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Use of Titanium Dioxide in Medicinal Products: FDA and EMA Updates
The Commission Staff Working Document confirms that titanium dioxide should continue to be allowed in medicines, following the updated analysis of the European Medicines Agency of April 2024. The FDA also allows for the safe use of TiO2 as a color additive in foods.
8/6/20251 min read
The European Commission has carefully assessed the EMA’s findings in its updated analysis of April 2024 on the feasibility of replacing titanium dioxide with alternatives. The EMA’s report highlights the following issues: (i) the importance of titanium dioxide for the safety, quality and efficacy of medicinal products;
(ii) the lack of feasible alternatives at this stage; and
(iii) the risk of shortages,
which could be detrimental to patients, considering the very large number of medicinal products affected.
In view of the EMA’s findings, the Commission takes the view that the use of titanium dioxide as a colour in medicinal products, as provided for in Regulation (EU) 2022/63 amending Regulation (EC) No 1333/2008, should be maintained.
The FDA also allows for the safe use of TiO2 as a color additive in foods according to the specifications and conditions, including that the quantity of titanium does not exceed 1% by weight of the food, as stated in FDA regulations (21 CFR 73.575). In foods that contain TiO2, it will appear on the ingredients label as either “artificial color” or “colored with titanium dioxide”, though it is not required to be listed.