G/TBT/W/609  
 
22 March 2019  
(19-1781) Page: 1/2 
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 UNITED STATES  TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
6 AND 7  MARCH  2019 
The following communication, dated 21 March 2019 , is being circulated at the request of the 
delegation of the United States . 
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1.  We would like to discuss the proposed harmonized classifications, labeling , and formulation 
requirements , via the EU 's CLP regulation,  for the substances: titanium  dioxide and cobalt, and the 
trade impacts these new requirements will on the substances and products that contain these 
substances . 
2.  The new proposed requirements as notified in G/TBT/N/EU/629, may be unnecessarily disruptive 
to billions of dollars in US-EU trade.  
3.  We are also concerned that the EU's process to reclassify and label these two substances have 
not been transparent in terms of when potential regulatory actions under CLP are notified to the 
WTO and providing time for meaningful consideration of WTO member comments.  
4.  Disappointingly, while the EU provided a sixty-day comment period via the WTO on the draft 
regulation ending on 10 February , the Commission met to vote on the draft regulation on 
14 February , only four days after the WTO comment per iod closed, which raises questions about 
how comments were taken into account.  
5.  While the Commission's vote had to be delayed until 7 March, this rush to finalize the measure 
without meaningful consideration of WTO member comments, is surprising, as the not ification 
received over 400 comments via the WTO and the EU's domestic Better Regulations consultation.  
6.  In the case of Titanium Dioxide, the US has submitted questions to the European Commission 
asking them to clarify how the draft regulation for TiO2 alig ns with the UN Globally Harmonized 
System (GHS) for the labeling and classification of chemicals, and if not, why?  
7.  The US has asked for clarification, since if we understand the notified classification correctly, it 
may require a substance that the EU has in the ECHA scientific opinion labeled as "low toxicity" to 
be classified as a carcinogen.  
8.  We have also asked ECHA to clarify which products and articles in addition to chemicals will be 
impacted by the draft regulation notified to the WTO, as these were not included in the notification, 
despite there being many.  
9.  We are concerned that a number of products that contain Titanium Dioxide, including paints, 
cosmetics and plastics will have to reformulate or be labeled as containing a carcinogen.  
10.  Similarly, i n the case of cobalt, we do not understand why the Commission is rushing towards 
a restriction on the presence of cobalt in metal compounds.  G/TBT/W/609  
 
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  11.  The EU, by its own admission in the text of notified draft regulation, notes that it has not yet 
completed its scie ntific assessment of cobalt in metal compounds, and yet instead of issuing an 
exemption for metal compounds until testing could be completed, the European Commission is 
moving forward.  
12.  If this restriction goes through for example, it will affect US export s of medical products and 
food processing equipment to the EU, since the stainless steel in these products contains two to 
three percentage cobalt, which cannot be removed. The EU restriction is based upon an arbitrary 
one percent generic limit set by CLP -rather than an actual scientific evaluation.  
13.  Given these concerns, we ask that the EU postpone its vote on the proposed classification and 
labeling proposals on these two substances, until it can:  
• Undertake a meaningful review of the other 400 comments pr ovided via the draft 
regulation notification  
• Address in its response to WTO TBT Committee Members, if the EU is diverging from the 
GHS for TiO2 and why, given that there are far less trade disruptive alternatives  
• Consider delaying the inclusion of metal co mpounds in the CLP ATP listing for cobalt, until 
the necessary testing is completed  
• We also request that the EU in its response to comments, also consider how it might adapt 
the timing and use of WTO notifications in its regulatory processes for both the R EACH 
and CLP regulations, so as to ensure that comments by interested parties can be taken 
into account.  
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