   
  
G/SPS/GEN/2038  
 
20 June 2022  
(22-4750) Page: 1/5 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
RESPONSE OF THE EUROPEAN UNION TO G/SPS/GEN/2002  ON EU MRLS FOR CERTAIN 
PLANT PROTECTION PRODUCTS – STC NO. 448 
SUBMISSION BY THE EUROPEAN UNION  
The following document , received on 18 June 2022, is being circulated at th e request of the 
Delegation of the European Union . 
 
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This document provides the European Union response to the questions raised in G/SPS/GEN/2002  
regarding STC 448.  
MODIFICATION OF EUROPEAN UNION MRLS FOR PLANT PROTECTION PRODUCTS  
The delegations of Colombia, Ecuador , Guatemala and Paraguay would like to ask the European 
Union the following questions further to the replies received from the European Union in document 
G/SPS/GEN/1970 , and in light of the provisions of Article 5.8 of the SPS Agreement:  
The European  Union  would like to thank the delegations of Colombia, Ecuador, Guatemala and 
Paraguay for the questions. Since several questions are related to specific aspects of emergency 
authorization s, the European  Union  would like to provide some general additional clari fications 
regarding emergency authorization s complementing document G/SPS/GEN/1970 . More information 
is also available in guidance document SANCO/10087/2013 rev. 1.1 
Article 53 of Regulation (EC) No 1107/2009 allows the member States of the European Union to 
author ize the placing on  the market of plant protection products, in special circumstances and 
derogating from the regular authorization  process, for a period not exceeding 120 days and for 
limited and controlled use , where such a measure is necessary because of a danger which ca nnot 
be contained by any other reasonable means.  
Emergency authorization s are granted by EU member States, who should duly notify the other 
member States and the European Commission through a dedicated IT system , the Plant Protection 
Products Application M anagement System (PPPAMS).2 
For the vast majority of emergency authorization s granted by EU member States, the authorized 
use is covered by already existing EU maximum residue levels (MRLs). Approximately 90% of 
emergency authorization s are for plant prot ection products (PPPs) containing active substances 
approved in the European  Union  and many of the specific uses are already author ized in another 
EU member State, hence EU MRLs already apply. Only in cases where an emergency authorization  
is granted for a  use that would result in residues above the established EU MRL, a national temporary 
MRL may be needed.  
In such cases, consumer safety must be ensured and specific control measures must be put in place. 
A member State that author izes the placing on the ma rket of treated food or feed not complying 
with EU MRLs established by Regulation (EC) No 396/2005, may only do so in exceptional 
circumstances and only within its territory  (Article 18(4) of Regulation (EC) No 396/2005). 
 
1 https://ec.europa.eu/food/system/files/2021 -
03/pesticides_aas_guidance_wd_emergency_authorisations_article53_post -210301.pdf . 
2 https://ec.europa.eu/food/plants/pesticides/authorisation -plant-protection -products/pppams_en . G/SPS/GEN/2038  
 
