G/TBT/W/541  
 
20 June 2018  
(18-3884) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION — REVISED PROPOSAL FOR  THE CATEGORIZATION O F COMPOUNDS 
AS ENDOCRINE DISRUPT ORS OF 19 FEBRUA RY 2013 BY DG ENVIRO NMENT  
STATEMENT BY THE UNI TED STATES TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
20 AND 21  JUNE 2018 
The following communication, dated 20 June 2018 , is being circulated at the request of the 
delegation of the United States . 
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1.  The United States takes the floor to raise our ongoing concerns with the EU 's hazard -based 
approach to regulating s ubstances identified as endocrine disruptors.  
2.  We understand that on 20 April the European Commission formally adopted criteria for 
identifying endocrine disruptors in plant protection products, and will implement these criteria on 
November 10.  We would li ke to note that these revised criteria which have now been adopted will 
lead to the banning of many more substances than previously suggested in the EU 's 2016 WTO 
notifications.  
3.  Could the EU clarify how it is applying the interim criteria during this perio d leading up to the 
November 10 implementation date? Particularly, in light of statements delivered to the European 
Parliament by Commissioner Andriukaitis that "there is no benefit for health and the environment 
in keeping the interim criteria," and the c riteria are "clearly not fit for purpose" as they "fail to 
identify real endocrine disruptors."  
4.  The EU recently notified a proposal to withdraw authorization for the active substance 
pymetrozine (G/TBT/N/EU/554). Although the European Food Safety Authority  did not finalize an 
assessment on the potential for endocrine disruption, the EU nevertheless considered this 
substance to have endocrine disrupting properties in accordance with the interim criteria in 
Regulation (EC) No. 1107/2009.  
5.  We ask that the EU ex plain how these actions achieve its objectives. By simply identifying 
hazards without identifying potential risks or considering reasonable methods for managing risk —
or worse yet, identifying hazards using criteria that are not even clearly fit for that pu rpose—these 
actions may offer no benefit, and indeed hurt the public by removing access to important tools.  
6.  We also understand that the EU is in the process of clarifying its policy for managing import 
tolerances for substances that trigger the hazard -based cut -offs, and that this policy involves 
consideration of import tolerances only on a "case -by-case" basis, factoring in "legitimate factors" 
and the precautionary principle.  
7.  Regrettably, the EU 's case -by-case approach does not seem to be examining the s pecific 
circumstances relevant to each substance, as would be considered in a risk -based approach. No 
one has answered what a "legitimate factor" is, which leads to an ad -hoc approach to the precise 
legal regime that may apply.  
8.  This ad -hoc approach will ca use considerable uncertainty for applicants and producers. Nor 
would it obscure any WTO concerns or satisfy the concerns raised by Members in this Committee. 
If the EU is interested in addressing those concerns, the EU needs to clarify this matter with G/TBT/W/541  
 
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  precision by explaining what the factors are, how these factors relate to safeguarding human 
health and the environment, how long the process is anticipated to take, and how producers can 
effectively take advantage of it.  
9.  We continue to remind our European co lleagues that other less trade restrictive regulatory 
approaches exist that provide the high levels of human health and environmental protection, 
without posing unnecessary barriers to trade.  
10.  To that end, we stress the importance that is approach comport with the principles of non -
discrimination, transparency, necessity, and predictability in the implementation of TBT measures.  
 
 
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