   
  
G/TBT/W/628  
 
8 April  2019 
(19-2235) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - TITANIUM DIOXIDE: REGUL ATION (EC) NO . 1272/2008  
(CLP REGULATION), AN NEX VI, PART 2  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
6 AND 7  MARCH  2019 
The following communication, dated 5 April  2019, is being circulated at the request of the delegation 
of the European Union . 
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1.  The EU would like to thank  the Delegations of the United States,  Canada, New Zealand and 
Australia for their  comments on the draft Regulation on hazard classifica tion of several substances, 
including cobalt and t itanium dioxide , amending the EU Regulation (EC) No . 1272/2008 on the 
classification, labelling and packaging of substances and mixtures (CLP Regulation).  
2.  Titanium dioxide and cobalt have been included in the 2018 Adaptation to Technical and scientific 
Progress (ATP) amending the CLP Regulation. Several  discussions on the classification of cobalt and 
TiO2 and the classification of mixtures containing TiO2 have taken place in the expert gro up for 
REACH and CLP ("CARACAL")  and in the regulatory committee (the REACH Committee). In addition, 
a full -day meeting of the CARACAL SubGroup was organised, dedicated to a discussion of the 
classification of TiO2.  
3.  The proposed classification of cobalt a nd TiO2 are based the Risk Assessment Committee 
(i.e., RAC, one of the scientific committee of the European Chemical Agency) opinion as well as of 
the comments received and concerns expressed by Member States and stakeholders.  
4.  With regards TiO2:  only the r espirable particles of TiO2 (diameter smaller than 10 µm) will be 
classified as suspected carcinogen. In addition, the introduction of a note is proposed to limit the 
classification of mixtures to the ones placed on the market in powder form and if they co ntain more 
than 1% of such small TiO2 particles. Liquid mixtures (e.g., paints) as well as solid mixtures will not 
have to be classified. For such non -classified mixtures, the addition of a sentence on the label is 
proposed:  'Warning! Hazardous respirable  droplets /dust may be formed when sprayed /used . Do not 
breathe sp ray or mist/dust) .  
5.  The downstream legal consequences of classification of TiO2 as a carcinogen Category 2 remain 
limited in our view. The most significant consequences occur for substances cl assified as carcinogen 
category 1, rather than category 2. Substances classified as carcinogens category 1 are normally 
directly banned in  cosmetics, toys, pesticides and REACH for consumer uses . However, for 
carcinogen category 2, there are no such direct  significant consequences. More specifically, with 
regard to  legislation on plant protection products, biocidal products, food additives, contaminants, 
water and pharmaceuticals , there would be no or minor consequences Regarding other sectoral 
legislation,  the use of TiO2 could continue under certain conditions (e.g. granting of authorisation, 
exemption, demonstration of safe use): this is the case for waste, food contact materials, plastic 
food contact materials, toys, feed additives, cosmetics and EU Ecol abel.   
6.  Regarding cobalt, the Commission believes that the classification as carcinogen for all route of 
exposure as advised by RAC is in line with the CLP Regulation as well as the UN GHS ( UN Globally 
Harmonized System of Classification and Label ling of C hemicals ). However, the Commission 
considered that the method that was used to determine the Specific Concentration Limit of 0.01% G/TBT/W/628  
 
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  should be assessed in order to discuss if the method is relevant for inorganic compounds like TiO2. 
The proposed entry of Cob alt is without such specific limit and the generic limit of 0.1% should be  
therefore applied.  
7.  The EU would like to reassure the TBT Committee that all comments sent by WTO Members have 
been distributed to Member States and they will be duly taken into acc ount by the Commission and 
Member States in the decision making process for the formal adoption of a RAC opinion.  A vote in 
the REACH Committee should  take place on 7 of March 2019.  
8.  Finally, the EU would like to stress that ECHA's RAC committee took into a ccount in its scientific 
assessment all available data, including the information submitted during the public consultation 
period. Review of a RAC opinion is only possible if new scientific information is available.  
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