Titanium dioxide is safe

Titanium dioxide has been approved for use in Europe for a century, with studies repeatedly showing no harmful effects to the public or workers.

 

Titanium dioxide (TiO2) is a vital and important ingredient in hundreds of products, including paints, plastics, inks, papers, cosmetics, pharmaceuticals and food. Its varied properties mean it can be used in many ways, for example as a vibrant white colourant, to protect from UV radiation, and to reduce pollution.

It has been used safely for around 100 years in a staggering number of products. It has a history of regulatory approval, with thorough and continuous scientific assessment of its uses and production.

 

  • TiO2 is derived from one of the most abundant natural materials on earth and its chemically stable state provides a base for its use in numerous applications.

 

  • Several long-term studies on workers with regular exposure to titanium dioxide showed no harmful effects.

 

Introduction

TiO2 is one of the most versatile compounds in the world, found in an extraordinarily diverse range of products and technologies we see and use every day, including paint, plastics, cosmetics, sunscreens, food, glass, and even catalytic converters.

TiO2 has been assessed for safety by a large number of regulatory authorities and has consistently been found safe for many of its intended applications.

Over the years, however, its omnipresence has led to questioning and research to determine whether it has any impact on our health, as well as any associated side effects linked to exposure. This concern is particularly the case in relation to its use within the food and cosmetic industries.

 

Is titanium dioxide safe for consumers?

Sourced from one of the most common elements on earth, titanium dioxide (TiO2) has been confirmed by a large number of regulatory bodies to be an inert, and safe material.

Its vibrant white colour makes it an ideal substance for many of its uses. It is also safely used as a colourant, UV protectant and thickener in food and cosmetics, as there are low instances of allergy or intolerance associated with its consumption or application.

It is also approved for use in a variety of products and materials, including sunscreen, toothpaste and pharmaceuticals.

toothbrush and white toothpaste

 

Does the classification of TiO2 mean it is unsafe for consumers?

On 18 February 2020, the EU classified TiO2 in its powder form as a suspected carcinogen (category 2) by inhalation.

The classification is not based on new information about hazards or risks for humans but on decades-old rat inhalation data. There is no scientific evidence on cancer in TiO2 workers from titanium dioxide.

The EU authorities have underlined in the classification that the suspected hazard could occur if dust – like titanium dioxide powder – is inhaled in extremely high concentrations over a long period of time, causing lung impairment. TiO2 is not hazardous in the absence of the extreme inhalation conditions acknowledged in the classification. In fact, the EU authorities point out that the classification does not address or signal that humans are, or can ever be, exposed to the suspected hazardous level.

This means that the classification is of very limited relevance to consumers. In most products, including paints and plastics, TiO2 is bound into the finished product and there is almost no risk of inhaling it.

In fact, the regulatory discussions on the proposal to classify TiO2 concluded that it is unrealistic for the hazard to occur under normal and foreseeable circumstances. You can click here for more information about what the classification of titanium dioxide means.

 

Is titanium dioxide production safe?

In nature, titanium is often associated with other common elements such as iron. Two methods are used to separate these substances to form pure TiO2: a sulphate process and a chloride process.

Similar production processes are used to manufacture titanium metals for the aerospace, medical, shipbuilding, and construction industries. As with all chemical processes, they are subject to stringent environmental laws and both TiO2 methods employ and adhere to stringent health, safety, and handling standards.

The manufacture of titanium dioxide is optimised to recycle or reuse raw materials. Typically, chlorine and sulphuric acid are recycled and iron is converted into valuable co-products.

TiO2 production is regulated via EU-wide standards, including SEVESO, and leading producers in Europe also adhere to Responsible Care® principles.

Both SEVESO and Responsible Care® help ensure sustainable production and improvements to how TiO2 is manufactured. Life Cycle Assessment has been carried out to measure the environmental impact of manufacturing titanium dioxide.

Find out more about the sustainability measures.

 

Is TiO2 safe for workers?

Current evidence shows that workers at titanium dioxide manufacturing plants such as those in the EU, which follow standard occupational health and safety requirements, should not be concerned about TiO2 exposure.

In addition to national bodies, which monitor the substances being used in their respective countries, the European Union’s REACH legislation monitors the safety of all chemicals being used. This requires industries to assess any hazards and manage any potential risks related to those substances.

In its registration of TiO2 under REACH, the industry gathered and assessed available scientific data on TiO2 and determined that there was no evidence of hazard according to  REACH evaluation criteria.

TiO2 production is carefully managed by the industry. Producers take all necessary measures to comply with EU and member state laws and regulations for the safe handling of materials used in the manufacturing of TiO2.

Moreover, titanium dioxide has been commercially available for around 100 years. Over this period, extensive studies of workers in the TiO2 manufacturing industry have found no evidence of an increased risk of cancer.

Four large epidemiology studies in North America and Europe, involving more than 24,000 workers in the titanium dioxide manufacturing industry, indicated no increased risk of cancer or other adverse effects from exposure to TiO2.

glass vial

 

Is titanium dioxide safe in food?

Under EU legislation, every food additive needs to undergo a thorough safety assessment to be placed on the market and used in foods. Titanium dioxide has been listed as E171 among the approved and safe food additives for many years.

Safety of E171 has been systematically reviewed and no verifiable link has ever been proved between general intake of titanium dioxide and harm to human health. The European Food Safety Authority (EFSA) examined the safety of titanium dioxide in food four times, in 2016, 2018, May 2019 and June 2019. In all cases, the EFSA excluded health concerns for consumers linked to titanium dioxide in food.

The latest EFSA opinion on E171 published in May 2021 finds no conclusive evidence showing harmful effects from the intake of E171. Yet, the EFSA concluded that it no longer considers E171 safe as a food additive because concerns for genotoxicity could not be ruled out. The EFSA’s latest opinion is based on new assessment criteria that the TDMA believes to be inappropriate for carrying out a risk assessment of substances used as a food additive, as these criteria are not representative of realistic conditions of use.

The TDMA continues to stand behind the safety of E171 in all intended applications. The TDMA is addressing the EFSA’s opinion by updating its science programme to generate further data to confirm the safety of E171 to meet the EFSA’s new risk assessment approach for food additives. Read more about the safety of titanium dioxide in food.

Learn more about the use and safety of E171.

 

Conclusion

With a legacy of around 100 years of safe production and safe commercial use across a vast number of industries, titanium dioxide has brought major benefits to society, with no harmful effects on people or the environment.

Long-term studies have shown that the consumption, usage and production of titanium dioxide do not harm human beings and many regulatory bodies have determined it is non-toxic and non-carcinogenic to humans.

Visit What is titanium dioxide? to find more information.