G/TBT/W/592  
 
20 December 2018  
(18-8070) Page: 1/1 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - TITANIUM DIOXIDE: REGUL ATION (EC) NO 1272/2 008  
(CLP REGULATION), AN NEX VI, PART 2  
STATEMENT BY THE EUR OPEAN UNION TO THE C OMMITTEE ON TECHNICA L BARRIERS TO TRADE  
14 AND 15 NOVEMBER 2 018 
The f ollowing communication, dated 18 December 2018, 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 Delegation of the United States for its comments on the RAC 
opinion on the hazard classification of titanium dioxide by th e ECHA risk assessment committee 
(RAC) in accordance with EU Regulation (EC) No 1272/2008 on the classification, labelling and 
packaging of substances and mixtures (CLP Regulation). The RAC opinion was delivered in 
September 2017.  
2.  Titanium dioxide has been  included in the 2018 Adaptation to Technical and scientific Progress 
(ATP) amending the CLP Regulation. Several discussions on the classification of 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 topic.  
3.  The proposed entry into Annex VI to CLP takes account of the RAC opinion  as well as of the 
comments received and concerns expressed by Member States and stakeholders: only the respirable 
particle of TiO2 (diameter smaller than 10 µm) will be classified as suspected carcinogen. In addition, 
the introduction of a note is propose d for the classification of mixtures. Only mixtures containing 
more than 1% of such small TiO2 particles and placed on the market in powder form will have to be 
classified. Liquid mixtures containing more than 1% of these particles will not have to be clas sified. 
For such non -classified mixtures, the addition of a sentence on the label is proposed: 'Warning! 
Dangerous droplets may be formed when sprayed. See information supplied by the manufacturer. 
Comply with the safety instructions '.  
4.  The downstream lega l consequences of 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 categor y 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.  
5.  The EU would like to reassure the TBT Committee that any proposal to classi fy titanium dioxide 
as a carcinogenic substance to be included in Annex VI of the CLP Regulation will be notified to the 
WTO, as usual, at the latest 60 days before the vote in the REACH Committee. All comments sent 
by WTO Members will be duly taken into a ccount by the Commission in the decision making process 
for the formal adoption of a RAC opinion. A vote in the REACH Committee will at the earliest take 
place in February 2019.  
6.  Finally, the EU would like to stress that ECHA's RAC committee took into accou nt 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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