Titanium Dioxide (E171) - A practical example of UK divergence from EU law

United KingdomScotland

On 7 August 2022, the European Food Safety Authority (EFSA) will start to implement a ban of the food additive titanium dioxide in the EU following recent scientific developments. In contrast, the Food Standards Authority (FSA) and Food Standards Scotland (FSS), who regulate food in Great Britain, do not propose to implement a ban. Instead, they will continue to test and risk assess the substance. As Great Britain moves away from shared food regulation, this is a good example of what may become an increasingly divergent approach to risk. The divergence began to emerge prior to the UK’s withdrawal from the EU in the differing attitudes of the FSA and EFSA to the regulation of CBD based products. The difference in treatment of titanium dioxide may be explained by the FSA no longer being bound by the EU Maastricht Treaty precautionary principle and more willing to embrace an innovative approach.

Titanium dioxide (also known as TiO2 or e-number E171) is used as a colouring in a variety of food products including chewing gum, candies, pastries, cake decorations and chocolate. EFSA concluded that the substance should not be considered safe as a food additive due to uncertainties around possible inflammation and neurotoxicity. Some small test-tube research has shown that these nanoparticles are absorbed by intestinal cells and may lead to oxidative stress and cancer growth. On the basis of the new data and strengthened methods EFSA scientists could not rule out a concern for genotoxicity and consequently they could not establish a safe level for daily intake of TiO2 as a food additive.

Following the publication of Commission Regulation 2022/63, amending Annexes II and III to Regulation No 1333/2008, the import of titanium dioxide into the EU as a food additive is no longer permitted, and foods containing the substance will no longer be legally placed on the market in the EU from later this year.

The decision results in harmonisation across the region, after a ban of the additive in 2019 in France and the Netherlands Food and Consumer Product Safety Authority also delivered an opinion on possible health effects of food additive titanium dioxide. The EU ban will also be implemented in Northern Ireland due to the NI protocol. In contrast, the FSA and FSS have confirmed that after reviewing the evidence, no safety concerns have been identified, meaning that there will be no change to the regulation of titanium dioxide as an additive in the regions that they govern. Both regulators are completing risk assessments which should be ready for early 2023.

The developments highlight that the UK’s legislation is further diverging from EU laws. The UK's exit from the EU means that the FSA and FSS can take different decisions to EFSA. Another example is that there is a UK specific application process that is separate to the EU process and so any new ingredients could be authorised in one jurisdiction but not the other. In relation to this substance when used in food, the approach in Great Britain is more aligned with the USA, where titanium dioxide is generally recognised as safe (GRAS) and is permitted as an additive when used in prescribed conditions, including maximum volumes and with associated consumer communications.

For businesses operating in both jurisdictions, in GB and the EU, the fragmentation is likely to cause disruption and complications. Food business operators (FBOs) will need to ensure products sold in both the EU and UK that usually contain the E171 additive have different ingredients in each jurisdiction, or omit titanium dioxide altogether, or are reformulated to avoid falling foul of the new rules. Equally, with these restrictions come opportunities for FBOs who offer viable alternatives to titanium dioxide to demonstrate that innovative approach.