The European Food Safety Agency (EFSA) has deemed titanium dioxide, a widely used food additive, to be unsafe in its latest study, contradicting an earlier conclusion and paving the way for an EU-wide ban after a decade of debate.
In a new opinion, published on Thursday (6 May), EFSA found that concern for genotoxicity “could not be ruled out” and, consequently, a “safe level for daily intake of the food additive could not be established”.
Genotoxicity refers to the ability of a chemical substance to damage DNA, the genetic material of cells, which may then lead to carcinogenic effects.
After evaluating new evidence, EFSA’s experts therefore no longer consider titanium dioxide safe when used as a food additive.
Titanium dioxide (known as E171) is a common food additive which is used as a white food colourant. It has no nutritional or functional benefits in food.
E171 is composed of a mix of titanium dioxide particles which, due to their extremely small size, are classified as nanoparticles. The concern is that these nanoparticles may be able to infiltrate the natural protective barriers of the human body and pass into the body.
The main food categories where E171 can be found include baked goods, soups, broths and sauces, although its use is also widespread in hundreds of everyday products such as toothpaste, cosmetics and sunscreen.
Titanium dioxide is also widely used in the pharmaceutical sector, including packaging, coatings of pills, formulations and pigments.
Questions over the safety of the substance have been circulating for several years.
The International Agency for Research on Cancer (IARC) has previously classified titanium dioxide as “possibly carcinogenic to humans”.
Meanwhile, the French Health Security Agency (ANSES, previously AFSSA) has urged caution on the use of E171 for more than a decade, after flagging concerns over the use of nanoparticles in human food. This eventually resulted in a ban on E171 that entered into force on the French market in January 2020.
However, its authorisation in the EU was maintained after EFSA published a scientific opinion in September 2016, in which it concluded that evidence available at that time did not point to health problems for consumers.
The study did, however, highlight some uncertainties, underlining the need for further studies to fill data gaps, which this latest study set out to remedy.
However, EU stakeholders have continued to ring alarm bells over the use of the additive.
Maged Younes, chair of EFSA’s expert panel on food additives and flavourings (FAF), said that a critical element in reaching this conclusion is that “we could not exclude genotoxicity concerns after consumption of titanium dioxide particles”.
“After oral ingestion, the absorption of titanium dioxide particles is low, however, they can accumulate in the body,” he added.
Matthew Wright, both a member of the FAF Panel and chair of EFSA’s working group on E171, concurred, stressing that this meant it was not possible to establish a safe level for daily intake of the food additive.
In light of the conclusions of the study, the European Commission will now be expected to propose that this additive should be removed from the EU list of authorised food additives.
This would then require a vote in the EU’s standing committee on plants, animals, food and feed (ScoPAFF).
EURACTIV reached out to the Commission for a comment but did not receive a response by the time of publication.
While EFSA’s opinion involves only foodstuffs, the decision may raise questions for the use of titanium dioxide elsewhere.
Besides being used as a white colourant, titanium dioxide is also used as an ‘opacifying agent’. This helps avoid degradation of medicine components induced by radiation or heat, and is therefore important for a robust dosage form, protecting active ingredients, ensuring shelf-life stability and, thus, securing the efficacy of pharmaceuticals for longer periods.
Although the study acknowledged that titanium dioxide is widely used in medicinal products, it highlighted that “no information on the extent and level of use of E171 in medicinal products was made available to EFSA” and, therefore, its exposure from this use could not be considered.
Likewise, exposure to titanium dioxide via cosmetics (e.g. toothpaste) was not considered in this opinion.
One EU source told EURACTIV that if EFSA did decide to move against titanium dioxide for other uses, the complex regulatory requirements in the pharmaceutical sector would make it “very difficult” to change products without disruption.
“It will be slow and expensive to achieve for all parties involved, to the detriment of patients,” the source warned.
[Edited by Zoran Radosavljevic]