  
  
G/SPS/GEN/1762  
3 March  2020 
(20-1585)  Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
 
SPECIFIC TRADE CONCE RNS – EUROPEAN LEGIS LATION ON  
ENDOCRINE DISRUPTORS  (NO.382 ) 
COMMUNICATION FROM P ARAGUAY  
The following communication , received on  26 February  2020, is being circulated at the request of 
the delegation of Paraguay . 
 
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Paraguay wishes to put the foll owing questions to the European Union (EU) regard ing specific trade 
concern No. 382 and the European legislation on endocrine disruptors . 
 
 
1  EUROPEAN LEGISLATION ON ENDOCRINE DISRUPTORS ( G/SPS/N/EU/166/ADD.2 ) 
1.  Could the EU provide a scientific definition of "endocrine disruptors "? 
2.  Commission Regulation (EU)  2018/605 – on scientific criteria for the determination of endocrine 
disrupting properties  – establishes in recital (3) of its preamble that the implementation  of the 
criteria should be based on "all relevant  scientific evidence ", inclu ding studies submitted  in 
accordance with Regulation (EC) No  1107/2009, which are "mostly  based on internationally agreed 
study protocols ". In light of the above : 
(a) Can the EU explain  how it distingu ishes between relevant  scientific evidence and 
non-relevant scientific evidence?  
(b) Can the EU indica te which  other protocols form the basis for studies that are not based 
on internationally agreed study protocols?  
3.  Could the EU explain how the provisions of Commission Regulation (EU) 2018/605 are in 
conform ity with the obliga tions set out  in Articles 5.1 and 5.2 of the SPS Agreement?  
4.  Could the EU expand on  how its risk assessments take account of  key elements  of risk 
characterization , such as the strength , severity and reversibility  of effects?  
5.  Commission Regulation (EU) 2018/605  establishes in recital (4) of its preamble  that "both known 
and presumed endocrine disrupting substances" must be identified . Does the EU consider that the 
application of Commission Regulation (EU) 2018/605 is covered by Article 5.7 of the SPS Agreement?  
6.  Does the EU consider that the prohibition o f substances to which exposure represents  a negligible  
risk of endocrine disruption is scientific ally justified ? 
7.  Could the EU provide more details on how the " import tolerance " mechanisms  will function that 
are provided for in Regulation (EC) No 396/2005 o n maximum residue levels of pesticides in or on 
food and feed of plant and animal origin?  G/SPS/GEN/1762  
 
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  8.  Could the EU explain  how it reconciles its assertion  that import tolerances will be analysed on a 
case-by-case basis (in line with its  statements  in the SPS Committee ) if the y are to be based  on a 
risk analysis ? 
9.  Could the EU provide deta iled information  on applications for import tolerances  that have already 
been received  and the number of applications that  have already been approved ? 
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