G/SPS/GEN/1896  
 
1 April  2021 
(21-2745) Page: 1/8 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
RESPONSE OF THE EUROPEAN UNION TO G/SPS/GEN/1886  ON EU MRLS FOR  
CERTAIN PLANT PROTECTION PRODUCTS – (CONC ERN NO. 448 ) 
SUBMISSION BY THE EUROPEAN UNION  
The following submission , received on 26 March 2021, is being circulated at the request of the 
Delegation of the European Union . 
 
_______________  
 
 
1.   Further to the European Union's assertion in point 1 of docume nt G/SPS/GEN/1872 :  
(a)  Could the European Union define the "lowest achievable level " in the setting of MRLs?  
In accordance with the EU MRL Regulation (Regulation (EC) No 396/20051), "Good Agricultural 
Practice " (GAP) is the nationally recommended, authorize d or registered safe use of plant protection 
products under actual conditions at any stage of production, storage, transport, distributio n and 
processing of food and feed. It also implies the application of the principles of integrated pest control 
in a given climate zone, as well as using the minimum quantity of pesticides and setting 
MRLs/temporary MRLs at the lowest level which allows th e desired effect to be obtained.  
"Critical GAP " means the GAP, where there is more than one GAP for an active substance/product 
combination, which gives rise to the highest acceptable level of pesticide residue in a treated crop 
and is the basis for establishing the MRL.  
As such, MRLs are set at the lo west level possible in achieving the desired effect, in line with the As 
Low As Reasonably Achievable (ALARA) principle.  
(b)  Could the European Union indicate whether "good agricultural practice(s) " can vary 
from country to country?  
Yes, Good Agricultura l Practices can vary from country to country and from crop to crop.  
(c)  Does the European Union accept "good agricultural practices authorized in third 
countries ", even though they are different from those established in the European Union?  
Yes, a third country can submit an application for an import tolerance in such cases with the required 
supporting evidence. The data are then evaluated first by a member State of the EU (the "Rapporteur 
member State ") and then by the European Food Safety Authority (EFS A). If the outcome of this 
evaluation is favourable, an import tolerance can be established.  
2.   In light of the European Union's statements in point 2 of document G/SPS/GEN/1872 :  
(a)  Does the European Union consider that, in cases where scientific evidence does not 
exist or is insufficient and the European Food Safety Authority (EFSA) is unable to 
conclude that an MRL is safe, Article 5.7 of the SPS Agreement is being applied?  
 
1 http://publications.europa.eu/resource/cellar/7deccc8e -5c03-11eb-b487-
01aa75ed71a1.0006.02/DOC_1 . G/SPS/GEN/1896  
 
