G/TBT/W/657  
 
18 July 2019  
(19-4778) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION — REGULATION (EC) NO 1272 /2008 (CLP REGULATIO N) 
STATEMENT BY THE EUR OPEAN UNION TO THE C OMMITTEE ON TECHNICA L BARRIERS TO TRADE  
20 AND 21 JUNE 2019  
The following communication, dated 17 July 2019, is being circulated at the request of the delegation 
of the European Union . 
 
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1.  The European thanks the Delegations of the United States and Mexico for their comments on the 
draft Regulation on hazard classification of several su bstances, 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 Adaptatio n 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 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 
Februa ry and March 2019. Taking into account the upcoming change of the legal procedure for the 
adoption of amendments to the CLP Regulation, the Commission will continue the discussion 
(provisionally scheduled for July) in the framework of the CARACAL expert gr oup, before deciding 
on the adoption of a Commission Delegated Regulation.  
3.  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.  
4.  With regard to TiO2, only the respirable particles of TiO2 (diameter smaller than 10 µm) will be 
classified as suspected carcinogen. In addition, the introductio n 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 m ixtures 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 spay or mist/dust).   
5.  The downstream l egal 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 protectio n 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/657  
 
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  the above -mentioned concentration limit, so that the impact under waste legislation would also be 
limited.  
6.  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). Howev er, 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% 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 have been and will be d uly 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, 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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