G/SPS/GEN/1846  
21 October  2020 
(20-7297) Page: 1/2 
Committee on Sanitary and  
Phytosanitary Measures  Original:  Spanish  
 
  
SPECIFIC TRADE CONCERNS - EUROPEAN LEGISLATION ON  
ENDOCRINE DISRUPTORS ( NO. 382) 
COMMUNICATION FROM PARAGUAY  
The following communication, received on 14 October 2020, is being circulated at the request of the 
delegation of Paraguay.  
_______________  
Paragu ay wishes to put the following questions to the European Union (EU) regarding specific trade 
concern (STC) No. 382  and European legislation on endocrine disruptors, under Article  5.8 of the 
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).  
EUROPEAN LEGISLATION ON ENDOCRINE DISRUPTORS ( G/SPS/N/EU/166/ADD.2 ) 
1.  In its statement of 25 and 26 June 2020  pertaining to STC No. 382 , the EU replied that in order 
to determine the relevance of scientific data, scientific peer review literature could also be used, if 
relevant.  
In the light of this reply:  
(a) Could the EU please specify the criteria used to determine that this type of literature is 
relevant?  
(b) Could the EU also confirm whether it has used this type of source when analysing  
relevant scientific data? If so, could it provide specific examples of the studies used and 
indicate which  substances with endocrine properties the studies were used for ? 
In its reply, the EU also referred to the " Commission Communications in the framewor k of setting 
out the data requirements for active substances and plant protection products ", in accordance with 
Regulation No. 1107/2009, and a "Guidance Document published in 2018 and developed by EFSA, 
ECHA and JRC".  
(c) Could the EU please provide copies of  these documents?  
2.  Could the EU elaborate on its assertion that there is no direct link between the presumed1 
existence of the endocrine disrupting property of a substance (as stipulated in Regulation (EU) 
2018/605) and the precautionary principle ?  
3.  What c riteria or requirements does the EU use to demonstrate that exposure to a substance 
represents a negligible risk of endocrine disruption?  
4.  In the EU's view, when does a risk analysis  demonstrate that the protection of European 
consumers is ensured?  
 
1 "Presumed" is not the same as "confirmed".  G/SPS/GEN/1846  
- 2 - 
  5.  The EU h as affirmed that maximum pesticide residue levels (MRLs) can be set only whe re there 
is sufficient information to demonstrate that the MRL adequately protects consumers, and that the 
burden lies with the applicant to show that the MRLs are safe.  
(a) In the EU' s view, what constitutes  sufficient information?  
(b) If the information available were insufficient, would the EU's measures concerning  MRLs 
fall within the scope of Article 5.7 of the SPS Agreement ?2 If not, could the EU please 
explain why it believes that insufficient information would not entail the application of 
that Article?  
(c) Could the EU please explain how the reversal of the burden of proof is consistent with its 
obligations under the SPS Agreement  and, i n particular, with Articles 2.2 and 5.1 thereof , 
which require WTO Members  to base their measures on scientific evidence ? 
6.  In its "Farm to Fork Strategy", published on 30 May 2020, the EU identified "promoting the global 
transition" as  one of its objectives , and specifically stated  that " [t]he Commission will take into 
account environmental aspects when assessing requests for import  tolerances for pesticide 
substances no longer approved in the EU" .3 The EU  also provides assurances  that WTO standards 
and obligations will be respected in the process. In this light:  
(a) Could the EU please indicate whether it plans to make any changes to Regulation (EC) 
No. 396/2005 in respect of import tolerances?  
(b) Could the EU please provide a definition  or list of what it views as "environmental 
aspects"?  
(c) Could the EU please explain how it intends to incorporate these "environmental aspects" 
into the assessment of requests for import tolerances for pesticide substances?  
(d) In the EU's view, would taking int o account environmental aspects in other WTO Members 
mean applying its Regulations extraterritorially on a de facto basis?  
 
__________  
 
2 Article 5.7 of the SPS Agreement provides as follows: "In cases where relevant scientific evidence is 
insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available 
pertinent information, including that from th e relevant international organizations as well as from sanitary or 
phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the 
additional information necessary for a more objective assessment of risk and review the sanitary or 
phytosanitary measure accordingly within a reasonable period of time."  
3 Farm to Fork Strategy, page 18.