European Commission adopts CMR 2 classification for titanium dioxide
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On 4 October 2019, the European Commission adopted the Delegated Regulation amending for the 14th time the CLP Regulation on classification, labelling and packaging of substances and mixtures. In particular, this text provides for the addition of Titanium dioxide to its Annex VI, as a category 2 carcinogen by inhalation for mixtures placed on the market in powder form containing 1% or more of titanium dioxide particles with diameter ≤ 10 μm.
In June 2017, the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) proposed to classify Titanium dioxide as as suspected of causing cancer (category 2, through the inhalation route).
This opinion was followed by the European Commission, which included this provision in the Delegated Regulation adopted on 4 October.
The text also provides for changes in the classifications of five other ingredients used in cosmetics.
Provisions for Titanium dioxide
In Annex VI to the CLP Regulation
The following row is inserted.
• Titanium dioxide ([in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 µm)
• No.CE: 236-675-5 / No.CAS: 13463-67-7
• Classification: Carc. 2
• Hazard statement H351 - Suspected of causing cancer (inhalation)
• Pictogram, Signal Word: GHS08 - Wng : Warning
• Notes: V, W, 10
The three notes V, W and 10 are also added in Annex VI.
• V: If the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure ...