EFSA has updated its safety assessment of the food additive titanium dioxide (E-171), following a request by the European Commission in March 2020.
The updated evaluation revises the outcome of EFSA’s previous assessment published in 2016, which highlighted the need for more research to fill data gaps.
Prof Maged Younes, Chair of EFSA’s expert Panel on Food Additives and Flavourings (FAF), said: “Taking into account all available scientific studies and data, the Panel concluded that titanium dioxide can no longer be considered safe as a food additive. A critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after the consumption of titanium dioxide particles. After oral ingestion, the absorption of titanium dioxide particles is low, however, they can accumulate in the body”.
The assessment was conducted following a rigorous methodology and taking into consideration many thousands of studies that have become available since EFSA’s previous assessment in 2016, including new scientific evidence and data on nanoparticles.
Titanium dioxide E-171 contains at most 50% of particles in the nano range (i.e. less than 100 nanometres) to which consumers may be exposed.
What is titanium dioxide?
Titanium dioxide is used as a food colour (E-171) and, as with all food colours, its technological function is to make food more visually appealing, to give colour to food that would otherwise be colourless, or to restore the original appearance of food. Titanium dioxide is also present in cosmetics, paints, and medicines. Titanium dioxide (E-171) is authorised as a food additive in the EU according to Annex II of Regulation (EC) No 1333/2008.
What foods contain it?
The main food categories contributing to dietary exposure of E-171 are fine bakery wares, soups, broths and sauces (for infants, toddlers and adolescents); and soups, broths, sauces, salads and savoury based sandwich spreads (for children, adults and the elderly). Processed nuts are also a main contributing food category for adults and the elderly.
What is EFSA saying in its 2021 opinion on the safety of titanium dioxide as a food additive?
After conducting a review of all the relevant available scientific evidence, EFSA concluded that a concern for genotoxicity (refers to the ability of a chemical substance to damage DNA, the genetic material of cells) of titanium dioxide particles cannot be ruled out. Based on this concern, EFSA’s experts no longer consider titanium dioxide safe when used as a food additive. This means that an Acceptable Daily Intake (ADI) cannot be established for E-171.
Is EFSA banning titanium dioxide?
No. EFSA’s role was limited to evaluating the risks linked to titanium dioxide as a food additive. This included an assessment of relevant scientific information on E-171, its potential toxicity and estimates of human dietary exposure.
Any legislative or regulatory decisions on the authorisations of food additives are the responsibility of the risk managers (i.e. European Commission and Member States).
What happens next?
EFSA’s scientific advice will be used by risk managers (the European Commission, Member States) to inform any decisions they take on possible regulatory actions.