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Parliamentary questions
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16 May 2019
Answer given by Mr Vella on behalf of the European Commission
Question reference: E-000925/2019

Regulation (EC) No 1272/2008(1) (CLP Regulation) requires chemical substances to be classified according to their health hazards. When a substance has harmonised classification in CLP, a specific entry in Annex VI with all its listed properties identifies its classification.

In 2017, the Risk Assessment Committee of the European Chemicals Agency proposed ‐based on scientific evidence‐ a harmonised classification of titanium dioxide (TiO2) as suspected of causing cancer (carcinogen Category C). Subsequently, the European Commission submitted a draft Regulation amending Annex VI to the CLP Regulation to the committee composed of the representatives of the Member States, suggesting classifying TiO2 particles with an aerodynamic diameter ≤10 µm as suspected of causing cancer. Mixtures containing such TiO2 particles will only need to be classified if they are in powder form and the content of the TiO2 particles is ≥1%. The committee has not adopted an opinion on the draft Regulation yet.

Other substances with poorly soluble, low toxicity (PSLT) particles may exhibit similar properties to TiO2. However, they remain subject to self-classification in CLP as long as their classification is not harmonised.

The classification of TiO2 will not necessarily result in an automatic ban in downstream legislation and will thus not affect the placing on the market of colours and paints.

If the amendment of Annex VI to the CLP Regulation is adopted, 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, and if the TiO2 content exceeds the concentration limit (1%) mentioned in Annex III to Directive 2008/98/EC(2) (Waste Framework Directive). Member States are responsible for preventing adverse impacts of hazardous waste, including through selective demolition with removal and safe handling of hazardous substances.(3) Hazardous waste has to be managed by operators in permitted facilities.

(1)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, p. 1-1355.
(2)Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives. OJ L 312, 22.11.2008, p. 3-30.
(3)Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives. OJ L 312, 22.11.2008, p. 3-30, Articles 9 and 11.

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