G/SPS/GEN/2139  
 
6 July 2023  
(23-4595) Page: 1/9 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
RESPONSE OF THE EUROPEAN  UNION TO G/SPS/GEN/2076  
ON EU MAXIMUM  RESIDUE LEVELS (MRLS) FOR CERTAIN  
PLANT PROTECTION PRODUCTS - STC NO. 448 
SUBMISSION BY THE EUROPEAN UNION  
The following document, received on 5 July 2023, is being circulated at the request of the Delegation 
of the European Union . 
 
_______________  
 
 
This document provides the  European  Union response to the questions raised in G/SPS/GEN/2076  
regarding STC 448.  
FOLLOW -UP TO: G/SPS/GEN/2076  
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  State s? 
Please indicate all the approved applications that have been sent for mutual recognition 
and to which member  State s. 
(d) How many emergency authorizations have been appro ved each year?  
The European  Union would like to thank the delegations of Colombia, Ecuador, Guatemala and 
Paraguay for the questions. The full list of emergency authorisations that have been granted by 
EU member  States is publicly accessible via the EU eme rgency Authorisation Database 
(https://ec.europa.eu/food/plant/pesticides/eu -pesticides -database/ppp/screen/home ). There is 
no information at EU level on the number of received or sent applications, only those approved 
by EU  member  States is presented in the database. Overall, over the last three years, there are 
on average around 650 emergency authorizations granted per year by all 27 EU  member  States. 
Figures  vary by country (depending on sizes and agricultural production of the respective 
member  States) and by year. The vast majority (approximately 80 %) of emergency 
authorisations concern Plant Protection Products containing approved active substances. 
Additionally, the EU would like to refer to the reply to question 8 with regards to the recent 
judgment by the European Court of Justice of 19 January 2023 in Case C -162/21.  G/SPS/GEN/2139  
 
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  2.  Could each European  Union member  State  please indicate how long, on average, it takes to 
approve an emergency authorization in its territory?  
No specific data exist on the evaluation and approval times by member  States for emergency 
authorisations. Data on average times for evaluations in the context of the regular 
approval/authorisation pr ocesses are available in the REFIT (Regulatory Fitness and Performance 
program) evaluation of the EU pesticides legislation conducted by the European Commission 
in 2020 in order to assess if the regulations meet the needs of citizens, businesses and public  
institutions in an efficient manner.  
3.  Could each European  Union member  State  please indicate the disaggregated and total cost of 
active substance evaluations, including import tolerances, and emergency authorizations?  
According to the findings of the REFIT evaluation1, the overall annual costs for member  States on 
approval and authorisation procedures for Plant Protection Products are estimated at 44 million 
euros, with around 930 full -time staff equivalents working as risk assessors and risk managers. 
Approvals and renewals of approval of active substances are esti mated to account for 23 % of 
these resources, at a cost of 10 million euros (210 full -time staff equivalents). For MRL procedures, 
the estimated costs for member  States are 5 million euros.  
4.  Could the European  Union please provide a list of the active subs tances (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 many emergency authorizations 
and import tolerances have bee n granted?  
The full list of MRLs that are established in the European  Union is publicly accessible via the 
EU Pesticide  Database  (https://ec.europa.eu/food/ plant/pesticides/eu -pesticides -
database/start/screen/mrls ). The  database does not distinguish between MRLs based on CXLs and 
MRLs not based on CXLs, it also includes all import tolerances, but they are not flagged separately. 
In accordance with the WTO -SPS Agreement, the European  Union communicates to its trading 
partners all of its intended measures lowering MRLs, including for cases when the newly proposed 
MRLs are not harmonised with existing Codex MRLs. In each session of the Codex Committee on 
Pesticid es Residues it also transparently informs all delegations about which of the proposed 
Codex MRLs it can support. This is based on an EFSA scientific report2 published each year and 
captured in the respective reports of the annual CCPR meetings. A specific  overview table listing 
the import tolerances applications that were received and assessed at EU level during the 
period  2009-2020 is provided on the European Commission website 
(https://food.ec.europa.eu/system/files/2021 -01/pesticides_mrl_guidelines_overview -it-
table.pdf ). 
5.  How many import tolerance applications have been submitted? How many have been rejected?  
An overview table listing the impor t tolerances applications that were received and assessed at 
EU level during the period 2009 -2020 is provided on the European Commission website 
(https://food.ec.europa.eu/system/files/2021 -01/pesticides_mrl_guidelines_overview -it-
table.pdf ). The table also contain information concerning the number of import tolerance that 
were established in the European  Union in that same period.  
 
