What is the use of titanium dioxide
Titanium dioxide: E171 is no longer considered safe when used as a food additive
EFSA updated its safety assessment for titanium dioxide (E171) at the request of the European Commission in March 2020.
The updated assessment revises the outcome of EFSA's previous 2016 assessment, which highlighted the need for more research to fill data gaps.
Prof. Maged Younes, Chair of EFSA's Panel of Experts on Food Additives and Flavorings (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 key factor in this conclusion is that we could not rule out genotoxicity concerns after consuming titanium dioxide particles. Oral absorption of titanium dioxide particles is low, but they can accumulate in the body. "
The assessment was carried out following a rigorous methodology and taking into account the thousands of studies that have become available since the previous EFSA assessment in 2016, including new scientific knowledge and data on nanoparticles.
Our scientific experts first applied the 2018 EFSA Scientific Committee guidelines on nanotechnology to the safety assessment of food additives. Titanium Dioxide E171 contains no more than 50% nano-scale particles (i.e. less than 100 nanometers) to which consumers may be exposed.
Genotoxicity refers to the ability of a chemical substance to damage the genetic material of cells. Since genotoxicity can lead to carcinogenic effects, it is essential to assess the potential genotoxic effects of a substance in order to be able to draw conclusions about its harmlessness.
Prof. Matthew Wright, both a member of the FAF Panel and Chair of the EFSA Working Group on E 171, said: “Although the evidence for general toxic effects was inconclusive, based on the new data and advanced methods, we could raise concerns about the Do not rule out genotoxicity and consequently do not establish a safe daily intake of the food additive. "
The risk managers at the European Commission and in the EU Member States have been informed of the EFSA's conclusions and will consider appropriate measures to ensure consumer protection.
Titanium dioxide (E171) is approved as a food additive in the EU according to Annex II of Regulation (EC) No. 1333/2008.
The safety of the food additive E171 was reassessed in 2016 within the framework of Regulation (EU) No. 257/2010 by the ANS panel of EFSA as part of the program for the re-evaluation of food additives authorized in the EU before January 20, 2009.
In its 2016 opinion, the ANS Panel recommended that new studies be carried out to fill the gaps in relation to possible effects on the reproductive system, which could allow it to set a daily allowable intake. The one related to the characterization of the material used as a food additive (E171) was also highlighted, particularly with regard to the particle size and particle size distribution of titanium dioxide used as E171.
In 2019, EFSA published an opinion on the risk assessment of the food additive titanium dioxide (E171) carried out by the French Agency for Food, Environment and Health at Work (ANSES). In its opinion, EFSA emphasized that the ANSES opinion echoed the uncertainties and data gaps previously identified by EFSA and did not provide any information that would invalidate the Authority's earlier conclusions on the safety of titanium dioxide.
In the same year (2019), the Dutch Food and Consumer Product Safety Authority (NVWA) issued an opinion on possible health effects of the food additive titanium dioxide, in which the importance of studying immunotoxicological effects in addition to possible reprotoxicological effects was emphasized.
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