G/TBT/W/726  
 
10 March  2020 
(20-1848) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - REGULATION (EC) NO 1272 /2008 (CLP REGULATIO N) 
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
26 – 27 FEBRUARY  2020 
The following communication, dated 9 March  2020, is being circulated at the request of the 
delegation of the European Union . 
 
_______________  
 
 
1.  The European Union thanks the Delegations of Russia for its comments on the draft Regulation 
on hazard classification of several substances, including cobalt a nd 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 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 
February and March 2019. Taking int o account the 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 
4 October 2019. The Council and the European Parliament have not objected to the measure, so it 
has has been published in the Official Journal of the EU. The classification of TiO2 and cobalt will 
thus become applicable as of 1 October 2021 but may be applie d before that date on a voluntary 
basis. The 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 concern s expressed by the Member States and stakeholders.  
3.  With regard to TiO2, only the respirable particles of TiO2 (diameter smaller than 10 µm) will be 
classified as suspected carcinogen. In addition, a note was introduced to limit the classification of 
mixtur es 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 -classifi ed mixtures, the addition of a sentence 
on the label is required: "Warning ! Hazardous 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 carcino gen 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, with regard to the legislation on plant protection products, biocidal products, 
food additives, contaminants, water and pharmaceuticals, there will be no or minor consequences. 
Regarding other legislation, the use of TiO2 can 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, cosm etics and EU Ecolabel. Finally, waste 
containing TiO2 will be classified as hazardous only if it is in powder form and TiO2 exceeds the 
above -mentioned concentration limit, so that the impact under waste legislation will also be limited.  G/TBT/W/726  
 
- 2 - 
 
  5.  With regard to co balt, 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 cobalt. 
The 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 duly taken into account b y the Commission 
and Member States in the decision -making process. 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 consu ltation period. Review of a RAC opinion is only possible 
if new scientific information is available.  
 
__________