G/TBT/W/704  
 
29 November 2019  
(19-8216) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - TITANIUM DIOXIDE & C OBALT REGULATION NO.  1272/2008  
(CLP REGULATION)  
STATEMENT BY THE UNITED STATES 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 United states . 
 
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The United States ' concerns with the EU 's CLP regulations for the classification and labeling of 
chemicals an d products are well known.  
a. First, we are concerned about the lack of transparency of how the EU notifies and conducts 
public consultations on chemicals via the CLP regulation, both within the EU and to the 
WTO. 
b. Second, the EU 's WTO notifications tend to c ome only after its own scientific and regulatory 
committees have completed their sometimes years -long reviews, raising transparency 
concerns regarding consideration of international stakeholder input at an early and 
appropriate stage in the development of a regulation.  
c. For highly complex products, such as chemicals, where the science of assessing hazards 
and risks is quickly evolving and scientific studies can take years, this is a missed 
opportunity to meaningfully integrate international participation and  comments, bringing 
the consultative intent of the EU 's WTO notifications into question.  
d. Third, we are disappointed that in the cases of specific substances such as TiO2 and cobalt, 
the EU has not sought to consult with, much less address, the concerns of many WTO 
Members, who have provided substantive comments on the proposed classification and 
labeling requirements.  
The U.S. specifically inquired for TiO2 as to why ECHA did not follow well -established 
methodologies to test inhalation toxicity —and why the Commission continues to side -step relevant 
international standards for chemical classification and labeling such as the UN Globally Harmonized 
System for the Classification of Chemicals that would allow for the management of any "potential 
hazard " from TiO2 particles without disrupting trade.  
The United States has several questions regarding the delegated act that is now pending 
legislation with the European Parliament and the EU Council of Ministers:  
a. The delegated act adds a new amendment to the CLP Regulation on the criteria used to 
classify and to label all substances henceforth —not just TiO2 and cobalt.  
b. This amendment, Note W, states that when the carcinogenic hazard of a substance arises 
from inhalation of respirable dust, that this is not a "criterion for classification: "  
i. Can you explain this amendment, and how it will affect the classification of all 
substances —not just TiO2 —with respirable dust?  G/TBT/W/704  
 
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  ii. [If relevant, following EU response] Why does the delegated act still propose that TiO2 
be lis ted as a carcinogen via inhalation in Annex VI, if it cannot be classified based on 
inhalation of "respirable dust? " 
We also take note of the concerns from downstream industries, such as the toy industry, who 
have stated that they find the TiO2 labeling re quirements in the delegated act confusing —particularly 
as it requires a hazard label for all liquid and solid mixtures containing TiO2, even when there are 
other EU regulations that govern the safety of chemicals when used in these products.  
a. For example, why do toys such as finger paint have to carry a hazard label even when 
they are considered safe under the EU Toy Safety Directive?  
We would also appreciate if the EU could confirm if stainless steel will be considered a case 
requiring further evaluation u nder Article 12 of the CLP Regulation, and not subject to the cobalt 
classification and labeling requirements, as the Commission did not have enough information to 
determine if there is a risk of cobalt exposure via metal compounds.  
Given the extent of the  concerns and comments expressed by many WTO members as to the 
trade disruptions of the EU 's actions on TiO2 and cobalt, as well as the CLP regulation more broadly, 
we ask that the ECHA and the Commission consider how it can bring greater transparency and 
consideration of WTO members and industry inputs in the future.  
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