Positions/Statements/Q&A

The impact of Titanium Dioxide products on health and environment has been frequently discussed in medias and scientific community.

 

The members of TDMA wish to contribute with their opinions to these discussions.

 

For TDMA positions/statements on the dossier from the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) proposing a harmonised classification (CLH) for Titanium Dioxide as a carcinogen 1B by inhalation, (H350i), please see the dedicated section 'CLH Dossier' accessible from the main menu above. 

 

 

What is Titanium Dioxide?

Titanium is the 9th most abundant element in the world and TiO2 is the oxide of the metal, which occurs naturally in several kinds of rock and mineral sands. Pure TiO2 is a fine, white powder and is the brightest, whitest pigment available. Highly refractive, ultraviolet absorbing, non-toxic and inert, TiO2 has been used for many years (over 90) in a vast range of industrial applications and consumer goods to impart whiteness and opacity to paints, printing inks, plastics, textiles, ceramics, construction materials, cosmetics, food, pharmaceuticals, etc.

 

Are there different types of TiO2?

TiO2 is produced primarily in the pigmentary form (over 98% of total production) making use of its excellent light-scattering properties in the wide range of applications that require white opacity and brightness.TiO2 is also produced as an ultrafine (nanomaterial) product when different properties such as transparency and maximum UV light absorption are required, such as in cosmetic sunscreens. Ultrafine TiO2 products are also used in a range of environmental applications such as catalysts supports in the automotive industry to remove harmful exhaust gas emissions, and in power stations to remove nitrous oxides (NOx). Approximately 1-2% of the total production of TiO2 is in this ultrafine form.

 

Where is TiO2 produced in Europe?

Titanium dioxide is produced in facilities around Europe, including Belgium, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Slovenia, Spain and the UK.

 

In which kinds of products do you find TiO2?

TiO2 has been used for over 90 years in a vast range of industrial applications and consumer goods such as paints, printing inks, plastics, paper and board, textiles, ceramics, construction materials, cosmetics, food, and pharmaceuticals. The www.brilliantwhite.life website shows many examples of the uses of TiO2.

 

Why is TiO2 used in these products?

As a pigment, TiO2 has excellent light-scattering properties and is used in a variety of applications that require white opacity and brightness. In its ultrafine form, TiO2 absorbs UV light, and is used for example in sunscreens to protect your skin from the sun.  In exterior applications the coolness conferred by TiO2 coloured surfaces leads to considerable energy savings in warm and tropical area by light reflectance thus reducing the need for air-conditioning. TiO2 as a nanomaterial (ultrafine) appears transparent whilst still providing UV light absorption.

 

Is TiO2 safe?

Titanium dioxide is safe in all of the applications in which it is used. Since the introduction of TiO2 as a commercial product in 1923, there have been no identified health concerns associated with its exposure among workers, consumers or the general population.

 

Does TiO2 cause cancer?

Titanium dioxide has been commercially available for nearly 100 years, and during this time period there has been no evidence of it causing cancer in humans. Extensive studies of workers in the TiO2 manufacturing industry, and therefore those most likely to be exposed to the substance, have found no evidence of an increased risk of lung problems. The International Agency for Research on Cancer (IARC) in 2006 suggested titanium dioxide is “possibly carcinogenic to humans” (Group 2B) on the basis of a small amount of research on rats. However, it is generally recognised that this is due to rats suffering from something called “lung overload” which is not observed in other species such as hamsters, mice or indeed humans.

 

How is TiO2 regulated in Europe?

In Europe a number of bodies ensure that the substances available to the public are safe in the applications in which they are used. Aside from national bodies, the European Union’s REACH legislation is a framework to monitor the chemicals we use to ensure their safety. Industry is obliged to register substances under REACH and have a duty to ensure any potential risks from substances are managed. Similarly, the European Food Safety Authority (EFSA) examines the substances in our foods, including titanium dioxide, and gives each additive an ‘E-number’. For TiO2 that number is E171. It also sets the amount we can safely consume every day through food.

 

 Should workers be worried about their exposure to TiO?

The current evidence suggests workers should not be concerned. Four large epidemiology studies in North America and Europe, involving more than 20,000 workers in the titanium dioxide manufacturing industry, indicated no association with increased risk of cancer or with any other adverse effects from exposure to TiO2.

 

Why is TiO2 used in food?

Titanium dioxide has been safely used in food for decades to brighten colour and enhance texture and shine. TiO2 is used as a colourant to food to make it look more appealing with examples being confectionary, bakery or sauces as well as non-food products such as toothpaste and pharmaceutical products.

 

Should people be worried about TiO2 in food?