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  No, the precautionary principle allows risk managers to take SPS measures when scientific 
uncertainty persists, but the possibility of harmful effects on health has been identified based on 
available scientific evidence and such  measures are necessary to ensure a high level of health 
protection in the European Union.  
(b)  Article 5.7 of the SPS Agreement indicates that in cases where relevant scientific 
evidence is insufficient, a Member may provisionally adopt sanitary or phyto sanitary 
measures on the basis of available pertinent information. Could the European Union 
indicate why it adopts definitive measures when EFSA studies do not deliver conclusive 
results?  
In accordance with European Union law (Article 7(2) of Regulation 1 78/2002 ), food safety measures 
adopted under the conditions of scientific uncertainty are reviewed within a reasonable period of 
time, depending on the nature of the risk to life or health identified and the type of scientific 
information needed to clarify  the scientific uncertainty and to conduct a more comprehensive risk 
assessment.  
(c)  Does the European Union consider that the submission of reservations regarding 
MRLs adopted by the Codex Alimentarius (CXLs) releases it from its obligations under 
Artic le 3 of the SPS Agreement?  
The purpose of raising reservations is to increase transparency and predictability in international 
trade. The EU is one of the very few or the only Codex member openly raising reservations and 
communicating to Codex membership every time when not in a position to adopt a new Codex MRL, 
providing scientific reasons for the reservations and consequent non -alignment. The EU encourages 
other Members to do likewise.  
(d)  The European Union has indicated that many CXLs are outdated an d should therefore 
be reviewed again by EFSA. In this regard, could the European Union indicate how many 
CXLs have been reviewed since November 2017?   
The European Union is currently carrying out a comprehensive review programme for existing MRLs. 
This re view includes also the review of the existing CXLs of the active substance. The number of the 
reviewed CXLs is different for each active substance. Around 270 substances have been reviewed so 
far.  
Details of the respective European Food Safety Authority ( EFSA) risk assessments can be found on 
the EFSA website: https://www.efsa.europa.eu/en/publications . Using the search function and the 
name of the substance, the relevant risk assessment can be eas ily retrieved.  
In addition, EFSA on a quarterly basis publishes the detailed work programme (progress report) and 
its indicative time schedule for the substances to be reviewed. The document is published on the 
EFSA website: https://www.efsa.europa.eu/sites/default/files/pesticides -MRL-review -progress -
report.pdf . 
(e)  We refer once again to the consultations on the degree of alignment between CXLs 
and Eu ropean Union MRLs from November 2017 to date.  
Relevant EU legislation requires that where international standards exist, they are to be taken into 
consideration in the development or adaptation of food law. More specifically, the MRL Regulation 
stipulates  that pesticide MRLs set at international level by the Codex Alimentarius Commission should 
be considered when EU MRLs are being set, taking into account corresponding good agricultural 
practice.  
As a consequence, EU MRLs are regularly and systematically aligned with Codex MRLs (CXLs), 
provided that these CXLs are higher than existing EU MRLs, are related to commodities for which 
the EU sets MRLs, and are acceptable in terms of consumer protection, supporting data and 
extrapolation rules.  
For instance, between 2012 and 2019, a total of 2567 CXLs for food commodities were adopted by 
Codex. In that period, the EU has taken on board 1833  MRLs out of these 2567 CXLs. Taking into G/SPS/GEN/1896  
 
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  account EU -MRLs that are set at the same or higher level than the CXLs for the same food products, 
the EU is aligned with more than 70% of the CXLs established in this period.  
However, at times the European Union deviates from international standards when justified for the 
protection of public health and on the basis of  EFSA's scientific advice. In doing so the European 
Union acts in conformity with Article 3 SPS Agreement.  
3.   With regard to emergency authorizations granted by the European Union to its 
member States for plant protection products which are not already author ized in the 
European Union and whose MRLs have therefore been reduced to 0.01 mg/kg:    
(a)  Could the European Union indicate how many emergency authorizations have been 
granted since 2017, indicating the full list of products and member States where they  
have been granted?  
In February 2020, the European Commission launched a public database containing information on 
the notifications made by member States on emergency authorization s. Users can search to identify 
emergency authorization s granted from June 2016 onwards.   
According to this database, based on the information supplied by member States, 2604 emergency 
authorization s have been granted since 2017.  
Third countries can search the database to obtain information on the substances, uses and member 
States in which the eme rgency use was authorize d.  
(b)  Could the European Union indicate whether, when emergency authorizations are 
issued to member States, agricultural products that use these substances can be 
marketed within the European Union and also exported to third countries?  
Emergency authorization s are not issued to member States; rather, they are issued by the member 
States – each member State is responsible individually for granting emergency authorization s. The 
European Commission does not issue emergency authorization s; nor are emergency authorization s 
issued at EU level.  
Agricultural products that are treated with plant protection  products whose use is permitted by an 
emergency authorization  can be circulated within the European Union or exported outside of the 
European Union provided that they comply with the relevant MRL established in the EU or the 
importing country.  
A member S tate of the EU may authorize  the placing on the market only within its territory  of 
treated food or feed not complying with MRLs  established by the MRL Regulation in exceptional 
circumstances (and provided that there is no unacceptable risk to consumers). In such cases, in 
order for treated produce to be circulated within the EU, treated produce must be restricted to the 
territory of the member State granting the emergency authorization  until such level is set at EU 
level.  
Further details can be found in t he EU guidance on emergency use, published in January 2021: 
https://ec.europa.eu/food/sites/food/files/plant /docs/pesticides_aas_guidance_wd_emergency_ aut
horization s_article53_post -210301.pdf . 
(c)  What criteria are taken into account to issue an emergency authorization for the use 
of prohibited substances? How many consecutive times can an emergency authorization 
be renewed for the use of substances above the MRLs in force established by European 
legislation?  
Details can be found in the EU guidance on emergency use, published in January 2021: 
https://ec. europa.eu/food/sites/food/files/plant/docs/pesticides_aas_guidance_wd_emergency_ aut
horization s_article53_post -210301.pdf . 
(d)  Do emergency authorizations have any impact on import tolerances with regard to 
like or similar plant protection products?  G/SPS/GEN/1896  
 
