What you should know about EU titanium dioxide regulations
The use and manufacture of chemical substances – including titanium dioxide (TiO2) – must comply with a strict registration, testing and approval process, based on European Union (EU) regulations and standards, before being manufactured or used within the EU. These legal requirements ensure that chemicals are safe for human health and the environment in their intended applications. As the voice of the titanium dioxide industry, TDMA is working closely with EU authorities to ensure the safe use of TiO2 in all its applications. TiO2 is regulated under both the EU’s chemicals legislation and under product-specific legislation in its various applications. This ensures that TiO2 is continuously assessed by industry and third-party experts and regulatory authorities, and that approval processes are based on the highest standards of scientific information. How does the EU’s REACH Regulation monitor the use of titanium dioxide? The REACH Regulation is the EU’s primary legislation on chemicals. It aims to protect human health and the environment from the risks of chemical substances, while promoting innovation in the EU chemicals industry. This is achieved through four processes: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Registration TiO2 is registered in all forms at the highest tonnage band under REACH, which is a mandatory requirement for most chemicals before being allowed on the EU market. The registration dossier provides information about the properties and uses of TiO2. Evaluation Producers, EU Authorities, and Member States carry out regular evaluations of substances, in order to update and check the quality of their registration dossiers and determine whether they pose a risk to human health and the environment. In 2018, French Authorities began a substance evaluation of TiO2. Since then, TDMA has been working closely with the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) and the European Chemicals Agency (ECHA) to provide information and expertise responding to their concerns and questions during this process. This evaluation is expected to be completed in 2019, after which ANSES can ask for more data and/or recommend further risk management measures if deemed necessary. Restriction and authorisation TiO2 is not subject to any authorisation requirements or any restrictions under REACH. How does the EU Classification, Labelling and Packaging Regulation relate to titanium dioxide? The EU’s regulation on the classification, labelling and packaging of substances and mixtures (CLP) uses standardised labelling to provide information about the intrinsic potential hazards of different chemicals. The classification of substances under the CLP Regulation is purely hazard-based and does not reflect the actual risks related to the use of a substance. For example, it does not take into account if there is an actual or potential exposure to the substance. Proposed classification of titanium dioxide TiO2 is currently undergoing an EU harmonized classification and labelling (CLH) process under the CLP Regulation. In May 2016, ANSES submitted a proposal to ECHA for the classification of TiO2 as a presumed carcinogen (category 1B) by inhalation. After evaluating the proposal, ECHA’s Committee for Risk Assessment (RAC) decided in September 2017 that there was insufficient evidence to classify TiO2 in category 1B. Instead, the RAC was of the opinion that the evidence could only support a lower classification of TiO2 as a suspected carcinogen (category 2) by inhalation only. The RAC’s opinion was essentially based on a single rat study, which had originally been excluded by ANSES for being of too poor quality. It is also contrary to a vast body of scientific evidence showing that TiO2 does not cause cancer in humans. The scientific evidence on TiO2 and cancer is reviewed in detail here. Since the publication of the RAC’s opinion, there have been ongoing discussions between the European Commission and the Member States about how to address the RAC opinion within the EU regulatory framework. There is currently no consensus on the way forward, or change to how TiO2 can be used or is regulated. Suspected hazard is limited to workplace and not intrinsic to titanium dioxide The regulatory discussions between the Member States, the European Commission and interested parties have concluded that the potential hazard described in the RAC’s assessment of TiO2, is limited to the workplace. This is because the suspected hazard described for TiO2 only applies to inhalation. It is based on ‘particle toxicity’ – a secondary dust effect, and is not intrinsic to TiO2 specifically – which is caused by prolonged inhalation of respirable particles at an extremely high concentration. If these extreme conditions are removed, the particle-form of TiO2 is non-hazardous. The regulatory discussions have consequently concluded that there are no risks for consumers, as the extremely high levels of exposure that would be required for TiO2 to be hazardous are unrealistic under normal and foreseeable consumer conditions. The hazard described by the RAC is therefore not expected to occur in any real-world scenario and is mainly a theoretical risk in the workplace. According to the RAC, the hazard profile described for TiO2 extends to all poorly soluble low toxicity substances (PSLTs), a group of 300+ substances. This highlights that the suspected hazard for TiO2 is a general issue associated with the potential inhalation of dust/powdered substances in the workplace. The classification of TiO2 would therefore start a domino-effect for this group of substances, as all would logically have to be treated equally. However, taking a substance-by-substance regulatory approach would result in years of regulatory action, requiring substantial time and effort, which is why some stakeholders have also proposed to address all of these PSLTs in a grouped way targeted at the workplace as a better solution. What is the position of TDMA and titanium dioxide stakeholders? The European Commission recently proposed classifying TiO2 as a suspected carcinogen in Annex VI of the CLP with derogations that limit the classification to inhalation of powder and powder mixtures. The European Commission’s classification assessment for TiO2 has been subject to a four-week public consultation as part of the 14th adaptation to