The EU harmonised classification of certain forms of titanium dioxide (TiO2) as a suspected carcinogen (cat. 2) by inhalation will enter into force on 1st October 2021.
The Titanium Dioxide Manufacturers Association (TDMA) disagrees with the classification of TiO2 as there is no reliable, acceptable or available data to suggest that TiO2 causes cancer. 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.
Despite disagreeing with the classification, the TDMA is working with industry and associates to help in its application as the new classification has created fundamental uncertainties by introducing several new concepts and terms without providing any meaningful definitions or interpretative guidelines.
As a result, the TDMA has updated its interpretation of the classification.
ECHA’s guide on the classification and labelling of TiO2
The European Chemicals Agency (ECHA) has published its guide on the classification and labelling of TiO2. The document aligned with guidance issued by the German Federal Institute for Occupational Safety and Health (BAuA) in September 2020 and appears to derive from the BAuA document.
The TDMA does not have any concerns with the guide, although it does not address the methodology to determine the content of particles with aerodynamic diameter less than or equal to 10 micrometers which is key to evaluate if a substance or mixture is classified.
TDMA’s updated interpretation document
The document expresses the TDMA’s interpretation of the scope and application of the new classification in a bid to support manufacturers, importers, and downstream users in applying the classification. However, considering the uncertainties inherent with this classification, alternative interpretations may exist. Ultimately only the Court of Justice of the European Union is competent to authoritatively interpret Union law and this document provides guidance only.
The document is available for download here after the conditions for use of the document are accepted and registration completed.
The TDMA would welcome feedback regarding the content of the document via: email@example.com.
Method to determine the content of particles with aerodynamic diameter less than or equal to 10 micrometers
The CLP entry indicates that the classification of TiO2 is based on the release of respirable particles that may be generated under normal conditions of use of the titanium dioxide product placed on the market.
TDMA carried out an analytical project to review the suitability of available test methods. These are summarised in TDMA Report TDMA1140j dated 21 April 2021 which showed EN 15051-2 Measurement of the dustiness of bulk materials – Rotating drum method provides the most consistent and repeatable results. The continuous drop method (EN15051-3) and DIN 55992-1 have also proven to be robust and suitable for determining the aerodynamic diameter of TiO2. All these tests are designed to mimic the dustiness of solid materials during typical handling and manipulation in a workplace. This information was presented and reviewed several times with EC officials including in the EU CARACAL meetings of 4 May 2021 and 30 June 2021. Details of these meetings are publicly available on the European Commission CIRCABC website.
Despite differing views, the European Commission concluded that tests according to EN 15051 and DIN 55992-1 are fit for purpose and widely recognized methods and no alternatives were proposed. TDMA is therefore recommending these methods.
To obtain further information regarding the classification status of TiO2 products, it is necessary to contact your suppliers directly as classification and labelling are decisions for the individual TiO2 suppliers.
Legal action against classification
TDMA disagrees with the classification of certain forms of TiO2 as there is no reliable, acceptable or available data to suggest that the now classified forms of TiO2 causes cancer. 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 not expected to rule before late 2022 or 2023 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.
European Commission still to update guidelines on waste
The TDMA has received questions about the implications of the classification for waste containing TiO2. The European Commission has been very clear that waste containing TiO2 will be classified as hazardous only if that substance is in the form or physical state referred to in the respective entry in Annex VI to the CLP Regulation, i.e. in powder form (Answer given by Commissioner Vella to the European Parliament E-000925/2019 – 16 May 2019).
The European Commission intends to table a proposal for the revision of the EU guidance on waste before 1 October to be adopted shortly after. The amendment clarifies that the form/physical state of the waste must be taken into account when determining its classification.
TDMA will keep stakeholders updated regarding the status of the guidance adoption.
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