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  There  is no direct connection. However, agricultural products that are treated with plant protection 
products whose use is permitted by an emergency authorization  can be circulated within the EU only 
provided that they comply with the relevant MRL. MRLs apply e qually to all food/feed on the market 
regardless of whether it is produced domestically or imported. The MRL may have been based on an 
EU GAP, a GAP of a non -EU country (import tolerance) or a CXL .2 
(e)  How does the European Union reconcile the emergency  authorizations granted to its 
member States with its obligations on national treatment under Article III of the GATT 
and Articles 2.3 and 5.5 of the SPS Agreement?  
See reply to question 3(b) above.  
Agricultural products that are treated with substances r esulting from emergency use of plant 
protection products must comply with the applicable MRL in order for them to be traded.  
In exceptional cases, a member State may authorize  the placing on the market of treated food or 
feed not complying with MRLs  estab lished by the MRL Regulation, but such treated food or feed 
must remain within its territory.  
4.   With regard to the European Union's reply in point 4 of document G/SPS/GEN/1872 :  
(a)  Could the European Union confirm that MRLs apply both to food and to feed?  
Yes, MRLs apply to both food and feed, more precisely to the specific commodities set out in Annex  1 
to Regulation (EC) No 396/2005.  
(b)  Do MRLs applied to feed have the purpose of protecting the life and health of animals?   
(c)  If so, does the European Union consider that MRLs applied to feed come within the 
scope of Article 5.3 of the SPS Agreement?   
Rules for animal feed are laid down  in specific EU legislation on feedstuffs. For certain products 
falling under the MRL Regulation it is not possible to determine whether they will be transformed 
into food or animal feed (e.g. cereals, oilseeds). Therefore, the MRL Regulation ensures that such 
products should be safe both for human and, where relevant, for animal consumption.  
(d)  Has the European Union conducted a regulatory impact analysis of the effects that 
would result from reducing the use of pesticides to 50% in the production of ce rtain foods 
regarding which no alternative pest control substances are registered?  
The Farm to Fork Strategy does not set any targets for third countries.  
The EU pesticide targets have been established based on the extensive experience gained in the 
development of the existing Harmonised Risk Indicator, and with consideration on meeting the aim 
of a significant reduction in the overall use and risk of chemical pesticides.  
An assessment of the impact of the Farm to Fork pesticide use and risk reduction targets will be 
specifically considered in an upcoming Better Regulation evaluation of the sustainable use of 
pesticides Directive and an impact assessment of its possible revision,  including the aforementioned 
targets. This initiative is expecte d to conclude in the first quarter of 2022 with the publication of a 
staff working document including the outcome of the evaluation,  impact assessment and the 
accompanying legislative proposal. This legislative proposal will aim to reduce the use and risk of 
chemical pesticides in line with the Green Deal and Farm to Fork Strategy objectives.  
5.   In point 5 of document G/SPS/GEN/1872 , the European Union h as indicated that it 
cannot provide an exhaustive list of "other legitimate factors " that could be taken into 
account when setting MRLs and cannot provide specific examples of the practice. 
 
