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.
EU Regulation No 1272/2008 on classification, labelling and packing (CLP) of substances and mixtures mandates that by October 1, 2021 hazard labels will be required on certain TiO2 powder products and certain powder mixtures containing TiO2 put on the market in the European Union. According to manufacturers this classification of TiO2 is not based on new science but instead on older scientifically questioned animal test data. Other studies and extensive data, including separate epidemiologic studies of TiO2 workers, have shown no TiO2 specific links to cancer.
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: [email protected].
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.
What is Tio2? (TDMA Video below)
Legal action against the classification of titanium dioxide
On 13 May 2020, Member Companies of the Titanium Dioxide Manufacturers Association (TDMA) as a part of a wider group of titanium dioxide (TiO2) producers and users submitted an action in annulment to the General Court of the European Union against the harmonised classification of TiO2 as a suspected carcinogen (cat 2.) by inhalation under the EU’s Classification and Labelling (CLP) Regulation.
The appeal challenges the legality of the classification adopted by the European Commission on 4 October 2019 and requests its annulment.
The appeal demonstrates that there is no reliable, acceptable or available data to suggest that TiO2 causes cancer. It also shows that the classification was adopted in breach of the Commission’s duty of care and several principles of EU law, including the principles of legal certainty, proportionality and the right of interested parties to be heard.
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.
About the TDMA
The Titanium Dioxide Manufacturers Association (TDMA) is a sector group of the European Chemical Industry Council (Cefic) and represents the leading producers of titanium dioxide (TiO2). The TDMA is a non-profit organisation established in 1974 dedicated to promoting the safe use and benefits of TiO2
(Source: Kronos Worldwide, Inc. a leading German producer of titanium dioxide pigments)
Titanium dioxide is a naturally occurring oxide of titanium. It has the highest refractive index of any material known to man, even the diamond, and is one of the whitest materials on earth. When ground into a fine powder, it transforms into a pigment that provides maximum whiteness and opacity. TiO2 pigments are used in paints and coatings, plastics, paper, building materials, cosmetics, pharmaceuticals, foods and many other commercial products. However, nature does not yield titanium dioxide in a usable form. It must be carefully mined in one of its pure forms, such as rutile beach sand, and refined into a fine uniform particle size.