At the request of the European Commission in March 2020, EFSA updated its safety assessment of the food additive titanium dioxide (E 171).
The updated assessment revise a previous assessment published by EFSA in 2016, which highlighted the need for more research to fill data gaps.
EFSA's Expert Group on Food Additives and Flavorings (FAF) said: "Taking into account all available scientific research and data, the group concludes that titanium dioxide can no longer be considered a safe food additive. A key factor in reaching this conclusion However, we cannot rule out the genotoxicity problem after consuming titanium dioxide particles. After oral administration, the absorption rate of titanium dioxide particles is low, but it can accumulate in the body."
The assessment was conducted following a rigorous methodology and took into account thousands of studies since EFSA's last assessment in 2016, including new scientific evidence and data on nanoparticles.
For the first time, scientific experts have applied the 2018 EFSA Scientific Committee Nanotechnology Guidelines to the safety assessment of food additives. Titanium Dioxide E 171 contains up to 50% nanoscale particles (i.e. smaller than 100 nanometers) to which consumers may be exposed.
Genotoxicity assessment
Genotoxicity refers to the ability of chemicals to damage DNA, the genetic material of cells. Since genotoxicity may lead to carcinogenic effects, the potential genotoxic effects of a substance must be evaluated to draw conclusions about its safety.
Professor on the expert panel said: "While the evidence for general toxic effects is inconclusive, based on the new data and the fortification approach we cannot rule out concerns about genotoxicity and therefore we cannot determine a safe level for daily intake of the food additive."
The European Commission and risk managers in EU Member States have been informed of EFSA's conclusions and will consider appropriate actions to ensure consumers are protected.
background
Titanium dioxide (E 171) is authorized as a food additive in the EU according to Annex II of Regulation (EC) No 1333/2008.
The EFSA ANS panel re-evaluated the safety of the food additive E 171 in 2016 within the framework of Regulation (EU) No 257/2010 as part of the EU's re-evaluation program for food additives authorized before 20 January 2009.
In its 2016 opinion, the ANS panel recommended new research to fill the gap on possible effects on the reproductive system, which could allow them to set an acceptable daily intake (ADI). Uncertainties in the properties of materials used as food additives (E 171) were also highlighted, particularly with regard to the particle size and particle size distribution of titanium dioxide used as E 171.
In 2019, EFSA issued a statement on the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) review of risks associated with exposure to the food additive titanium dioxide (E171). EFSA stressed in its statement that ANSES's opinion reiterates the uncertainties and data gaps previously identified by EFSA and does not present findings that invalidate the Authority's previous conclusions on the safety of titanium dioxide.
In the same year (2019), the Dutch Food and Consumer Product Safety Authority (NVWA) also issued an opinion on the possible health effects of the food additive titanium dioxide, emphasizing the importance of examining immunotoxicological effects in addition to potential reproductive toxicological effects .
