G/SPS/GEN/1885  
5 March  2021 
(21-1836) 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 , dated  3 March  2021, is being circulated at the request of the 
delegation of Paraguay . 
 
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EUROPEAN LEGISLATION ON ENDOCRINE DISRUPTORS (G/SPS/N/ EU/166/ADD.2)  
The following questions are being submitted in follow ‑up to the replies received from  the 
European  Union (EU) (document G/SPS/GEN/1 871) to the questions posed by Paraguay 
(document  G/SPS/GEN/1846 ), and in the li ght of Article  5.8 of the SPS Agreement : 
1.  In its re ply to question number 2  from Paraguay , the EU indicates that Article  5.7 of the 
SPS Agreement applies only to specific situations  where, in the light of insufficient scientific 
evidence , the EU's risk mana gement decisions may be based on the precautionary principle . 
Paraguay notes that  a significant number of MRLs have been adopted by the EU as a result of the 
decision not to renew certain substances found  in plant protection products, which is based on 
inconclusive scientific evidence . 
(a) Could the EU please indicate if, in these cases, it applies the precautionary principle in its 
risk management decisions ? 
(b) If the answer is no , could the EU please specify  how "insufficient scientific evidence" differs 
from "inconclusive  scientific evidence" ? 
2.  In its reply to question number 4, the EU states that the protection of European consumers is 
ensured when there exists  sufficient scientific certainty  to establish that substances have no harmful 
effects on human  health . 
(a) Could the EU please provide a definition of when it considers that "sufficient scientific 
certainty " exists ? Specific examples would be useful  in order to best demonstrate this.  
3.  Could the EU please confirm if environmental factors will be taken into account when granting 
emergency authorization s to member States to use subs tances  prohibited  within the EU ? 
4.  Could the EU please specify the technical criteria used when granting emergency authorization s 
to member States to use substances prohibited within the EU ? 
5.  We note that, at the seminar o f 20 January  2021 on environmental fa ctors and setting MRLs, the 
EU stated  that exports  from one EU member State to another  must comply with European MRLs and 
that few MRLs have been subject to emergency authorization s. 
(a) Could the EU please indicate in which cases, for which products and in which member States 
emergency authorizations have been granted ? G/SPS/GEN/1885  
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  (b) We note that the majority of products exported by third countries to the EU are unprocessed 
natural products ( such as sug ar cane , ma ize or  beet), while t hose traded  among 
EU member  States are mainly processed products (such as sugar). In this regard, would 
breaches of the limit of analytical determination be detected in processed products in the 
same way that they would be d etected in an unprocessed raw material ? 
6.  We reiterate the following questions that were posed by the delegation of Paraguay at the 
aforementioned seminar and subsequently submitted by note to DG SANTE on 21 January  2021:  
(a) Could the EU please explain how it intends  to incorporate environmental factors into import 
tolerances and how this incorporation would be compatible with the obligations laid down 
for the establishment of  sanitary measures under the SPS Agreement ? 
(b) Could the EU please  provide a definition and list of the "environmental factors" to be taken 
into account when assessing import tolerances ? 
(c) In October  2020, Paraguay submitted a series of questions to the EU relating to  specific 
trade concerns on MRLs and endocrine disruptor s. In its replies, the EU stated that no 
amendments to Regulation  No. 396/2005 are currently envisaged . Could the European  Union 
please confirm whether environmental factors may constitute "other legitimate factors " to 
be taken into account when determining  import tolerances ? 
(d) Can environmental factors determine the imposition of MRLs that are lower than those that 
would result from the application of purely  sanitary  factors ? 
7.  With regard to import tolerances, could the EU please provide a list covering the period from 
November  2017 to date of all requested import tolerances, the requesting country and whether the  
requests  were accepted or rejected ? In cases where requests were rejected, could the EU please 
provide the reason for th is rejection ? 
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