07.03.18
In June, EU Member States will continue to discuss the possible classification of titanium dioxide (TiO2) as a carcinogen (category 2) by inhalation. The discussions started at the end of last year and unveiled several complexities and uncertainties. The Titanium Dioxide Manufacturers Association (TDMA) has been one of the stakeholders involved in the process, and acknowledges the concerns raised by authorities. However, as the June meeting of the CARACAL approaches, we believe that more time will be needed to iron out these complexities and uncertainties.
Throughout the discussions on the possible classification of TiO2, the Commission and other regulators involved in the process have recognized the complexity of this file. In November, the Commission itself already said that the classification of TiO2 has a number of particularities, which it would like to discuss with CARACAL members and observers.
The classification of TiO2 has proven a complex and challenging issue for three main reasons.
Firstly, as raised by several stakeholders in the process, the discussions showed that a number of scientific questions remain open. This was already acknowledged by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) in its opinion of October 2017. As the RAC said, there are no robust carcinogenicity studies in species other than rats (RAC opinion, p.39 para 1). Furthermore, these studies have been carried out on rats under conditions of lung overload. The RAC itself said that “relevance of lung overload in animals to humans is currently not clear and is subject to continued scientific debate.” (RAC opinion, p. 16 para 4). These same uncertainties have also been raised by the European Commission in November 2017, as they submitted questions to the Competent Authorities for REACH and CLP ahead of the CARACAL meeting. Discussions so far have not brought any clear answer to these questions. To support bridging this information gap, TDMA has launched an extensive scientific program to provide further scientific information on the substance and assuage concerns raised by some stakeholders
Secondly, the concerns over possible hazard of TiO2 are not specific to this substance but common to all dust substances, or “poorly soluble, low toxicity” substances (PSLTs) as concluded by the RAC and it has also been acknowledged by the Commission that the carcinogenicity profile described for TiO2 is “not exclusively characteristic.” However, the CLP regulation is designed to address “intrinsic hazard,” defined as hazards specific to a given substance and it is therefore unclear whether this applied to the alleged ‘particle toxicity’ of TiO2. Based on this, Member States and the Commission have been discussing whether a classification is the appropriate regulatory tool. It is however clear that the potential classification would set a precedent and may have unforeseen regulatory consequences on all other dust substances which share the same potential hazard profile described by ECHA.
Thirdly, because the potential hazard is associated with the inhalation of TiO2, classification would only be relevant in a workplace environment. Therefore, Member States and some stakeholders have raised the question of whether a classification will bring added value to workers’ protection. As stated by the Commission, “the risk for consumers is negligible given the very high levels of exposure that would be required, which are unrealistic under normal and foreseeable conditions” (CARACAL document no. CA/45/2018). Furthermore, impacts of classification in downstream legislation and products do not consider the inhalation route and could have serious impact in several sectors (cosmetics, paints, coatings, pharmaceuticals, etc.).
TDMA has been involved in these discussions on the classification of TiO2 as part of a group of stakeholders invited by the authorities to provide scientific information and expertise. We acknowledge the concerns raised by authorities and, without disregarding the scientific opinion expressed by ECHA, we believe that more time is needed to reflect on this complexity.
The Titanium Dioxide Manufacturers Association (TDMA) represents the major producers of titanium dioxide (TiO2 ) and has been their voice in Europe since 1974. For more information go to https://tdma.info/.
Throughout the discussions on the possible classification of TiO2, the Commission and other regulators involved in the process have recognized the complexity of this file. In November, the Commission itself already said that the classification of TiO2 has a number of particularities, which it would like to discuss with CARACAL members and observers.
The classification of TiO2 has proven a complex and challenging issue for three main reasons.
Firstly, as raised by several stakeholders in the process, the discussions showed that a number of scientific questions remain open. This was already acknowledged by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) in its opinion of October 2017. As the RAC said, there are no robust carcinogenicity studies in species other than rats (RAC opinion, p.39 para 1). Furthermore, these studies have been carried out on rats under conditions of lung overload. The RAC itself said that “relevance of lung overload in animals to humans is currently not clear and is subject to continued scientific debate.” (RAC opinion, p. 16 para 4). These same uncertainties have also been raised by the European Commission in November 2017, as they submitted questions to the Competent Authorities for REACH and CLP ahead of the CARACAL meeting. Discussions so far have not brought any clear answer to these questions. To support bridging this information gap, TDMA has launched an extensive scientific program to provide further scientific information on the substance and assuage concerns raised by some stakeholders
Secondly, the concerns over possible hazard of TiO2 are not specific to this substance but common to all dust substances, or “poorly soluble, low toxicity” substances (PSLTs) as concluded by the RAC and it has also been acknowledged by the Commission that the carcinogenicity profile described for TiO2 is “not exclusively characteristic.” However, the CLP regulation is designed to address “intrinsic hazard,” defined as hazards specific to a given substance and it is therefore unclear whether this applied to the alleged ‘particle toxicity’ of TiO2. Based on this, Member States and the Commission have been discussing whether a classification is the appropriate regulatory tool. It is however clear that the potential classification would set a precedent and may have unforeseen regulatory consequences on all other dust substances which share the same potential hazard profile described by ECHA.
Thirdly, because the potential hazard is associated with the inhalation of TiO2, classification would only be relevant in a workplace environment. Therefore, Member States and some stakeholders have raised the question of whether a classification will bring added value to workers’ protection. As stated by the Commission, “the risk for consumers is negligible given the very high levels of exposure that would be required, which are unrealistic under normal and foreseeable conditions” (CARACAL document no. CA/45/2018). Furthermore, impacts of classification in downstream legislation and products do not consider the inhalation route and could have serious impact in several sectors (cosmetics, paints, coatings, pharmaceuticals, etc.).
TDMA has been involved in these discussions on the classification of TiO2 as part of a group of stakeholders invited by the authorities to provide scientific information and expertise. We acknowledge the concerns raised by authorities and, without disregarding the scientific opinion expressed by ECHA, we believe that more time is needed to reflect on this complexity.
The Titanium Dioxide Manufacturers Association (TDMA) represents the major producers of titanium dioxide (TiO2 ) and has been their voice in Europe since 1974. For more information go to https://tdma.info/.