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  This means such food/feed may not be traded, neither to other EU member States, nor to third 
countries.  
Detailed information is required from a member State that takes such exceptional measures on the 
levels it sets and the control measures put in place. In very rare cases, at a later stag e an EU wide 
temporary MRL may be established if an emergency situation occurs in several member States, 
the situation cannot be contained by the member State alone, and provided that sufficient data were 
submitted in the application leading to a favourabl e risk assessment of the European Food Safety 
Authority. As the name "temporary MRL " indicates, such measures are limited in time.  
It is possible to grant an emergency authorization  for a PPP already author ized in the pertinent 
member State (where the particular danger to plant health exists) but where the authorization  does 
not cover the particular crop/pest combination in question. Usually notifications of this type relate 
to uses in minor crops  but it is also possible that new and em erging phytosanitary risks and other 
phytosanitary issues in major crops need immediate action. Such emergency authorization s are 
eventually replaced  by a regular extension of an existing authorization  or a new authorization . 
1.  With regard to the procedures for emergency authorizations (Article 53 of Regulation 1107/2009) 
and import tolerances (Article 6 of Regulation 396/2005):  
a) How long does it take on average to approve an emergency authorization and to approve an 
import tolerance?  
• The evaluation of an import tolerance takes around 24 months.  
• Regarding emergency authorization s, as already indicated, they are granted by EU 
member States and the time for the evaluation process is determined by them.  
b) What is the average cost of the emergency authorization a pproval process and the average 
cost of the import tolerance approval process?  
• For the evaluation of use of an active substance, including import tolerance applications, 
member States may recover the costs associated with any work they carry out, by means 
of fees or charges. Fees or charges for evaluations are set by member States and they 
may vary.  
• Regarding emergency authorization s, they are granted by EU member States. Fees to 
cover these evaluations are set by member States as well and they may vary.  
2.  With regard to emergency authorizations:  
a) Could the European Union please explain why section 11 (concerning temporary MRLs) of 
an emergency authorization is, in general, left blank? In such cases, what is the applicable 
MRL?  
If section 11 does not include information on a temporary MRL, no t -MRL applies and EU 
MRL applies. Please see the additional clarifications provided at the beginning of this 
document.  
b) If a temporary MRL is granted, does this mean the product can be marketed in other 
European Un ion member States?  
Please see point 9a of G/SPS/GEN/1970  and the additional clarifications provided at the 
beginning of this document.  
c) Can third States, which are not members of the European Union, benefit from authorized 
temporary MRLs?  
No, since national temporary MRLs are granted by individual EU member States. Other EU 
member States which have not granted a national temporary MRL cannot benefit either. 
Treated food products that do not comply with the applicable EU MRL cannot be imported 
into the European  Union  and cannot circulat e in the EU internal market either.  G/SPS/GEN/2038  
 
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  d) What MRL is applicable in emergency authorizations for minor crops? How is this MRL 
determined?  
Please see the additional clarifications provided at the beginning of this document. 
Regarding your question on the setting  of MRLs for minor crops, please see the technical 
guidelines on data requirements for setting MRLs, comparability of residue trails and 
extrapolation of residue data on products f rom plant and animal origin 
(https://ec.europa.eu/food/system/files/2020 -11/pesticides_mrl_guidelines_app -d.pdf). 
e) Could the European Union provide some figures regarding the number of emergency 
authorizations that have been refused?  
Granting (or refusing) emergency authorization s is the responsibility of the EU member 
States. The  available figures on refusals are limited to the start of the IT tool (PPPAMS) in 
2016 as follows:  
− Applications rejected: 336 (figures are for all member States including United Kingdom 
for 2016 -2018);  
− Applications withdrawn: 153;  
− Applications completed – authorization  cannot be granted: 243.  
It should also be noted that – in some cases – member States may have refused an 
emergency authorization  before an appl ication was even added to the respective IT tool 
PPPAMS (e.g. in the event of pre -discussions where the member State authorities made it 
clear that emergency authorization  would not be possible/granted). In addition, some 
member States only ask applicants to include information in PPPAMS once a decision to 
authori ze has been made, hence the true number of refusals is likely to be significantly 
higher.  
3.  How are import tolerances assessed for minor crops?  
The requirements for setting MRLs as well as the facilities in place for minor crops are the 
same for European  Union  and imported products. The European  Union  acknowledges the 
insufficient availability of PPPs for minor uses for a number of different reaso ns. In order 
to address this, several actions have been proposed, including a commitment from the 
European Commission to regularly update the Extrapolation Guidelines to facilitate MRL 
setting for minor crops ( https://ec.europa.eu/food/system/files/2020 -
11/pesticides_mrl_guidelines_app -d.pdf). 
These actions are also applicable for import tolerances, as the setting of pesticide residues 
follows the same procedu re regardless of whether the data come from an European  Union  
or a third -country applicant. As an example, some flexibility is allowed in the number of 
residue trials required and the extrapolation possibilities are maximi zed. 
4.  The requirements to be met by  an import tolerance applicant are stricter than those to be met 
by an applicant for an emergency authorization for a new combination of substance and basic 
product. Is this correct? What is the basis for this distinction?  
As the European Union already exp lained, it is not possible to compare the requirements 
for import tolerances and emergency authorization s because these are two completely 
different procedures (please also see general comments at the beginning of this 
document). There are different actors  involved, the scope is different and there is a 
limitation in time (120 day) in the case of emergency authorization s. Imported products 
can circulate in the EU market, while for temporary MRLs granted by EU member States 
the treated food cannot leave the national territory of that member State.  
5.  In its reply to question No. 4 in document G/SPS/GEN/1970 , the European Union refers to 
relevant Dispute Settlement Body (DSB) rulings. Which DSB rulings does the European Union 
consider relevant?  
The European Union would like to kindly refer the Delegations to the WTO website which 
provides a list of 52 requests for consultations where the SPS Agreement has been cited, 
with a breakdown by article.  G/SPS/GEN/2038  
 
