G/TBT/W/563  
29 November  2018 
(18-7542) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
EUROPEAN UNION – REVISED PRO POSAL FOR THE CATEGORIZATION  
OF COMPO UNDS AS ENDOCRINE DISRUPTORS OF  
19 FEBRUARY 2013 BY DG ENVIRONMENT  
STATEMENT B Y ARGENTINA TO THE COMMITTEE ON  
TECHNICAL BARRIERS TO TRADE  
14 AND 15 NOVEMBER 2018  
The following communication, dated 22  November  2018, is being circulated at the request of the 
delegation of Argentina . 
 
_______________  
 
 
1.  Argentina wishes to refer once again to the EU's policy on pesticides, in o rder to reiterate its 
concerns with respect to the "hazard -based" approach taken by the EU for identifying substances 
with endocrine -disrupting properties, instead of one based on a "complete risk assessment ". 
2.  Regrettably, the EU has decided to take an approach that creates unnecessary obstacles to 
international trade in agricultural products, having opted for an alternative that restricts trade more 
than is necessary to fulfil a legitimate objective, such as the protection of health and the 
environment.  
3.  Furthermore, the European Commission recently published the Communication "Towards a 
comprehensive framework for endocrine disruptors in the EU" with a view to extending the approach 
applied to pesticides and biocides to other products (e.g. toys, cosmeti cs, packaging or material in 
contact with food) , based on the "precautionary principle".  
4.  Throughout all our interventions in this Committee as well as the SPS Committee, our country 
has made clear its recognition of the right of each WTO Member to ensure a  high level of protection 
of human health and the environment . This right is not unlimited, however, and must be exercised 
within the framework of the WTO Agreements, in particular the TBT and SPS Agreements.  
5.  Regulation (EU) 2018/605, amending Annex II to Regulation (EC) No. 1107/2009 by setting out 
scientific criteria for the determination of endocrine -disrupting properties, took effect on 
10 November  last, and it is therefore urgent for the EU to provide clarifications on issues already 
raised by our coun try at the recent meeting of the Committee o n Sanitary and Phytosanitary 
Measures . At the time our country posed a series of questions that were not fully answered . With 
our thanks in advance for any information and comments that the EU may offer in this r egard, we 
would like  to revert to the following specific issues:  
- We would be grateful if the EU could explain what is meant by "legitimate factors" in the 
framework of the decision to be taken by the Commission once the European Food Safety 
Authority (EFSA ) issues an opinion under Regulation No. 396/2005 . Could these factors 
reverse a favourable EFSA opinion ? If so, in what cases or circumstances  has this happened before?  
 
- How does the EU envisage an efficient and pragmatic system for the application of import 
tolerances that ensures that import tolerances will continue in force when MRLs are abolished 
in the EU ? This would be necessary in order to avoid creating trade barri ers by temporarily 
and unnecessarily eliminating import tolerances,  then reinstating them after an interval that 
is disruptive to trade.  G/TBT/W/563  
- 2 - 
  6.  Furthermore, as regards the proposal on derogations, it is noted that the said proposal is not on 
the agenda for furthe r discussion/voting by the Standing Committee on Plants, Animals, Food and 
Feed (SCoPAFF) . This state of uncertainty is deeply worrying because, if the proposal on derogations 
is not adopted, the use of those substances exposure to which represents "insign ificant risk" of 
endocrine disruption would be prohibited without any scientific justification . We therefore wish to 
urge the Commission to expedite the treatment of the matter by the said Committee, with a view to 
its early approval.  
7.  Finally, we request t he Commission, in regard both to substances with endocrine -disrupting 
properties and to any other substance coming under the cut -off criteria, to maintain maximum 
residue levels and the application of import tolerances on the basis of risk assessments, hav ing 
regard to the provisions of Regulation No. 396/2005 . Otherwise, we will be faced with the creation 
of more significant, unnecessary and disproportionate barriers to international trade in agricultural 
products, without any scientific justification.  
__________