2 The CXL itself may also have been based on an EU GAP or a GAP of a non -EU country.  G/SPS/GEN/1896  
 
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  However, it has observed that "societal, economic, traditional, et hical and environmental 
factors " should be taken into account in risk management decisions.  
(a)  Given that most of these factors are not strictly scientific in nature – but rather 
sociological or anthropological – and that SPS measures must be based on s cientific 
principles, how would the consideration of these other factors be compatible with the 
European Union's obligations under Article 2.2 of the SPS Agreement?  
Any measures capable of directly or indirectly affect international trade, which the EU ju stifies by 
the necessity to protect human, animal or plant life or health, are fully compliant with Article 2.2 
SPS Agreement.  
(b)  Could the European Union indicate how these other factors are covered by the SPS 
Agreement?  
The SPS Agreement applies to mea sures defined in Annex A to the SPS Agreement.  Measures based 
on other grounds, e.g. environmental or ethical, fall outside the scope of the SPS Agreement, even 
if they apply to food products.   
(c)  Could weighting these other factors determine the settin g of lower MRLs than those 
derived from strictly scientific or sanitary factors?  
So far, the European Union has not resorted to the use of "other legitimate factors " when taking 
decisions on the setting of MRLs, including import tolerances.  
As already explained, environmental concerns of global nature may be taken into account in setting 
import tolerances. Measures will be taken on a case -by-case basis and founded on  the best available 
scientific evidence. For those specific cases, this may indeed result in lower MRLs.  
6.   We reiterate our request for specific examples that illustrate how comments by third 
countries have been taken into account by the European Union befor e taking a final 
decision.  
As already explained, all the comments received in response to notifications are duly considered and 
taken into account before a final decision is taken. Detailed replies are sent to all trading partners 
that submit comments. The  European Union always provides a reply to all the comments submitted 
by another WTO Member on an EU notification and explains in details the planned measures and 
their rationale.  
7.   The request for a single list containing all already reviewed substances an d the status 
of those being revised was presented to the European Union in its TPR of February 2020 
and reiterated in the subsequent SPS Committee meetings, but to date no copy of that list 
has been made available. The European Union has indicated, in poin t 7 of document 
G/SPS/GEN/1872 , that the feasibility of the request is being considered. While the 
European Union is analysing this feasibility:   
(a)  Could the European Union confirm whether the informal list contained in document 
RD/SPS/131 /Rev.1  and the information contained in that list are correct?  
The EU would like to thank Paraguay for the preparation of  the table distributed in document 
RD/SPS/131/Rev.1 . We confirm that the sources used for retrieving the information were the correct 
ones.  
8.   With regard to the process of setting MRLs for specific substances:  
(a) Co uld the European Union indicate whether account is taken in that process of the 
existence of alternative substances?  
 G/SPS/GEN/1896  
 
