EUROPEAN COMMISSION
ENVIRONMENT DIRECTORATE-GENERAL
Circular Economy and Green Growth
Sustainable Chemicals
DIRECTORATE-GENERAL INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMES
Consumer, Environmental and Health Technologies
REACH
Chemicals
Brussels, 8 November 2017
Doc.
CA/90/2017
25th Meeting of Competent Authorities for REACH and CLP (CARACAL)
Open Session
15-16 November 2017
Room: 0D Centre Albert Borschette
Rue Froissart 36
1040 Brussels, Belgium
Concerns:
Classification of TiO2 and mixtures containing TiO2
Agenda Point:
19
Action Requested: Written comments can be sent by 15 December 2017 to:
xxxxxxxxxxxx@xx.xxxxxx.xx,
xxxxxxxxxxx@xx.xxxxxx.xx,
@ec.europa.eu
@ec.europa.eu
1
link to page 2
CLASSIFICATION OF TIO2 AND MIXTURES CONTAINING TIO2
1. Background
On 14 September 2017, RAC adopted its Opinion proposing harmonised classification and
labelling at EU level of Titanium dioxide (TiO2, EC Number: 236-675-5; CAS Number:
1346367-7). The RAC Opinion was transmitted to the Commission on 12 October 2017, for
possible integration into Annex VI CLP.
RAC proposed classification as
category 2 carcinogen including the
hazard statement
H351 (inhalation), with the following “Note”:
“If the substance is placed on the market as
particles of the substance fulfilling the WHO fibre criteria or as particles with surface
coating their hazardous properties must be evaluated in accordance with CLP Title II to
assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure
(oral or dermal) should be applied.”
Compared to other classifications, the classification of TiO2 has a number of particularities,
which the Commission would like to discuss with CARACAL members and observers. At
this stage, the Commission does not yet have concrete proposals on how to translate those
particularities into a legal proposal. The objective of discussing the below issues is to get
more insight into the views of CARACAL members and observers, in order to allow the
Commission to reflect on whether and how those particularities could be taken into account in
the harmonised classification of TiO2.
The lead registrant dossier for the joint registration for titanium dioxide was opened for
dossier evaluation and a final decision targeting non-compliances relating to substance
identity information reporting was issued in 2014. The substance identity for registration was
defined very broadly and covered all crystal phases in all possible forms and also hydroxides,
metal titanates and doped TiO2’s. The final decision included requests relating to the
reporting of name & other identifiers, composition and analytical data with Annex VI.2 as the
legal basis for the requests made. The lead registrant challenged the requests to report
information on nanoforms, crystal phase and surface treated nanoforms. In 2017, the BoA
took the decision pointing out that registrants are at liberty to give a broad definition of the
substance which they intend to register. Therefore, the Board of Appeal considered that, in the
absence of explicit requirement for information on nanomaterials in Annex VI of REACH,
ECHA has no competence to request substance identity related information on nanomaterials.
On that ground, the Board of Appeal annulled the decision but specified that if registrants
give a broad definition of their substance, however, the hazards posed by all possible forms of
the substance covered by the substance definition must be addressed by the toxicological and
ecotoxicological information provided in the registration dossier.
2. Specific properties
• The mode of action cannot be considered “intrinsic toxicity” in a classical sense but is
characterised as particle toxicity.
“The evidence outlined in the CLH report and in this opinion do not indicate substantial
differences in the toxicity profile of the tested TiO2 materials. Rat lung carcinogenicity of the
two tested TiO2 materials is characterised as “particle carcinogenicity”.”1
1 RAC opinion, p. 36 third paragraph – the Opinion can be found at
https://echa.europa.eu/documents/10162/6cf0942a-6e18-5ce9-fc95-5cd7fd2fbdad
2
link to page 3 link to page 3 link to page 3 link to page 3 link to page 3 link to page 3
“RAC acknowledges that the TiO2 inhalation toxicity observed in rats is particle toxicity and
accepts the general understanding that the development of rat lung tumours is mediated by
the pathological consequences of a higher loading of macrophages with particles of rather
low solubility. The deposited particles, but not solutes of TiO2 molecules, can be assumed to
be responsible for the observed toxicity. RAC acknowledges as well that the carcinogenicity
profile described for TiO2 is not exclusively characteristic for TiO2 but applies to the whole
group of chemicals referred to as “poorly soluble low toxicity particles”.”2
“
The CLP regulation requires a classification to be based on the intrinsic properties of
substances. The CLP Guidance defines the intrinsic property of a substance as the basic
properties of a substance as determined in standard tests or by other means designed to
identify hazards. RAC considers the toxicity profile observed as a basic property of inhaled
and respirable particles of TiO2. With reference to the CLP definition of intrinsic properties,
RAC considers that the CLP regulation regards the properties of TiO2 or other substances
which are PSLT particles as relevant for classification”
3
“RAC acknowledges that the mode of action for the rat lung carcinogenicity in rats can not
be considered “intrinsic toxicity” in a classical sense: the deposited particles, but not solutes
of TiO2 molecules can be assumed to be responsible for the observed toxicity.”4
• The lung carcinogenicity is specifically linked to the inhalation route.
