Cancellation of the Titanium Dioxide’s CMR classification (CLP regulation)

Titanium Dioxide (TiO2) in the form of some powders is no longer considered as a carcinogenic compound via inhalation in the European Union

The Court of Justice of the European Union (CJEU) has recently announced the cancellation of the CLP regulation (2020/217 regulation) known as ATP14, with regard to the harmonised classification and labelling of titanium dioxide as a carcinogenic substance via inhalation in the form of some powders.

What is the context and how should the industry react?

As a reminder, the CLP regulation ruling over Classification, Labelling and Packaging of substances and mixtures applies to general products or detergents for instance.

1) Titanium Dioxide in cosmetics, general products and detergents

Also called TiO2, titanium dioxide is a naturally occurring mineral compound which can also be manufactured. It is used in paints, as a white pigment and opacifying agent. Its cosmetic European INCI name is titanium dioxide or CI77891. The white power extracted from this material is widespread in cosmetics formulations mainly as solar protection, in make-up or white products because of its deep whiteness, very useful as a pigment, opacifier and mineral UV filter thanks to its UVB reflexion properties (UVA to a lesser degree).

Using Titanium dioxide in the cosmetics industry is allowed and common in natural and organic products. The nano shape of titanium dioxide’s particles has been listed in the annexe VI of the Cosmetics European regulation since 2016 while its micrometric and nanometric form are authorised if authorised limits are respected.

One exception remains: the use of TiO2 In the form of sprays or other shapes potentially leading to lungs exposure via inhalation.

2) Titanium Dioxide under the radar of the European Union

Indeed, even if this compound displays great advantages, it is still a hot topic especially when it comes to nanoparticles (useful as UV filters for instance). As such, the International Agency for Research on Cancer (IARC) started to consider it as carcinogenic via inhalation for Humans in 2006, and the use of its nanoparticles in aerosols and products presenting a risk of inhalation were forbidden.

Later, in 2020, it was officially listed as a type 2 carcinogenic product through inhalation according to the quantity of inhalable particles. You can find this decision on the update of the CLP regulation.

Despite these strong measures, no scientific consensus has emerged from the various studies.

3) Titanium Dioxide in the form of some powders is no longer considered as a carcinogenic substance via inhalation in the European Union

The previous decision which categorised the inhalable form of TiO2 as CMR is now cancelled on the basis of two main elements:
–        The main studies were found unreliable as experts were disagreeing on the particles’ density evaluation, supposed to determine the lung overload.  
–        The classification was relying on the titanium dioxide’s shape and size only while these parameters are not inherent properties of the TiO2.
On this basis, the Court of Justice of the European Union cancelled the harmonised classification of the TiO2. This decision has an immediate implementation
.

Beyond the case of titanium dioxide, the CJEU is now rejecting the assumption that Poorly Soluble Particles or PSP are carcinogenic, as part of a global scope. Of course, chronic exposure to this type of particles is known to lead to higher risks of carcinogenicity. However, one of the key elements to toxicity is the amount of inhaled particles, which should be high enough to weaken the particles’ elimination mechanism. This induced lung damage is creating chronic inflammation, leading to carcinogenic consequences.

Until this year, authorities were considering this mechanism as sufficient to consider TiO2 and all PSP by extension as carcinogenic. On the opposite, the CJEU is now stating that this mechanism is not an “inherent” toxicity imputable to titanium dioxide and that as such, cannot justify a carcinogenic classification.

This decision is extremely important in terms of jurisprudence because this reasoning can be applied to countless other substances of the same type, like carbon black or most of the pigments of mineral origin. It is now clarified that PSP cannot be classified as carcinogenic on the sole base of their physicochemical properties. As a result, one should prove an inherent carcinogenicity instead of a secondary carcinogenicity linked to lung overload.

Protection measures targeting populations, especially overexposed workers, should still be put in place. EU authorities’ strategy is expected, and it could come out as a harmonised classification on toxicity by repeated exposition or as a European exposition limit (which the initial strategy proposed by the industry). Choosing this option would prevent chronic inflammation, potentially leading to carcinogenicity.

Long term consequences of this decision are still uncertain and additional details must be brought on the table. To keep you updated of the last development and clarifications, do not hesitate to contact BIORIUS if you want to receive our regulatory expertise on the latest changes in the EU and worldwide.

Emma Varnier

Business Development Representative

emma.varnier@biorius.com

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