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  The main objective of the EU legislation on MRLs is consumer protection, which prevails over any 
economic considerations. An assessment of the economic impacts and alternative products available 
to farmers is not foreseen in this regulatory context. However, the EU supports a global move 
towards sustainable food systems through various programmes. Research, innovation and 
techno logies are part of this support to increase farmers sustainability and competitiveness and this 
is in line with the Farm to Fork Strategy, EU 's Common Agricultural Policy post 2020 proposal and 
the research programme Horizon Europe.  
The EU funds several s pecific programmes that can help farmers in third countries to find suitable 
alternatives, and to comply with EU regulatory requirements, notably:  
• The "Fit for market" programme ( https://e services.coleacp.org/en/fit -for-market -sps), by 
the Europe -Africa -Caribbean -Pacific Liaison Committee (COLEACP);  
• The "Plantwise+" programme by the Centre for Agricultural Bioscience International (CABI) 
(https://www.ca bi.org/ ); or 
• The "Better Training for Safer Food" (BTSF) by the Directorate -General for Health and Food 
Safety of the European Commission ( https://ec.europa.eu/food/safety/btsf_en ).  
(b)  Does the European Union consider the possibility that, after the process of reviewing 
all substances and setting MRLs at the analytical detection limit, there will be no 
alternative plant protection products  for specific crops?   
The question seems to suggest that all MRLs are lowered to the limit of quantification after a review 
of MRLs. This is however not the case. MRLs are lowered to the limit of quantification only under the 
following circumstances:  
− if there are no longer existing authorization s in the EU;  
− if no information of authorize d uses has been provided (neither for EU uses nor for uses in 
non-EU countries);  
− if no or insufficient data have been submitted to support authorize d uses;  
− if a consumer r isk has been identified; or  
− if insufficient data have been submitted or there are concerns about toxicity of a substance.  
As stated above the most important objective of the MRL Regulation is consumer protection, which 
prevails over any economic considera tions and public health is therefore given clear priority over 
crop protection. Should one of the conditions above be fulfilled, this may indeed lead to the lowering 
of the respective MRL to the Limit of quantification for a given substance. To help farmer s to find 
suitable alternatives, the EU funds several important programmes, explicitly targeted to farmers in 
non-EU countries (see the reply to question 8a).  
(c)  Has the European Union carried out an estimate of the total cost at European level 
that wou ld result from the withdrawal of various plant protection products that are 
currently available for farmers?  
Please see the reply to question 8a.  
9.   In point 9 of document G/SPS/GEN/1872 , the European Union indicates that the 
burden of supplying scientific evidence is shifted onto applicants because they have a 
direct or indirect commercial interest in placing their product on the market. Moreover, in 
point 2 of document G/SPS/GEN/1872 , the European Union indicates that, to establish an 
MRL, an EFSA risk assessment must show that the MRL is safe for consumers.  
(a)  Does the European  Union consider that under the SPS Agreement it is for the Member 
that imposes a sanitary measure to undertake the risk assessment on which this measure 
is based?  
Members should have access to high -quality, independent and efficient scientific and technica l 
support.  G/SPS/GEN/1896  
 
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  In the European Union, the European Food Safety Authority has the role of an independent scientific 
point of reference in risk assessment and source of advice. The confidence of the Union institutions, 
the general public and interested parties in the European Food Safety Authority is essential. For this 
reason, it is vital to ensure its independence, high scientific quality, transparency and efficiency.  
(b) In the European Union's view, does the SPS Agreement provide for the burden of 
supplying scientific evidence to fall on an applicant third country? Could the European 
Union indicate where the legal basis for this is to be found in the text of the SPS 
Agreement?   
The European Union has already replied to this question in document G/SPS/GEN/1872  (point 11). 
The SPS Agreement does not specify sources where data and information necessary for carrying out 
risk assessment must come from.  
(c)  What specific scientific evidence should applicants provide who have an interest in 
exporting to the European market?  
Applicants that have an interest in exporting to the European market can make an application for 
an import tolerance request. A specific guideline with further information is available on the following 
website  of the European  Commission:  
https://ec.europa.eu/food/sites/f ood/files/plant/docs/pesticides_mrl_guidelines_mrl -setting -
proc_v5 -5.pdf. 
(d)  In cases where the European Union adopts MRLs lower than those established by the 
Codex Alimentarius and, in light of the provisions of Article 3.3 of the SPS Agreement, 
does the European Union consider that the burden of providing scientific evidence for 
stricter MRLs than those provided for in international standards also falls on applicants?  
The burden of providing relevant information and data is shifted ont o applicants if they have a direct 
or indirect commercial interest in placing the product on the market and – therefore – in actively 
contributing to risk assessment procedures. Risk assessment is carried out in an independent 
manner and applicants cannot influence its outcome.  
10.   At the seminar organized by the European Union on the weighting of environmental 
factors in setting MRLs, held online in Brussels on 20 January 2021, the European Union 
asserted that imported food that does not meet the relevant env ironmental standards of 
the European Union will not be allowed into the European market in order to avoid the 
transfer of non -sustainable practices. Moreover, the European Union indicated that 
environmental factors that will be taken into account are those  that are of global concern 
and, as specific examples, the decline in the population of pollinators and the 
accumulation in the environment of persistent, bioaccumulative and/or toxic substances 
(PBTs and vPvBs) were mentioned.   
(a)  Could the European Un ion provide a definition of "sustainable practices " and the 
criteria taken into account to define them?  
The EU remains committed to the 2030 Agenda. Sustainable practices must be understood as 
practices that are in line with the Sustainable Development Go als and its three dimensions: the 
economic, social and environmental.  
(b)  Could the European Union provide a definition of "global concern " and the criteria 
taken into account to define it?  
Global concerns are those which are transboundary. Biodiversity loss is an example of a global 
concern.  
(c)  The Stockholm Convention of 2001 only refers to POPs (persistent organic 
pollutants). Could the European Union provide an exhaustive list of the substances that it 
considers to be PBTs and vPvBs?  G/SPS/GEN/1896  
 
