EFSA statement on the review of the risks related to the exposure to the food additive titanium dioxide (E 171) performed by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES)

Abstract

On 15 April 2019, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published an opinion on the risks related to the exposure to the food additive titanium dioxide (E 171) taking into account the most recent scientific studies available. Further to this publication, EFSA was requested by the European Commission to provide urgent scientific and technical assistance regarding the opinion issued by ANSES. In the ANSES opinion, 25 new relevant publications published between 2017 and 2019 were reviewed together with previous opinions by EFSA and ANSES and a systematic review on in vitro genotoxicity of nano titanium dioxide. In this statement, EFSA concludes that the ANSES opinion published in April 2019 does not identify any major new findings that would overrule the conclusions made in the previous two scientific opinions on the safety of titanium dioxide (E 171) as a food additive issued by the EFSA ANS Panel in 2016 and 2018. The ANSES opinion reiterates the previously identified uncertainties and data gaps, which are currently being addressed in the context of the follow‐up activities originating from the previous EFSA evaluations and their recommendations. In addition to the aspects for which the follow‐up work is currently ongoing, ANSES recommends further investigation of in vivo genotoxicity. EFSA considers this recommendation should be revisited once the ongoing work on the physico‐chemical characterisation of the food additive titanium dioxide (E 171) is completed.

Physicochemical Characterization of the Pristine E171 Food Additive by Standardized and Validated Methods

“…More recently, Talamini et al showed that the repeated administration of E171 to mice resulted in TiO 2 deposition in the gastrointestinal tract and the liver, and it is associated with molecular and cellular alterations in the inflammatory response [48]. In addition, the French Agency for Food, Environmental, and Occupational Health and Safety (ANSES) proposed that titanium dioxide should be considered as being potentially carcinogenic to humans when inhaled, but there was no carcinogenic concern for oral and dermal exposure [49][50][51]. These studies urged relevant governmental agencies to reassess the safety of titanium dioxide as a food additive.…”

Impact of Food Additive Titanium Dioxide on Gut Microbiota Composition, Microbiota-Associated Functions, and Gut Barrier: A Systematic Review of In Vivo Animal Studies

“…In April 2019, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published a review suggesting a genotoxic and carcinogenic potential even if further in vivo mammalian studies are warranted to confirm or rule out these hypotheses [ 12 ]. As requested by the European Commission, EFSA provided urgent scientific and technical review regarding the opinion issued by ANSES [ 13 ]. The EFSA concluded that the latest ANSES opinion does not identify any major new findings that would overrule the conclusions made in the previous two scientific opinions in 2016 and 2018.…”

Analysis of the Characteristics and Cytotoxicity of Titanium Dioxide Nanomaterials Following Simulated In Vitro Digestion

“…Until now, there is no consensus on the use of TiO 2 as a food additive. The European Food Safety Authority (EFSA) Panel on "Food Additives and Nutrient Sources Added to Food" stated that the food additive E171 containing TiO 2 (anatase or rutile structure) does not raise a genotoxic concern [10,11]. However, other regulatory bodies such as the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) have emphasized the need to conduct studies to fully characterize the potential health effects related to ingestion of this food additive [12], leading to the ban of its use in food in France, since January 2020.…”