G/SPS/GEN/1753  
 
20 November 2019  
(19-7906) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
RESPONSE OF THE E UROPEAN UNION  TO G/SPS/GEN/1740/REV.1  
COMMUNICATION FROM THE EUROPEAN UNION  
The foll owing communication, received on 19 November  2019, is being circulated at the request of 
the Delegation of  the European Union . 
 
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This document provides the EU response to the questions raised in G/SPS/GEN/1740/Rev.1  
regarding STC 44 8. 
1.  The risk assessment carried out by the European Food Safety Authority ( EFSA) provides the 
scientific rationale for the current EU MRL for imazalil in bananas as defined in Commission 
Regulation (EU) 2019/1582 of 25 September 2019 .1 See EFSA's relevant r easoned opinions of 2017 ,2 
20183 and 20184. These opinions revealed unacceptable risks in respect of the previous EU  MRL, 
noting an exceedance of the acute reference dose (ARfD ) of 157%. For the existing Codex MRLs 
(CXL) at the time of assessment, the exceedance was of 184%. No safe fall-back options could be 
identified by EFSA since the other GAPs5 considered in the review also led to exceedances of the 
ARfD or were not support ed by data.  
2.  The EU MRL for imazalil in bananas is based on EFSA's risk assessment and, therefore, consistent 
with Article 2.2 of the WTO SPS Agreement. EFSA's risk assessment is consistent with the 
requirements of Article 5.1 of the WTO SPS Agreement (see reasoned opinions cited above). For 
products where no safe use could be identified from the available data, MRLs were set at the limit 
of quantification (LOQ), in the case of bananas, 0.01 mg/kg. An LOQ, as opposed to zero tolerance, 
provides legal certain ty to the operators.  
3.  EFSA's risk assessment takes into account all relevant factors in accordance with Article 5.2 of 
the WTO SPS Agreement (see reasoned opinions cited above). It is worth noting that EFSA's risk 
assessment also took into account the exist ing CXLs at the time of assessment , based on the use of 
imazalil as assessed by the JMPR (FAO 1977, 1984, 1985, 1994).  
4.  Article 5.3 is not relevant in the case of SPS measures as defined in Annex A , paragraph 1.b.  
5.  The EU MRL for imazalil in bananas , as defi ned in Commission Regulation (EU) 2019/1582 of 
25 September 2019 , is consistent with the provisions of Articles 5.4 and 5.6 of the WTO SPS 
Agreement in that no safe alternative options could be identified to ensure the EU level of protection 
as defined in Article 4 of Regulation (EC) 1107/2009 of the European Parliament and of the Council 
of 21  October 2009 .6 Applications for new MRLs/import tolerances can always be submitted under 
                                                
1 https://eur -lex.europa.eu/legal -content/EN/TXT/HTML/?uri=CELEX:32019R1582&from=EN . 
2 European Food Safety Authority; Review of the existing maximum residue leve ls for imazalil according 
to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(9):4977 . 
3 European Food Safety Authority; Modification of the existing maximum residue levels for imazalil in 
various commodities. EFSA Journal 2018;16(6):5329; E uropean Food Safety Authority . 
4 Reasoned Opinion on the updated review of the existing maximum residue levels for imazalil according 
to Article 12 of Regulation (EC) No 396/2005 following new toxicological information. EFSA Journal 
2018;16(10):5453.  
5 Good Agricultural Practices . 
6 https://eur -lex.europa.eu/legal -content/EN/TXT/HTML/?uri=CELEX:32009R1107&from=EN . G/SPS/GEN/1753  
 
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  Regulation (EC) No 396/2005 of the European Parliament and of the Council of  23 February 2005 
on maximum residue levels of pesticides in or on food and feed of plant and animal origin.  
6.  The measure establishing EU MRLs for imazalil as defined in Commission Regulation 
(EU) 2019/1582 of 25 September 2019 is consistent with the provis ions of Article 5.5 of the WTO 
SPS Agreement. The MRLs are justified by the risk assessment carried out by EFSA, where safe fall-
back options could be identified for certain foods.  
7.  Article 5.7 of the WTO SPS Agreement is not relevant in that the results of  EFSA's risk assessment 
provide appropriate scientific justification for the measures adopted in Commission Regulation 
(EU) 2019/1582 of 25 September 2019.  
 
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