RIVM on Advanced Materials, March 2024

Two years ago, the EU European Union (European Union) banned the use of the white food colourant titanium dioxide (E 171), because of concerns regarding genotoxicity. Yet, products with this food additive may still be found on the European market. Several institutes outside the EU do not share EU concerns. Therefore, titanium dioxide remains being used in food products outside the EU. As a result, imported products are a potential source of illegal presence of titanium dioxide in food on the EU market.

Decrease in products containing E 171 on the EU market

On January 14, 2022, the European Commission banned the use of titanium dioxide (E 171) as a white food colourant. Consequently, foods containing E 171 can no longer be put on the European market since August 7, 2022, unless their shelf life has not yet been expired. In France, E 171 was already banned in 2018. A study conducted by a French control laboratory showed a steady decrease in products containing E 171 on the French market between 2018 and 2021. However, some products still contained E 171 without listing it on the label. In 2022, the same laboratory found that products from outside the EU were more likely to contain E 171. 

Different views on the safety of E 171 outside the EU

The ban on E 171 is based on the EFSA opinion that it is not certain whether its use in food is safe. The main reason for this conclusion is that EFSA cannot rule out that E 171 can cause DNA damage in cells. 

In response to the opinion by EFSA, several other institutes have meanwhile published their own opinions on titanium dioxide as a food additive: Health Canada (June 2022), Food Standards Australia New Zealand (FSANZ) (September 2022), and recently also the Joint FAO/WHO Expert Committee on Food Additives (JECFA) discussed the topic. They have concluded that there is no solid evidence that E 171 poses a health risk. While they acknowledge uncertainties about its genotoxicity, they find insufficient evidence that it leads to changes in DNA or causes cancer. They also do not see enough evidence for other negative health effects. 

EFSA’s opinion also differs from that of the British food standard organization FSA (Food and Safety Authority) and the United States’ FDA. FSA sees no reason to ban the additive from the market, and the FDA sees no concern regarding its use as colour additive in food. However, the FDA is currently reassessing the food additive due to petitions by different parties questioning its safety. Also in the UK discussions remain ongoing

Reflections by RIVM

The interpretation and importance given to studies on the possible negative health effects of E 171 differs from one institute to another. There are several reasons for this. 

Different approach to studies on other titanium dioxide than E 171 

The white food colouring by E 171 is provided by titanium dioxide particles between 200 and 300 nanometres in size. However, when producing E 171 also nanoparticles smaller than 100 nm are formed, making up to 50% of the total number of particles in E 171. For this reason, EFSA also looked at studies examining titanium dioxide with relatively more nanoparticles than E 171. These studies often have a more exploratory design than the usual studies into the possible negative health effects of substances. In its Opinion, EFSA gave more importance to studies with the food additive itself than to studies with titanium dioxide nanoparticles. However, the other institutes left these studies with smaller sized titanium dioxide out of their review entirely. They considered these studies irrelevant because they did not use the food additive. According to RIVM such studies should not be ignored. 

Different approach to non-dietary studies 

Health Canada, FSANZ and JECFA agree that some animal studies indicate negative health effects of titanium dioxide. However, such effects do not occur in studies in which titanium dioxide is mixed into the animals' feed. The negative effects only seem to occur if titanium dioxide is administered to the animals in a different way, such as in water. A possible explanation may lie in what happens when titanium dioxide is mixed with food. It could then form larger particles which cannot be absorbed as easily by the animals’ intestines. Compared to EFSA, the other institutes consider studies where titanium dioxide is mixed with food to be more relevant than those where it is given to animals in water. 

According to EFSA it is not clear whether animal studies that use food containing E 171 are comparable to humans eating foodstuffs containing E 171 such as chewing gum, sweets or bakery products. Making sure E 171 is precisely distributed in food to achieve the desired colour or shine requires a lot of effort. Such effort is not done when the substance is just mixed into animal feed. This difference could affect the outcome of studies. RIVM is of the opinion that more research is needed to understand the relationship between different ways of giving titanium dioxide to animals. This includes understanding how well titanium dioxide is distributed in food, together with its uptake and potential health outcomes. 

Uncertainties inherent to risk assessment

Apart from the different assumptions mentioned above, general uncertainties in risk assessment may play a role in the different conclusions from EFSA and the other institutes. Regarding E 171, EFSA concludes that it is 'uncertain whether the use is safe'. In contrast, other parties conclude that there is 'insufficient evidence of concern'. 

E 171 not always on the food label

In many non-EU countries, the use of E 171 as a food additive is still permitted. As a result, food items imported from such countries may potentially contain this banned additive. The French laboratory study has confirmed this suspicion. This practice can be easily missed by customs checking goods at the border, as E 171 is not always declared on the label. This lack of declaration may be due to ignorance on the part of small-scale importers and exporters who are not aware of the current status of E 171 as a food additive on the EU market.

RIVM on Advanced Materials, March 2024