The European Commission adopted on 4 October the 14th adaptation to technical progress (ATP) of the EU’s classification and labelling (CLP) Regulation, including the proposal to classify TiO2 as a suspected carcinogen (cat 2.) by inhalation (annex). The harmonised classification and labelling (CLH) is not final as the 14th ATP is currently subject to two months scrutiny by the European Parliament and Council of the EU, ending in early December 2019. TDMA will communicate to stakeholders on the progress of the scrutiny.
If no objections are raised during the scrutiny by either of the institutions, the classification of TiO2 will probably be published in the official EU journal in January 2020. There will be an implementation period of 18 months after which the classification will be applied in the EU.
TDMA regrets the European Commission’s decision to put the 14th ATP forward for scrutiny without resolving the fundamental scientific, legal and regulatory issues raised by Member States and interested parties. These are summarised in the explanatory memorandum accompanying the act.
The classification of TiO2 is limited to powders: powder TiO2 and mixtures placed on the market in powder form containing 1% or more of TiO2 which is in the form of or incorporated in particles. Liquid and some solid mixtures will not be classified, but specific warning statements and labels need to be applied to those that contain more than 1% TiO2. The text further acknowledges that the hazard only occurs under prolonged inhalation exposure to respirable particles at an extremely high concentration.
The hazard described for TiO2 is a secondary dust effect and not an intrinsic property as required for CLP classification. If the extreme inhalation conditions specified in the Annex VI entry are removed, the particle-form of TiO2 is non-hazardous. The European Commission TiO2 technical meeting (23 April 2018) concluded that there are “negligible” concerns for consumers given the extremely high level of exposure of inhalable TiO2 particles required for the hazard to occur. Such conditions were considered unrealistic by the Authorities under normal and foreseeable circumstances.
TDMA firmly believes that more proportionate and effective alternative regulatory options are available to address the inhalation concerns described for TiO2 such as an appropriate EU harmonised occupational exposure limit. While strict standards and controls are already in place in the workplace, industry supports a consistent and appropriate minimum standard across Europe.
TDMA is currently assessing the legal text of the proposal and is committed to provide more information to and to work with TiO2 stakeholders to develop consistent understandings as soon as possible.
TDMA continues to stand by the safety of TiO2 in all of its intended applications. Over 50 years of data on more than 24,000 TiO2 workers demonstrates there is no link between cancer in humans and exposure to TiO2.
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