There is no proven link between titanium dioxide in food and adverse health effects in humans. In September 2016, the European Food Safety Authority’s (EFSA) Scientific Panel on Food Additives and Nutrient Sources published an Opinion confirming TiO2 is considered safe. For further information see the industry response to the Agency’s Opinion.

 

Are there alternatives to TiO2?

Titanium dioxide has a unique way of interacting with light that no other substances have. While some particles may have white pigment–like properties, no commercially available substances can absorb UV light and scatter visual light to add opacity as well as titanium dioxide.

 

What is the EU’s harmonised classification and labelling (CLH) process?

The EU CLH process is a regulatory regime that seeks to harmonise the classification of substances on the basis of their hazard properties and provide labels that allow the safe handling and use of the substances by workers. Over 200 substances have already undergone this process.

 

Who is seeking to classify TiO2 as cancer causing?

The French competent authorities (ANSES) have suggested the classification of TiO2 as potentially carcinogenic via inhalation to humans based on animal data from studies carried out over 20 years ago under conditions which are not acceptable according to the EU’s current testing guidelines.

 

What effect would a classification have on the use of TiO2?

A classification of TiO2 would result in exposure controls including stringent workplace exposure limits and control measures for workers. Signage and notifications such as increased hazard labelling requirements including a warning pictogram would be required. Likewise, products considered Category 1B carcinogen are restricted to professional use with the potential that for example, do-it-yourself stores would not be able to sell paint to general consumers.

 

Classification could lead to further assessment processes under REACH such as restrictions and authorisation requirements over the long term. Finally, it would potentially lead to safety assessments of the substance in a range of applications such as cosmetics, pharmaceuticals and food and in some cases may lead to an eventual ban in these applications.

 

When will a decision be taken on the classification of TiO2?

The EU classification and labelling process is by its nature a long one with both a scientific and a regulatory phase. European safety authorities (the European Chemicals Agency’s Risk Assessment Committee) will give an opinion on the proposal to classify TiO2 in late 2017. Any eventual decision to classify by the European Commission is unlikely to be taken before 2019.

 

What is the industry’s position on the potential classification of TiO2?

The industry believes that TiO2 should not be classified as potentially carcinogenic to humans. The data on which the French proposal relies shows effects in rats, which are not reproducible in other species such as mice or hamsters. Most importantly, there is no evidence of effects in humans – where the industry has large amounts of data. We believe that the effect that is seen in this small number of studies referred to in the ANSES proposal is due to the biology of the rat, which is different from other species, including humans. In essence the rat cannot physically absorb the amount of the substance it is exposed to and this causes the effect. This reaction is not unique to TiO2 but common to many other substances that are also poorly soluble. The amount of TiO2 that the rats were exposed to in the studies referred in the proposal is far in excess of that to which human workers would ever be exposed. Moreover, the exposure conditions in the rat study used to support the proposal would invalidate the results as compared to current EU testing guidelines for an acceptable study. Learn more on the opinion of industry.

 

What are nanomaterials?

According to the European Commission, nanomaterials are usually considered to be materials with at least one external dimension that measures 100 nanometres (nm) or less or with internal structures measuring 100 nm or less. They may be in the form of particles, tubes, rods or fibres. Click here for more information on ultrafine TiO2.

 

How are nanomaterials regulated?

Nanomaterials are regulated at the European level as with all forms of chemicals, under the REACH Regulation and the CLH, which sets up a framework to ensure the safe management of chemicals placed on the European market. This includes the submission of safety data by industry and where necessary regulatory measures to reduce any risks arising from the production and use of substances.

 

Which applications of TiO2 contain nanomaterials?

The most commonly used form of TiO2 is pigmentary, which used in the vast majority of consumer applications and is not a nanomaterial. Due to its enhanced transparency and UV absorbing properties, nano-scale TiO2 is used for certain applications such as sunscreens where it provides additional protection against the sun’s rays. It is also used in certain combustion processes (boilers, power plants and diesel engine) as a catalyst, where it helps convert harmful emissions of nitrogen oxide into harmless water and nitrogen. 

 

How does the industry ensure the safety of nano-scale TiO2?

Industry is committed to managing any risks from its products as part of its commitment to product stewardship and in compliance with regulatory processes such as REACH, the European chemicals legislation. In addition, it has initiated and sponsored research into the safety of nanomaterials and nano-enabled products. Significant progress has been made in test methods, data collection and assessments to evaluate any potential risks of nanomaterials in common applications.

 

What is the industry’s position on the regulation of nano-scale TiO2?

We believe that nanomaterials are similar to other chemicals/substances in that each substance should be assessed on its own merits. Evaluation should be on a case-by-case basis using existing regulation, such as REACH and the Classification and Labelling Regulation, and is sufficient to ensure the safety of workers, consumers and the environment.