E171 as it was not determined whether the test material was compliant with the specification of E171 requirements. The EFSA 2016 review determined that E171 TiO2 consisted mainly of micro-sized TiO2 particles, with a nano-sized (<100 nm) fraction which was less than 3.2% by mass. Uncertainties around the identity and characterisation of E171 were highlighted, noting that no limits for the particle size of E171 were set. In 2019, the specifications of E171 titanium dioxide were reviewed by the EFSA FAF Panel (Food and Feed). A recommendation for re-assessment of the safety of titanium dioxide was proposed.  
3. In the EFSA 2021 Opinion, the EFSA FAF Panel considered that some findings regarding immunotoxicity, inflammation and neurotoxicity with respect to TiO2 nanoparticles may be indicative of adverse effects. On the basis of the currently available evidence and the uncertainties, in particular a concern regarding genotoxicity which could not be resolved, the EFSA Panel concluded that E171 can no longer be considered as safe when used as a food additive. 
4. In 2021 the COT published an interim position on titanium dioxide (COT 2021)  capturing the outcomes of the discussions and outlining the next steps. Members were asked to evaluate the EFSA Opinion and comment on whether they agreed with EFSA’s conclusions and further guidance on the next steps that should be taken; producing an opinion paper following a review of the new EFSA opinion and the extended one generation reproductive toxicity (EOGRT) study data by both the COT and COM (Committee on Mutagenicity).  
5. This draft statement (Annex A) includes the COT conclusions on the following endpoints: ADME, Aberrant Crypt Foci as a marker for Carcinogenicity, Allergenicity, Reproductive and Developmental Toxicity, potential evidence of Immunotoxicity, Inflammation and Neurotoxicity and the derivation of a Health-Based Guidance Value, and a review and conclusions of genotoxicity endpoints by the COM. An Executive Summary has also been included and the conclusions have been updated.

Questions for the Committee 

6. The Committee are asked to consider the following questions: 

i: Are Members content with the layout and structure of the statement?

ii: Are Members content with the layout and structure of the Executive Summary?

iii: Do Members agree with the risk characterisation and conclusions?

iv: Do Members have any other comments?

Secretariat

May 2024