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EFSA Publishes Scientific Opinion on Proposed Amendment to EU Specifications for Titanium Dioxide (E 171)

Date: 18/7/2019

On July 12, 2019, the European Food Safety Authority (EFSA) published in the EFSA Journal its “Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution.” 

The opinion addresses the assessment of data provided by interested business operators in support of an amendment of the European Union (EU) specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution. According to the opinion, titanium dioxide (E 171), which is used as a food additive in food, undergoes no surface treatment and is not coated. The opinion states that interested business operators have proposed to revise the EU specifications for E 171 to include “a specification of more than 100 nm for median Feret min diameter and less than 50% of the number of constituent particles below 100 nm; measured by EM in both cases.” 

The EFSA Panel on Food Additives and Flavourings, after reviewing the data, “concluded that a specification of more than 100 nm for median minimal external dimension, equivalent to less than 50% of the number of constituent particles with a median minimal external dimension below 100 nm, should be inserted in the current EU specifications.” According to the opinion, the Panel determined that the conclusions made, and the uncertainties identified, in previous EFSA assessments of E 171 remain valid. 

The Panel reiterates the need for further research as recommended in previous opinions to decrease the level of uncertainty and acknowledges that interested business operators are carrying out additional studies with characterized E 171. More information on EFSA’s 2018 review of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171) is available here.

Source: Bergeson & Campbell, P. C.

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4 µm is the median aerodynamic diameter of particles that fall within the respirable size range.