Brussels, 04 November 2019
WK 12346/2019 INIT
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General Secretariat of the Council
N° Cion doc.:
ST 12919/19 + ADD 1
Commission Delegated Regulation (EU) …/... of 4.10.2019 amending, for the
purposes of its adaptation to technical and scientific progress, Regulation (EC)
No 1272/2008 of the European Parliament and of the Council on classification,
labelling and packaging of substances and mixtures and correcting that Regulation
- Greek position
Delegations will find in the Annex the Greek position on the above delegated act.
WK 12346/2019 INIT
Independent Authority for Public Revenue
General Chemical State Laboratory
Directorate of Energy, Industrial and Chemical Products
Greek Position on the Commission delegated act on the 14th ΑΤP of CLP regulation
As far as the Commission new delegated act on the 14th ΑΤP of CLP regulation is concerned, we would like to inform
you that, the Greek Competent Authority supports the classifications included in the above mentioned delegated
act, except the classification of Titanium Dioxide (TiO2).
We cannot support the classification of Titanium Dioxide (TiO2), position already expressed in the REACH COMMITTEE
and CARACAL meetings of the last months, for the following reasons:
1. The classification of Titanium Dioxide represents a borderline case between Carcinogenicity, Category 2 and no
An overload method (rats are exposed to exceptionally high concentrations) has been used to classify the
substance as Carcinogen cat. 2 (the high concentrations at which findings of lung tumours were described in
the study by Lee et al
. (250 mg/m³) which “clearly exceeded the maximum tolerable dose (MTD)”(RAC opinion).
The mode of action presents distinct differences between rats and humans in their response to the overload
method.It is clear that inhaled particles are retained to a greater degree in the human lung interstitium
compared to rats, where the particles remain in the alveolar space. In rats, the particles are removed from the
alveolar through the activation of macrophages and extensive inflammation is observed. In humans, mainly
systemic inflammation has been observed, the origin of which, according to the RAC, could not totally rule out
local inflammatory response. Therefore, the above mentioned mode of action cannot be considered “intrinsic
toxicity” in a classical sense
but is characterized as particle toxicity.This was also recognized in RAC opinion.
TiO2 belongs to the class of poorly soluble low toxicity particles (PSLT). These substances consist a category on
their own and the applicability of TiO2 classification refers only to its PSLT character.
2. There is a need of further scientific discussion on classification of the case of poorly soluble low toxicity particles
(PSLT) separately for better regulatory management in the framework of CLP Regulation.
3. COM, based on the RAC's opinion on TiO2's “borderline intrinsic risk
”, proposes the classification of TiO2 mixtures
(liquids and solid) by introducing new provisions to this ATP (3 new notes, 2 new EUH statements), which are not
included in RAC opinion. This approach needs more scientific discussion.
4. Finally, we believe that the inclusion of this classification in Annex VI would lead to an overestimation of the
hazard and consequently will have a large impact in the broad TiO2 industry and circular economy.