1 COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE 
COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Evaluation of Regulation (EC) No 1107/2009 
on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum 
residue levels of pesticides . 
2 https://www.efsa.europa.eu/en/publications . G/SPS/GEN/2139  
 
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  6.  Regarding the r eply to question 9 in document G/SPS/GEN/2038 : 
(a) Could the European  Union please explain what information is required from 
member  State s 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 European  Union member  State  please explain what sort of information it 
provides to meet this requirement?  
Article 18(4) of Regulation (EC) No 396/2005 sets the framework in case the grant ing of an 
emergency authorisation in an EU  member  States would require the setting of a national 
temporary MRL higher than the EU MRL. If the use of the plant protection product results in 
residues in food and feed above the EU MRLs, the authorising EU  member State may exceptionally 
allow the placing on the market of food/feed in its own territory provided that the food or feed 
does not constitute an unacceptable risk. This provision has rarely been used in practice.  
In such cases, concerned products must stay on the territory of the EU  member  State. 
These  products cannot be traded with other EU  member  States or non -EU countries. The control 
and enforcement actions are under the purview of each EU  member  States, not the Commission.  
The vast ma jority of emergency authorizations relate to plant protection products containing EU 
approved active substances, and to cases for which serious plant health risks relate to e.g. minor 
crops for which regular authorisations have not yet be granted.  
7.  Could t he European  Union please indicate which specific GATT articles are applicable for the 
establishment of MRLs under other specific 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.  
8.  We have searched 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  State s 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 place? When an emergency authorization 
is being requested from a member  State , or once a member  State  has already approved 
the emergency authorizatio n? G/SPS/GEN/2139  
 
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  (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 thiamethoxam, clothianidin and imidacloprid in sugar beet crops.  
(h) Why a re 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 agricultural practice of crop rotation is used?  
We refer, by way of exampl e, 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 bee t/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 for a member  State  if EFSA considers the emergency 
authorization t o be unjustified?  
We note that, in Romania's case, the emergency authorization for the active substances 
thiamethoxam, clothianidin and imidacloprid, for the combination maize/Tany mecus 
dilaticollis , was considered unjustified by EFSA in 2018, and yet a ne w authorization 
was granted by Romania in January 2022.  
(j) In cases where member  State s fail to provide EFSA with the information needed to 
determine whether the emergency authorization is justified, are there any 
consequences such as, for instance, greater s crutiny or a control system for the 
emergency authorizations granted by those member  State s following the EFSA 
evaluation?  
For example, we note that in relation to the active substances thiamethoxam, 
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/ Tanymecus dilaticollis , Agriotes  spp. and Melonthina melonthina  and 
sunflo wer/Agriotes  spp. 
a), b) and c) Article 53 of Regulation (EC) No 1107/2009 allows member  States to grant 
authorisations for products containing active substances not approved in the European Union. 
These authorisations can only be granted for a period not exceeding 120 days, for a limited and 
controlled use provided such use is necessary because of a danger that cannot be contained by 
any other reasonable means and consumer safety must be ensured. Granting of emergency 
authorisations are the responsibility of the member  States and do not need the European 
Commission's approval.  
EFSA verified, on two requests of the European Commission, whether a limited number of 
emergency authorisations granted by a number of member  States were justified. Based on the 
outco me of the assessment by EFSA and the reaction of the EU countries concerned, the European 
Commission adopted two decisions requiring two countries not to grant emergency authorisations 
in accordance with Article 53(3) for certain uses of these neonicotinoi ds for future seasons. 
For further information, 
please  see the European  Commission's  website  (https://food.ec.europa.eu/plants/pestici des/appr
oval-active -substances/renewal -approval/neonicotinoids_en ). 
Please note that given the judgment by the European Court of Justice of 19 January 2023 in 
Case C-162/21( https://eur -lex.europa.eu/legal -content/en/TXT/?uri=CELEX:62021CJ0162 ), 
member  States cannot grant any further emergency authorisations for products containing 
restricted neonicotinoids.  G/SPS/GEN/2139  
 
