G/TBT/W/588  
 
14 December 2018  
(18-7922) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION — REVISED PROPOSAL FOR TH E CATEGORIZATION OF COMPOUNDS 
AS ENDOCRINE DISRUPT ORS OF 19 FEBRUARY 2 013 BY DG ENVIRONMEN T  
STATEMENT BY CANADA  TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
14 AND 15  NOVEMBER  2018 
The following communication, dated 13 December 2018 , is being circulated at t he request of the 
delegation of Canada . 
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1.  Canada is concerned with the hazard -based approach the EU has taken on the regulation of active 
ingredients. First, as we h ave mentioned on numerous occasions in both this Committee and the 
WTO SPS Committee, hazard -based cut -offs, without  giving consideration to exposure or without 
performing  a complete risk assessment, appears to be at odds with the WTO commitments we have 
all accepted, and can unnecessarily restrict trade.  There is a growing number of examples where 
active ingredients are prevented from going through the entire re authorization process in the EU 
due to these hazard -based cut -offs.  
2.  Second, as we have express ed in past meetings, Canada is concerned with the EU 's criteria for 
identifying compounds as endocrine disruptors . Even more concerning is the hazard -based approach 
to regulatory decision -making once a compound is identified as an endocrine disruptor, or m eet 
other hazard -based cut offs, such as reproductive toxicants, which lead to the regulatory non -
approval of substances and default maximum residue limits, regardless of actual risk.   
3.  Canada was disappointed that the regulatory amendment for derogation ba sed on negligible risk 
originally notified to the WTO in 2016 was not included in Commission Regulation (EU) 2018/605. 
Without the inclusion of this technical amendment, default MRLs for food and feed are required once 
a substance is identified as an 'endocrine disrupting chemical ', regardless of actual risk under real 
world exposure scenarios.  
4.  Canada would like to reiterate, as we have previously expressed at the TBT and SPS Committee 
meetings and in Brussels, that we remain deeply concerned with the EU 's movement towards a 
hazard -based approach for regulatory decisions for pest control products. It is at odds with good 
regulatory practice and it appears offside with the EU 's WTO obligations.  
5.  Canada would agree that the hazard identification of a chemical i s an important first step in the 
scientific risk assessment framework.  However, it is imperative that potential adverse effects be put 
into context with consideration of potency, and the level of likely human and environmental exposure 
based on the conditi ons of use.  
6.  More broadly, Canada seeks concrete assurance from the EU that decisions on setting MRLs and 
import tolerances will continue to be made on the basis of complete risk assessments, as set out in 
Regulation 396/2005.  
7.  Canada urges the EU to ensure it is respecting its international trade commitments when 
determining its approach to setting import tolerances for the categorization of compounds as 
endocrine disruptors , and for establishing all import tolerances.  G/TBT/W/588  
 
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  8.  Canada would also appreciate informatio n detailing how the EU plans to work with trading 
partners to develop its revised measure in a manner that is consistent with its international trade 
obligations, and that avoids unnecessary disruptions to trade.  
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