The European Ceramics industry association (Cerame-Unie) welcomes the European Commission’s commitment to ensuring the efficacy of its legislation through thorough, transparent, and self-critical reviews. We are pleased to contribute to this process and we believe that the evaluations must be based on the best available scientific data to allow the right conditions to design and adapt fit-for-purpose legislation. We strongly believe that the classification of titanium dioxide (TiO2) as a suspected carcinogen (cat. 2) is inappropriate from the toxicological and epidemiological perspective. TiO2 is naturally present as an impurity in the natural raw materials use for the production of ceramics such as clay and therefore can’t be eliminated or substituted. That is why we would like to highlight the concerns of our industry over the ongoing regulatory developments of the adaptation to technical progress to the Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP), affecting TiO2.
First, CLP is not the most appropriate regulatory tool to address the concerns and potential hazards and that OELs alone would most effectively address the potential concerns. The Risk Assessment Committee of the European Chemicals Agency (ECHA) proposes in its opinion to classify TiO2 as a suspected carcinogen (cat. 2) by inhalation. However, TiO2 is not marketed to consumers in inhalable (powder) form for the ceramic sector. Therefore, there is no risk for consumers and only workers at highly exposed workplaces could, in theory, be exposed to inhalation of TiO2. Health and safety at work measures, such as occupational exposure limits (OELs), already exist at national level to address this hazard, and could be further harmonized at EU level.
Second, the classification of TiO2 will trigger unintended consequences through sector and product legislation even though there is no potential for inhalation. We fear that it will impact our sector, As regards our sector, it will impact on the operation of the Waste Framework Directive (2008/98/EC), the Industrial Emissions (IPPC) Directive (2010/75/EC), REACH provisions on Safety Data Sheets (SDS), the Food Contact Material Framework Regulation (1935/2004), the revision of EU Ecolabel criteria, as well as others.
Furthermore, the proposed classification of TiO2 would be harmful to the EU’s circular economy and burdensome to Member States as waste containing over 1% of TiO2 would automatically be classified as hazardous under the EU waste legislation making it more difficult to recycle and reuse. Importantly, evidence shows that the classification’s limitation to the inhalation route is unlikely to be taken into account when classifying waste.
Based on these important issues, we recommend that more time is given by putting the process on hold until more information is available, and the most suitable regulatory approach can be identified.
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