The EU Court of Justice has annulled the European Commission delegated regulation of 2019, which labeled titanium dioxide (TiO2) as a carcinogenic substance by inhalation in certain powder forms. The judges found a lapse of judgment of the EU executive body decision, deeming the Commission’s ruling a “manifest error in its assessment,” as the scientific study used as a pillar to justify the ban didn’t take into account “relevant factors.”

EU political authorities imposed an EU-wide titanium dioxide ban that came into full force on August 7, forcing companies to innovate alternatives for the key whitening ingredient that has multiple food applications.

This decision from EU judges has only just happened and it is not yet clear how it impacts the EU ban. 

However, it raises questions about the European Commission’s credibility, especially as the UK, US and Canada food safety authorities all regarded TiO2 as safe for consumption earlier this year. 

“[The ruling] means that TiO2 is not classified as a hazardous substance in the EU, and the obligations related to hazardous classification will not apply in future,” a spokesperson of the Titanium Dioxide Manufacturers Association, tells FoodIngredientsFirst. 

“TDMA welcomes the outcome although recognizes that there have also been some lessons learned for the TiO2 industry about improving the scientific communication related to the safety of TiO2.”

The TDMA points out that “the ban on E171 (TiO2) in food is a separate regulation and therefore not directly related to the annulment of the classification." According to the colorant manufacturers association, the classification only relates to the inhalation route of exposure.

TiO2 is used as a colorant in the food, nutrition and cosmetic industries.Flawed scientific base?
The EU judges state that the “requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied.”

According to the court, the Committee for Risk Assessment “committed a manifest error of assessment,” specifically regarding the density of the particles. 

This opinion doesn’t come as a surprise and is not exclusive to the EU Court of Justice.  

“The 2021 opinion did not consider the different particle sizes (macro, micro or nano) of titanium dioxide and their effect on toxicity and did not include some of the most relevant safety studies. Therefore, the 2021 opinion reflects a hazard assessment of titanium dioxide nanomaterials but does not reflect human exposure to titanium dioxide and is not relevant as such to demonstrate its use as a food additive,” said the US Department of Agriculture (USDA) in March. 

The Committee for Risk Assessment’s scientific findings “were implausible,” according to the judges.

Regulation landscape
In a statement sent to FoodIngredientsFirst, the US FDA clarified that TiO2 meets all the safety parameters in the country.

The USDA also states that the food industry “has indicated to the US that there are no good alternatives to titanium dioxide that can provide similar pigment/opacity properties.”

According to some sections of the US F&B industry, replacements require studies and regulatory filings, which would take significant time, up to ten years or more, and reformulation cost estimates range from US$600,000 to US$1.8 million per product, depending on the complexity. 

The health authorities of Canada explained that many studies have raised concerns about the safety of TiO2 use. Some forms of the substance have different properties than food-grade TiO2. Revealing adverse effects were found in a few non-dietary studies, with the same results not being found in food-grade TiO2. 

“The methods and test materials relied on in the 2021 opinion do not reflect realistic human exposure to food containing E171, nor are they representative of E171 properties. The 2021 EFSA opinion was also the result of an unusual and inconsistent application of new nanoparticles guidance,” David Lockley, chair of TDMA’s scientific task force, told FoodIngredientsFirst after Canada deemed TiO2 as safe to use this June.EU political authorities imposed an EU-wide titanium dioxide ban that came into full force on August 7.

In March, the UK’s Food Standards Agency dismissed the EU research findings, declining to ban the artificial additive.

EU companies had to keep moving
With the ban in full force in the EU, food manufacturers had to innovate alternatives promptly.

CAPOL developed a natural whitening agent for the hard sugar panning process that provides excellent opacity using the company’s rice encapsulation technology. 

Earlier this year, ADM launched its new line of PearlEdge, alternative white color solutions derived from natural sources. Ingredient producer Blue California also unveiled clean-label whitening agents as an alternative to the colorant.

Some in the industry have further found impetus in the ban to increase their clean-label claim abilities across multiple products. Anil Andrade, VP of sales and business development at ACG’s capsule division, told NutritionInsight that the ban inspired developments in the nutraceutical space.