Strong evidence suggests that titanium dioxide is a carcinogen, but industry manufacturers are moving to block the implementation of European legislation to label the dangerous chemical in their products. If it’s successful, this lobbying effort could put at risk one of the strongest science-based regulations to protect public health from harmful substances.
Titanium dioxide can be found in a variety of products we use every day — from toothpaste, to sunscreen, to food. Many of these products contain the nano form of titanium dioxide — particles tens of thousands of times smaller than a human hair, with unknown health effects. In the nano form, titanium dioxide, or TiO2, may invade vital organs like the lungs and liver, accumulating in your body and becoming toxic.
That’s why the European Commission is considering classifying TiO2 as a suspected carcinogen under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the overarching European Union law that regulates chemical substances.
Though the connection between TiO2 and cancer has been shown by numerous studies, producers of the chemical have pushed back against the label in the largest and most coordinated lobbying effort REACH has ever seen (and it has seen a lot!)
Yet, ironically, the recommendation to label all forms of TiO2 as carcinogens stems directly from industry bullishness.
In order to comply with REACH, companies must register all substances they manufacture, providing information on potential hazards and how they will be managed. Back in 2010, industry registered TiO2 as a single substance. In other words, they didn’t distinguish between the different forms of the substance, like the powder or liquid forms, various shapes and sizes (including nano), and so on. The European Chemicals Agency (ECHA) requested more information on how the properties and hazards differed from one form of the chemical to another, but industry refused to clarify or provide more data.
If an EU state is concerned about the potential risks of a substance, they can further assess that substance’s toxicity and suggest that the substance be classified and/or restricted under REACH. So France evaluated TiO2 and found that it was a likely carcinogen. Because TiO2 was registered as a single substance under REACH, France recommended that all TiO2 be labeled as a carcinogen Category 1b, which indicates that the substance has a cancer risk for humans.
Then, the French evaluation was passed on to the Risk Assessment Committee (RAC) of ECHA. The RAC is an expert body that evaluates the scientific data on a substance and makes a recommendation to the European Commission on how to classify it under REACH. Based on their scientific evaluation, the RAC’s opinion was that all forms of TiO2 should be labeled as suspected carcinogens via inhalation — Carcinogen Category 2, a step less restrictive than 1b. This means the substance is suspected, but not confirmed, to be a carcinogen. Whether this classification is adopted is now up to the European Member States, who will decide on a formal proposal by the European Commission. Thus far, the European Commission and Member States have never derogated from RAC’s opinion, as their recommendations are based on strong scientific evidence.
Under REACH, companies can choose to give a broad definition of the substance they intend to register, but if they do so, possible hazards from all forms must be addressed in the same registration dossier and specifically identified. The consideration of all forms of TiO2 for classification is therefore the result of a deliberate strategy by industry to refuse to differentiate between the various forms of the substance.
At this point, it is important to understand some of the provisions that underpin the implementation of REACH. Under this comprehensive legal framework, substances can be classified, restricted, and/or banned. Classification decisions are supposed to be based on the intrinsic hazards of the substance. It requires producers to label all consumer products including that substance, but does not restrict its use. Conversely, restrictions or bans are based on an assessment of risks (both the intrinsic hazards of the substance and the exposure level), as well as socio-economic arguments.
The RAC’s opinion is science-based and relies on well-supported evidence regarding the intrinsic hazards of TiO2. The arguments against the RAC opinion are almost exclusively socio-economics (Consumers will stop buying paint or candies), suspect at best (Tests on rats are inadequate to assess the hazards of TiO2 to humans), or entirely flawed (All paints will have to be treated as hazardous waste if TiO2 is classified). But decisions on how to classify potentially dangerous chemicals must — legally — be based on a scientific assessment of the dangers. The careful balance of the current framework guarantees that, while all arguments are considered, the process as a whole remains science-based and focused on the protection of citizens and the environment. To derogate from the RAC’s opinion at this stage based on socioeconomic arguments would create a dangerous precedent and would put in jeopardy the carefully established balance of REACH.
Following an unprecedented lobbying push by the TiO2 industry, the European Commission, Slovenia, and the United Kingdom proposed classifying only the powder forms of TiO2 as carcinogens, due to the risk mostly being from inhalation. This limitation is supported by TiO2 producers. Yet such an exemption represents both a danger to human health and a deliberate move away from science-based legislation. The scientific evaluation provides the risks of TiO2 as a single substance, so the proposal to classify only a single form isn’t based on the available scientific data. As just one example of why this is troubling, powder isn’t the only form of TiO2 that can be inhaled; liquid aerosols (such as spray paint, cosmetics, or aerosol sunscreens) containing TiO2 would carry a similar risk.
Deviating from the RAC’s science-based recommendation for the first time ever would not only mean that the public isn’t protected against the carcinogenic effects of TiO2; it would also jeopardize the very foundation of REACH as a strong, science-based guardian of public health. This would set a dangerous precedent for the future of REACH and other public-health regulations — teaching industry that if they throw enough money at a problem, they can protect their own profits at the expense of public health.
By Anderson Lanham, Communications Intern, and David Azoulay, Managing Attorney, Geneva Office
Originally posted on September 24, 2018