As of 7 February 2022, pursuant to Commission Regulation (EU) 2022/63 (the “Titanium Dioxide Regulation”)[1], titanium dioxide (E171) has been removed from Annexes II and III of Regulation (EC) No 1333/2008 (the “Additives Regulation”), which sets out the regulatory framework for the use of additives in foods in the European Union.

Accordingly, since 7 February 2022, the use of titanium dioxide (E171) as a food additive in the European Union is prohibited. However, food operators will note that the Titanium Dioxide Regulation provides for a 6 month transition period, where foods produced in accordance with the rules applicable before 7 February 2022 may continue to be placed on the market until 7 August 2022. After that date, food products may remain on the market until their date of minimum durability or ‘use by’ date.[2]

The Titanium Dioxide Regulation has been introduced following a series of  European Food Safety Authority (“EFSA”) safety assessments of the use of titanium dioxide (E171) as a food additive, including the most recent food safety assessment issued on 6 May 2021 (the “EFSA Opinion”), pursuant to which EFSA indicated that, based on is assessment of all the available evidence, a concern for genotoxicity could not be ruled out, and therefore concluded that titanium dioxide (E 171) can no longer be considered safe when used as a food additive.[3]

The EU ban on the use of titanium dioxide (E171) as an additive is likely to have great impact on food operators, particularly given how common its use has been in the food industry – it has been used for many years as a food colouring, to bring visual appeal and colour to foods, or to restore the appearance of food in a wide range of foods ranging from bakery products, soups, sauces to sandwich spreads[4]. It is also extensively used in among others, medicines and cosmetic products, including sunscreens and pressed powders.

Operators should note the deadlines for placing on the market of food products containing titanium dioxide (E171) as an additive, and will likely be giving thought to reformulation of ingredients of food products to replace titanium dioxide with a suitable authorised alternative.

Given the prevalence of use titanium dioxide (E171) in other non-food products, particularly medicinal and cosmetics products, the current ban on use in food products may influence its regulation of use in these industries.

The Titanium Dioxide Regulation already sets the scene for potential changes in the medicinal products sphere. The European Commission has decided to continue to provisionally allow its use in medicinal products as a colour to avoid shortages of medicines, which has been highlighted as a potential effect of an immediate ban by the European Medicines Authority. However, the Titanium Dioxide Regulation emphasises that development of adequate alternatives for its replacement should continue, and that the European Commission will review the necessity to maintain titanium dioxide (E 171) or otherwise  prohibit its use as a colour in medicinal products within three years after the date of entering into force of the Titanium Dioxide Regulation.

The Titanium Dioxide Regulation and the ban on use of titanium dioxide (E171) is effective in each European Union Member State.

No similar ban for the use of titanium dioxide (E171) as a food additive has been implemented in the UK.

However, the use of titanium dioxide (E171) is no longer permitted in Northern Ireland as a result of the application of the Northern Ireland Protocol.

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[1] COMMISSION REGULATION (EU) 2022/63 of 14 January 2022 amending 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); https://eur-lex.europa.eu/eli/reg/2022/63/oj

[2] Article 2, ibid.

[3] European Food Safety Authority, 6 May 2021, Titanium dioxide: E171 no longer considered safe when used as a food additive; https://www.efsa.europa.eu/en/news/titanium-dioxide-e171-no-longer-considered-safe-when-used-food-additive 

[4] European Food Information Council; https://www.eufic.org/en/whats-in-food/article/foodadditives#:~:text=The%20European%20Commission%20and%20EU%20Members%20states%20were%20informed%20of,into%20force%20in%20early%202022