G/TBT/W/457  
 
17 November 2017  
(17-6298) 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 FEBRUARY 2 013 BY DG ENVIRONMEN T 
STATEMENT BY CANADA  TO THE TBT COMMITTEE , 8-9 NOVEMBER 2017  
The following communication, dated 17 November 2017, is being circulated at the request of the 
delegation of Canad a. 
 
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1.  Canada is concerned with the hazard -based approach the EU is taking on the regulation of 
active ingredients.  
2.  First, as w e have mentioned on numerous occasions in both this Committee and the WTO SPS 
Committee, hazard -based cut -offs, without giving any consideration to exposure or without 
performing a complete risk assessment, can unnecessarily restrict trade. There is a grow ing 
number of examples where active ingredients are prevented from going through the re -
authorization process in the EU based on hazard -based cut -offs, such as glufosinate ammonium, 
and now possibly propiconazole.  
3.  Second, as we have expressed in past meet ings, Canada is concerned with the EU 's proposed 
criteria for identifying compounds as Endocrine Disruptors.  
4.  Even more concerning is the hazard -based approach to regulatory decision -making once a 
compound is identified as an endocrine disruptor, or meets other hazard -based cut -offs, such as 
for reproductive toxicants. Such European Chemical Agency classification decisions trigger 
regulatory non -approval and default maximum residue limits (MRLs), regardless of actual risk, in 
the opinion of the European Foo d Safety Authorit y.  
5.  Now, while there was hope that the derogation process would provide a way to address trade -
related concerns, Canada was disappointed that the regulatory amendment for derogation based 
on negligible risk was not introduced in the Europe an Parliament. This means that 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.  
6.  Canada was further dismayed to learn of the Euro pean Parliament 's 4 October  2017 decision to 
object to the European Commission 's draft regulation setting out criteria for identifying endocrine 
disruptors in the area of plant protection products (PPPs).  
7.  While this objection temporarily delays the adopti on of the criteria, which Canada has not 
supported without the accompanying derogation, it creates further long -term uncertainty and 
unpredictability for exporters seeking to gain or maintain access to the European market.  
8.  In the wake of this objection, th e implementation of the European Union 's interim criteria have 
the potential to remove twice as many pesticide active ingredients from the market than those set 
out in the proposed criteria.  
9.  As the EU reconsiders its approach – on endocrine disruptors and  more broadly, Canada would 
agree that the hazard identification of a chemical is an important first step in the scientific risk 
assessment framework.  However, it is our view that it is even more  imperative that potential G/TBT/W/457  
 
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  adverse effects be put into contex t with consideration of potency, and the level of likely human 
and environmental exposure based on the conditions of use.  
10.  More broadly, Canada seeks concrete assurance from the EU that decisions on setting MRLs 
and import tolerances will continue to be mad e on the basis of complete risk assessments, as set 
out in Regulation 396/2005.  
11.  Canada urges the EU to take its international trade commitments into account when 
determining its approach to setting import tolerances, for the categorization of compounds as 
endocrine disruptors, and for establishing all import tolerances.  
12.  Canada appreciates the efforts of the EU regarding the extensive consultations taken to 
inform the Committee of developments in this area, and would appreciate any update from the EU 
on plan ned next steps for this criteria.  
13.  Canada would also appreciate information 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 avoid unnec essary disruptions to market access.  
 
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