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  d) In the mandates on emergency authorisations, the Commission ask ed EFSA to consider the 
technical information provided by member  States when verifying the justifications for these 
authorisations.  
e) and f) So far, the European Commission has mandated EFSA after the emergency authorisation 
was granted by the member  State as Article 53 of regulation (EU) No 1107/2009 does not foresee 
that member  States notify the European Commission before issuing the authorisation. The 
European Commission however mandated the EFSA to develop fit -for-purpose protocols for 
evaluating emerg ency authorisations starting with a protocol for insecticides and acaricides by 
May 2025. Protocols for other types of pesticides will follow at a later date. Once available, these 
protocols will also help member  States in their evaluations.  
g) and h) The reasons why EFSA considered these emergency authorisations justified can be found 
in the respective technical reports on the EFSA website 
(https://www.efsa.europa.eu/en/news/neonicotinoids -efsa-assesses -emergency -uses-sugar -
beet-202021 ). 
i) The consequences for non -justified emergency authorisations are described in Article 53(3) of 
Regulation (EC) No 1107/2009. In 2020, the European Commission a dopted two decisions requiring 
two EU  member  States not to grant emergency authorisations in accordance with Article 53(3) for 
certain uses of neonicotinoids for future seasons. Commission Implementing 
Decision  (EU) 2020/152 of 3 February 2020 prohibited o ne of the member  States to repeat only 
the granting of authorisation under Article 53(1) of Regulation (EC) No 1107/2009 for plant 
protection products containing the active substances clothianidin or imidacloprid for use on Brassica 
napus against the pests  Phyllotreta  spp. or Psylliodes  spp. The emergency authorisations granted 
by that member  State in 2022 were either for different active substances or different crops.  
j) In such cases, the European Commission may ask the member  State to provide further 
information or decide to ask EFSA for another opinion in case there is a specific need to do so (e.g. 
if there is further repetition of the measure). In the event that an emergency authorisation is not 
considered justified, the consequences outlined in point (i) above may apply. Independently of any 
mandate sent by the European Commission to EFSA, all member  States need to include all relevant 
information, including justifications, in the online notification tool. Guidance on what information is 
needed for the se notifications is given in the relevant guidance document. All member  States are 
subject to periodical audits by the European Commission during which a check of the emergency 
authorisation process can be done. More info on the EU audit programme can be f ound on the 
European Commission's website ( https://food.ec.europa.eu/horizontal -topics/official -controls -
and-enforcement/he alth-and-food-audits -and-analysis_en ). 
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, diflubenzur on, ethoxysulfuron, ioxynil, 
molinate, picoxystrobin and tepraloxydim . 
We note the following text in the "Description of 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 ." G/SPS/GEN/2139  
 
