Titanium dioxide was assessed as part of the European chemicals regulations. One of the processes provides for the so-called EU-wide harmonised classification according to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (“CLP Regulation”), which was completed in February 2020. The second process deals with the substance evaluation of titanium dioxide as part of the European chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals; (EC) Nr. 1907/2006). Both regulatory processes were initiated by France. Neither process explicitly distinguishes between conventional titanium dioxide (pigment) and titanium dioxide in nanoform. Rather, the scope of the relevant EU regulations covers all forms of titanium dioxide.
1) Harmonised classification according to CLP Regulation (Regulation (EC) No 1272/2008)
Industrial chemicals with particularly hazardous properties (e.g. carcinogenic, mutagenic or toxic to reproduction) are classified throughout the EU in accordance with the CLP Regulation. This is a harmonised legal classification, which is legally binding in the European Economic Area for manufacturers, importers and users of the substance as such and for the substance in mixtures. If general or specific concentration limits of the harmonised classified substance (or harmonised classified substances) in mixtures are exceeded, these mixtures must be labelled in accordance with the legal classification(s).
A harmonised CLP classification is unrestricted, i.e. it can apply to all chemicals on the EU market and, unless specified otherwise, includes all forms of a substance. References to the classification are made in various legal standards; the existence of a harmonised CLP classification and in particular the higher classification categories (e.g. carcinogen category 1B, “may cause cancer”) sometimes trigger drastic legal consequences and various risk reduction measures in other areas of law outside chemicals law (e.g. product, cosmetics, toy, waste law).
Titanium dioxide has undergone process of classification in accordance with the CLP Regulation because of possible hazards in terms of carcinogenicity after inhalation of the substance. This was triggered by a corresponding proposal submitted by France in 2015 and partially confirmed by the Committee for Risk Assessment (RAC) at the European Chemicals Agency (ECHA) in 2017. According to the RAC opinion , titanium dioxide is presumed to be carcinogenic to humans when inhaling dusts of the substance. Accordingly, in October 2019, the EU Commission decided on a classification and labelling according to which titanium dioxide [in powder form with at least 1% particles with an aerodynamic diameter ≤ 10 µm] is probably carcinogenic when inhaled (carcinogen category 2, H351i).
In February 2020, the proposed classification of titanium dioxide was adopted as part of the 14th ATP (Adaptation to technical progress) and the relevant Delegated Regulation (EU) No 2020/217 was published in the Official Journal of the EU . The implementation of the classification thus became binding on 09/09/2021; guidance on the application of the harmonised classification is published at the national REACH-CLP Biocides Helpdesk . In 2020, however, the harmonised classification of titanium dioxide was challenged before the European Court of Justice by several industry representatives. In November 2022, the Court ruled that the harmonised classification of titanium dioxide dusts as carcinogenic by inhalation must be annulled. The reasons for the cancellation of the harmonised classification can be viewed here: https://curia.europa.eu/juris/document/document.jsf?text=&docid=268096&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=2303522 .
In spring 2023, France and the European Commission lodged an appeal[1] against the judgement of the European Court of Justice. As a result, the classification remains valid for the time being. A hearing on the matter is scheduled to take place in 2024 and a final decision on the harmonised classification of titanium dioxide in powder form as an inhalation carcinogen is expected in 2025.
2) Substance evaluation under the REACH Regulation
The purpose of substance evaluation under the REACH Regulation (EC 1907/2006) is to check whether there is an initial suspicion that a substance poses a risk to health or the environment, to request information from the manufacturer or importer of the substance that is relevant but missing for the assessment of a risk and, if necessary, to determine the need for action to minimise the risk. The initiative for a substance assessment usually lies with the authorities of the EU member states.
In 2018, the French competent authority (ANSES) initiated a substance evaluation of the different forms of titanium dioxide because of ambiguity in the available data regarding the potential genotoxic properties of the different forms (including different nanoforms). The initial assessment revealed that relevant data for a final assessment of the potential genotoxicity of the different forms of titanium dioxide are missing and need to be provided by the REACH registrants of the substance. A corresponding study request was sent to the registrants in July 2021. This data is expected to be received in 2024. Once the requested information has been received, an assessment of the new data will be carried out by France.
