EUROPE – The European Commission’s delegated regulation from 2019 that classified titanium dioxide (TiO2) as a chemical that causes cancer when inhaled in specific powder forms has been overturned by the EU Court of Justice.

The Commission’s decision was deemed to have a “manifest error in its assessment,” by the judges since the scientific study that served as the foundation for the ban did not take into account “relevant factors.”

An EU-wide ban on titanium dioxide, a fundamental whitening ingredient with numerous food applications, was imposed by political authorities in the EU and went into effect on August 7.

This forced businesses to develop substitutes for the important whitening ingredient, which has numerous food applications.

It is not yet apparent how the ruling by EU judges will affect the EU ban because it just occurred.

However, it casts doubt on the integrity of the European Commission, particularly in light of the fact that earlier this year, food safety regulators in the UK, US, and Canada unanimously declared TiO2 to be safe for ingestion.

“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.

“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,” a spokesperson of the Titanium Dioxide Manufacturers Association, tells FoodIngredientsFirst.

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.

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 is not exclusive to the EU Court of Justice as the U.S Department of Agriculture (USDA) in March opined that 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. 

The Commission’s decision was deemed to have a “manifest error in its assessment,” by the judges since the scientific study that served as the foundation for the ban did not take into account “relevant factors.”

“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 Department. 

The judges concluded that the scientific findings of the Committee for Risk Assessment “were implausible.”

The U.S. FDA made it clear in a statement given to FoodIngredientsFirst that TiO2 complies with all national safety standards.

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

According to some sectors of the U.S food and beverage (F&B) industry, reformulation costs are estimated to vary from U.S$600,000 to U.S$1.8 million per product, depending on complexity, and require research and regulatory filings, which could take a long time, up to 10 years or more.

The Canadian health officials explained that numerous studies have raised concerns regarding the safety of using TiO2.

Some forms of the substance have different properties than food-grade TiO2

Several non-dietary investigations revealed harmful consequences, however, food-grade TiO2 did not provide the same outcomes.

The UK’s Food Standards Agency (FSA) declined to outlaw the synthetic ingredient in March, dismissing the results of EU research.

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