G/TBT/W/684  
 
25 November 2019  
(19-8000) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION – TITANIUM DIOXIDE: REGUL ATION (EC) NO 1272/2 008 (CLP 
REGULATION), ANNEX V I, PART 2  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
13 – 15 NOVEMBER  2019 
The following communication, dated 13 November  2019, is being circulated at the request of the 
delegation of the European Union . 
 
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1.   And thank you to the Delegations of the United States, Mexico, Canada, the Russian Federation, 
Australia, J apan and New Zealand for their comments on the draft Regulation on hazard classification 
of several substances, including cobalt and titanium 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 classificati on of mixtures containing TiO2 have taken place in the expert group 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. A draft Commission Regulation was discussed in the REACH Committee of 
February and March 2019. Taking into account the upcoming change of the legal procedure for the 
adoption of amendments to the CLP Regulation, the 14th ATP to CLP  was adopted by the Commission 
on the 4 October 2019. The Council and the European Parliament will have two months objection 
period following the adoption and transmission of the measure. The proposed classification of cobalt 
and TiO2 is based on the Risk Assessment Committee's (i.e., RAC, one of the scientific committees 
of the European Chemicals Agency) opinion as well as on the comments received and concerns 
expressed by the Member States and stakeholders.  
3.  With regard to TiO2, only the respirable particl es 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 with a diameter smaller 
than 10  µm and if they contain 1% or more 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! Hazard ous respirable droplets/dust may be formed 
when sprayed/used. Do not breathe spay or mist/dust).  
4.  The downstream legal consequences of the classification of TiO2 as a carcinogen Category 2 
remain limited in our view. The most significant consequences occur  for substances classified 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 
carcinogens category 2, there  are no such significant direct consequences. More specifically, with 
regard to the legislation on plant protection products, biocidal products, food additives, 
contaminants, water and pharmaceuticals, there would be no or minor consequences. Regarding 
other 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 food contact materials, 
plastic food contact materials, toys, feed additives, cosmetics and  EU Ecolabel. Finally, waste 
containing TiO2 would be classified as hazardous only if it was in powder form and TiO2 exceeded G/TBT/W/684  
 
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  the above -mentioned concentration limit, so that the impact under waste legislation would also be 
limited.  
5.  With regard to cobalt,  the Commission believes that the classification as carcinogen for all routes 
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 Labelling of Chemicals). However, the Commission 
considered that the method that was used to determine the Specific Concentration Limit of 0.01% 
should be assessed in order to discuss if the method is relevant for inorganic compounds like TiO2. 
The proposed entry in Annex VI to CLP for cobalt is without such specific limit and the generic limit 
of 0.1% will therefore be applied.  
6.  The EU would like to reassure the TBT Committee that all comments sent by WTO Members have 
been distributed to Member States and they have been and will be duly taken into account by the 
Commission and Member States in the decision -making process for the formal adoption of a RAC 
opinion. Finally, the EU would like to stress that ECHA's RAC committee took into account in its 
scientific assessment all available data, incl uding 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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