Titanium dioxide was assessed as part of the European chemicals regulations. One of the processes provides for the so-called EU-wide harmonised classification according to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (“CLP Regulation”), which was completed in February 2020. The second process deals with the substance evaluation of titanium dioxide as part of the European chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals; (EC) Nr. 1907/2006). Both regulatory processes were initiated by France. Neither process explicitly distinguishes between conventional titanium dioxide (pigment) and titanium dioxide in nanoform. Rather, the scope of the relevant EU regulations covers all forms of titanium dioxide.
1) Harmonised classification according to CLP Regulation (Regulation (EC) No 1272/2008)
Industrial chemicals with particularly hazardous properties (e.g. carcinogenic, mutagenic or toxic to reproduction) are classified throughout the EU in accordance with the CLP Regulation. This is a harmonised legal classification, which is legally binding in the European Economic Area for manufacturers, importers and users of the substance as such and for the substance in mixtures. If general or specific concentration limits of the harmonised classified substance (or harmonised classified substances) in mixtures are exceeded, these mixtures must be labelled in accordance with the legal classification(s).
A harmonised CLP classification is unrestricted, i.e. it can apply to all chemicals on the EU market and, unless specified otherwise, includes all forms of a substance. References to the classification are made in various legal standards; the existence of a harmonised CLP classification and in particular the higher classification categories (e.g. carcinogen category 1B, “may cause cancer”) sometimes trigger drastic legal consequences and various risk reduction measures in other areas of law outside chemicals law (e.g. product, cosmetics, toy, waste law).
Titanium dioxide has undergone process of classification in accordance with the CLP Regulation because of possible hazards in terms of carcinogenicity after inhalation of the substance. This was triggered by a corresponding proposal submitted by France in 2015 and partially confirmed by the Committee for Risk Assessment (RAC) at the European Chemicals Agency (ECHA) in 2017. According to the RAC opinion , titanium dioxide is presumed to be carcinogenic to humans when inhaling dusts of the substance. Accordingly, in October 2019, the EU Commission decided on a classification and labelling according to which titanium dioxide [in powder form with at least 1% particles with an aerodynamic diameter ≤ 10 µm] is probably carcinogenic when inhaled (carcinogen category 2, H351i).
In February 2020, the proposed classification of titanium dioxide was adopted as part of the 14th ATP (Adaptation to technical progress) and the relevant Delegated Regulation (EU) No 2020/217 was published in the Official Journal of the EU . The implementation of the classification thus became binding on 09/09/2021; guidance on the application of the harmonised classification is published at the national REACH-CLP Biocides Helpdesk . In 2020, however, the harmonised classification of titanium dioxide was challenged before the European Court of Justice by several industry representatives. In November 2022, the Court ruled that the harmonised classification of titanium dioxide dusts as carcinogenic by inhalation must be annulled. The reasons for the cancellation of the harmonised classification can be viewed here: https://curia.europa.eu/juris/document/document.jsf?text=&docid=268096&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=2303522 .
In spring 2023, France and the European Commission lodged an appeal[1] against the judgement of the European Court of Justice. As a result, the classification remains valid for the time being. A hearing on the matter is scheduled to take place in 2024 and a final decision on the harmonised classification of titanium dioxide in powder form as an inhalation carcinogen is expected in 2025.
2) Substance evaluation under the REACH Regulation
The purpose of substance evaluation under the REACH Regulation (EC 1907/2006) is to check whether there is an initial suspicion that a substance poses a risk to health or the environment, to request information from the manufacturer or importer of the substance that is relevant but missing for the assessment of a risk and, if necessary, to determine the need for action to minimise the risk. The initiative for a substance assessment usually lies with the authorities of the EU member states.
In 2018, the French competent authority (ANSES) initiated a substance evaluation of the different forms of titanium dioxide because of ambiguity in the available data regarding the potential genotoxic properties of the different forms (including different nanoforms). The initial assessment revealed that relevant data for a final assessment of the potential genotoxicity of the different forms of titanium dioxide are missing and need to be provided by the REACH registrants of the substance. A corresponding study request was sent to the registrants in July 2021. This data is expected to be received in 2024. Once the requested information has been received, an assessment of the new data will be carried out by France.
