Opinion of the EFSA Scientific Panel Re-evaluation of Titanium Dioxide (E171) as a Food Additive

On 14 September 2016, the European Food Safety Authority’s (EFSA) Scientific Panel on Food Additives and Nutrient Sources (ANS) published an Opinion in the EFSA Journal on the safety of titanium dioxide (TiO2, E 171) when used as a food additive. This Opinion resulted from a re-evaluation of food grade titanium dioxide applying the available data on absorption, distribution and excretion.

The Panel concluded that the absorption of orally administered TiO2 into the bloodstream is extremely low with the majority of TiO2 being eliminated by the faeces. A small amount (<0.12%) of oral ingested TiO2 was absorbed by the gut-associated lymphoid tissue (GALT) and subsequently eliminated. The bioavailability of TiO2 was determined to be low and appeared to be independent of particle size. Based on the above findings and the available genotoxicity data, the Panel also concluded that orally ingested micro- and nanoparticles are unlikely to present a genotoxic hazard in vivo. Overall TiO2 was considered as safe for use based on margin of safety assessments.

The Panel also recommended additional purposeful, tiered testing be performed to determine an Acceptable Daily Intake (ADI) for food grade TiO2 (E171). The EU specifications for E171 TiO2 were recommended to include a detailed particle size distribution and the maximum limits for heavy metal impurities were asked to be revisited.

The Panel’s conclusions are consistent with research performed in industry on the safety and bioavailability of orally administered titanium dioxide. The TDMA acknowledges the Panel’s recommendations and will work to satisfy remaining questions and ensure the continued safe use of food grade titanium dioxide.

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Re-evaluation of Titanium Dioxide (E 171) as a Food Additive