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  6.  It is our understanding that, according to the European Union, its MRL regime does not fall withi n 
the scope of Article 5.7 of the SPS Agreement, despite the existence of scientific uncertainty. Is this 
correct?  
Could the Delegations indicate which EU MRLs they wish to refer to? The European Union 
would also like to kindly refer the Delegations to its  previous replies where Article 5.7 of 
the SPS Agreement has been discussed.  
7.  In its reply to question No. 6 in document G/SPS/GEN/1970 , the European Union shares a 
summary table of figures regarding harmonization with the Codex since 2017. We would be grateful 
if the European Union c ould provide data disaggregated by:  
a) type of plant protection product (e.g. insecticide, fungicide, etc.);  
b) active substances in cases where they are not aligned with CXLs;  
c) active substances that have benefited from (i) emergency authorizations and (ii) impo rt 
tolerances.  
The European  Union  does not have disaggregated the information on CXLs as requested. 
However, the information is publicly available under the following link: 
https://ec.europa.eu/food/horizontal -topics/international -affairs/international -
standards/codex -alimentarius/ccpr_en . 
8.  In its reply to question No. 8(a) in document G/SPS/GEN/1970 , the European Union notes that 
around 90% of emergency authorizations are for plant prot ection products containing active 
substances that are approved in the European Union. With regard to the remaining 10% of cases:  
a) Are stricter requirements applied to the applicant when they request an emergency 
authorization for an active substance that is  no longer approved in the European Union?  
No. 
b) What type of scientific evidence is required from the applicant in these cases?  
Please see the additional clarifications provided at the beginning of this document.  
c) What MRL is imposed?  
Please see the addition al clarifications provided at the beginning of this document.  
9.  In its reply to question No. 9(a) in document G/SPS/GEN/1970 , the European Union states that 
no exports outside the Union are allowed in the event that food/feed does not comply with the 
European Union MRL due to an emerg ency authorization. What mechanisms do member States 
introduce to ensure that such products are not exported? Could the European Union provide specific 
examples of these control mechanisms?  
Emergency authorization  applications submitted in the Plant Protec tion Products 
Application Management System (PPPAMS) must include information on the measures 
taken in order to confine the commodities resulting from the treated crop to the 
territory of the member State  in which the application is submitted pending the p ossible 
setting of a temporary MRL at EU  level. (PRIMo EFSA  calculations to be included). Please 
also see the additional clarifications provided at the beginning of this document.  
10.  Further to the European Union's reply to question No. 10 in document G/SPS/GEN/1970 , 
according to which emergency authorizations are limited to European Union memb er States, what 
is the explanation for the 27 emergency authorizations granted by Norway?  
According to the European Economic Area Agreement, Norway has to apply EU legislation 
on pesticides, as laid down in Annex II to the Agreement, with the same obligati ons and 
rights as European Union member States.  G/SPS/GEN/2038  
 
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  11.  Further to the European Union's reply to question No. 15 in document G/SPS/GEN/1970 , which 
other WTO Agreements, and Articles thereof, would be applicable to MRLs that are set taking into 
account "other legitimate factors"?  
The General Agreement on Tariffs and Trade (GATT) applies to international trade in goods, 
unless it is superseded by a more specific agreement, depending on the objective of the 
measure at stake.  
12.  Regarding substances considered to be of global concern and for which i t has been announced 
that import tolerances will no longer be granted, could the European Union confirm whether 
emergency authorizations will no longer be granted either?  
No, please see the additional clarifications provided at the beginning of this docume nt. 
The European  Union  would like to reiterate that granting emergency authorization  is a 
member States responsibility and – in any case – any emergency authorization  granted 
must be fully justified. The justifications are followed up closely, and if neces sary, the 
European Food Safety Authority might evaluate the need of granting a specific emergency 
authorization . Evaluations and guidelines to provide justifications are publicly  available.  
 
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