G/TBT/W/645  
 
3 July 2019  
(19-4460) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION — REGULATION (EC) NO 1272 /2008 (CLP REGULATIO N) 
STATEMENT BY AUSTRAL IA TO THE COMMITTEE ON  TECHNICAL BARRIERS TO TRADE  
20 AND 21 JUNE 2019  
The following communication, dated 3 July 2019, is being circulated at the request of the delegation 
of Australi a. 
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1.  As previously noted in this Committee, Australia recognises the European Union's (EU) right to 
regulate for public and occupational health and safety, we also recogni se that appropriate 
classification and labelling for hazardous substances and mixtures can address legitimate public and 
occupational health concerns.  
2.  Australia would be interested in an update on the EU's internal processes to consider the proposed 
change s to the classifications of Titanium Dioxide (TiO2) and cobalt, including any relevant timelines, 
particularly given we understand there have been several postponements of a REACH Committee 
vote on these matters.  
3.  As per WTO TBT Agreement commitments, we wo uld urge the EU to ensure that any regulation 
to address concerns about the possible hazards associated with TiO2 and cobalt is no more trade 
restrictive than necessary, and does not unduly impact trade in goods which contain TiO2 and cobalt.  
1  TITANIUM DIOX IDE 
4.  Australia would like to reiterate the possible implications of the classification of Titanium Dioxide 
(TiO2) as a suspected carcinogen:  
a. as previously noted, TiO2 is a premium pigment that is used in the manufacture of a wide 
range of products, most com monly paint and coatings  
b. the classification may create unnecessary obstacles to international trade for TiO2 and 
products containing TiO2  
c. Australia suggests that alternative regulatory measures are available to address the EU's 
concerns that would more dir ectly address the potential health hazards of TiO2, without 
affecting trade.  
5.  The Australian industrial chemicals regulator, the National Industrial Chemicals Notification and 
Assessment Scheme (NICNAS), has undertaken assessments on the risks of TiO2 (excl uding 
nano particles of TiO2), and as previously noted has found:  
a. exposure to TiO2 in a finished product through dermal, inhalation and oral routes presents 
limited risks to human health  
b. appropriate work health and safety controls are adequate to protect p ublic and workers' 
health and safety in relation to TiO2 inhalation exposure  G/TBT/W/645  
 
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  c. the NICNAS information sheet on nanoparticles of TiO2 stated that there is some evidence 
that breathing in large quantities of TiO2 nanoparticles over a long period of time may 
cause toxic effects due to impairment of normal lung clearance mechanisms, but the 
studies available (up to 2012) do not provide sufficient evidence to conclude that 
TiO2 causes lung tumours in humans  
d. if a classification is proposed for TiO2, it should be li mited to nanoparticles of TiO2 (<100 
nm in size), and only through the inhalation route  
e. there should be clear evidence that the carcinogenicity is from TiO2 and not from the 
insoluble nature of TiO2 nanoparticles causing lung overloading.  
2  COBALT  
6.  Australia would also like to express its interest in the EU's proposed classification of cobalt as a 
Category 1B carcinogen for all routes of exposure, in addition to a Category 1B reprotoxin and 
Category 2 mutagen  
a. as noted by other Members  this may create unintende d downstream consequences and 
unnecessary obstacles to international trade for goods containing small amounts of cobalt 
and nickel, such as stainless steel products  
b. we note that Australia is also an exporter of nickel and cobalt to the EU  - in 2017 -18 
Australia exported AU D 16 million worth of nickel ores to the EU, along with AUD 6.5 
million of nickel articles and AUD 92 million of cobalt mattes.  
c. Australia asks that the EU take this into account as it considers a holistic risk assessment 
profile for the re classification of cobalt.  
7.  The Australian industrial chemicals regulator, NICNAS, has assessed cobalt under its Inventory 
Multi-tiered Assessment and Prioritisation (IMAP) scheme, and concluded it is a likely carcinogen for 
inhalation in a work health and safety context  
a. we would like to suggest that consideration be given to removing 'all routes of exposure' 
from the proposed Category 1B Carcinogen classification of cobalt metal, for example 
applying an interim classification for the inhalation route only i n the absence of further 
scientific evidence  
b. consideration could also be given to exempting uses where the cobalt is bound and not 
bioavailable, for example in alloys like stainless steel.  
 
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