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  The active substances carbon tetrachloride  and omethoate  were never approved in the 
European  Union for the use in plant protection products. Temporary MRLs were set for carbon 
tetrachloride in cereals by Commission Regulation (EC) No 149/2008 and omethoate 
(main  metabolite of dimethoate) in several products by Commission Regulation (EU) 2017/1135.  
In the context of the non -renewal of the approval of chlorothalonil  the European Food Safety 
Authority (EFSA)3 could not exclude a genotoxicity concern for residues to which consumers will 
be exposed. In addition, the assessment of consumer risk from dietary exposure could not be 
completed because of lack of da ta to confirm the definition of the residue in plants and the 
livestock exposure assessment, including the toxicological assessment of a metabolite.  
In the context of the non -renewal of the approval of chlorpropham , EFSA4 concluded that a final 
consumer r isk assessment through dietary intake cannot be performed due to several data gaps 
and uncertainties identified for the food crop uses. Nevertheless, a critical area of concern for 
chlorpropham was identified regarding the results of an indicative consumer  risk assessment 
where acute and chronic dietary risks for consumers have been identified both for chlorpropham 
and for its major metabolite 3 -chloroaniline.  
In the context of the non -renewal of the approval of dimethoate , EFSA5 could not exclude a risk 
to consumers due to the exposure to residues of dimethoate, for which the genotoxic potential 
could not be excluded, and to its main metabolite omethoate which was concluded to be an in 
vivo mutagenic agent.  
In the context of the non -renewal of the approval  of ethoprophos , EFSA6 was not possible to 
conclude on the genotoxic potential of ethoprophos and therefore health -based reference values 
could not be established. Consequently, the consumer and non -dietary risk assessments could 
not be conducted. In addi tion, several areas of the risk assessment could not be finalised including 
the consumer assessment with respect to residues in food of plant and animal origin, the 
assessment of developmental neurotoxicity. The endocrine disrupting potential of ethopropho s 
could not be concluded either.  
In the context of the non -renewal of the approval of fenamidone , EFSA7 was not possible to 
conclude on the genotoxic potential of fenamidone and no health -based reference values could be 
set. Consequently, the consumer and  non-dietary risk assessments could not be conducted. 
The residue definitions for risk assessment in plant and livestock commodities were not finalised 
in terms of the inclusion of potentially relevant metabolites.  
In the context of the non -renewal of the approval of methiocarb , EFSA8 could not conduct the 
consumer risk assessment because the residue definition for risk assessment in plant commodities 
could not been finalised since the genotoxic potential of metabolite M01 could not be ruled out 
based on t he available data.  
In the context of the non -renewal of the approval of propiconazole , EFSA9 concluded that 
Maximum Residue Levels (MRLs) in accordance with Regulation (EC) No 396/2005 of the European 
Parliament and of the Council could not be confirmed for plant and animal products since data on 
the magnitude and toxicity of metabolites that are  included in the residue definition for risk 
assessment was not available. In addition, several other aspects of the consumer risk assessment 
necessary to conclude on the risk to consumers through dietary intake could not be finalised based 
on the informat ion available in the dossier.  
In the context of the non -renewal of the approval of pymetrozine , EFSA10 concluded that the 
toxicological profile of metabolites included in the plant residue definition for risk assessment 
could not be confirmed.  
In conclusion, the approval of the active substances chlorothalonil , chlorpropham , 
dimethoate , ethoprophos , fenami done , methiocarb , propiconazole  and pymetrozine  
were not renewed by different Commission Implementing Regulations.11 Consequently, for carbon 
tetrachloride, chlorothalonil, dimethoate, ethoprophos, fenamidone, methiocarb, omethoate, 
propiconazole and pymet rozine the MRLs were set at the limit of quantification (LOQ). G/SPS/GEN/2139  
 
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  For chlorpropham, a temporary MRL has been set for potatoes, which is to be regularly reviewed, 
for the rest of the food/feed products MRLs are at the LOQ.  
The approval of active substance imaz alil was renewed by Commission Implementing Regulation 
(EU) No 705/2011. The existing MRLs for imazalil were reviewed in accordance with Article 12(1) 
of Regulation (EC) No 396/2005, based on EFSA's reasoned opinion12, the MRLs which are safe 
for consumers  in the European  Union were considered for MRL setting.  
The approval of the active substances buprofezin  has been restricted to non -edible crops because 
confirmatory information required was not fully provided and that exposure of consumers to 
 
