G/TBT/W/666  
 
22 July 2019  
(19-4826) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION — REGULATION (EC) NO 1272 /2008 (CLP REGULATIO N) 
STATEMENT BY THE RUSSIAN FEDERATION  TO THE COMMITTEE ON  TECHNICAL BARRIERS  
TO TRADE  - 20 AND 21 JUNE 2019  
The following communication, dated 19 July 2019, is being circulated at the request of the delegation 
of the Russian Federation . 
 
_______________  
 
 
1.  In the document G/TBT/N/EU/629  the European Union notified the draft amendments to 
Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, 
labelling and packaging of substances and mixtures and corrigendum to the Commission Regulation 
(EU) No. 2018/669.  
2.  The proposed amendments by the European Union include, inter alia, classification of cobalt as 
a carcinogen category 1B for all routes of exposure under the CLP regulation, and a s a reprotoxic 
category 1B. The proposal could disrupt trade in a wide variety of products containing even small 
amounts of cobalt such as stainless steel. Given that stainless steel is the largest end -use of nickel, 
the proposal could also affect trade in  nickel and nickel goods, such as nickel concentrates or mattes.  
3.  Since Russia 's comments mostly were left unaddressed by the European Union we had to raise 
the issue in the Committee.  
4.  The EU 's proposal has not taken into consideration the full range of stu dies to come to this 
proposed classification and the full range of impacts that could result from the proposed 
classification. In particular, the carcinogenicity classification for the inhalation route of exposure is 
based on the results of a two -year carc inogenicity study in mice and rats by inhalation. Nevertheless , 
there is no data, animal or human, to indicate that the oral rou te is of concern. There is also no 
evidence  of systemic tumors in the workers ' medical history  and in patients with cobalt containing 
alloy implants . We note that the best international practice of classification of chemicals stipulates 
for classification decisions made on the basis of risk rather than hazard .  
5.  The classification of cobalt containi ng metal as  a Repro toxic category  1B is also considered to be 
precautionary and not based on solid evidence. T here are no definitive one -generation, two 
generation, or extended one generation studies with cobalt containing metal that demonstrate 
reproducti ve effects or support this classification . 
6.  We are deeply concerned that the Commission decides to rush w ith the classification proposal 
for all routes  of exposure  in the absence of solid positive systemic carcinogenicity animal data while 
in the presence o f thousands of data points in humans where an absence of cancer is noted. The 
only case where such a course of action would be justifiable is the case when there are reasonable 
grounds to suspect serious and immediate threat to public health, which is not the case here.  
7.  This approach contr adicts REACH provisions  that are based on the idea that industry itself is best 
placed to ensure that the chemicals it manufactures and puts on the market in the EU do not 
adversely affect human health or the environment.  
8.  There are no reasonable grounds for foregoing an imminent scientific research that will provide 
hard data for sound decisions and push for a pre -emptive classification without data.   G/TBT/W/666  
 
- 2 - 
 
  9.  We are aware  of the ECHA 's RAC opinion and we note  one more time  that th is opinion is not  
based on scientific data as neither the opinion nor the background document contain references to 
actual scientific data showing CMR  effects of the cobalt metal for all routes of exposure. We shall 
refer to this fact further on here below .  
10.  The new information, the EU delegation usually refers to, has not yet been considered by the 
International Agency for Research on Cancer  as sufficient for reviewing the existing opinion on the 
CMR classification  of the cobalt metal.  
11.  Russia questions the lack of consideration to the procedure of the WTO notification, as the 
Commission initially scheduled a vote on the regulation only 4 days after the WTO commenting 
period had expired. Russia understands that many comments have been rec eived, and it seems that 
the European Commission has gone ahead without meaningful consideration of the WTO Members ' 
comments. Hence forth, Russia is asking the EU to undertake a thorough review of the comments 
received.  
12.  Finally, it also seems the measure m ay be considered inconsistent with the Article 2.2 of the 
Agreement on TBT because it  is more trade restrictive than necessary, Article 2.4 because the 
methodology is not based on international practices and recommendations  and obligations under 
Article 2. 9.2 because the adaptation period was not provided.  
13.  Besides, we take note that the proposed classification has already caused negative  public 
perception of stainless steel as carcinogen , because large consumers, such as IKEA started to make 
requests for  Cobalt-free stainless steel . 
14.  As far as we know, t he European Commission has changed t rack in its attempt to classify 
titanium dioxide and cobalt as a ca rcinogen and will now try to push through the CLP proposal in the 
form of a delegated act .  
15.  Commission  will cons ult on the draft Regulation containing  titanium dioxide and cobalt 
classification with its expert group, most likely the competent authorities for REACH and CLP 
(Caracal). Discussions are expected on 1 July 2019 . 
16.  In this sense, we kindly ask the EU t o provide us with the detailed clarifications regarding this 
procedure.  
17.  In conclusion, the Russian Federation requests that  the European Commission : 
a. refrain from including the current proposal on cobalt metal in the CLP until further studies 
clarify the ne cessity of such classification.  
b. propose a new classification of Cobalt that would be based on scientific grounds. It shall 
not contain the classification for all routes of exposure and shall be based on toxicological 
data. 
c. abandon the unscientific chemical classification methodology.  
 
__________