EU and Northern Ireland – Food Supplements

• From 7 August 2022, food supplement products containing titanium dioxide cannot be placed on the EU/NI.
• Food supplement products containing titanium dioxide can remain on the EU/NI market until the end of their shelf-life if produced before 7 August 2022.
• From 1 October 2023, food supplement products containing titanium dioxide sent from GB to NI via Northern Ireland Retail Movement Scheme (NIRMS) can be marketed into NI.

EU and Northern Ireland – Medicines

• Companies can continue to place medicines containing titanium dioxide on the EU and NI markets.
• The pharmaceutical industry must make any possible effort to find suitable alternatives to replace titanium dioxide in medicinal products in these markets.
• The pharmaceutical industry should be aware that the decision to allow exclusive use of titanium dioxide in medicinal products will be up for review by February 2025. It is not certain whether the European Commission will continue to allow the use of titanium dioxide in medicinal products after this date.

GB – Food Supplements Medicines

• In GB, there are currently not restrictions on the use of titanium dioxide in food supplements or medicinal products.
• Companies currently using titanium dioxide within food supplements formulations should consider that a maximum permitted level of 1,000 mg/kg bw/day of titanium dioxide may be established, therefore, reformulation may be required.
• There are no timelines established for when the FSA could publish a final statement on the safety of titanium dioxide as a food additive.

Implications for Customers

The use of Titanium dioxide in medicines is common, and its potential ban in the EU/EEA could lead to significant challenges for the pharmaceutical industry, including medicine shortages, discontinuations, and safety risks for patients. Reformulating products to exclude titanium dioxide could take years, and the necessary regulatory processes would further extend the transition period.

The impact on the UK industry would be compounded if the EU were the only region to ban titanium dioxide in medicines, requiring UK companies to reformulate many oral solid-dosage forms.

As the UK follows EU regulations for medicines, a ban in the EU could also necessitate a similar ban in the UK, even if titanium dioxide remains allowed in food supplements.

The PAGB is currently working with the MHRA, DHSC, FSA, and other trade associations to assess the impact of these potential changes on medicines in both Great Britain and Northern Ireland.