3 Conclusion on the peer review of the pe sticide risk assessment of the active substance chlorothalonil. 
EFSA Journal2018;16(1):5126, 40 pp.; https://doi.org/10.2903/j.efsa.2018.5126 . 
4 Conclusion on the peer review of the pesticide risk assessment of the active substance chlorpropham. 
EFSA Journal 2017;15(7):4903, 29 pp. doi:10.2903/j.efsa.2017.4903.  
5 EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pest icide risk 
assessment of the active substance dimethoate EFSA Journal 2018;16(10):5454. 
https://www.efsa.europa.eu/en/efsajournal/pub/5454 . 
6 Conclusion on the peer review of the pesticide risk assessment of the active substance ethoprophos. 
EFSA Journal 2018;16(10):5290, 34 pp. doi:10.2903/j.efsa.2018.5290 . 
7 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance f enamidone. EFSA Journal 2016;14(2):4406, 173 pp. 
doi:10.2903/j.efsa.2016.4406 . 
8 EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk 
assessment of the active substance methiocarb EFSA Journal 2018;16(10):5429.  
9 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance propiconazole. EFSA Journal 2017;15(7):4887, 28 pp. 
10.2903/j.efsa.2017.4887.  
10 EFSA (European Food Safety Authority), 2014 . Conclusion on the peer review of the pesticide risk 
assessment of the active substance pymetrozine. EFSA Journal 2014;12(9):3817, 102 pp. 
doi:10.2903/j.efsa.2014.3817.  
11 Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non -renewal of 
the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the market, and 
amending Commission Implem enting Regulation (EU) No 540/2011 (OJ L 114, 30.4.2019, p. 15).  
Commission Implementing Regulation (EU) 2019/989 of 17 June 2019 concerning the non -renewal of 
approval of the active substance chlorpropham, in accordance with Regulation (EC) No 1107/2009 o f the 
European Parliament and of the Council concerning the placing of plant protection products on the market, and 
amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 160, 18.6.2019, p. 11).  
Commission Implementing Regulation ( EU) 2019/1090 of 26 June 2019 concerning the non -renewal of 
approval of the active substance dimethoate, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on th e market, and 
amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 173, 27.6.2019, p. 39).  
Commission Implementing Regulation (EU) 2019/344 of 28 February 2019 concerning the non -renewal 
of approval of the active substance ethopr ophos, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the market, and 
amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 62, 1.3.2019, p. 7).  
Commission Implementing Regulation (EU) 2018/1043 of 24 July 2018 concerning the non -renewal of 
approval of the active substance fenamidone, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council conc erning the placing of plant protection products on the market, and 
amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 188, 25.7.2018, p. 9).  
Commission Implementing Regulation (EU) 2019/1606 of 27 September 2019 concerning the non-
renewal of the approval of the active substance methiocarb, in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending the Annex to Commi ssion Implementing Regulation (EU) No 540/2011 (OJ L 250, 
30.9.2019, p. 53).  
Commission Implementing Regulation (EU) 2018/1865 of 28 November 2018 concerning the non -
renewal of approval of the active substance propiconazole, in accordance with Regulation ( EC) No 1107/2009 
of the European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 304, 29.11.2018, p. 6).  
Commission Implementing Regulat ion (EU) 2018/1501 of 9 October 2018 concerning the non -renewal of 
approval of the active substance pymetrozine, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection produc ts on the market, and 
amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 254, 10.10.2018, p. 4).  
12 European Food Safety Authority; Reasoned Opinion on the updated review of the existing maximum 
residue levels for imazalil according to Artic le 12 of Regulation (EC) No 396/2005 following new toxicological 
information. EFSA Journal 2018;16(10):5453.  G/SPS/GEN/2139  
 
