The European Commission banned titanium dioxide as a food additive

The European Commission banned titanium dioxide as a food additive by publishing Commission Regulation (EU) no. 2022/63 of 14 January 2022 that amends Annexes II and III to Regulation (EC) no. 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (E 171).

What was the timeline?

14 September 2016. EFSA published a scientific opinion on the re-evaluation of the safety of E 171 as a food additive concluding that the margins of safety calculated in the opinion would not be of concern. However, EFSA recommended additional toxicological testing and amendments to EU specifications by introducing a characterization of the particle size distribution and the percentage of particles in the nanoscale present in titanium dioxide used as a food additive, and revising the maximum limits for impurities of toxic elements.

12 July 2019. EFSA published a scientific opinion in which it stated that additional parameters related to particle size distribution have to be included in the specifications. EFSA recommended a revision of the definition of the food additive titanium dioxide taking into account the data requirements specified in 2018 Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain.

6 March 2020. The Commission requested EFSA to assess the safety of the food additive titanium dioxide.

6 May 2021. EFSA published a scientific opinion on the safety assessment of titanium dioxide as a food additive, indicating that, based on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, it concluded that titanium dioxide can no longer be considered safe when used as a food additive.

14 January 2022. In light to the conclusion of EFSA’s opinion about the safety of E 171, it is appropriate to remove the authorization to its use in foods. As EFSA did not identify an immediate health concern and in order to allow for a smooth transition, foods that contain titanium dioxide may be placed on the market until six months after that date. Those foods may then continue to be marketed until their date of minimum durability or ‘use by’ date.

What about the use of titanium dioxide in pharmaceuticals?

8 September 2021. The EU Commission asked EMA (European Medicines Agency) a scientific analysis on the technical purpose of the use of titanium dioxide (E 171) in medicinal products, the feasibility of replacement and possible timeframes for alternatives. In its conclusions, EMA indicated that titanium dioxide is mainly used in medicinal products as a color and opacifier, even if it has multiple functions.

Based on EMA scientific analysis, titanium dioxide will remain provisionally on the list of authorized additives to allow its use in medicinal products as a color. Anyway, the Commission will review the necessity to maintain titanium dioxide or delete it from the EU list of food additives for exclusive use as a color in medicinal products within three years after the date of entering into force of the Regulation no. 2022/63. This review should be based on an updated assessment by EMA to be performed before 1 April 2024.

What can we do to control the presence of titanium dioxide in your products?

Thanks to the high experience in nanotechnologies, our experts have developed a multistep multi-technique approach to detect, characterize and quantify nanomaterials in different products in order to provide:

1. Qualitative screening
2. Size distribution and morphology
3. Chemical identification
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