EU court annuls titanium dioxide regulation over lack of relevant and reliable factors to support studies

EUROPE – The EU Court of Justice has overturned the European Commission delegated regulation of 2019, which classified certain forms of titanium dioxide (TiO2) as a suspected carcinogen (category 2) by inhalation.

Only TiO2 in powder form, containing greater than or equal to 1% of particles with an aerodynamic diameter less than or equal to 10 µm, was classified.

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.”

Titanium dioxide is an odorless powder that enhances the white color or opacity of foods and over-the-counter products, including coffee creamers, candies, sunscreen, and toothpaste.

Titanium dioxide is also added to some food packaging to preserve the shelf life of a product. Packaging containing this additive has been shown to decrease ethylene production in fruit, thus delaying the ripening process and prolonging shelf life.

Furthermore, this packaging has been shown to have both antibacterial and photocatalytic activity, the latter of which reduces ultraviolet (UV) exposure.

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.

The Commission acted to ban TiO2 in food following the publication of a scientific opinion by the European Food Safety Authority (EFSA). EFSA reported uncertainties concerning the safety of TiO2 nanoparticles, which meant it could no longer be considered safe.

The scientific opinion also highlighted the potential of TiO2 to directly damage DNA and genetic material inside cells, known as genotoxic effects.

The EU judgment 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, and the scientific findings “were implausible.”

“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.

In response, the Titanium Dioxide Manufacturers Association (TDMA), the voice of the titanium dioxide industry, issued a statement saying: “This 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.”

With the ban in full force in the EU, food manufacturers had to innovate alternatives promptly, regardless of whether other food safety authorities – such as Health Canada and the UK’s Food Standards Agency – have reported that titanium dioxide is safe to consume.

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.

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