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  aniline via consumption of processed crops cannot be excluded.13 Therefore, the MRLs have been 
set at the  LOQ. 
At the time, the approval of the active substance diflubenzuron  was restricted to non -edible 
crops as information submitted in the review process did not dem onstrate that the risk from the 
potential exposure of consumers to metabolite 4 -chloroaniline (PCA) as a residue is acceptable.14 
In particular, the presence of PCA in the metabolic pathway has been demonstrated in some plants 
and livestock and could not b e excluded in others. Moreover, studies indicated a significant 
transformation of diflubenzuron residues into PCA under conditions similar or equal to food 
sterilisation processes, and such transformation could not be excluded for household processing 
practices. Given the genotoxic and carcinogenic properties of PCA and the absence of a threshold 
for acceptable exposure, it could not be established by EFSA that the exposure of consumers to 
PCA as a residue has no harmful effects. Since toxicological referen ce values for PCA cannot be 
set and as consequently no safe residue levels can be identified, any exposure of consumers to 
PCA should be prevented. Therefore, the MRLs have been set at the LOQ. In addition, the approval 
in the European  Union expired on 31  December 2020.  
In the context of the non -renewal of the approval of picoxystrobin , EFSA15 considered it not 
possible to complete the assessment of genotoxicity for picoxystrobin and consequently 
health -based reference values for use in risk assessment coul d not be established and therefore 
consumer and non -dietary risk asessements could not be conducted. The dietary risk assessment 
from exposure to metabolites could not be finalised as further data were needed to define the 
toxicological profile of several metabolites; consequently, residue definitions for risk assessment 
purposes could not be derived. Consequently, the approval of the active substance picoxystrobin 
was not renewed by Commission Implementing Regulation (EU) 2017/145516 and the MRLs have 
been set at the LOQ.  
The approval expired for active substance ethoxysulfuron  on 31 March 2014, ioxynil 
on 28 February 2015, molinate on 31 July 2014 and tepraloxydim  on 31 May 2015. No MRLs 
based on Codex maximum residue limits (CXLs) or import tolerance requ ests existed. All existing 
authorisations for plant protection products containing these active substances have been 
revoked. Therefore, the MRLs have been set at the LOQ.  
Nevertheless, according to EU procedures, import tolerances can be requested for all  those 
substances, according to Article 6 of Regulation (EC) 396/2005 and provided they receive a 
favourable assessment by EFSA, such import tolerances can be established  
10.  According to the 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 health risks 
("a human health concern may not be excluded"). Is this co rrect?  
 
13 European Food Safety Authority; Conclusion on the peer review on the review of the approval of the 
active substance buprofezin. EFSA Journal 2015 ; 13(8): 4207, 24 pp. doi: 10.2903/j.efsa.2015/420 . 
14 European Food Safety Authority; Conclusion on the peer review on the review of the approval of the 
active substance diflubenzuron regarding the metabolite PCA. EFSA Journal 2015;13(8):4222. [30 pp.] 
doi:10.2903/j.efsa.2015.4222.  
15 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance picoxystrobin. EFSA Journal 2016;14(6):4515, 26 pp. 
doi:10.2903/j.efsa.2016.4515.  
16 Commission Implementing Regulation (EU) 2017/1455 of 10 August 2017 concerning the non -
renewal of approval of the active substance picoxystrobin, in accordance with Regulation (EC) No 1107/2009 of 
the European Parliament and of the Council concerning the placing of p lant protection products on the market, 
and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. (OJ L 208, 11.8.2017, 
p. 28.) G/SPS/GEN/2139  
 
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  The measures covered by the SPS Agreement are those mentioned in Annex A( 1) of the SPS 
Agreement. Under Article 5.7 of the SPS Agreement WTO Members are entitled to take provisional 
measures on the basis of available pertinent information. The EU MRLs are fully compliant with 
the provisions of the SPS Agreement.  
A measure setti ng an MRL solely on the basis environmental risks falls outside the scope of 
the SPS Agreement and, therefore, such measures necessarily do not fall within the scope of 
Article  5.7 of the SPS Agreement. Such measures are notified under the TBT Agreement.  
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