G/SPS/GEN/20 76 
2 November  2022 
(22-8230) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  
QUESTIONS FOR THE EUROPEAN UNION CONCERNING DOCUMENT G/SPS/GEN/2002  ON 
EUROPEAN UNI ON MAXIMUM RESIDUE LEVELS (MRLS) FOR CERTAIN PLANT 
PROTECTION PRODUCTS – STC NO.  448 
COMMUNICATION FROM COLOMBIA, ECUADOR, GUATEMALA AND PARAGUAY  
The follow ing communication, received on 1 November 2022, is being circulated at the request of 
the delegations of Colombia , Ecuador , Guatemala  and Paraguay . 
 
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FOLLOW -UP TO: G/SPS/GEN/2038  
1.  Could each European Union member State please indicate:  
(a) How many emergency authorization  applications it receives , on average , each year ? 
(b) How many of these applications are approved ? 
(c) How many are sent for mutual recognition to other European Union member States ? Please 
indicate all the approved applications that have been  sent for mutual recognition and to 
which member States.  
(d) How many emergency authorizations have been approved each year?  
2.  Could each European Union member State please indicate how long, on averag e, it takes to 
approve an emergency authorization in its territory?  
3.  Could each European Union member State please indicate the disaggregated and total cost of 
active substance  evaluations , including import tolerances, and emergency authorizations?  
4.  Could th e European Union please provide a list of the active substances (in combination with the 
relevant product) for which it requires an MRL that is not harmonized with the Codex? With regard 
to these substances, could the European Union please indicate how man y emergency authorizations 
and import tolerances have been granted?  
5.  How many import tolerance applications have been submitted? How many have been rejected?  
6.  Regarding the reply to question 9 in document  G/SPS/GEN/2038 : 
(a) Could the European Union please explain what information is required from member States 
concerning the steps taken to confine to their territory products that have been treated with 
substances not authorized in the European Union and that have benefited from emergency 
authorizations?  
(b) Could each E uropean Union  member State please explain what sort of information it provides 
to meet this requirement?  
7.  Could the European Union please indicate which specific GATT articles are applicable for the 
establishment of MRLs under other specific factors?  G/SPS/GEN/2076  
 
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  8.  We have se arched through the  EFSA publications on emergency authorization evaluations on the 
websites indicated by the European Union in document G/SPS/GEN/2038  and have only found 
18 dossiers (eight for 2018 and 10  for 2021) on emergency approvals for neonicotinoids. Could the 
European Union please indicate:  
(a) Whether these dossiers constitute all the emergency authorization evaluations conducted by 
EFSA? 
If not, please provide copies of any other evaluations related to the products covered by this 
STC. 
(b) In what circumstances might EFSA evaluate the need to grant or maintain an emergency 
authorization?  
(c) How many times can a member State renew an emergency authorization? Is there a limit 
on the number of renewals?  
(d) How does the European Union [the Commission?] use the technical information in the dossier 
provided by member States when granting an emergency authorization?  
(e) Why does the evidence submitted by members States in their dossiers not provide sufficient 
justification for EFSA to re -evaluate MRLs?  
(f) At what point does the EFSA evaluation take p lace? When an emergency authorization is 
being requested from a member State, or once a member State has already approved the 
emergency authorization?  
(g) Could the European Union please explain why an emergency authorization is justified even 
in cases where highly effective alternatives (chemical or non -chemical) exist?  
We refer to EFSA's evaluations, conducted in 2021, of the emergency authorizations 
granted by Belgium, Croatia, Denmark, Germany, Slovakia and Spain for the use of the 
active substances thiam ethoxam, clothianidin and imidacloprid in sugar beet crops.  
(h) Why are emergency authorizations for using certain active substances justified when EFSA 
notes that for certain crop/pest combinations their use is not/may not be necessary when 
the good agricultu ral practice of crop rotation is used?  
We refer, by way of example, to EFSA's 2021 evaluations of the emergency 
authorizations for thiamethoxam, clothianidin and imidacloprid granted by Belgium (for 
the combination sugar beet/ Agriotes lineatus  and Tipula sp.); by Denmark (for the 
combination sugar, fodder and energy beet/ Atomaria linearis ,Pegomya  hyoscyami , 
Thrips angusticeps ); and by Slovakia (for the combination sugar beet/ Aphids , Atomaria 
linearis  and Chaetocnema tibialis ). 
(i) What consequences are there f or a member State if EFSA considers the emergency 
authorization to be unjustified?  
We note that, in Romania's case, the emergency authorization for the active substances 
thiamethoxam, clothianidin and imidacloprid, for the combination 
maize/ Tanymecus  dilaticollis,  was considered unjustified by EFSA in 2018, and yet a 
new authorization was granted by Romania in January 2022.  
(j) In cases where member States fail to  provide EFSA with the information needed to determine 
whether the emergency authorization is just ified, are there any consequences such as, for 
instance, greater scrutiny or a control system for the emergency authorizations granted by 
those member States following the EFSA evaluation?  
For example, we note that in relation to the active substances thi amethoxam, 
clothianidin and imidacloprid, the required information was not submitted by Croatia in 
2021 for sugar beet/ Alphididae ; by Bulgaria in 2018 for maize and 
sunflower/ Tanymecus dilaticollis  and Agriotes spp.; or by Hungary in 2018 for 
maize/ Tanymec us dilaticollis , Agriotes spp. and Melonthina  melonthina  and 
sunflower/ Agriotes spp. 
9.  We refer to notifications G/SPS/N/EU/394  – Maximum residue levels for carbon tetrachloride, 
chlorothalonil, chlorpropham, dimethoate, ethoprophos , fenamidone, methiocarb, omethoate, 
propiconazole and pymetrozine ; G/SPS/N/EU/319  – Maximum residue levels for imazalil ; and 
G/SPS/N/EU/264  – Maximum residue levels for buprofezin, diflubenzuron, ethoxysulfuron, ioxynil, 
molinate, picoxystrobin and tepraloxydim . G/SPS/GEN/2076  
 
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  We note the following text in the "Description o f content" section of the notification: "Lower MRLs 
are set after updating the limits of determination and/or deleting old uses which are not authorised 
any more in the European Union or for which a human health concern may not be excluded ." 
10.  According to t he replies previously received from the European Union regarding this STC, the 
European Union claims that its MRL measures do not fall within the scope of Article 5.7 of the 
SPS Agreement, despite the absence  of categorical scientific evidence concerning h ealth risks 
("a human health concern may not be excluded"). Is this correct?  
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