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  Substances con sidered as PBT and vPvB are listed under the Candidate List of substances of very 
high concern for Authorization  at the website of the European Chemicals Agency (ECHA): 
https://echa.europa.eu/candidate -list-table. 
This list includes not only PBT and vPvB but also other substances of very high concern as substances 
classified as carcinogenic, mutagenic and toxic for  reproduction (CMR) and Endocrine Disruptors 
(ED).  
(d)  Has the classification of substances as PBTs and vPvBs been undertaken by the 
European Union itself or is it based on some international standard?  
The criteria of definition of PBT and vPvB are repor ted in Regulation 1907/2006 on Registration, 
Evaluation, Authorization  and Restriction of Chemicals (REACH), notably its Annex XIII ( Criteria for 
the identification of Persistent, Bioaccumulative And Toxic Substances, and Very Persistent and Very 
Bioaccumu lative  Substances) : 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX:02006R1907 -20140410 . 
It describes the information that must be considered for the pu rpose of assessing the persistent, 
bioaccumulative and toxic properties of a  substance . For the identification of  PBT substances 
and vPvB substances a weight -of-evidence determination using expert judgement shall be applied, 
by comparing all relevant and available information listed in Section 3.2 with the criteria set out in 
Section 1 of that Annex.  
In the context of active substances used in plant protection products (pesticides), criteria to 
determine if a substance is considered to be PBT or vPvB are established in points 3.7.2 and 3.7.3 
of Annex II to Regulation (EC) No 1007/2009: https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CEL EX%3A02009R1107 -20191214&qid=1616159236649 . 
In the context of active substances used in biocides, criteria to determine if a substance is considered 
to be PBT or VPvB are established in Art 3 (f) of the Regulation (EC) No 528/2012: https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A02012R0528 -
20191120&qid=1616159282520 . 
During the EU risk assessment of such substances these properties ( persistence, bioaccumulation 
and toxicity) must be examined and a decision is taken based on the outcome of the evaluation of 
the available information.  
(e)  Can a pesticide be of "global concern ", according to the European Union, in cases 
where a CXL exis ts for that pesticide?  
This will be determined on a case -by-case basis and taking into account the best available scientific 
evidence.  
11.   At the same seminar referred to above, the European Union indicated that it 
considers the fact that current risk assessme nt tools do not correctly reflect the complex 
behaviour of these substances to be problematic. In these cases, would Article 5.7 of the 
SPS Agreement apply?  
As already explained, the precautionary principle applies in specific circumstances where, followin g 
an assessment of available information, the possibility of harmful effects on health is identified but 
scientific uncertainty persists. If these conditions are fulfilled, provisional risk management 
measures may be adopted if it is necessary to ensure th e high level of health protection chosen in 
the European Union. Whether or not any decision can be referred to as "based on the precautionary 
principle " must be therefore verified taking into account these specific circumstances . 
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