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EFSA Finds Titanium Dioxide is Not Safe for Food

  • On May 6, 2021, the European Food Safety Authority (EFSA) updated its 2016 safety assessment of the food additive titanium dioxide (TiO2, E 171) and concluded that it can no longer be considered safe as a food additive despite EFSA’s findings in 2016 that E 171 did not raise a genotoxic concern.  Currently, TiOis authorized as a food additive in the European Union according to Annex II of Regulation (EC) No 1333/2008.

  • EFSA’s expert panel on Food Additives and Flavourings (Panel) stated that it reached this conclusion because of the food additive’s genotoxicity concerns when it is absorbed by the body.  The Panel concluded that, although the absorption of TiO2 particles is low, it has the potential to accumulate in the body, as the food additive contains at most 50% of particles in the nano range (i.e., less than 100 nanometers) to which consumers may be exposed.  EFSA noted that although the evidence for general toxic effects was not conclusive, the new data and strengthened methods did not allow the Agency to rule out a concern for genotoxicity.  By way of background, French authorities suspended the marketing of foods containing TiOin 2019, as there were gaps and uncertainties in the food additive’s safety data.

  • Based on EFSA’s opinion, the European Commission and the EU member states will meet to consider phasing out TiO2 from the EU legislation on food.  This action will likely prohibit the use of TiO2 in applications such as medicines, toothpaste, food contact materials, pet foods, and other consumer goods.  This potential EU decision will be notified to the World Trade Organization, which will then be considered by the Codex Alimentarius Commission.  It remains to be seen whether there will be ripple effects in other countries.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 126
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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