technical progress of the CLP. More than 430 of the submissions to the consultation opposed the proposal to classify TiO2 for many scientific, legal and policy reasons. In line with the conclusion that the concerns are limited to the workplace, most of the submissions, including TDMA’s, support a binding EU harmonised occupational exposure limit (OEL) as an alternative risk management measure. This would be a more effective and proportionate measure to address the workplace hazard rather than the use of the CLP Regulation. Industry has communicated its willingness to engage in discussions on other regulatory solutions that have a more direct benefit on safety without the unwarranted and unintended negative consequences of using a CLH classification. This and other options would also avoid the many unintended impacts expected from the CLP classification. Is titanium dioxide safe in the workplace? Protection against dust and powder exposure is mainly a matter for health and safety in the workplace. Dust management measures can include the use of personal protection equipment. As TiO2 tends to be fully incorporated into the end product, potential consumer exposure to TiO2 in powder form is extremely low. Most EU Member States already have general limits for dust in the workplace in their occupational health and safety legislation, to prevent impairment of respiratory function due to a general dust effect. The TiO2 industry has always been committed to the safety of its employees and users (up and down stream) by implementing personal protection equipment and otherwise adhering to other dust exposure laws and guidelines for the workplace. Four large epidemiology studies in North America and Europe, involving more than 24,000 workers in the TiO2 manufacturing industry, showed no association with any adverse effects from exposure to TiO2. In particular, they showed no increase in lung cancer and no evidence indicating a causal relationship between exposure to TiO2 and development of lung cancer in humans. There have also been no recognised cases of occupational disease in Germany due to TiO2 exposure, or physician-reported cases of respiratory illness from worker exposures to TiO2. Strict testing of titanium dioxide in food, cosmetics and pharmaceuticals The use of TiO2 in consumer applications is subject to rigorous testing and standards, ensuring the safety of products for human health and the environment. However, questions are often raised regarding regulation of the application of TiO2 in food, cosmetics and pharmaceuticals. European regulatory authorities have regularly reviewed and approved TiO2 in these end-use applications. How safe is titanium dioxide in food? TiO2 is approved for use in food as the colouring additive E171, under the EU’s General Food Law Regulation. The safety of E171 is evaluated by the European Food Safety Authority (EFSA), which established in 2016 that data on E171 showed no health concerns for consumers. EFSA later reaffirmed the safety of E171 on 29 June 2018, following a request for a scientific opinion from the European Commission in view of new data. TDMA is committed to bringing forward new evidence on the safety of E171. In consultation with ANSES, EFSA and the European Commission, TDMA has commissioned a study which will enable EFSA to determine an acceptable daily intake (ADI) of E171. This study is now underway, and the final report is expected by the end of July 2020. TDMA is also supporting a study on the ingestion of E171, that so far shows no impact. A full report is expected by July 2019. Despite the continuous confirmations of the safety of E171, the French Government unilaterally decided on 25 April 2019 to suspend the use of E171 in foodstuff in France from 1 January 2020 for a period of one year. TDMA regrets this decision and will continue to work with the French and European Authorities to address the potential concerns around the substance. How safe is titanium dioxide in cosmetics and sunscreen? TiO2 is included in the list of approved colourants under the EU’s Cosmetics Products Regulation. It was also evaluated and approved for use as a UV filter in sunscreens in 2014 by the EU’s Scientific Committee on Consumer Safety (SCCS) at a maximum concentration of 25%, when applied on healthy, intact or sunburnt skin. TiO2 benefits when used in sunscreens include: Non-comedogenic and gentle on sensitive skin Extremely effective at blocking short-wave UVA and UVB, making it a great choice for casual daily sun exposure Invisible after application It also preserves the safety, efficacy and quality of the active pharmaceutical ingredient, and provides shelf-life stability. In addition, the Danish Environmental Protection Agency (Milj?styrelsen) tested the use of nano-sized TiO2 in sunscreens, finding its use to be harmless. How safe is titanium dioxide in pharmaceuticals? Ultra-high purity TiO2 is used in many medicinal products as an excipient, mainly as the colourant E171. TiO2’s purity meets the requirements of important official pharmaceuticals standards, such as the European pharmacopoeia, the Japanese pharmacopoeia and the US pharmacopoeia. What additional efforts has the industry undertaken to address TiO2 potential hazard and risk concerns? The classification proposal for TiO2 is not based on new science on the hazards or risks of TiO2, but is due to a precautionary interpretation of old studies. Therefore, the TiO2 industry is undertaking an extensive science program to fill the perceived data needs and to ensure the safe use of TiO2. Additionally, the industry has undertaken a Risk Management Options Analysis (RMOA) to assess whether additional measures are needed to protect against the hazard described by the RAC, which would therefore not be expected to occur. The RMOA concluded that existing risk mitigation measures already effectively address potential risks of inhalation exposure. If this situation is to be enhanced, the analysis recommended EU-wide occupational health and safety measures as the most efficient and proportionate. The industry is working closely with downstream users in discussions with the Commission and Member States. It has advocated alternative regulatory options that will ensure enhanced protection against the workplace dust concerns identified in the RAC opinion, but in a more effective, proportionate, and practical manner than the classification of TiO2.