The EU harmonised classification of certain forms of titanium dioxide (TiO2) as a suspected carcinogen (cat. 2) by inhalation published in the EU Official Journal on 18 February 2020 creates fundamental uncertainties. It introduces several new concepts and terms without providing any meaningful definitions or interpretative guidelines.
Given the uncertainties and ambiguities created in the classification, the Titanium Dioxide Manufacturers Association (TDMA) and its members have attempted to find a practical and defensible interpretation of the classification to enable meaningful and consistent compliance.
The TDMA’s Interpretation document is now available for downloading by the business operators manufacturing, importing or using TiO2 and products containing TiO2. It expresses the TDMA’s interpretation of the scope and application of the new classification so as to help manufacturers, importers and downstream users in applying this classification to the extent possible. However, considering the uncertainties inherent to this classification, alternative interpretations may exist. Ultimately only the Court of Justice of the European Union is competent to authoritatively interpret Union law.
The document is available for download here after the conditions for use of the document are accepted and registration completed.
This is still considered a preliminary document and alternative interpretations may exist. The TDMA would welcome feedback by users regarding the content of the document via: firstname.lastname@example.org.
The TDMA continues to disagree with the classification of TiO2 as there is no reliable, acceptable or available data to suggest that TiO2 causes cancer. The Member Companies of the TDMA as a part of a wider group of TiO2 producers and users submitted on 13 May 2020 an action to the General Court of the European Union seeking annulment of the harmonised classification.
The decision of the General Court is expected to take 2 to 3 years and therefore will be after the classification comes into force on 1 October 2021. In the meantime, TDMA and its members will focus on finding a way to implement the regulation from that date despite the uncertainties of the classification.