“Generally, classification for carcinogenicity does not specify a route of exposure. However,
the profile of lung carcinogenicity described for TiO2 is specifically linked to the inhalation
route of application. Currently, there is no experimental evidence for TiO2 carcinogenicity
for the oral or dermal route of application. TiO2 lung carcinogenicity is associated with
inhalation of respirable TiO2 particles. Based on the data available today RAC considers it
conclusively proven that no other route of exposure causes the carcinogenicity hazard.
Correspondingly, RAC proposes to classify TiO2 as a Category 2 carcinogen, with the hazard
statement H351 (inhalation).”5
“The carcinogenicity profile observed thus is specifically related to exposure to respirable
TiO2 particles with different crystal structures and different primary particle sizes, but which
do not possess WHO fibre characteristics or additional specific surface toxicity because of
coating of the TiO2 particles.”6
•
Further considerations
“In the context of a weight-of-evidence approach RAC recognises that the described
experimental conditions for rat lung tumour development indicate that TiO2 can be
considered a relatively weak rat lung carcinogen.”7
“In the opinion of RAC, the mode-of-action proposed for the rat is consistent with the
assumption a practical threshold. Based on the experimental data available, rat lung tumours
develop if exposure levels are associated with marked overloading of macrophages and
chronic alveolar inflammation. The Guidance on the Application of the CLP Criteria (chapter
2 Idem, P. 38 penultimate paragraph
3 Idem, p. 38 last paragraph
4 Idem, P. 40 fourth but last paragraph
5 Idem, P. 40 third but last paragraph
6 Idem, P. 40 last paragraph
7 Idem, P. 35 penultimate paragraph
3
link to page 4 link to page 4
3.6.2.2.4) refers to such considerations and indicates that the assumption of a practical
threshold can be viewed as decreasing the level of concern for human carcinogenicity.”8
3. Questions raised
As correctly remarked by RAC, the CLP regulation does not exclude a health hazard
classification triggered by physico-chemical characteristics of a chemical, and
the Commission has no reasons to question the correctness of the proposed classification of
TiO2 if inhaled as small particles. Nevertheless, the proposed classification will also apply to
other forms of TiO2, on their own or in mixtures, for which there is no evidence of such
health hazards.
• The proposed classification does not specifically refer to particles although the
observed effects seem to be related to inhalable particles only
9. Therefore, the
classification would apply to all forms of TiO2 and mixtures containing TiO2,
including larger particles/massive forms etc., as well as dispersions.
In this context, for some of the classified mixtures such as paints containing TiO2,
pursuant to Annex I, section 1.3.4. (for mixtures containing polymers and mixtures
containing elastomers), if they do not present a hazard to human health by inhalation,
a derogation for
labelling could be applied. Nevertheless, even if these considerations
are accepted, there is a need to clarify borderline cases such as spraying applications
for some mixtures like paints. In addition, such derogation would not apply to
classification. Moreover, section 1.3.4 would not apply to mixtures containing TiO2
but not containing polymers or elastomers.
For the application of section 1.3.4, there is a need to demonstrate that there is no
hazard to human health by inhalation.. Other criteria such as the application of Article
12(b) could also be taken into account to not classify mixtures containing TiO2,
arguing that non-respirable particles do not lead to lung exposure and that therefore
there is no bioavailability.
Do CARACAL members and observers consider that the proposed classification
of TiO2 can be translated directly into Annex VI, or, taking into account the
scientific evidence, is there a possibility for adaptations (e.g. through further
footnotes to differentiate between particles that can be inhaled and larger
particles/massive forms of TiO2
)?
What are the views of CARACAL members and observers on the application of
derogations such as Article 12(b) or Annex I, section 1.3.4?
• There are also questions why only TiO2 will be subject to harmonised classification
whereas the effects seem to be common to poorly soluble low toxicity particles
(PSLT) of different chemistries.
Is it appropriate to limit harmonised classification to TiO2? or would it not be
preferable to also classify poorly soluble low toxicity particles (PSLT), or a well-
defined group of PSLT, in the same way in a grouping approach?
8 Idem, P. 36 second paragraph
9 This is without prejudice to the issue of fibres and coated particles which are addressed in a footnote stating
that for those particles a more severe classification may apply and also other exposure routes might be
relevant.
4
4. Next steps
Member States are invited to consider the above questions and comment at the
CARACAL meeting/provide written comments by 15 December 2017 to:
xxxxxxxxxxxx@xx.xxxxxx.xx,
xxxxxxxxxxx@xx.xxxxxx.xx,
@ec.europa.eu
@ec.europa.eu
5
Document Outline